CITI training includes- Responsible Conduct, Ethics, RCR, Law, HTH & IRB

Which of the following is true regarding data analysis?

Data analysis methods should be specified in advance before a study begins.

Which of the following most accurately describes data lifecycle management (DLM)

It refers to the tools and processes for handling data during a research study and after it concludes.

Which of the following is true regarding the reporting of research results?

Clear specification of the methods and procedures used is essential.

What is the primary responsibility of oversight bodies such as an IRB or an IACUC

To detect compliance with regulatory requirements, including those relating to protecting research subjects.

Which of the following is true regarding data acquisition?

Data acquisition should follow a detailed collection plan that is set in advance.

In the research context, the term validity most commonly refers to:

Whether operationalized terms actually measure what they purport to measure.

What are the three main goals of data lifecycle management?

Confidentiality, availability, and integrity

Which of the following is true regarding data sharing and stewardship

Researchers who receive federal funding may have to adhere to a data sharing requirement.

If an employer allows a friendship to interfere with a hiring decision, this is typically referred to as:

A personal conflict of interest.

If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:

A conflict of conscience

The entity that normally is supposed to determine whether an academic researcher's conflict of interest can be managed is:

A conflict of interest committee

Which of the following most accurately describes a conflict of commitment?

It occurs when outside activities interfere with obligations to one's primary employer.

The main focus of NIH's conflict of interest policy is:

Financial conflicts of interest

Which of the following most accurately describes an institutional conflict of interest?

It occurs when an institution's financial interests could interfere with its research activities

Which of following is true about the management of conflicts of interest?

Management plans are often created to reduce the impact of conflicts of interest rather than completely eliminating them

Which of following is true about conflicts of interest

They increase the likelihood of bias.

Which of the following statements best exemplifies the importance of mentoring?

A mechanism to transmit values and standards of professional conduct.

What is the most appropriate course of action for a trainee who has a problem with a mentor?

After first attempting to communicate directly with the mentor, the trainee should seek the counsel of a trusted senior person in the department or organization.

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?

The trainee must take an active role in the relationship and clearly communicate needs and expectations.

Which of the following statements most accurately describes the mentoring relationship?

Mentors teach trainees about aspects of academic life that are not covered in textbooks

The defining characteristic of a mentor is someone who:

Takes a sincere interest in the growth and development of a trainee.

According to the U.S. Federal Research Misconduct Policy, fabrication involves:

Making up data or results and recording or reporting them.

Which of the following is most likely to be considered plagiarism?

Using materials from a source without proper citation.

Which of the following is the most effective strategy for preventing research misconduct?

Good mentoring

Which of the following is true regarding the U.S. Federal Research Misconduct Policy?

To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.

Which type of research misconduct most likely occurred if someone intentionally removes data points on a graph in order to generate a deceptive conclusion?

Falsification

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?

Good mentoring

In response to a research misconduct allegation, what is the next main phase that takes place after the inquiry if there is sufficient evidence to proceed?

An investigation

According to the U.S. Federal Research Misconduct Policy, falsification involves:

Manipulating research materials, equipment, or processes, or changing or omitting data.

What is the primary responsibility of oversight bodies such as an IRB or an IACUC?

To detect compliance with regulatory requirements, including those relating to protecting research subjects.

What are the three main goals of data lifecycle management?

Confidentiality, availability, and integrity

In the research context, the term validity most commonly refers to:

Whether operationalized concepts actually measure what they purport to measure.

Which of the following statements is true concerning data selection?

Establishing a data selection strategy prior to collecting data decreases the chance of a biased outcome.

Which of following is most likely to own the data resulting from a research project?

The institution where a federally-funded project takes place.

Which of the following is true regarding data sharing and stewardship?

Agencies that fund research may include data sharing requirements in their funding contracts.

Which of the following most accurately describes the practice of ghost authorship?

It is a situation where the individual who wrote the manuscript is not listed as an author.

Which of the following is a responsibility of each author?

Confirming that data have been accurately presented.

Which of the following is an example of plagiarism?

Presenting someone else's ideas or words and claiming them as one's own.

Which of the following is true regarding an acknowledgments section?

The contributions of students and technicians are often listed in the acknowledgments section if they do not meet all of the criteria for authorship.

Which of the following is true regarding publishing the same content in multiple papers?

Using the same content in multiple papers is deceptive if it is not properly disclosed.

Which author is normally responsible for sharing reprints of a publication with readers?

The corresponding author.

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines?

Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section.

Which of the following is the primary criterion for authorship?

Having made a significant intellectual contribution to the work.

Which of the following statements is true regarding authorship practices?

Different disciplines have different practices about who should be included as an author.

Which of the following statements most accurately describes the review process for grant proposals?

Funding agencies usually have committees, often with external reviewers, that assess the quality of the proposal.

A reviewer's main responsibility is to:

Be professional and prompt.

The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:

Intellectual merits and broader impacts.

Which of the following statements is true regarding the responsibilities of a reviewer?

A reviewer's conflict of interest should be disclosed to the journal editor or grant agency

Which of the following is true regarding single-blind and double-blind review:

Under single-blind review, the identity of the author is revealed to the reviewer.

The main reason that grant proposal reviewers with a conflict of interest should remove themselves from the review process is because:

Their removal lessens the chance that bias will affect the review process​.

Which of the following is most directly related to successful mentoring?

Someone who is committed to the professional development of the trainee.

What is the most appropriate course of action for a trainee who has a problem with a mentor?

After first attempting to communicate directly with the mentor, the trainee should seek the counsel of a trusted senior person in the department or organization.

Which of the following is to be avoided when seeking an effective mentor?

Trainees should assume that whoever is assigned to them as the thesis or research adviser will be their best choice for a mentor.

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?

The trainee must take an active role in the relationship and clearly communicate needs and expectations.

Which of the following statements most accurately describes the mentoring relationship?

Mentors teach trainees about aspects of academic life that are not covered in textbooks.

Which of the following statements best exemplifies the importance of mentoring?

A mechanism to transmit values and standards of professional conduct.

The defining characteristic of a mentor is someone who:

Takes a sincere interest in the growth and development of a trainee.

Which of the following is most likely to create a poor relationship between mentor and trainee?

A faculty member searches out trainees merely for that person's own career advancement.

Which of following is true about the management of conflicts of interest?

Management plans are often created to reduce the impact of conflicts of interest rather than completely eliminating them.

If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:

A conflict of conscience

Which of the following most accurately describes a conflict of commitment?

It occurs when outside activities interfere with obligations to one's primary employer.

The main focus of NIH's conflict of interest policy is:

Financial conflicts of interest

The entity that normally is supposed to determine whether an academic researcher's conflict of interest can be managed is:

A conflict of interest committee

Which of the following most clearly illustrates an example of an academic conflict of interest?

A researcher becomes overly attached to a specific research outcome.

Which of the following most accurately describes an institutional conflict of interest?

It occurs when an institution's financial interests could interfere with its research activities.

Which of following is true about conflicts of interest?

They increase the likelihood of bias.

if an employer allows a friendship to interfere with a hiring decision, this is typically referred to as:

A personal conflict of interest.

Data ownership is typically determined by:

The type and source of funds used to support the project.

Which of the following is a key reason why international collaborations can be challenging?

Language barriers and cultural differences among collaborators can complicate communication.

Which of the following is true regarding academic-industry collaborations?

The industry sponsor typically owns the data from research that it funds.

What is the most appropriate process for determining which journal a collaborative research team should submit their work to?

It should be discussed early on in the collaboration by the members of the research team.

Which of the following is true regarding industry-sponsored research?

Industry sponsors of research may place restrictions on the disclosure of research results.

What is the main function of the Bayh-Dole Act of 1980 as it relates academic institutions?

It allows institutions to have control over the intellectual property from federally-funded research.

What is the main function of a Technology Transfer Office?

It helps researchers to commercialize their work.

A research collaboration can be enhanced by:

Discussing intellectual property issues while the collaboration is forming.

Which of the following is true regarding the use of animals in research?

The attending veterinarian must be allowed to have access to all research animals at all times.

Which of the following is the main reason why proper training in euthanasia techniques is important?

Improper techniques can cause unnecessary pain and distress in animals.

Which of the following is empowered by the U.S. federal government to review and approve research activities involving vertebrate animals?

The Institutional Animal Care and Use Committee (IACUC)

Prior to implementing any significant change in the use of animals, what is the most important thing that the research team must do?

Obtain IACUC approval for the change.

Which of the following most accurately describes the process that must occur when working with research animals covered by U.S. federal regulations?

The research team must obtain IACUC approval for the proposed research procedures prior to starting the work.

Which entity is responsible for monitoring institutional compliance with PHS Policy?

The Office of Laboratory Animal Welfare (OLAW)

What is the primary purpose of the "3Rs" concept from Russell and Burch?

To decrease the use of animals in research and to minimize pain and distress caused by animal experiments.

Which of the following is the general guideline that IACUCs use to evaluate the potential pain of a procedure conducted with animals?

Any procedure that causes pain or distress in human beings may cause pain or distress in other animals.

Which justification would an IACUC most likely accept if a research team plans to withhold pain relief (analgesia) from animals during a project?

...

Which statement best describes information that must be included in a consent form:

A description of the research's potential benefits and risks.

Which of the following best describes when a protocol may be eligible for expedited review by the IRB:

The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified by the federal government.

Which of the following statements most clearly illustrates the principle of beneficence:

Determining whether the benefits of a study outweigh the risks.

Which statement best describes the role of an IRB:

a committee that reviews different types of human subjects research.

Which of the following studies most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report:

The Tuskegee Study.

The three ethical principles discussed in the Belmont Report are:

Respect for Persons, Beneficence, Justice.

As a first step, what must be done before enrolling a young child in a research protocol:

the risks and benefits must be explained to the child's parents or legally authorized representative.

Which statement most accurately describes the process leading to the development of the Nuremberg Code:

it was created in response to the harms caused by Nazi researchers around the time of the Second World War.

Which of following protocols most likely requires IRB review:

A study to evaluate a newly designed wheelchair by asking elderly individuals to use it.

Which statement best describes what an IRB is responsible for reviewing:

Any form of research involving a human subject.

With the context of rcr, stewardship primarily refers to:

The obligation to use resources available for research ethically in order to conduct the best research possible

Within the context of rcr, social responsibility primarily refers to:

The obligation to design technology or acquire information in ways that take into account what effects those actions may have on society

Which of the following most accurately describes U.S. federal policy related to rcr instruction?

Some federal agencies have rcr policies but they differ in terms of the particular format of training that is required

Within the context of rcr, compliance primarily refers to:

The obligation to follow specific directive, such as laws and regulations, that govern a research activity

Which of the following most accurately describes the main goal of rcr education and training?

To promote greater awareness of proper research practice and research ethics

Within the context to rcr, integrity primarily refers to:

Having a sincere commitment to upholding one's word and adhering to ethical and professional standards

The view that there is a social contract between researchers and the public is most accurately described by stating that:

The public supports research in various ways and researchers have a corresponding obligation to avoid abusing the public's trust

Which of the following is true regarding an acknowledgments section?

The contributions of technicians and other researchers are often listed in the acknowledgements section if they do not meet all of the criteria for authorship

Which author is normally responsible for sharing reprints of a publication with readers?

The corresponding author

Which of the following statements is true regarding authorship practices?

Different disciplines have different practices about who should be included as an author.

Which of the following is the primary criterion for authorship?

Having made a significant intellectual contribution to the work.

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines?

Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section.

Which of the following is a responsibility of each author?

Confirming that data have been accurately presented

Which of the following is an example of plagiarism?

Presenting someone else's ideas or words and claiming them as one's own

Which of the following most accurately describes the practice of ghost authorship?

It is a situation where the individual who wrote the manuscript is not listed as an author

Which of the following is true regarding authors who seek to publish the same content in multiple papers?

Using the same content in multiple papers is deceptive if it is not properly disclosed to journal editors or other relevant entities

What is the main function of a technology transfer office?

It helps researchers to commercialize their work

The most important factor determining whether a research collaboration will be successful is:

Whether there is ongoing communication about goals and responsibilities

What is the main function of the Bayl-Dole Act of 1980 as it relates to academic institutions?

It allows institutions to have control over the intellectual property from federally-funded research

Which of the following is a key reason why international collaborations can be challenging?

Language barriers and cultural differences among collaborators can complicate communication

Which of the following is true regarding academic-industry collaborations?

The industry sponsor typically owns the data from research that it funds

What is the most appropriate process for determining which journal a collaborative research team should submit their work to?

It should be discussed early on in the collaboration by the members of the research team.

Which of the following is true regarding industry-sponsored research?

Industry sponsors of research may seek to place restrictions on the disclosure of research results.

Which of the following statements is true regarding international research and U.S. regulations?

U.S. funded research is often governed by U.S. regulations no matter where the research takes place

Data ownership is typically determined by:

The type and source of funds used to support the project

A research collaboration can be enhanced by:

Discussing intellectual property issues while the collaboration is forming

Which of the following most accurately describes a conflict of commitment?

It occurs when outside activities interfere with obligations to one's primary employer

Which of the following most accurately describes an institutional conflict of interest?

It occurs when an institution's financial or non-financial interests could interfere with its research activities

Which of the following is true about the management of conflicts of interest?

Management plans are often created to reduce the impact of conflicts of interest rather than completely eliminating them.

If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:

A conflict of conscience

The entity that normally is supposed to determine whether an academic researcher's conflict of interest can be managed is:

A conflict of interest committee

Which of the following is true about conflicts of interest?

Conflicts of interest increase the likelihood of bias

If a friendship with an applicant could interfere with a hiring decision, this is typically referred to as:

A personal conflict of interest

The main focus of NIH's conflict of interest policy is:

Financial conflicts of interest

What are the three main goals of data lifecycle management?

Confidentiality, availability, and integrity

Which of the following is true regarding data analysis?

Data analysis methods should be specified in advance before a study begins

Which of the following is true regarding data acquisition?

Data acquisition should follow a detailed collection plan that is set in advance

Which of the following is true regarding data sharing and stewardship?

Researchers who receive federal funding may have to adhere to a data sharing requirement

What is the primary responsibility of oversight bodies such as IRB or an IACUC?

To detect compliance with regulatory requirements, including those relating to protecting research subjects

Which of the following most accurately describes data lifecycle management (DLM)?

It refers to the tools and processes for handling data during a research study and after it concludes

Which of the following is most likely to own the data resulting from a research project?

The institution where a federally-funded project takes place

Which of the following statements is true concerning data selection?

Establishing a data selection strategy prior to collecting data decreases the chance of a biased outcome.

Which of the following is true regarding the reporting of research results?

Clear specification of the methods and procedures used is essential

In the research context, the term validity most commonly refers to:

Whether operationalized terms actually measure what they purport to measure

Which of the following statements about mentoring is true?

Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of research

Which of the following most accurately describes good mentoring practice?

Encouraging trainees to receive mentoring from a collection of individuals

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?

The trainee must take an active role in the relationship and clearly communicate needs and expectations

What is the most appropriate course of action for a trainee who has a problem with a mentor?

After first attempting to communicate directly with the mentor, the trainee should seek counsel of a trusted senior person in the department or organization

The defining characteristic of a mentor is someone who:

Takes a sincere interest in the growth and development of a trainee

Which of the following is mostly likely to create a poor relationship between a mentor and a trainee?

A mentor who searches out trainees merely for the mentor's own career advancement

Which of the following is most directly related to successful mentoring?

Someone who is committed to the professional development of the trainee

Which of the following statements most accurately describes the mentoring relationship?

Mentors teach trainees bout aspects of academic life that are not covered in textbooks

Which of the following statements is true regarding the responsibilities of reviewers?

Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed

Which of the following is true regarding the traditional peer review process:

Under single-blind review, the identity of the author is revealed to the reviewer.

A reviewer's main responsibility is to:

Be professional and prompt

Which of the following is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly?

the author can contact the editor with their concerns

The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:

Intellectual merit and broader impact

Reviewers have a responsibility to promote ethical peer review by:

Preserving the confidentiality of the submission

The main reason that grant proposal reviewers with a conflict of interest should remove themselves from the review process is because:

Their removal lessens the chance that bias will affect the review process

Which of the following statements most accurately describes the review process for grant proposals?

Funding agencies usually have committees, often with external reviewers, that assess the quality of the proposal

Which of the following statements is true regarding the responsibilities of a reviewer?

A reviewer's conflict of interest should be disclosed to the journal editor or grant agency

The main reason that the Royal Society of London developed the modern form of peer review was to:

Control the quality of published papers.

Which of the following is true regarding the U.S. Federal Research Misconduct Policy?

To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly

If a researcher creates the idea for a project and is not listed in the preferred author order position on resulting publications, is this considered to be research misconduct under federal policy?

No; instead it is a type of authorship dispute

Which of the following is most likely to be considered plagiarism?

Using materials from a source without proper citation

Which of the following is the most effective strategy for preventing research misconduct?

Good mentoring

Which type of research misconduct most likely occurred if someone intentionally removes data points from the data set in order to generate a deceptive conclusion?

Falsification

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?

Plagiarism

According to the U.S. Federal Research Misconduct Policy, fabrication involves:

Making up data or results and recording or reporting them

The typical first main phase in response to a research misconduct allegation is called:

The inquiry

Which of the following is true regarding research misconduct?

Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct

Which type of inappropriate practice mostly likely occurred if a researcher takes credit for someone else's idea and does not acknowledge the original source?

Plagiarism

According to the U.S. Federal Research Misconduct Policy, falsification involves:

Manipulating research materials, equipment, or processes, or changing or omitting data

In response to a research misconduct allegation, what is the next main phase that takes place after the inquiry if there is sufficient evidence to proceed?

The investigation

Paraphrasing another author's paragraph by substituting one or two words in each sentence and then adding one citation to the author at the end of the paragraph:

May constitute plagiarism because the original material has not been sufficiently modified to constitute a proper paraphrase

An idea is most likely to represent "common knowledge" if:

It can be safely assumed that the readers and the author are both thoroughly familiar with the ideas and its source

Authors who reuse portions of text that have appeared in one of their earlier published papers run the risk of being accused by journal editors of:

Self-plagiarism

Which of the following situations is most likely to constitute an act of plagiarism?

Copying someone else's text word-for-word without using quotation marks and adding a citation at the end of the material

Ethical writing and scholarship is based on an implicit contract between the author and readers, whereby reader assume that what they read is accurate, has been written by the author, and has:

Not been disseminated before unless noted otherwise

Which one of the following statements most accurately describes how plagiarism has been defined in this module?

Plagiarism applies not only to ideas that are found in print but also those that are communicated verbally

Proper paraphrasing of a sentence written by someone else may be accomplished by:

Using your own words and writing voice to express the idea conveyed in the sentence

When authors summarize the work of others, they typically should:

Provide a condensed (shorter) version of the original material

According to federal research misconduct policies, what is the maximum number of consecutive words that one can use before it is classified as an instance of plagiarism?

There is no official, federal standard for the number of consecutive words that can be used

Which of the following situations is most likely to constitute an instance of plagiarism?

Summarizing a published article in 2-3 distinct paragraphs and including this in a paper

Unless the subject matter is considered common knowledge, citations are necessary when writing about:

Ideas, methodologies, or data from other authors and also your own previously published ideas, methodologies, or data

The reuse of one's previously published material in a new journal is most appropriate if:

The author informs all the relevant parties and obtains permission to do so

Which of the following are the three principles discussed in the Belmont Report?
A. IRB review, Federal regulations, Declaration of Helsinki.
B. Informed Consent, Institutional Assurance, Researcher responsibility.
C. Privacy, Confidentiality, Equitable selection of subjects.
D. Respect for Persons, Beneficence, Justice.

D. Respect for Persons, Beneficence, Justice.

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?
A. Providing detailed information about the study and obtaining the subject's consent to participate.
B. Determining that the study has a maximization of benefits and a minimization of risks.
C. Ensuring that the selection of subjects includes people from all segments of the population.
D. Ensuring that persons with diminished autonomy are protected.

B. Determining that the study has a maximization of benefits and a minimization of risks.

All of the following are true regarding the Belmont Report, EXCEPT:
A. The Belmont Report describes the need to carefully consider how research discoveries and risks will be fairly distributed in the society.
B. The Belmont Report describes the concept of "Respect for Persons".
C. The Belmont Report defines and delineates the differences between "Practice" and "Research".
D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts

D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
C. The Harvard T3 study.
D. Tearoom Trade Study (Humphreys).

A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.

The Belmont principle of beneficence requires that:
A. Subjects derive individual benefit from study participation.
B. Potential benefits justify the risks of harm.
C. The study makes a significant contribution to generalizable knowledge.
D. Risks are managed so that they are no more than minimal.

B. Potential benefits justify the risks of harm.

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
A. Respect for persons.
B. Justice.
C. Beneficence.

A. Respect for persons.

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
A. Beneficence.
B. Respect for persons.
C. Justice.

C. Justice.

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
A. Ensuring that subjects understand that participation is voluntary.
B. Ensuring that the selection of subjects is fair.
C. Providing detailed information about the study to potential subjects.
D. Ensuring that risks are reasonable in relationship to anticipated benefits.

D. Ensuring that risks are reasonable in relationship to anticipated benefits.

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
A. Do not report the adverse drug experience to the IRB since it is a common adverse experience.
B. Report the adverse drug experience to the IRB only if there are several other occurrences.
C. Report the adverse drug experience as part of the continuing review report.
D. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

D. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

How long is an investigator required to keep consent documents, IRB correspondence, and research records?
A. Until the study is closed
B. Until data analysis is complete
C. For a minimum of three years after completion of the study
D. As long as the investigator is at that institution

C. For a minimum of three years after completion of the study

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
A. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
B. The study is required for a student research project
C. The study does not require informed consent or survey instruments.
D. The study includes only research subjects that are healthy volunteers.

A. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
A. The investigator keeps careful records of all changes and includes them in the final report.
B. They only involve changes to the consent form.
C. They are eligible for review using expedited procedures.
D. The changes must be immediately implemented for the health and well being of the subject.

D. The changes must be immediately implemented for the health and well being of the subject.

IRB continuing review of an approved protocol must:
A. Be conducted by a convened IRB.
B. Include copies of all signed consent forms.
C. Occur only when the level of risk changes.
D. Occur at least annually.

D. Occur at least annually.

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?
A. The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn't have to ask the parents for permission.
B. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.
C. If it is the best interests of the community that the children participate in the study, parental permission is optional.
D. The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes.

B. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?
A. In the event of any distress you may have related to this research, you will be given access to appropriate resources.
B. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.
C. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.
D. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

D. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:
A. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.
B. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material.
C. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.
D. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

D. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A waiver of the requirement for documentation of informed consent may be granted when:
A. The subjects are literate in their own language; however, they do not read, write, or speak English
B. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
C. Potential subjects might find some of the research questions embarrassing, personal, or intrusive
D. The investigator has no convenient place to store signed consent forms separate from the research data

B. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

As part of the consent process, the federal regulations require researchers to:
A. Provide potential subjects with information at the appropriate reading comprehension level.
B. Provide a list of the IRB members who reviewed the protocol.
C. Recommend that potential subjects discuss their decision to participate with family members.
D. Describe penalties that may be imposed for non-participation.

A. Provide potential subjects with information at the appropriate reading comprehension level.

Data are made anonymous by
A. Keeping the key linking names to responses in a secure location.
B. Reporting data in aggregate form in publications resulting from the research.
C. Requiring all members of the research team to sign confidentiality agreements.
D. Destroying all identifiers connected to the data.

D. Destroying all identifiers connected to the data.

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
A. Waiving documentation of consent.
B. Using pseudonyms in research reports.
C. Using data encryption for stored files.
D. Securing a Certificate of Confidentiality.

D. Securing a Certificate of Confidentiality.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
A. Using pseudonyms in reports removes the concern about any confidences shared in the group.
B. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
C. If group members know each other confidentiality is not an issue.
D. The researcher cannot control what participants repeat about others outside the group.

D. The researcher cannot control what participants repeat about others outside the group.

A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
A. Confidentiality of the data has been breached
B. There was both a violation of privacy and a breach of confidentiality.
C. The subjects' privacy has been violated.
D. There was neither a violation of privacy nor a breach of confidentiality

D. There was neither a violation of privacy nor a breach of confidentiality

Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.
B. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
C. A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.
D. A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

D. A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

A faculty member wants to measure the effectiveness of a new psychological assessment instrument before including it in his new textbook. He plans to conduct a pilot test by administering both the new instrument and an established instrument and then compare the results. Which of the following populations might be most vulnerable to undue influence to participate in his research?
A. Members of his community organization
B. Senior faculty in his department
C. Members of his professional society
D. Students taking one of his courses

D. Students taking one of his courses

An investigator is recruiting subjects for a study of a new antidepressant drug. The investigator has targeted a population of patients who might clearly benefit, but who are also institutionalized for a variety of psychiatric conditions. The patients are in a controlled environment and it is believed there would be little problem recruiting subjects for the study. Which of the following issues of vulnerability should be of most concern to the IRB?
A. The patients have clinical depression, which is a difficult disease to treat.
B. The patients are institutionalized.
C. The patients are probably illiterate.
D. The patients may have experience participating in research.

B. The patients are institutionalized.

An investigator planning to study behavioral changes during alcohol intoxication will pay subjects $600 for 6 hours of testing that includes drinking a moderate level of alcohol and completing several written questionnaires. He plans to recruit college students taking his courses, as well as economically disadvantaged and homeless people. Which of the following is the most important for the investigator to address before submitting the protocol to the IRB?
A. Potential undue influence or coercion of subjects
B. Method of payment to subjects
C. Forms of advertising for subject recruitment
D. Literacy of homeless subjects

A. Potential undue influence or coercion of subjects

A group of elderly men, whose government disability benefits are the sole source of income, is approached regarding an experimental research study. The study involves using different therapeutic interventions in men with colon cancer. The study involves more than minimal risk, but offers substantial financial incentives that are equal to two months of disability benefits. The IRB will be most concerned about the possibility of:
A. Conflict of interest
B. Inadequacy of research design
C. Inaccuracy of data
D. Undue influence on the subjects

D. Undue influence on the subjects

A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
A. Fraud
B. Research Misconduct
C. Conflict of Interest
D. Malfeasance

C. Conflict of Interest

A conflict of interest implies:
A. The elimination of bias.
B. An awareness of bias.
C. The actual involvement of bias.
D. The potential for bias.

D. The potential for bias.

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
A. Any equity interest in a publicly held company that exceeds $50,000
B. Any equity interest in a publicly held company that exceeds $5,000
C. Any equity interest in a publicly held company that exceeds $15,000
D. Any equity interest in a publicly held company that exceeds $30,000

B. Any equity interest in a publicly held company that exceeds $5,000

The most important ethical concerns related to conflicts of interest in research are:
A. Establishing open dialog with sponsors and security of study records
B. Maintaining a supply of volunteers for research studies and their active involvement in research
C. Ensuring the objectivity of research and the protection of human subjects
D. Protecting proprietary information and fidelity to contracts with sponsors

C. Ensuring the objectivity of research and the protection of human subjects

Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
A. Institutional Review Boards
B. Designated institutional officials
C. Funding agency or sponsor
D. Subjects/participants

B. Designated institutional officials

The Belmont principle of beneficence requires that:

A. Subjects derive individual benefit from study participation.
B. Potential benefits justify the risks of harm.
C. The study makes a significant contribution to generalizable knowledge.
D. Risks are managed so that they are no more than minimal.

B. Potential benefits justify the risks of harm.

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

A. Beneficence.
B. Respect for persons.
C. Justice.

C. Justice

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

A. Milgram's "Obedience to Authority" study

B. The Tuskegee study

C. Zimbardo's "Stanford Prison Experiment"

D. Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study

D.

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

A. Justice.

B. Beneficence.

C. Respect for persons.

C.

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?

A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
C. Tearoom Trade Study (Humphreys).
D. The Harvard T3 study.

A.

A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?

A. The IRB will not review this study because it does not involve an investigational new device.

B. The IRB will not review this study because it is not research as defined by the federal regulations.

C. The IRB will review this study because it includes human subjects and is considered research.

D. The IRB will not review this study because it does not include human subjects as defined by the federal regulations.

B. The IRB will not review this study because it is not research as defined by the federal regulations.

According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:

A. De-identified private information.

B. Observations of public behavior.

C. Identifiable public information.

D. Identifiable private information.

D. Identifiable private information

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A. A researcher uses the Customs Office's passenger lists for ships bringing immigrants to the US between 1820-1845 to track the numbers of immigrants from certain ethnic groups.

B. A researcher conducts a linguistic study of comments posted on a local public blog.

C. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.

D. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS.

C.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger's comments on a similar topic in a weekly magazine.

B. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches.

C. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.

D. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques.

C.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.

B. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department.

C. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.

D. An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership.

C.

Census data is an example of:

Public information.

Private behavior.

Private information.

Public behavior.

Public information

A medical record is an example of:

private information

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided.

A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs.

An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.

A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

prisoners

According to the federal regulations, research is eligible for exemption, if:

All the subjects are adults and the risk is minimal.

The investigator is experienced in the field of inquiry.

Participation in the research will involve 10 minutes or less of the subjects' time.

The research falls into one of six categories of research activity described in the regulations.

The research falls into one of six categories of research activity described in the regulations.

According to federal regulations, the expedited review process may be used when the study procedures pose:

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.

More than minimal risk, but the study replicates previously approved research.

Any level of risk, but all the subjects are adults.

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

Institutional priorities take precedence over all IRB determinations.

Department chairs can overturn an IRB disapproval.

Officials of the institution may overturn an IRB disapproval.

Officials of the institution may overrule an IRB approval.

Officials of the institution may overrule an IRB approval.

Continuing review of an approved and ongoing protocol

Must be conducted by a convened IRB.

Is limited to review of unanticipated problems.

Must occur within 12 months of the approval date.

Is not required unless additional risks have been identified.

Must occur within 12 months of the approval date.

Identify the example of when situation and time are key to assessing risk of harm in a research study:

A study on the efficacy of a behavioral intervention for smoking cessation involves both adults and teenagers

Asking women if they have had an abortion

Research on the prevalence of HIV-infected individuals in communities

A survey about sexually transmitted diseases

Asking women if they have had an abortion

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Breach of confidentiality, loss of autonomy, and study procedures

Study procedures, breach of confidentiality, and loss of employment

Invasion of privacy, adverse reaction to study drug, and discrimination

Invasion of privacy, breach of confidentiality, and study procedures

Invasion of privacy, breach of confidentiality, and study procedures

What statement about risks in social and behavioral sciences research is most accurate:

Anonymizing data effectively manages the risk of creating emotional distress.

Risks are specific to time, situation, and culture.

There are never any risks.

If a study offers potential benefits, it is not necessary to minimize risks.

Risks are specific to time, situation, and culture.

The primary purpose of a Certificate of Confidentiality is to:

Allow law enforcement to investigate abuse cases.

Protect researchers from disclosing conflicts of interest.

Prevent subjects from knowing the purpose of a study.

Protect identifiable research information from compelled disclosure.

Protect identifiable research information from compelled disclosure.

A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

Solely by the probability of expected harm.

Both the magnitude (or severity) and the probability (or likelihood) of harm.

Solely by the magnitude or severity of expected harm.

Neither the magnitude or probability of harm.

Both the magnitude (or severity) and the probability (or likelihood) of harm.

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?

The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn't have to ask the parents for permission.

The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes.

If it is the best interests of the community that the children participate in the study, parental permission is optional.

The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.

The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.

In the event of any distress you may have related to this research, you will be given access to appropriate resources.

The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:

A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material.

A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.

A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.

A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A waiver of the requirement for documentation of informed consent may be granted when:

The investigator has no convenient place to store signed consent forms separate from the research data

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

Potential subjects might find some of the research questions embarrassing, personal, or intrusive

The subjects are literate in their own language; however, they do not read, write, or speak English

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

As part of the consent process, the federal regulations require researchers to:

Provide potential subjects with information at the appropriate reading comprehension level.

Recommend that potential subjects discuss their decision to participate with family members.

Provide a list of the IRB members who reviewed the protocol.

Describe penalties that may be imposed for non-participation.

Provide potential subjects with information at the appropriate reading comprehension level.

Data are made anonymous by:

Reporting data in aggregate form in publications resulting from the research.

Requiring all members of the research team to sign confidentiality agreements.

Keeping the key linking names to responses in a secure location.

Destroying all identifiers connected to the data.

Destroying all identifiers connected to the data.

A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?

The subjects' privacy has been violated.

Confidentiality of the data has been breached.

There was neither a violation of privacy nor a breach of confidentiality.

There was both a violation of privacy and a breach of confidentiality.

There was neither a violation of privacy nor a breach of confidentiality.

Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?

A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.

In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.

A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.

A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?

Using pseudonyms in research reports.

Securing a Certificate of Confidentiality.

Using data encryption for stored files.

Waiving documentation of consent.

Securing a Certificate of Confidentiality.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

The researcher cannot control what participants repeat about others outside the group.

Using pseudonyms in reports removes the concern about any confidences shared in the group.

If group members know each other confidentiality is not an issue.

If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.

The researcher cannot control what participants repeat about others outside the group.

A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:

Age appropriate.

Not an excessive incentive.

Educational.

Of high quality.

Not an excessive incentive.

A sociologist wants to study a culture that occurs in some women's prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:

A valid use of a statistical technique referred to "snowball sampling" wherein the inclusion of the first subject leads to the recruitment of another one subject.

A useful tactic in obtaining a sample of prisoners who both meet the criteria and who will be honest with the researcher.

Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.

Acceptable only when the researcher's IRB grants a special waiver.

Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.

A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:

Approve this project since the risk appears to be no more than minimal.

Not approve this project because the prisoners are merely a population of convenience for the student.

Approve this project since the superintendent is the ultimate authority on what happens in his facility.

Approve this project but submit it for federal review.

Not approve this project because the prisoners are merely a population of convenience for the student.

Which example of research with prisoners would be allowable under the regulations?

Examining age at first arrest as a predictor of adult criminal history.

Examining the use of financial incentives to improve compliance with dentist appointments.

Investigating genetic biomarkers as predictors of intelligence.

Determining safety of a new formulation of deodorant.

Examining age at first arrest as a predictor of adult criminal history.

A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of getting employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

Do nothing in regards the Subpart C since the research does not meet the criteria for prison research: individuals on parole are not considered prisoners. The definition applies to both minors and adults.

Have made initial contact with potential subjects while they were in prison.

Obtain the permission of the Parole Board to ensure that no negative consequences will happen to those who decline to take part, and who return to prison.

Stop since this type of study is not permitted under CRS 42.44.101.

Do nothing in regards the Subpart C since the research does not meet the criteria for prison research: individuals on parole are not considered prisoners. The definition applies to both minors and adults.

A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:

All prisoners receive HIV testing.

A medical doctor serves as co-investigator.

The survey instrument is standardized.

Confidentiality of the prisoners' health status is maintained.

Confidentiality of the prisoners' health status is maintained.

A researcher's study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims and the IRB chair agrees that the study is exempt from IRB review. This decision:

Is wrong since the chair is the only person who can determine that a study is exempt from further review. It is not the researcher's call.

Is correct if the IRB chair is also the prisoner representative for the Board.

Is correct since the lack of direct interaction removes the concern of undue influence that might occur with contact with prisoners.

Is wrong. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.

Is wrong. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children. This research would be eligible for which type of IRB review?

This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting.

This research would require full committee review since it involves children.

This research would be eligible for expedited IRB review since the researcher is participating in the activities observed.

This research would be eligible for expedited IRB review since the researcher is not interacting with the children and the playground is public.

This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting.

Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research?

Parents must approve written documentation.

Documentation is required unless waived by an IRB.

To protect minors documentation is always required.

Federal regulations do not require the documentation of minors' assent.

Federal regulations do not require the documentation of minors' assent.

A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?

Parents must be notified that the study is taking place.

An independent consultant must approve the waiver.

The students must be offered an optional classroom activity.

The research must pose no more than minimal risk.

The research must pose no more than minimal risk.

The specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as:

Subpart B: Additional Protections for Children Involved as Subjects in Research

Subpart A: The Common Rule

Subpart D: Additional Protections for Children Involved as Subjects in Research

Subpart C: Protections for Children in Research

Subpart D: Additional Protections for Children Involved as Subjects in Research

According to federal regulations, "children" are defined as:

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved.

Persons who are under 18 years of age.

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.

Persons who are under 21 years of age.

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.

A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?

The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population.

The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.

The new research would need full review by a convened IRB because children are a protected population.

Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.

Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.

According to Subpart D, research with children may be eligible for exemption when:

The children will be asked to complete a survey

The research involves the use of educational tests

The children will be interviewed by the researcher.

The research with children will involve participant observation with researcher interaction.

The research involves the use of educational tests

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

All research involving children

All research that is more than minimal risk

All research funded by any federal agency

All research funded by HHS

All research funded by HHS

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

Stated in the human subject protection regulations, but not in the drug or device regulations

Included in the consent process

Determined by research staff

Determined by the institution in its written policies and procedures

Determined by the institution in its written policies and procedures

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on DHS regulations, the researcher report this event to the IRB?

No, this does not need to be reported since the subject had the heart attack when they were home, not at the focus group.

No, this does not need to be reported since it is unrelated to participation in the study.

No, this does not need to be reported because two weeks have passed.

No, this does not need to be reported since the subject recovered.

No, this does not need to be reported since it is unrelated to participation in the study.

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?

Yes, this must be reported because it was not listed as a risk of study participation in the consent form (was unexpected) and the subject experienced harm.

Yes, this must be reported because it involved a subject in a research study and it's up to the IRB to determine if it was related to participation.

No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.

No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study.

No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.

Researchers must report potential unanticipated problems that involve risks to others directly to:

Institutional Risk Manager

American Psychological Association

HIPAA Compliance Officer

Institutional Review Board (IRB)

Institutional Review Board (IRB)

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (i.e., the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?

Promptly

Within 48 hours

Within 24 hours

Within two weeks

Promptly

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:

Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk

Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk

Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk

Expected, related or possible related to the research, suggests the research puts others at greater risk

Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk

Researchers must report potential unanticipated problems that involve risks to others directly to:

Institutional Risk Manager

American Psychological Association

HIPAA Compliance Officer

Institutional Review Board (IRB)

...

CITI training includes- Responsible Conduct, Ethics, RCR, Law, HTH & IRB - Subjecto.com

CITI training includes- Responsible Conduct, Ethics, RCR, Law, HTH & IRB

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Which of the following is true regarding data analysis?

Data analysis methods should be specified in advance before a study begins.

Which of the following most accurately describes data lifecycle management (DLM)

It refers to the tools and processes for handling data during a research study and after it concludes.

Which of the following is true regarding the reporting of research results?

Clear specification of the methods and procedures used is essential.

What is the primary responsibility of oversight bodies such as an IRB or an IACUC

To detect compliance with regulatory requirements, including those relating to protecting research subjects.

Which of the following is true regarding data acquisition?

Data acquisition should follow a detailed collection plan that is set in advance.

In the research context, the term validity most commonly refers to:

Whether operationalized terms actually measure what they purport to measure.

What are the three main goals of data lifecycle management?

Confidentiality, availability, and integrity

Which of the following is true regarding data sharing and stewardship

Researchers who receive federal funding may have to adhere to a data sharing requirement.

If an employer allows a friendship to interfere with a hiring decision, this is typically referred to as:

A personal conflict of interest.

If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:

A conflict of conscience

The entity that normally is supposed to determine whether an academic researcher’s conflict of interest can be managed is:

A conflict of interest committee

Which of the following most accurately describes a conflict of commitment?

It occurs when outside activities interfere with obligations to one’s primary employer.

The main focus of NIH’s conflict of interest policy is:

Financial conflicts of interest

Which of the following most accurately describes an institutional conflict of interest?

It occurs when an institution’s financial interests could interfere with its research activities

Which of following is true about the management of conflicts of interest?

Management plans are often created to reduce the impact of conflicts of interest rather than completely eliminating them

Which of following is true about conflicts of interest

They increase the likelihood of bias.

Which of the following statements best exemplifies the importance of mentoring?

A mechanism to transmit values and standards of professional conduct.

What is the most appropriate course of action for a trainee who has a problem with a mentor?

After first attempting to communicate directly with the mentor, the trainee should seek the counsel of a trusted senior person in the department or organization.

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?

The trainee must take an active role in the relationship and clearly communicate needs and expectations.

Which of the following statements most accurately describes the mentoring relationship?

Mentors teach trainees about aspects of academic life that are not covered in textbooks

The defining characteristic of a mentor is someone who:

Takes a sincere interest in the growth and development of a trainee.

According to the U.S. Federal Research Misconduct Policy, fabrication involves:

Making up data or results and recording or reporting them.

Which of the following is most likely to be considered plagiarism?

Using materials from a source without proper citation.

Which of the following is the most effective strategy for preventing research misconduct?

Good mentoring

Which of the following is true regarding the U.S. Federal Research Misconduct Policy?

To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.

Which type of research misconduct most likely occurred if someone intentionally removes data points on a graph in order to generate a deceptive conclusion?

Falsification

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?

Good mentoring

In response to a research misconduct allegation, what is the next main phase that takes place after the inquiry if there is sufficient evidence to proceed?

An investigation

According to the U.S. Federal Research Misconduct Policy, falsification involves:

Manipulating research materials, equipment, or processes, or changing or omitting data.

What is the primary responsibility of oversight bodies such as an IRB or an IACUC?

To detect compliance with regulatory requirements, including those relating to protecting research subjects.

What are the three main goals of data lifecycle management?

Confidentiality, availability, and integrity

In the research context, the term validity most commonly refers to:

Whether operationalized concepts actually measure what they purport to measure.

Which of the following statements is true concerning data selection?

Establishing a data selection strategy prior to collecting data decreases the chance of a biased outcome.

Which of following is most likely to own the data resulting from a research project?

The institution where a federally-funded project takes place.

Which of the following is true regarding data sharing and stewardship?

Agencies that fund research may include data sharing requirements in their funding contracts.

Which of the following most accurately describes the practice of ghost authorship?

It is a situation where the individual who wrote the manuscript is not listed as an author.

Which of the following is a responsibility of each author?

Confirming that data have been accurately presented.

Which of the following is an example of plagiarism?

Presenting someone else’s ideas or words and claiming them as one’s own.

Which of the following is true regarding an acknowledgments section?

The contributions of students and technicians are often listed in the acknowledgments section if they do not meet all of the criteria for authorship.

Which of the following is true regarding publishing the same content in multiple papers?

Using the same content in multiple papers is deceptive if it is not properly disclosed.

Which author is normally responsible for sharing reprints of a publication with readers?

The corresponding author.

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines?

Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section.

Which of the following is the primary criterion for authorship?

Having made a significant intellectual contribution to the work.

Which of the following statements is true regarding authorship practices?

Different disciplines have different practices about who should be included as an author.

Which of the following statements most accurately describes the review process for grant proposals?

Funding agencies usually have committees, often with external reviewers, that assess the quality of the proposal.

A reviewer’s main responsibility is to:

Be professional and prompt.

The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:

Intellectual merits and broader impacts.

Which of the following statements is true regarding the responsibilities of a reviewer?

A reviewer’s conflict of interest should be disclosed to the journal editor or grant agency

Which of the following is true regarding single-blind and double-blind review:

Under single-blind review, the identity of the author is revealed to the reviewer.

The main reason that grant proposal reviewers with a conflict of interest should remove themselves from the review process is because:

Their removal lessens the chance that bias will affect the review process​.

Which of the following is most directly related to successful mentoring?

Someone who is committed to the professional development of the trainee.

What is the most appropriate course of action for a trainee who has a problem with a mentor?

After first attempting to communicate directly with the mentor, the trainee should seek the counsel of a trusted senior person in the department or organization.

Which of the following is to be avoided when seeking an effective mentor?

Trainees should assume that whoever is assigned to them as the thesis or research adviser will be their best choice for a mentor.

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?

The trainee must take an active role in the relationship and clearly communicate needs and expectations.

Which of the following statements most accurately describes the mentoring relationship?

Mentors teach trainees about aspects of academic life that are not covered in textbooks.

Which of the following statements best exemplifies the importance of mentoring?

A mechanism to transmit values and standards of professional conduct.

The defining characteristic of a mentor is someone who:

Takes a sincere interest in the growth and development of a trainee.

Which of the following is most likely to create a poor relationship between mentor and trainee?

A faculty member searches out trainees merely for that person’s own career advancement.

Which of following is true about the management of conflicts of interest?

Management plans are often created to reduce the impact of conflicts of interest rather than completely eliminating them.

If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:

A conflict of conscience

Which of the following most accurately describes a conflict of commitment?

It occurs when outside activities interfere with obligations to one’s primary employer.

The main focus of NIH’s conflict of interest policy is:

Financial conflicts of interest

The entity that normally is supposed to determine whether an academic researcher’s conflict of interest can be managed is:

A conflict of interest committee

Which of the following most clearly illustrates an example of an academic conflict of interest?

A researcher becomes overly attached to a specific research outcome.

Which of the following most accurately describes an institutional conflict of interest?

It occurs when an institution’s financial interests could interfere with its research activities.

Which of following is true about conflicts of interest?

They increase the likelihood of bias.

if an employer allows a friendship to interfere with a hiring decision, this is typically referred to as:

A personal conflict of interest.

Data ownership is typically determined by:

The type and source of funds used to support the project.

Which of the following is a key reason why international collaborations can be challenging?

Language barriers and cultural differences among collaborators can complicate communication.

Which of the following is true regarding academic-industry collaborations?

The industry sponsor typically owns the data from research that it funds.

What is the most appropriate process for determining which journal a collaborative research team should submit their work to?

It should be discussed early on in the collaboration by the members of the research team.

Which of the following is true regarding industry-sponsored research?

Industry sponsors of research may place restrictions on the disclosure of research results.

What is the main function of the Bayh-Dole Act of 1980 as it relates academic institutions?

It allows institutions to have control over the intellectual property from federally-funded research.

What is the main function of a Technology Transfer Office?

It helps researchers to commercialize their work.

A research collaboration can be enhanced by:

Discussing intellectual property issues while the collaboration is forming.

Which of the following is true regarding the use of animals in research?

The attending veterinarian must be allowed to have access to all research animals at all times.

Which of the following is the main reason why proper training in euthanasia techniques is important?

Improper techniques can cause unnecessary pain and distress in animals.

Which of the following is empowered by the U.S. federal government to review and approve research activities involving vertebrate animals?

The Institutional Animal Care and Use Committee (IACUC)

Prior to implementing any significant change in the use of animals, what is the most important thing that the research team must do?

Obtain IACUC approval for the change.

Which of the following most accurately describes the process that must occur when working with research animals covered by U.S. federal regulations?

The research team must obtain IACUC approval for the proposed research procedures prior to starting the work.

Which entity is responsible for monitoring institutional compliance with PHS Policy?

The Office of Laboratory Animal Welfare (OLAW)

What is the primary purpose of the "3Rs" concept from Russell and Burch?

To decrease the use of animals in research and to minimize pain and distress caused by animal experiments.

Which of the following is the general guideline that IACUCs use to evaluate the potential pain of a procedure conducted with animals?

Any procedure that causes pain or distress in human beings may cause pain or distress in other animals.

Which justification would an IACUC most likely accept if a research team plans to withhold pain relief (analgesia) from animals during a project?

Which statement best describes information that must be included in a consent form:

A description of the research’s potential benefits and risks.

Which of the following best describes when a protocol may be eligible for expedited review by the IRB:

The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified by the federal government.

Which of the following statements most clearly illustrates the principle of beneficence:

Determining whether the benefits of a study outweigh the risks.

Which statement best describes the role of an IRB:

a committee that reviews different types of human subjects research.

Which of the following studies most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report:

The Tuskegee Study.

The three ethical principles discussed in the Belmont Report are:

Respect for Persons, Beneficence, Justice.

As a first step, what must be done before enrolling a young child in a research protocol:

the risks and benefits must be explained to the child’s parents or legally authorized representative.

Which statement most accurately describes the process leading to the development of the Nuremberg Code:

it was created in response to the harms caused by Nazi researchers around the time of the Second World War.

Which of following protocols most likely requires IRB review:

A study to evaluate a newly designed wheelchair by asking elderly individuals to use it.

Which statement best describes what an IRB is responsible for reviewing:

Any form of research involving a human subject.

With the context of rcr, stewardship primarily refers to:

The obligation to use resources available for research ethically in order to conduct the best research possible

Within the context of rcr, social responsibility primarily refers to:

The obligation to design technology or acquire information in ways that take into account what effects those actions may have on society

Which of the following most accurately describes U.S. federal policy related to rcr instruction?

Some federal agencies have rcr policies but they differ in terms of the particular format of training that is required

Within the context of rcr, compliance primarily refers to:

The obligation to follow specific directive, such as laws and regulations, that govern a research activity

Which of the following most accurately describes the main goal of rcr education and training?

To promote greater awareness of proper research practice and research ethics

Within the context to rcr, integrity primarily refers to:

Having a sincere commitment to upholding one’s word and adhering to ethical and professional standards

The view that there is a social contract between researchers and the public is most accurately described by stating that:

The public supports research in various ways and researchers have a corresponding obligation to avoid abusing the public’s trust

Which of the following is true regarding an acknowledgments section?

The contributions of technicians and other researchers are often listed in the acknowledgements section if they do not meet all of the criteria for authorship

Which author is normally responsible for sharing reprints of a publication with readers?

The corresponding author

Which of the following statements is true regarding authorship practices?

Different disciplines have different practices about who should be included as an author.

Which of the following is the primary criterion for authorship?

Having made a significant intellectual contribution to the work.

Which of the following statements is true regarding the International Committee of Medical Journal Editors (ICMJE) guidelines?

Individuals who do not meet the criteria for authorship but who have made a noteworthy contribution are normally listed in the acknowledgments section.

Which of the following is a responsibility of each author?

Confirming that data have been accurately presented

Which of the following is an example of plagiarism?

Presenting someone else’s ideas or words and claiming them as one’s own

Which of the following most accurately describes the practice of ghost authorship?

It is a situation where the individual who wrote the manuscript is not listed as an author

Which of the following is true regarding authors who seek to publish the same content in multiple papers?

Using the same content in multiple papers is deceptive if it is not properly disclosed to journal editors or other relevant entities

What is the main function of a technology transfer office?

It helps researchers to commercialize their work

The most important factor determining whether a research collaboration will be successful is:

Whether there is ongoing communication about goals and responsibilities

What is the main function of the Bayl-Dole Act of 1980 as it relates to academic institutions?

It allows institutions to have control over the intellectual property from federally-funded research

Which of the following is a key reason why international collaborations can be challenging?

Language barriers and cultural differences among collaborators can complicate communication

Which of the following is true regarding academic-industry collaborations?

The industry sponsor typically owns the data from research that it funds

What is the most appropriate process for determining which journal a collaborative research team should submit their work to?

It should be discussed early on in the collaboration by the members of the research team.

Which of the following is true regarding industry-sponsored research?

Industry sponsors of research may seek to place restrictions on the disclosure of research results.

Which of the following statements is true regarding international research and U.S. regulations?

U.S. funded research is often governed by U.S. regulations no matter where the research takes place

Data ownership is typically determined by:

The type and source of funds used to support the project

A research collaboration can be enhanced by:

Discussing intellectual property issues while the collaboration is forming

Which of the following most accurately describes a conflict of commitment?

It occurs when outside activities interfere with obligations to one’s primary employer

Which of the following most accurately describes an institutional conflict of interest?

It occurs when an institution’s financial or non-financial interests could interfere with its research activities

Which of the following is true about the management of conflicts of interest?

Management plans are often created to reduce the impact of conflicts of interest rather than completely eliminating them.

If researchers allow their moral or other personal beliefs to influence their objectivity, this is most likely an example of:

A conflict of conscience

The entity that normally is supposed to determine whether an academic researcher’s conflict of interest can be managed is:

A conflict of interest committee

Which of the following is true about conflicts of interest?

Conflicts of interest increase the likelihood of bias

If a friendship with an applicant could interfere with a hiring decision, this is typically referred to as:

A personal conflict of interest

The main focus of NIH’s conflict of interest policy is:

Financial conflicts of interest

What are the three main goals of data lifecycle management?

Confidentiality, availability, and integrity

Which of the following is true regarding data analysis?

Data analysis methods should be specified in advance before a study begins

Which of the following is true regarding data acquisition?

Data acquisition should follow a detailed collection plan that is set in advance

Which of the following is true regarding data sharing and stewardship?

Researchers who receive federal funding may have to adhere to a data sharing requirement

What is the primary responsibility of oversight bodies such as IRB or an IACUC?

To detect compliance with regulatory requirements, including those relating to protecting research subjects

Which of the following most accurately describes data lifecycle management (DLM)?

It refers to the tools and processes for handling data during a research study and after it concludes

Which of the following is most likely to own the data resulting from a research project?

The institution where a federally-funded project takes place

Which of the following statements is true concerning data selection?

Establishing a data selection strategy prior to collecting data decreases the chance of a biased outcome.

Which of the following is true regarding the reporting of research results?

Clear specification of the methods and procedures used is essential

In the research context, the term validity most commonly refers to:

Whether operationalized terms actually measure what they purport to measure

Which of the following statements about mentoring is true?

Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of research

Which of the following most accurately describes good mentoring practice?

Encouraging trainees to receive mentoring from a collection of individuals

Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?

The trainee must take an active role in the relationship and clearly communicate needs and expectations

What is the most appropriate course of action for a trainee who has a problem with a mentor?

After first attempting to communicate directly with the mentor, the trainee should seek counsel of a trusted senior person in the department or organization

The defining characteristic of a mentor is someone who:

Takes a sincere interest in the growth and development of a trainee

Which of the following is mostly likely to create a poor relationship between a mentor and a trainee?

A mentor who searches out trainees merely for the mentor’s own career advancement

Which of the following is most directly related to successful mentoring?

Someone who is committed to the professional development of the trainee

Which of the following statements most accurately describes the mentoring relationship?

Mentors teach trainees bout aspects of academic life that are not covered in textbooks

Which of the following statements is true regarding the responsibilities of reviewers?

Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed

Which of the following is true regarding the traditional peer review process:

Under single-blind review, the identity of the author is revealed to the reviewer.

A reviewer’s main responsibility is to:

Be professional and prompt

Which of the following is the most appropriate step to take if authors believe that their manuscript was reviewed unfairly?

the author can contact the editor with their concerns

The two main criteria that the National Science Foundation (NSF) uses to evaluate grant proposals are:

Intellectual merit and broader impact

Reviewers have a responsibility to promote ethical peer review by:

Preserving the confidentiality of the submission

The main reason that grant proposal reviewers with a conflict of interest should remove themselves from the review process is because:

Their removal lessens the chance that bias will affect the review process

Which of the following statements most accurately describes the review process for grant proposals?

Funding agencies usually have committees, often with external reviewers, that assess the quality of the proposal

Which of the following statements is true regarding the responsibilities of a reviewer?

A reviewer’s conflict of interest should be disclosed to the journal editor or grant agency

The main reason that the Royal Society of London developed the modern form of peer review was to:

Control the quality of published papers.

Which of the following is true regarding the U.S. Federal Research Misconduct Policy?

To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly

If a researcher creates the idea for a project and is not listed in the preferred author order position on resulting publications, is this considered to be research misconduct under federal policy?

No; instead it is a type of authorship dispute

Which of the following is most likely to be considered plagiarism?

Using materials from a source without proper citation

Which of the following is the most effective strategy for preventing research misconduct?

Good mentoring

Which type of research misconduct most likely occurred if someone intentionally removes data points from the data set in order to generate a deceptive conclusion?

Falsification

According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?

Plagiarism

According to the U.S. Federal Research Misconduct Policy, fabrication involves:

Making up data or results and recording or reporting them

The typical first main phase in response to a research misconduct allegation is called:

The inquiry

Which of the following is true regarding research misconduct?

Federal funding agencies typically rely on an institution to make the initial response to an allegation of research misconduct

Which type of inappropriate practice mostly likely occurred if a researcher takes credit for someone else’s idea and does not acknowledge the original source?

Plagiarism

According to the U.S. Federal Research Misconduct Policy, falsification involves:

Manipulating research materials, equipment, or processes, or changing or omitting data

In response to a research misconduct allegation, what is the next main phase that takes place after the inquiry if there is sufficient evidence to proceed?

The investigation

Paraphrasing another author’s paragraph by substituting one or two words in each sentence and then adding one citation to the author at the end of the paragraph:

May constitute plagiarism because the original material has not been sufficiently modified to constitute a proper paraphrase

An idea is most likely to represent "common knowledge" if:

It can be safely assumed that the readers and the author are both thoroughly familiar with the ideas and its source

Authors who reuse portions of text that have appeared in one of their earlier published papers run the risk of being accused by journal editors of:

Self-plagiarism

Which of the following situations is most likely to constitute an act of plagiarism?

Copying someone else’s text word-for-word without using quotation marks and adding a citation at the end of the material

Ethical writing and scholarship is based on an implicit contract between the author and readers, whereby reader assume that what they read is accurate, has been written by the author, and has:

Not been disseminated before unless noted otherwise

Which one of the following statements most accurately describes how plagiarism has been defined in this module?

Plagiarism applies not only to ideas that are found in print but also those that are communicated verbally

Proper paraphrasing of a sentence written by someone else may be accomplished by:

Using your own words and writing voice to express the idea conveyed in the sentence

When authors summarize the work of others, they typically should:

Provide a condensed (shorter) version of the original material

According to federal research misconduct policies, what is the maximum number of consecutive words that one can use before it is classified as an instance of plagiarism?

There is no official, federal standard for the number of consecutive words that can be used

Which of the following situations is most likely to constitute an instance of plagiarism?

Summarizing a published article in 2-3 distinct paragraphs and including this in a paper

Unless the subject matter is considered common knowledge, citations are necessary when writing about:

Ideas, methodologies, or data from other authors and also your own previously published ideas, methodologies, or data

The reuse of one’s previously published material in a new journal is most appropriate if:

The author informs all the relevant parties and obtains permission to do so

Which of the following are the three principles discussed in the Belmont Report?
A. IRB review, Federal regulations, Declaration of Helsinki.
B. Informed Consent, Institutional Assurance, Researcher responsibility.
C. Privacy, Confidentiality, Equitable selection of subjects.
D. Respect for Persons, Beneficence, Justice.

D. Respect for Persons, Beneficence, Justice.

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?
A. Providing detailed information about the study and obtaining the subject’s consent to participate.
B. Determining that the study has a maximization of benefits and a minimization of risks.
C. Ensuring that the selection of subjects includes people from all segments of the population.
D. Ensuring that persons with diminished autonomy are protected.

B. Determining that the study has a maximization of benefits and a minimization of risks.

All of the following are true regarding the Belmont Report, EXCEPT:
A. The Belmont Report describes the need to carefully consider how research discoveries and risks will be fairly distributed in the society.
B. The Belmont Report describes the concept of "Respect for Persons".
C. The Belmont Report defines and delineates the differences between "Practice" and "Research".
D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts

D. The Belmont Report indicates that it is necessary to rigorously avoid conflicts

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?
A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
C. The Harvard T3 study.
D. Tearoom Trade Study (Humphreys).

A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.

The Belmont principle of beneficence requires that:
A. Subjects derive individual benefit from study participation.
B. Potential benefits justify the risks of harm.
C. The study makes a significant contribution to generalizable knowledge.
D. Risks are managed so that they are no more than minimal.

B. Potential benefits justify the risks of harm.

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
A. Respect for persons.
B. Justice.
C. Beneficence.

A. Respect for persons.

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
A. Beneficence.
B. Respect for persons.
C. Justice.

C. Justice.

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
A. Ensuring that subjects understand that participation is voluntary.
B. Ensuring that the selection of subjects is fair.
C. Providing detailed information about the study to potential subjects.
D. Ensuring that risks are reasonable in relationship to anticipated benefits.

D. Ensuring that risks are reasonable in relationship to anticipated benefits.

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
A. Do not report the adverse drug experience to the IRB since it is a common adverse experience.
B. Report the adverse drug experience to the IRB only if there are several other occurrences.
C. Report the adverse drug experience as part of the continuing review report.
D. Report the adverse drug experience in a timely manner, in keeping with the IRB’s policies and procedures, using the forms or the mechanism provided by the IRB.

D. Report the adverse drug experience in a timely manner, in keeping with the IRB’s policies and procedures, using the forms or the mechanism provided by the IRB.

How long is an investigator required to keep consent documents, IRB correspondence, and research records?
A. Until the study is closed
B. Until data analysis is complete
C. For a minimum of three years after completion of the study
D. As long as the investigator is at that institution

C. For a minimum of three years after completion of the study

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
A. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
B. The study is required for a student research project
C. The study does not require informed consent or survey instruments.
D. The study includes only research subjects that are healthy volunteers.

A. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:
A. The investigator keeps careful records of all changes and includes them in the final report.
B. They only involve changes to the consent form.
C. They are eligible for review using expedited procedures.
D. The changes must be immediately implemented for the health and well being of the subject.

D. The changes must be immediately implemented for the health and well being of the subject.

IRB continuing review of an approved protocol must:
A. Be conducted by a convened IRB.
B. Include copies of all signed consent forms.
C. Occur only when the level of risk changes.
D. Occur at least annually.

D. Occur at least annually.

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?
A. The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn’t have to ask the parents for permission.
B. The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children.
C. If it is the best interests of the community that the children participate in the study, parental permission is optional.
D. The therapist creates her clients’ records; therefore, she does not need parents’ permission to use the information for research purposes.

B. The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children.

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject’s legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?
A. In the event of any distress you may have related to this research, you will be given access to appropriate resources.
B. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.
C. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.
D. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

D. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:
A. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.
B. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects’ attention on the material.
C. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.
D. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

D. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A waiver of the requirement for documentation of informed consent may be granted when:
A. The subjects are literate in their own language; however, they do not read, write, or speak English
B. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.
C. Potential subjects might find some of the research questions embarrassing, personal, or intrusive
D. The investigator has no convenient place to store signed consent forms separate from the research data

B. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

As part of the consent process, the federal regulations require researchers to:
A. Provide potential subjects with information at the appropriate reading comprehension level.
B. Provide a list of the IRB members who reviewed the protocol.
C. Recommend that potential subjects discuss their decision to participate with family members.
D. Describe penalties that may be imposed for non-participation.

A. Provide potential subjects with information at the appropriate reading comprehension level.

Data are made anonymous by
A. Keeping the key linking names to responses in a secure location.
B. Reporting data in aggregate form in publications resulting from the research.
C. Requiring all members of the research team to sign confidentiality agreements.
D. Destroying all identifiers connected to the data.

D. Destroying all identifiers connected to the data.

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?
A. Waiving documentation of consent.
B. Using pseudonyms in research reports.
C. Using data encryption for stored files.
D. Securing a Certificate of Confidentiality.

D. Securing a Certificate of Confidentiality.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?
A. Using pseudonyms in reports removes the concern about any confidences shared in the group.
B. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.
C. If group members know each other confidentiality is not an issue.
D. The researcher cannot control what participants repeat about others outside the group.

D. The researcher cannot control what participants repeat about others outside the group.

A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?
A. Confidentiality of the data has been breached
B. There was both a violation of privacy and a breach of confidentiality.
C. The subjects’ privacy has been violated.
D. There was neither a violation of privacy nor a breach of confidentiality

D. There was neither a violation of privacy nor a breach of confidentiality

Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects’ privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?
A. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.
B. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
C. A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.
D. A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

D. A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

A faculty member wants to measure the effectiveness of a new psychological assessment instrument before including it in his new textbook. He plans to conduct a pilot test by administering both the new instrument and an established instrument and then compare the results. Which of the following populations might be most vulnerable to undue influence to participate in his research?
A. Members of his community organization
B. Senior faculty in his department
C. Members of his professional society
D. Students taking one of his courses

D. Students taking one of his courses

An investigator is recruiting subjects for a study of a new antidepressant drug. The investigator has targeted a population of patients who might clearly benefit, but who are also institutionalized for a variety of psychiatric conditions. The patients are in a controlled environment and it is believed there would be little problem recruiting subjects for the study. Which of the following issues of vulnerability should be of most concern to the IRB?
A. The patients have clinical depression, which is a difficult disease to treat.
B. The patients are institutionalized.
C. The patients are probably illiterate.
D. The patients may have experience participating in research.

B. The patients are institutionalized.

An investigator planning to study behavioral changes during alcohol intoxication will pay subjects $600 for 6 hours of testing that includes drinking a moderate level of alcohol and completing several written questionnaires. He plans to recruit college students taking his courses, as well as economically disadvantaged and homeless people. Which of the following is the most important for the investigator to address before submitting the protocol to the IRB?
A. Potential undue influence or coercion of subjects
B. Method of payment to subjects
C. Forms of advertising for subject recruitment
D. Literacy of homeless subjects

A. Potential undue influence or coercion of subjects

A group of elderly men, whose government disability benefits are the sole source of income, is approached regarding an experimental research study. The study involves using different therapeutic interventions in men with colon cancer. The study involves more than minimal risk, but offers substantial financial incentives that are equal to two months of disability benefits. The IRB will be most concerned about the possibility of:
A. Conflict of interest
B. Inadequacy of research design
C. Inaccuracy of data
D. Undue influence on the subjects

D. Undue influence on the subjects

A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
A. Fraud
B. Research Misconduct
C. Conflict of Interest
D. Malfeasance

C. Conflict of Interest

A conflict of interest implies:
A. The elimination of bias.
B. An awareness of bias.
C. The actual involvement of bias.
D. The potential for bias.

D. The potential for bias.

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
A. Any equity interest in a publicly held company that exceeds $50,000
B. Any equity interest in a publicly held company that exceeds $5,000
C. Any equity interest in a publicly held company that exceeds $15,000
D. Any equity interest in a publicly held company that exceeds $30,000

B. Any equity interest in a publicly held company that exceeds $5,000

The most important ethical concerns related to conflicts of interest in research are:
A. Establishing open dialog with sponsors and security of study records
B. Maintaining a supply of volunteers for research studies and their active involvement in research
C. Ensuring the objectivity of research and the protection of human subjects
D. Protecting proprietary information and fidelity to contracts with sponsors

C. Ensuring the objectivity of research and the protection of human subjects

Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
A. Institutional Review Boards
B. Designated institutional officials
C. Funding agency or sponsor
D. Subjects/participants

B. Designated institutional officials

The Belmont principle of beneficence requires that:

A. Subjects derive individual benefit from study participation.
B. Potential benefits justify the risks of harm.
C. The study makes a significant contribution to generalizable knowledge.
D. Risks are managed so that they are no more than minimal.

B. Potential benefits justify the risks of harm.

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:

A. Beneficence.
B. Respect for persons.
C. Justice.

C. Justice

The researcher’s failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?

A. Milgram’s "Obedience to Authority" study

B. The Tuskegee study

C. Zimbardo’s "Stanford Prison Experiment"

D. Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study

D.

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:

A. Justice.

B. Beneficence.

C. Respect for persons.

C.

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection?

A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
B. Stanford Prison Experiment (Zimbardo).
C. Tearoom Trade Study (Humphreys).
D. The Harvard T3 study.

A.

A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates’ friends, family members and business acquaintances. The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB?

A. The IRB will not review this study because it does not involve an investigational new device.

B. The IRB will not review this study because it is not research as defined by the federal regulations.

C. The IRB will review this study because it includes human subjects and is considered research.

D. The IRB will not review this study because it does not include human subjects as defined by the federal regulations.

B. The IRB will not review this study because it is not research as defined by the federal regulations.

According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:

A. De-identified private information.

B. Observations of public behavior.

C. Identifiable public information.

D. Identifiable private information.

D. Identifiable private information

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A. A researcher uses the Customs Office’s passenger lists for ships bringing immigrants to the US between 1820-1845 to track the numbers of immigrants from certain ethnic groups.

B. A researcher conducts a linguistic study of comments posted on a local public blog.

C. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.

D. A researcher asks the director of a local free clinic about the number of patients in the last two years with newly diagnosed HIV/AIDS.

C.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A. A researcher conducts a comparison of the comments made in a publicly available blog and the blogger’s comments on a similar topic in a weekly magazine.

B. A researcher sets up a meeting with the superintendent of a large and diverse public school system to get data about the ethnic composition of the school system and the number of students receiving free lunches.

C. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.

D. Undergraduate students in a field methods class are assigned a research question and asked to interview another classmate, to be followed by a class discussion on interview techniques.

C.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A. A researcher receives anonymized data for secondary analysis from a survey about gender-related differences in stress levels conducted by a colleague at another university.

B. A university designs an in-house study to improve the mentoring of women students in its engineering department with the proposed outcome consisting of a report of recommendations for the department.

C. An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests.

D. An organization for women academics in engineering asks a federal agency to provide the number of women investigators funded by that agency to include in a report for its membership.

C.

Census data is an example of:

Public information.

Private behavior.

Private information.

Public behavior.

Public information

A medical record is an example of:

private information

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

The collection of data, by a playground designer hired by the superintendent of schools, about the physical dimensions of school playgrounds, presence of fencing, and the kinds of equipment currently provided.

A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs.

An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.

A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

prisoners

According to the federal regulations, research is eligible for exemption, if:

All the subjects are adults and the risk is minimal.

The investigator is experienced in the field of inquiry.

Participation in the research will involve 10 minutes or less of the subjects’ time.

The research falls into one of six categories of research activity described in the regulations.

The research falls into one of six categories of research activity described in the regulations.

According to federal regulations, the expedited review process may be used when the study procedures pose:

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.

More than minimal risk, but the study replicates previously approved research.

Any level of risk, but all the subjects are adults.

No more than minimal risk and the research activities fall within regulatory categories identified as eligible.

Which of the following statements about the relationship between an institution and the institution’s IRB(s) is correct?

Institutional priorities take precedence over all IRB determinations.

Department chairs can overturn an IRB disapproval.

Officials of the institution may overturn an IRB disapproval.

Officials of the institution may overrule an IRB approval.

Officials of the institution may overrule an IRB approval.

Continuing review of an approved and ongoing protocol

Must be conducted by a convened IRB.

Is limited to review of unanticipated problems.

Must occur within 12 months of the approval date.

Is not required unless additional risks have been identified.

Must occur within 12 months of the approval date.

Identify the example of when situation and time are key to assessing risk of harm in a research study:

A study on the efficacy of a behavioral intervention for smoking cessation involves both adults and teenagers

Asking women if they have had an abortion

Research on the prevalence of HIV-infected individuals in communities

A survey about sexually transmitted diseases

Asking women if they have had an abortion

Risk of harm in social and behavioral sciences generally fall in three categories, which are:

Breach of confidentiality, loss of autonomy, and study procedures

Study procedures, breach of confidentiality, and loss of employment

Invasion of privacy, adverse reaction to study drug, and discrimination

Invasion of privacy, breach of confidentiality, and study procedures

Invasion of privacy, breach of confidentiality, and study procedures

What statement about risks in social and behavioral sciences research is most accurate:

Anonymizing data effectively manages the risk of creating emotional distress.

Risks are specific to time, situation, and culture.

There are never any risks.

If a study offers potential benefits, it is not necessary to minimize risks.

Risks are specific to time, situation, and culture.

The primary purpose of a Certificate of Confidentiality is to:

Allow law enforcement to investigate abuse cases.

Protect researchers from disclosing conflicts of interest.

Prevent subjects from knowing the purpose of a study.

Protect identifiable research information from compelled disclosure.

Protect identifiable research information from compelled disclosure.

A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

Solely by the probability of expected harm.

Both the magnitude (or severity) and the probability (or likelihood) of harm.

Solely by the magnitude or severity of expected harm.

Neither the magnitude or probability of harm.

Both the magnitude (or severity) and the probability (or likelihood) of harm.

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?

The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn’t have to ask the parents for permission.

The therapist creates her clients’ records; therefore, she does not need parents’ permission to use the information for research purposes.

If it is the best interests of the community that the children participate in the study, parental permission is optional.

The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children.

The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children.

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject’s legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.

In the event of any distress you may have related to this research, you will be given access to appropriate resources.

The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.

Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:

A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects’ attention on the material.

A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance.

A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects.

A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A waiver of the requirement for documentation of informed consent may be granted when:

The investigator has no convenient place to store signed consent forms separate from the research data

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

Potential subjects might find some of the research questions embarrassing, personal, or intrusive

The subjects are literate in their own language; however, they do not read, write, or speak English

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

As part of the consent process, the federal regulations require researchers to:

Provide potential subjects with information at the appropriate reading comprehension level.

Recommend that potential subjects discuss their decision to participate with family members.

Provide a list of the IRB members who reviewed the protocol.

Describe penalties that may be imposed for non-participation.

Provide potential subjects with information at the appropriate reading comprehension level.

Data are made anonymous by:

Reporting data in aggregate form in publications resulting from the research.

Requiring all members of the research team to sign confidentiality agreements.

Keeping the key linking names to responses in a secure location.

Destroying all identifiers connected to the data.

Destroying all identifiers connected to the data.

A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred?

The subjects’ privacy has been violated.

Confidentiality of the data has been breached.

There was neither a violation of privacy nor a breach of confidentiality.

There was both a violation of privacy and a breach of confidentiality.

There was neither a violation of privacy nor a breach of confidentiality.

Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects’ privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)?

A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.

In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.

A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study.

A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information?

Using pseudonyms in research reports.

Securing a Certificate of Confidentiality.

Using data encryption for stored files.

Waiving documentation of consent.

Securing a Certificate of Confidentiality.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct?

The researcher cannot control what participants repeat about others outside the group.

Using pseudonyms in reports removes the concern about any confidences shared in the group.

If group members know each other confidentiality is not an issue.

If group participants sign confidentiality agreements, the researcher can guarantee confidentiality.

The researcher cannot control what participants repeat about others outside the group.

A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children’s first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:

Age appropriate.

Not an excessive incentive.

Educational.

Of high quality.

Not an excessive incentive.

A sociologist wants to study a culture that occurs in some women’s prisons: "state families," in which individual prisoners take on certain roles within a group of like-minded prisoners. There is previous evidence that younger prisoners will use older inmates who play the roles of grandparents as a resource before they will turn to staff for help and advice. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher. The use of this staff is:

A valid use of a statistical technique referred to "snowball sampling" wherein the inclusion of the first subject leads to the recruitment of another one subject.

A useful tactic in obtaining a sample of prisoners who both meet the criteria and who will be honest with the researcher.

Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.

Acceptable only when the researcher’s IRB grants a special waiver.

Wrong and is prohibited; subject selection needs to be free from intervention by prison authorities or prisoners.

A graduate student wants to examine the effect of print media versus televised media on individuals’ position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student’s IRB should:

Approve this project since the risk appears to be no more than minimal.

Not approve this project because the prisoners are merely a population of convenience for the student.

Approve this project since the superintendent is the ultimate authority on what happens in his facility.

Approve this project but submit it for federal review.

Not approve this project because the prisoners are merely a population of convenience for the student.

Which example of research with prisoners would be allowable under the regulations?

Examining age at first arrest as a predictor of adult criminal history.

Examining the use of financial incentives to improve compliance with dentist appointments.

Investigating genetic biomarkers as predictors of intelligence.

Determining safety of a new formulation of deodorant.

Examining age at first arrest as a predictor of adult criminal history.

A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of getting employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

Do nothing in regards the Subpart C since the research does not meet the criteria for prison research: individuals on parole are not considered prisoners. The definition applies to both minors and adults.

Have made initial contact with potential subjects while they were in prison.

Obtain the permission of the Parole Board to ensure that no negative consequences will happen to those who decline to take part, and who return to prison.

Stop since this type of study is not permitted under CRS 42.44.101.

Do nothing in regards the Subpart C since the research does not meet the criteria for prison research: individuals on parole are not considered prisoners. The definition applies to both minors and adults.

A researcher is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that:

All prisoners receive HIV testing.

A medical doctor serves as co-investigator.

The survey instrument is standardized.

Confidentiality of the prisoners’ health status is maintained.

Confidentiality of the prisoners’ health status is maintained.

A researcher’s study uses a dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims and the IRB chair agrees that the study is exempt from IRB review. This decision:

Is wrong since the chair is the only person who can determine that a study is exempt from further review. It is not the researcher’s call.

Is correct if the IRB chair is also the prisoner representative for the Board.

Is correct since the lack of direct interaction removes the concern of undue influence that might occur with contact with prisoners.

Is wrong. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.

Is wrong. 45 CFR 46.101(b) states that research conducted in prisons may not be exempt.

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children. This research would be eligible for which type of IRB review?

This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting.

This research would require full committee review since it involves children.

This research would be eligible for expedited IRB review since the researcher is participating in the activities observed.

This research would be eligible for expedited IRB review since the researcher is not interacting with the children and the playground is public.

This research would not require IRB review because it would be eligible for exemption since the researcher is not interacting with the children and the playground is a public setting.

Which of the following statements most accurately describes the requirement for the documentation of minors’ assent to participate in research?

Parents must approve written documentation.

Documentation is required unless waived by an IRB.

To protect minors documentation is always required.

Federal regulations do not require the documentation of minors’ assent.

Federal regulations do not require the documentation of minors’ assent.

A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?

Parents must be notified that the study is taking place.

An independent consultant must approve the waiver.

The students must be offered an optional classroom activity.

The research must pose no more than minimal risk.

The research must pose no more than minimal risk.

The specific Department of Health and Human Services (HHS) Regulations that apply to research with children are known as:

Subpart B: Additional Protections for Children Involved as Subjects in Research

Subpart A: The Common Rule

Subpart D: Additional Protections for Children Involved as Subjects in Research

Subpart C: Protections for Children in Research

Subpart D: Additional Protections for Children Involved as Subjects in Research

According to federal regulations, "children" are defined as:

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research was approved.

Persons who are under 18 years of age.

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.

Persons who are under 21 years of age.

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.

A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?

The research would only be eligible for expedited review if the adolescents are capable of understanding the same consent forms used for the adult population.

The research would only be eligible for expedited review if the adolescents have been declared to be emancipated minors.

The new research would need full review by a convened IRB because children are a protected population.

Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.

Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.

According to Subpart D, research with children may be eligible for exemption when:

The children will be asked to complete a survey

The research involves the use of educational tests

The children will be interviewed by the researcher.

The research with children will involve participant observation with researcher interaction.

The research involves the use of educational tests

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

All research involving children

All research that is more than minimal risk

All research funded by any federal agency

All research funded by HHS

All research funded by HHS

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

Stated in the human subject protection regulations, but not in the drug or device regulations

Included in the consent process

Determined by research staff

Determined by the institution in its written policies and procedures

Determined by the institution in its written policies and procedures

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on DHS regulations, the researcher report this event to the IRB?

No, this does not need to be reported since the subject had the heart attack when they were home, not at the focus group.

No, this does not need to be reported since it is unrelated to participation in the study.

No, this does not need to be reported because two weeks have passed.

No, this does not need to be reported since the subject recovered.

No, this does not need to be reported since it is unrelated to participation in the study.

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?

Yes, this must be reported because it was not listed as a risk of study participation in the consent form (was unexpected) and the subject experienced harm.

Yes, this must be reported because it involved a subject in a research study and it’s up to the IRB to determine if it was related to participation.

No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.

No, this does not need to be reported to the IRB since the researcher reported it to the sponsor of the study.

No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.

Researchers must report potential unanticipated problems that involve risks to others directly to:

Institutional Risk Manager

American Psychological Association

HIPAA Compliance Officer

Institutional Review Board (IRB)

Institutional Review Board (IRB)

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher’s car on the way home from work. This is an unanticipated problem that must be reported because the incident was (a) unexpected (i.e., the researchers did not anticipate the theft); (b) related to participation in the research; and (c) placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. According to OHRP, this unanticipated problem must be reported to the IRB in which timeframe?

Promptly

Within 48 hours

Within 24 hours

Within two weeks

Promptly

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:

Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk

Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk

Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk

Expected, related or possible related to the research, suggests the research puts others at greater risk

Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk

Researchers must report potential unanticipated problems that involve risks to others directly to:

Institutional Risk Manager

American Psychological Association

HIPAA Compliance Officer

Institutional Review Board (IRB)

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