A. Institutional vulnerability
B. Communicative vulnerability
C. Economic vulnerability
D. Social vulnerability
A. Coercion, undue influence, neglect and disrespect
B. Physical control, coercion, undue influence, and manipulation
C. Prejudice, physical control, manipulation and coercion
D. Physical control, coercion, undue influence and neglect
A. Pregnant women, prisoners, children
B. Prisoners, children, and older adults
C. Pregnant women, prisoners, and individuals who are economically disadvantaged
D. Children, prisoners, and individuals who are critically ill
A. Deferential vulnerability
B. Therapeutic misconception
C. Medical Vulnerability
D. Economic vulnerability
A. A college professor recruiting among his students
B. An army medical officer recruiting subjects among lower ranks
C. A physician recruiting his patients
D. An employer recruiting among persons who directly report to him
A. Economic vulnerability
B. Communicative vulnerability
C. Situational cognitive vulnerability
D. Capacity-related cognitive vulnerability
A. Are there adequate resources to conduct the study?
B. Is there a power differential between researchers and subjects?
C. Are the research procedures greater than minimal risk of harm?
D. Has the researcher completed required training?
A. Like coercion, undue inducement is easy for IRBs to determine.
B. Offering $10 for an hour long research study constitutes undue inducement.
C. Inducements, like coercion, are always inappropriate, as they violate the ethical principle of respect for persons.
D. Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
A. High risk for exploitation
B. High potential for individual benefit from participating in research
C. Difficulty providing voluntary, informed consent arising from limitations in decision-making capacity
D. Difficulty providing voluntary, informed consent arising from or situational circumstances
A. HHS Inspector General Report of 1998
B. 1983 Presidential Commission Report
C. “Shut Downs” by OHRP
D. Death of Jesse Gelsinger
A. The 1974 National Research Act
B. The Nuremberg Code
C. Kefauver-Harris Drug Amendments to the Federal Food, Drug ; Cosmetics Act
D. US Public Health Service Policy
A. Identified the basic ethical principles of human subjects research
B. Identified guidelines to ensure the ethical conduct of research.
C. Required that all federal agencies have the same regulations governing human subjects research.
D. Established the National Commission.
C. Respect for Persons
A. Prisoners are not free to say no
B. Privacy and confidentiality concerns when research occurs in prisons
C. Prisoners participating in research that only benefits the larger society
D. Prisoners are not a representative sample of the general population
A. An identification of basic ethical principles
B. Additional FDA regulations
C. Realization that ethical abuses are not limited to the Nazi regime
D. Multiple Congressional hearings
A. Voluntary consent
B. Equitable selection of subjects
C. Additional Protection for vulnerable subjects
D. Confidentiality of data
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 does not include human subjects as defined by the federal regulations.
C. The IRB will not review this study because it is not research as defined by the federal regulations.
D. The IRB will review this study because it includes human subjects and is considered research.
A. Identifiable private information.
B. De-identified private information.
C. Observations of public behavior.
D. Identifiable public information.
A. 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.
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. 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.
A. A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem solving behaviors.
B. 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. 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.
D. 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.
A. A developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression.
B. 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. A researcher uses the Customs Office’s passenger lists for ships bringing immigrants to the US between1820-1845 to track the numbers of immigrants from certain ethnic groups.
D. A researcher conducts a linguistic study of comments posted on a local public blog.
A. Public behavior.
B. Public information.
C. Private information.
D. Private behavior.
A. 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.
B. An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information.
C. A feasibility study for implementing a year-round school program, focusing on economic issues such a facilities utilization and transportation costs.
D. 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. Private behavior.
B. Public behavior.
C. Private information.
D. Public information.
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 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 as part of the continuing review report.
A. Until data analysis is complete
B. For a minimum of three years after completion of the study
C. As long as the investigator is at that institution
D. Until the study is closed
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 includes only research subjects that are healthy volunteers.
B. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations
C. The study does not require informed consent or survey instruments.
D. The study is required for a student research project
A. The investigator keeps careful records of all changes and includes them in the final report.
B. They are eligible for review using expedited procedures.
C. They only involve changes to the consent form.
D. The changes must be immediately implemented for the health and well being of the subject.
A. Be conducted by a convened IRB.
B. Occur only when the level of risk changes.
C. Include copies of all signed consent forms.
D. Occur at least annually.
Which of the following is the most appropriate action to take for the investigator?
A. Exclude the man from the study.
B. Send a copy of the informed consent via facsimile to the subject’s wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.
C. The investigator can go ahead and enroll the man without a signed consent.
D. Request the IRB meet and waive the requirement for a signed informed consent.
A. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
B. The investigator may stop you from participating in this research without your consent if you experience side effects that make your condition worse. If you become ill 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 your doctor or your right to health care or other services that you may be eligible for.
D. In the event of any injury you may have related to this research, you will be given medical treatment.
A. Withhold this new information to avoid confusing the subject with other treatment options or alternatives
B. Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
C. Do not tell the subject about the new drug since physicians have the right to try out new treatments with their patients
D. Tell the subject about the new drug but discourage him from switching treatments until the study is completed
A. To obtain a signature from a study subject in order to protect the investigator, the study staff and the institution.
B. To obtain a signature from a study subject in order to document his or her agreement to participate in research.
C. To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.
D. To document the investigator’s participation in the consent process.
A. Do not use the test article until either the subject or the subject’s legal representative can give consent.
B. Use the test article without obtaining consent from the subject or the legal representative then notify the IRB.
C. The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.
D. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so test article can be used immediately.
A. Waiving documentation of consent.
B. Using pseudonyms in research reports.
C. Securing a Certificate of Confidentiality.
D. Using data encryption for stored files.
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. Destroying all identifiers connected to the data.
D. Requiring all members of the research team to sign confidentiality agreements.
A. The subjects’ privacy has been violated.
B. There was neither a violation of privacy nor a breach of confidentiality.
C. Confidentiality of the data has been breached.
D. There was both a violation of privacy and a breach of confidentiality.
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.
A. 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.
B. A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.
C. A researcher asks cocaine users to provide names and contact information of other cocaine users
D. In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees.
A. Securing a Certificate of Confidentiality.
B. Using pseudonyms in research reports.
C. Using data encryption for stored files.
D. Waiving documentation of consent.
Which of the following considerations was relevant to the IRB’s determination that this activity does not constitute research with human subjects?
A. The researcher will not be interacting/intervening with subjects and the data has no identifiers.
B. The database reflects data collected originally for surveillance purposes.
C. The CDC is a federal agency.
D. The data was collected between 1996-2006.
A. The study is human subject research which is eligible for expedited review.
B. The research does not meet the federal definition of human subject C. The study is human subject research which must be reviewed by the full IRB.
D. The study is human subject research which is eligible for exemption.
A. A breach of confidentiality.
B. An invasion of privacy.
A. Ownership of biological specimens
B. Need for publication of results
C. Long term financial impact of results
D. Effects of findings on other family members
A. Long-term care insurance and religious discrimination
B. Health insurance and employment discrimination
C. Disability insurance and mortgage insurance
D. Gender discrimination
B. From subjects under 18 years of age
C. From subjects over 18 years of age
A. To evaluate how different racial and ethnic groups respond to certain drugs or classes of drugs
B. To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs
C. To evaluate whether genetic testing can reduce the cost of pharmaceuticals
D. To evaluate how the genomes of infectious agents impact the efficacy of certain antibiotics
A. No, because Investigator B’s research does not involve interaction with humans.
B. Yes, because the specimens are from human subjects.
C. No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.
D. No, because Investigator B cannot readily ascertain the identity of the specimen sources.
E. Yes, because Investigator A retains the identifiers and therefore the specimens are identifiable.
A. All genetic studies should be considered greater than minimal risk
B. Understanding the risks involved in other genetic studies is critical in determining the risk involved in a new study
C. All genetic studies should be considered no more than minimal risk
D. Understanding the purpose and context of a specific study is critical in determining the risk involved
A. Genes are primarily responsible for human traits, including health, behavior, and disease
B. Genetic testing can determine appropriate treatments for certain health conditions
C. Genetic information about an individual can foster stigma and discrimination
D. Parents determine the nature of their children through the inheritance of genes
A. Original signed consent documents include provisions for recontacting subjects
B. Biological specimens need to be replenished
C. Subjects received financial compensation for participation in the study
D. Discovery of related clinical information requires contacting subjects for follow-up
A. Yes, because research with biospecimens is minimal risk.
B. Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.
C. No, because it would be unethical to conduct research that is not consistent with the consent form the subjects originally signed.
D. No, the original research subjects must be re-consented for the cancer research.
A. The research result could be flawed from missing data
B. The organization can have policies that affect the research
C. It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research’s success
D. The members of the advisory board know each other
A. Their connections to the journal may yield some concern
B. There may be bias by the peer reviewer as to the area of research
C. The project has a limited scope
D. They are not informed of the area of work
A. An industry sponsor pays for the construction of a new research laboratory at the organization
B. One of the organization’s deans is the vice-chair of the organization’s IRB
C. The organization gives scholarships to some post-doctoral researchers
D. The organization’s president is a member of the board of trustees for a local non-profit organization that does not sponsor research at the organization
A. Researchers must only submit COI disclosures if they have a significant financial interest related to the research
B. Not until a notice of award is received
C. Never — the PHS regulation does not require researchers to submit COI disclosures
D. No later than the time of proposal submission
A. A researcher’s 10-year-old son wins a local science competition, the prize for which is a $5,000 scholarship to a workshop sponsored by a local company that sponsors one of the researcher’s ongoing projects.
B. A researcher’s wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study.
C. A researcher’s wife works at the same university as the researcher.
D. A researcher is considering buying stock in a publicly traded company that specializes in making and delivering hand tossed pizza.
A. Address disclosure of COIs in multi-center research when a COI is disclosed
B. Reduce IRB review burden when a COI is disclosed
C. Eliminate all COIs in research when a COI is disclosed
D. Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed
B. IRB Member
E. Applicants submitting marketing applications for drugs, biologics, or devices
A. Organizations to disclose financial COIs to the FDA no later than the time of submission of the IND application
B. Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies
C. Researchers to annually self-disclose financial COIs to the FDA
D. Sponsors to annually disclose to the FDA financial COIs of researchers who conducted clinical studies
A. Disclose their potential COI, but not answer any questions about the study
B. Disclose their potential COI and not participate in any action
C. Disclose their potential COI and may answer questions, but recuse themselves from voting
D. Leave the meeting immediately