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Question 1
Question :
What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?
Your answer : In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
Correct Answer : In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?
Comment :
The points to consider when obtaining informed consent in non-U.S. settings include in addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Sometimes, in non-U.S. communities, people other than the individual taking part in the research may be required to give permission before the potential subject may be asked to participate. These individuals may include a spouse, a head of household, or a group leader. However, another individual’s permission should not substitute for a subject’s voluntary informed consent unless an IRB or equivalent local review committee has waived that consent process. The witness signature line is an issue in documentation of informed consent; ensuring that consent process does not slow down recruitment is an issue in study design and not a non-U.S. setting specific issue, and maintaining confidentiality is a privacy/confidentiality issue.
Points Earned : 1
Question 2
Question :
Which of the following activities constitutes engagement in research?
Your answer : Obtaining informed consent and conducting research interviews.
Correct Answer : Obtaining informed consent and conducting research interviews.
Comment :
If an institution obtains informed consent and conducts research interviews it is engaged in research.
Points Earned : 1
Question 3
Question :
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?
Your answer : Does the potential subject population include children?
Correct Answer : Will the researcher have collaborators at the research site abroad?
Comment :
There are several factors that determine what kinds of review are needed for international research, including if the researcher have collaborators at the research site abroad. If international research is carried out without the involvement of foreign collaborators the research may be reviewed by the researcher’s home institution. The need for local review will be determined by policies and regulations rather than by U.S. law. When U.S. researchers collaborate with researchers at foreign institutions, determining the appropriate review type and method depends on whether the collaborating institution is engaged in the research. The other responses are incorrect because they do not help the IRB determine where the research should be reviewed.
Points Earned : 0
Question 4
Question :
What procedures must be described in an agreement called an "assurance of compliance" with OHRP?
Your answer : Procedures in place to outline how unanticipated problems will be reported to the local IRB.
Correct Answer : 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.
Comment :
If research involves collaboration with an institution that is "engaged" in research in the foreign country (See below for a discussion of "engagement in research"), the collaborating institution will need to have 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. These procedures must be described in an agreement called an "assurance of compliance" with OHRP. The written procedures for reporting unanticipated problems are institutional policy, the procedures outlining randomization should be covered in the research plan/protocol, and the procedures in place to comply with ethical principles is the Federalwide Assurance (FWA), not "assurance of compliance."
Points Earned : 0
Question 5
Question :
A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?
Your answer : If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted, but still require review by the institutional official at the local site.
Correct Answer : If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.
Comment :
A great deal of research in the social and behavioral sciences may qualify for exemption, depending upon institutional policy. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. Federal regulations do not require exempt research to be reviewed by an institution’s IRB or an institutional official -t hose decisions are left to institutional policy.
Question : 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 availably 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?
Your answer : Yes, they are engaged because the research is taking place at the clinic and they work there.
Correct Answer : 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.
Comment : 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. An institution is not engaged if its only involvement is to provide space for the U.S. researchers to conduct their own research.
Question 1
Question :
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:
Your answer : Any equity interest in a publicly held company that exceeds $50,000
Correct Answer : Any equity interest in a publicly held company that exceeds $50,000
Comment :
In 1998, the FDA issued its final rule requiring disclosure of: Any equity interest in a publicly held company that exceeds $50,000 in value. These must be disclosed only for covered clinical studies that are ongoing on or after February 2, 1999. The requirement applies to interests held during the time the clinical investigator is carrying out the study and for 1 year following completion of the study and significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following completion of the study. This requirement applies to payments made on or after February 2, 1999.
Points Earned : 1
Question 2
Question :
Significant financial interest, as defined by the 2011 final rule that amended Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply):
Your answers – Equity/stock interests (regardless of value) in a non-publicly traded company.
– Intellectual property rights upon receipt of income related to such rights.
– Consulting payments in excess of $5,000.
– Salary from an outside institution of between $2,000-$3,000 in any twelve-month period.
Correct Answer : – Equity/stock interests (regardless of value) in a non-publicly traded company.
– Intellectual property rights upon receipt of income related to such rights.
– Consulting payments in excess of $5,000.
Comment :
The PHS defines "significant financial interests" in terms of a monetary threshold (remuneration or equity interest of $5000) received from an entity within the last twelve months preceding the disclosure. For PHS, remuneration includes salary and any payment for services not otherwise identified as salary (for example, consulting fees, honoraria, paid authorship). Equity interest may be in form of stocks, stock options, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. An important distinction is made in the 2011 final rule with respect to non-publicly traded entities. It is now the case that a significant financial interest with respect to these organizations exists when there is remuneration received in the last twelve months that exceeds $5,000 or when an investigator (or the investigator’s spouse or dependent children) holds any equity interest. Notice that there is no threshold with respect to equity interest in non-publicly traded entities. Intellectual property rights upon receipt of income related to such rights also constitute a significant financial interest.
Points Earned : 0
Question 3
Question :
According to the HHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is:
Your answer : Greater than $5,000 of ownership in any single public entity/public company.
Correct Answer : Greater than $5,000 of ownership in any single public entity/public company.
Comment :
The federal rules for PHS define a threshold for reporting a significant financial interest as anything of monetary value. This includes equity interests (e.g., stocks, stock options, or other ownership interests) that exceed $5,000 in value either as remuneration or as ownership (stock/stock options/other ownership interests) interest in any single publicly traded company. For non-publicly traded any interest, regardless of value, must be disclosed. According to these rules, the equity interests of the investigator’s spouse and dependent children are aggregated to determine the threshold for disclosure.
Points Earned : 1
Question 4
Question :
A conflict of interest implies:
Your answer : The potential for bias.
Correct Answer : The potential for bias.
Comment :
A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. A conflict of interest implies only the potential for bias.
Points Earned : 1
Question 5
Question :
A financial conflict of interest could involve:
Your answer : Receiving stock in a company funding your research.
Correct Answer : Receiving stock in a company funding your research.
Comment :
Tangible, or financial conflicts of interests, are those that involve direct financial relationships.
Points Earned : 1
Question 1
Question :
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?
Your answer : Yes because it involves a form of falsification.
Correct Answer : No; instead it is a type of authorship dispute.
Comment :
Situations involving disagreements about author order are not considered to be research misconduct under federal policy.
Points Earned : 0
Question 2
Question :
Which of the following is the most effective strategy for preventing research misconduct?
Your answer : Creating hypercompetitive research environments
Correct Answer : Good mentoring
Comment :
Among the options mentioned, good mentoring is the most effective strategy for preventing research misconduct.
Points Earned : 0
Question 3
Question :
According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct?
Your answer : Gift authorship
Correct Answer : Plagiarism
Comment :
Along with fabrication and falsification, plagiarism is included within the federal definition of research misconduct.
Points Earned : 0
Question 4
Question :
Which of the following is true regarding the U.S. Federal Research Misconduct Policy?
Your answer : The Policy covers conflicts of interest and the misuse of grant funding.
Correct Answer : To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
Comment :
To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
Points Earned : 0
Question 5
Question :
The typical first main phase in response to a research misconduct allegation is called:
Your answer : The adjudication
Correct Answer : The inquiry
Comment :
The inquiry is generally the first main phase in response to a research misconduct allegation.
Question 1
Question :
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?
Your answer : An investigation
Correct Answer : An investigation
Comment :
The investigation phase occurs after the inquiry if there is sufficient evidence to indicate that research misconduct may have taken place.
Points Earned : 1
Question 2
Question :
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?
Your answer : Yes because it involves a form of falsification.
Correct Answer : No; instead it is a type of authorship dispute.
Comment :
Situations involving disagreements about author order are not considered to be research misconduct under federal policy.
Points Earned : 0
Question 3
Question :
Which type of inappropriate practice most likely occurred if a researcher takes credit for someone else’s idea and does not acknowledge the original source?
Your answer : Fabrication
Correct Answer : Plagiarism
Comment :
This situation most likely involves plagiarism. Plagiarism includes using another person’s ideas or words without giving appropriate credit to the original source.
Points Earned : 0
Question 4
Question :
According to the U.S. Federal Research Misconduct Policy, fabrication involves:
Your answer : Making up data or results and recording or reporting them.
Correct Answer : Making up data or results and recording or reporting them.
Comment :
Fabrication involves making up data or results, recording the data in a permanent record, sharing fake data informally or in a written report.
Points Earned : 1
Question 5
Question :
Which of the following is the most effective strategy for preventing research misconduct?
Your answer : Good mentoring
Correct Answer : Good mentoring
Comment :
Among the options mentioned, good mentoring is the most effective strategy for preventing research misconduct.
Question 1
Question :
Which of the following is a responsibility of each author?
Your answer : Confirming that data have been accurately presented.
Correct Answer : Confirming that data have been accurately presented.
Comment :
Along with other responsibilities, each author should confirm that data have been accurately presented.
Points Earned : 1
Question 2
Question :
Which of the following statements is true regarding authorship practices?
Your answer : Different disciplines have different practices about who should be included as an author.
Correct Answer : Different disciplines have different practices about who should be included as an author.
Comment :
Trainees should understand the authorship policies of each particular field or even sub-field. It is best that these policies are explained and understood when a trainee first begins a project.
Points Earned : 1
Question 3
Question :
Which of the following is true regarding an acknowledgments section?
Your answer : The acknowledgments section is necessary for disclosing if the research was supported by federal funds but not if it was supported by a corporate sponsor.
Correct Answer : The contributions of technicians and other researchers are often listed in the acknowledgments section if they do not meet all of the criteria for authorship.
Comment :
Acknowledgments are usually for giving credit to sponsors and others who were involved with a project but who do not meet all of the requirements of an author.
Points Earned : 0
Question 4
Question :
Which of the following most accurately describes the practice of ghost authorship?
Your answer : It is a situation where the individual who wrote the manuscript is not listed as an author.
Correct Answer : It is a situation where the individual who wrote the manuscript is not listed as an author.
Comment :
A ghost author is an individual who writes a manuscript but is not listed as an author.
Points Earned : 1
Question 5
Question :
Which author is normally responsible for sharing reprints of a publication with readers?
Your answer : The corresponding author.
Correct Answer : The corresponding author.
Comment :
The corresponding author is normally responsible for sharing reprints of a publication with readers.
Question 1
Question :
Which of the following is most directly related to successful mentoring?
Your answer : A working relationship in which the mentor harshly criticizes the trainee’s work.
Correct Answer : Someone who is committed to the professional development of the trainee.
Comment :
A mentor-trainee relationship will normally last for an extended period of time and permit the sharing of insights and ideas that will nurture the professional development of the trainee. A working relationship where ideas and insights are shared would be more normally a characteristic of a colleague.
Points Earned : 0
Question 2
Question :
Which of the following most accurately describes the responsibilities of a trainee in the mentoring relationship?
Your answer : The trainee must take an active role in the relationship and clearly communicate needs and expectations.
Correct Answer : The trainee must take an active role in the relationship and clearly communicate needs and expectations.
Comment :
Trainees must take an active role in determining their needs and career goals, finding a prospective mentor, and in maintaining open, clear and professional communication with their mentor throughout the relationship.
Points Earned : 1
Question 3
Question :
Which of the following is most likely to create a poor relationship between a mentor and a trainee?
Your answer : The trainee has an interest in learning more about the mentor’s field of study.
Correct Answer : A mentor who searches out trainees merely for the mentor’s own career advancement.
Comment :
A mentor is a person who will help the trainee along the road to becoming a professional. They will act as an adviser, teacher, friend and advocate.
Points Earned : 0
Question 4
Question :
Which of the following most accurately describes good mentoring practice?
Your answer : Informing trainees that they must rely on their adviser for all mentoring.
Correct Answer : Encouraging trainees to receive mentoring from a collection of individuals.
Comment :
In general, it is a good practice to encourage trainees to receive mentoring from a collection of individuals. Anyone can be an effective mentor by just being available and by providing constructive guidance.
Points Earned : 0
Question 5
Question :
Which of the following statements most accurately describes the mentoring relationship?
Your answer : Mentoring relationships happen naturally and do not require work.
Correct Answer : Mentors teach trainees about aspects of academic life that are not covered in textbooks.
Comment :
Mentors help graduate students learn things not covered in a textbook; for example they might discuss departmental politics and key conferences in the field. Both mentors and their students can gain from the relationship. Mentoring relationships may turn into friendships but not necessarily.
Question 1
Question :
What is the most appropriate course of action for a trainee who has a problem with a mentor?
Your answer : 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.
Correct Answer : 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.
Comment :
Trainees should develop the skills to be their own advocate. However there are times when the trainee will need to seek the advice and council of a senior member of the department to solve difficult or awkward problems.
Points Earned : 1
Question 2
Question :
Which of the following is most likely to create a poor relationship between a mentor and a trainee?
Your answer : The relationship includes clear discussions about each person’s expectations.
Correct Answer : A mentor who searches out trainees merely for the mentor’s own career advancement.
Comment :
A mentor is a person who will help the trainee along the road to becoming a professional. They will act as an adviser, teacher, friend and advocate.
Points Earned : 0
Question 3
Question :
Which of the following most accurately describes good mentoring practice?
Your answer : Informing trainees that faculty are the only individuals who have enough experience to serve as mentors.
Correct Answer : Encouraging trainees to receive mentoring from a collection of individuals.
Comment :
In general, it is a good practice to encourage trainees to receive mentoring from a collection of individuals. Anyone can be an effective mentor by just being available and by providing constructive guidance.
Points Earned : 0
Question 4
Question :
Which of the following statements about mentoring is true?
Your answer : Trainees are bound to find the one individual who is the "truly complete mentor".
Correct Answer : Mentors can provide valuable advice to trainees regarding career decisions and contacts with leaders in their field of research.
Comment :
Mentoring support can and should range to include many aspects of any researcher’s career development.
Points Earned : 0
Question 5
Question :
Which of the following statements best exemplifies the importance of mentoring?
Your answer : A mechanism to get additional grant support.
Correct Answer : A mechanism to transmit values and standards of professional conduct.
Comment :
Mentors are a primary mechanism for one generation of scholars to impart their knowledge to generations that follow. Further, good mentors will provide trainees insights to appropriate values and standards of professional conduct.
Question 1
Question :
Data ownership is typically determined by:
Your answer : The individual who does the most work on the project.
Correct Answer : The type and source of funds used to support the project.
Comment :
The type and source of funds used to support the project typically determines who owns the data from a collaborative project.
Points Earned : 0
Question 2
Question :
Which of the following statements is true regarding international research and U.S. regulations?
Your answer : International research collaborations involving American researchers are not governed by U.S. regulations when the work takes place at a private university.
Correct Answer : U.S. funded research is often governed by U.S. regulations no matter where the research takes place.
Comment :
U.S. funded research is often governed by U.S. regulations no matter where the research takes place.
Points Earned : 0
Question 3
Question :
What is the main function of a Technology Transfer Office?
Your answer : It sets up new e-mail accounts.
Correct Answer : It helps researchers to commercialize their work.
Comment :
Technology Transfer Offices at universities help researchers to commercialize their work.
Points Earned : 0
Question 4
Question :
What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions?
Your answer : It protects the confidentiality of research results.
Correct Answer : It allows institutions to have control over the intellectual property from federally-funded research.
Comment :
The Bayh-Dole Act permits academic institutions and research organizations to retain the commercial and patent rights to intellectual property developed with federal funds.
Points Earned : 0
Question 5
Question :
Which of the following is true regarding industry-sponsored research?
Your answer : Industry sponsors are not permitted to review data from academic projects that they sponsor.
Correct Answer : Industry sponsors of research may seek to place restrictions on the disclosure of research results.
Question 1
Question :
Which of the following is true regarding industry-sponsored research?
Your answer : Industry sponsors of research may seek to place restrictions on the disclosure of research results.
Correct Answer : Industry sponsors of research may seek to place restrictions on the disclosure of research results.
Comment :
Industry-sponsors of research may place restrictions on the disclosure of results. The details of this arrangement with the industry sponsor are normally described in a non-disclosure agreement.
Points Earned : 1
Question 2
Question :
What is the main function of the Bayh-Dole Act of 1980 as it relates to academic institutions?
Your answer : It allows institutions to have control over the intellectual property from federally-funded research.
Correct Answer : It allows institutions to have control over the intellectual property from federally-funded research.
Comment :
The Bayh-Dole Act permits academic institutions and research organizations to retain the commercial and patent rights to intellectual property developed with federal funds.
Points Earned : 1
Question 3
Question :
What is the most appropriate process for determining which journal a collaborative research team should submit their work to?
Your answer : Submit the work to several journals that represent the interests of all the authors.
Correct Answer : It should be discussed early on in the collaboration by the members of the research team.
Comment :
The most effective way to identify a suitable journal is if the research team discusses the issue both before the work begins and throughout the project.
Points Earned : 0
Question 4
Question :
Which of the following is a key reason why international collaborations can be challenging?
Your answer : Language barriers and cultural differences among collaborators can complicate communication.
Correct Answer : Language barriers and cultural differences among collaborators can complicate communication.
Comment :
A key reason why international collaborations can be challenging is that language barriers and cultural differences among collaborators can complicate communication.
Points Earned : 1
Question 5
Question :
What is the main function of a Technology Transfer Office?
Your answer : It helps researchers to commercialize their work.
Correct Answer : It helps researchers to commercialize their work.
Comment :
Technology Transfer Offices at universities help researchers to commercialize their work.
Points Earned : 1
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