CITI Training

According to the U.S. Public Health Service, which of the following would be considered a significant financial interest?

An equity interest valued at $5,000 owned by the investigator’s spouse in a company that produces products related to the investigator’s institutional responsibilities.

According to the U.S. Public Health Service, a "significant financial interest" includes royalty income paid to an investigator and its disclosure is required:

Except if that income is from the institution that currently employs the investigator.

According to the U.S. Public Health Service regulations, investigators are required to disclose travel sponsored or reimbursed by:

A publicly traded company.

An investigator received $4,000 of consulting income from a publicly traded drug company over the past 12 months. The investigator also owns stock in that company valued at $2,000. The investigator is submitting a grant to the National Institutes of Health that involves evaluating the effectiveness of a drug produced by the same drug company. Which of the following is true?

The aggregate of the consulting income and the stock exceeds $5,000 and therefore is a significant financial interest.

Which of the following is true regarding the U.S. Public Health Service and its approach to the disclosure of significant financial interests?

Any equity interest in a non-publicly traded company must be disclosed.

Which of the following statements is true regarding the reporting of outside interests and the management of conflicts?

Investigators must disclose their significant financial interests related to their institutional responsibilities and not just those related to a particular project.

Institutions are required by the U.S. Public Health Service to do which of the following:

Evaluate whether a significant financial interest is related to an investigator’s research and constitutes a financial conflict of interest.

Which of the following statements most accurately describes a mitigation report?

A report to the U.S. Public Health Service of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest.

The U.S. Public Health Service (PHS) requires institutions to:

Disclose their investigators’ new financial conflicts of interest to the PHS awarding component within 60 days of discovering them.

Which of the following financial conflict of interest information must be made available by institutions on a public website or within five business days upon request?

The financial conflicts of interest of senior/key personnel on projects funded by the U.S. Public Health Service.

Which of the following statements is true?

Many institutions have conflict of commitment policies even though they are not strictly required to by federal agencies.

Which of the following is most likely to be considered a conflict of commitment?

A researcher cancels laboratory meetings in order to perform consulting work.

Which of the following is the most appropriate way to handle a conflict of conscience relating to a project?

Notify relevant parties that a conflict may exist and seek advice about whether to accept or decline the project.

Which statement most accurately describes a conflict of commitment?

It occurs when outside activities interfere with one’s responsibilities to an employer.

Which statement most accurately describes a conflict of conscience?

It occurs when an individual’s personal beliefs could affect the performance or outcome of research.

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of

Economic vulnerability

NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability?

High potential for individual benefit from participating in research

In considering NBAC’s analytic approach, an otherwise competent person who is acutely ill might be considered at especially high risk of harm for:

Situational cognitive vulnerability

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider:

Is there a power differential between researchers and subjects?

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four?

Physical control, coercion, undue influence, and manipulation

The Belmont principle of beneficence requires that:

Potential benefits justify the risks of harm.

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?

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

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

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

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

Justice.

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:

Respect for persons.

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

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

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

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

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.

A medical record is an example of:

Private information.

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:

Identifiable private information.

Continuing review of an approved and ongoing protocol

Must occur within 12 months of the approval date.

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

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.

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

Officials of the institution may overrule an IRB approval.

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.

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

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

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

Asking women if they have had an abortion

A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:

Experience emotional or psychological distress.

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

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 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.

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 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 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.

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.

Data are made anonymous by

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?

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 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?

Securing a Certificate of Confidentiality.

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

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

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

Confidentiality of the prisoners’ health status is maintained.

Which of the following statements about prison research is true?

Researchers may study the effects of privilege upgrades awarded by the prison.

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:

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

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:

Not an excessive incentive.

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

The research involves the use of educational tests

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?

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.

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

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

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.

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

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

In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:

FERPA, PPRA, and Subpart D of the federal regulations

According to Subpart D, which of the following research activities with children would qualify for an exemption?

Research about educational testing

If research in a private school is directly funded by the Department of Education, then:

PPRA applies.

Parental notification, in lieu of active parental permission, is allowed when:

An IRB has approved a waiver of the requirement for parental permission.

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to

Provide parents certain rights over their children’s educational records.

A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availability of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?

No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.

A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee as well as the Big State University IRB?

Will the researcher have collaborators at the research site abroad?

The age of majority in international research is determined by the

Laws, customs, and norms in the area in which the research will be conducted.

What procedures must be described in an agreement called an "assurance of compliance" with OHRP?

Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.

What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?

Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?

The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents’ IP addresses, but explains that on the Internet confidentiality cannot be absolutely guaranteed.

To minimize potential risks of harm, a researcher conducting an on-line survey can:

Design the survey so that no direct or indirect identifiers are collected.

Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?

A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.

The Internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the Internet as a research tool?

An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?

Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects’ significant others to be a part of the focus group.

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

There may be bias by the peer reviewer as to the area of research

An example of an institutional COI is:

An industry sponsor pays for the construction of a new research laboratory at the organization

A researcher’s membership on an advisory board with an organization sponsoring research can create a COI because:

It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research’s success

An example of an individual financial COI is:

A researcher’s spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study.

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?

Researcher

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

Determined by the institution in its written policies and procedures

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

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

Institutional Review Board (IRB)

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

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?

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

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.

Data ownership is typically determined by:

The type and source of funds used to support the project

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

The research team should discuss the issue early on and while the project is ongoing.

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

The collaborators may have different disciplinary and cultural backgrounds.

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.

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

A conflict of conscience

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

A personal conflict of interest.

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 is true about conflicts of interest?

Conflicts of interest increase the likelihood of bias.

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

The organization that receives federal funding for a project.

Which of the following is true regarding data analysis?

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

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.

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

Clear specification of the methods and procedures used is essential.

What are the three main goals of data lifecycle management (DLM)?

Confidentiality, availability, and integrity

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.

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

After trying to communicate directly with the mentor, the trainee should seek advice from a senior person that the trainee trusts.

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 is most likely to create a poor relationship between a mentor and a trainee?

A mentor who recruits trainees merely for the mentor’s own career advancement.

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.

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

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

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 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​.

Reviewers have a responsibility to promote ethical peer review by:

Preserving the confidentiality of the submission.

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

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

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

Good mentoring

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

The inquiry

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.

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 idea 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

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

Not been disseminated before unless noted otherwise.

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.

Which statement best describes the role of an IRB:

a committee that reviews different types of human subjects research.

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 statements most clearly illustrates the principle of beneficence:

Determining whether the benefits of a study outweigh the 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.