CIP Human Subjects Protection & Safety 5 — Questions and Answers
Question 1: Which of the following is the PRIMARY purpose of requiring IRB review of research?
- To ensure that research is conducted in a cost-effective manner for federal agencies
- To protect the rights and welfare of human research subjects (Correct answer)
- To verify that researchers hold appropriate academic credentials
- To confirm that the study will produce statistically significant results
Correct answer: To protect the rights and welfare of human research subjects
The fundamental mission of the IRB is to protect the rights and welfare of human subjects, as established by the National Research Act of 1974 and subsequent regulations.
Question 2: A researcher discovers mid-study that a commonly used drug interaction causes a serious adverse event not listed in the protocol. This finding must be reported to the IRB as:
- A minor protocol deviation requiring a memo to the file
- An unanticipated problem involving risks to subjects or others (Correct answer)
- A serious adverse event only if it occurred in a study participant
- A conflict of interest disclosure to the institution
Correct answer: An unanticipated problem involving risks to subjects or others
New information revealing previously unrecognized serious risks related to study procedures or interventions qualifies as a UPIRTSO requiring prompt IRB reporting.
Question 3: Under the Common Rule, which criterion for IRB approval requires that subject selection be equitable?
- 45 CFR 46.111(a)(1) — Risks minimized
- 45 CFR 46.111(a)(3) — Equitable selection of subjects (Correct answer)
- 45 CFR 46.111(a)(5) — Informed consent obtained
- 45 CFR 46.111(a)(7) — Privacy and confidentiality protections
Correct answer: 45 CFR 46.111(a)(3) — Equitable selection of subjects
45 CFR 46.111(a)(3) specifically requires IRBs to determine that the selection of subjects is equitable, with attention to the justice principle.
Question 4: A study involving collection of blood samples and survey data from adults is reviewed by the IRB. Which expedited review category would MOST likely apply?
- Category 1 — clinical studies of drugs or devices
- Category 6 — collection of data using noninvasive procedures, and Category 7 — research involving surveys and interviews (Correct answer)
- Category 9 — research not otherwise classifiable
- Category 2 — collection of blood samples by finger stick
Correct answer: Category 6 — collection of data using noninvasive procedures, and Category 7 — research involving surveys and interviews
Blood collection from healthy adults via venipuncture within safe limits (Category 2) and survey data collection (Category 7) are both listed expedited categories commonly applicable to this study type.
Question 5: The National Commission for the Protection of Human Subjects produced the Belmont Report in 1979 primarily in response to:
- The Tuskegee Syphilis Study and other historical research abuses (Correct answer)
- Widespread fraud in NIH-funded grant applications
- Public concern over animal welfare in biomedical research
- Ethical issues arising from early genetic engineering experiments
Correct answer: The Tuskegee Syphilis Study and other historical research abuses
The Belmont Report was commissioned following public outcry over the Tuskegee Syphilis Study and other abuses that demonstrated the need for formal ethical principles in human subjects research.
Question 6: When can an IRB waive the requirement for signed informed consent under 45 CFR 46.117(c)(1)?
- When the study involves only healthy adult volunteers with no foreseeable risks
- When the research presents no more than minimal risk and involves no procedures for which signed consent is normally required outside research (Correct answer)
- When the PI has a waiver from the sponsoring federal agency
- When participants are fluent in English and can verbally affirm understanding
Correct answer: When the research presents no more than minimal risk and involves no procedures for which signed consent is normally required outside research
Under 46.117(c)(1), the IRB may waive the signature requirement if the research is no greater than minimal risk and involves procedures that would not require signed consent outside of a research context.
Question 7: A researcher proposes paying subjects $500 to participate in a one-hour study about dietary preferences. The IRB's primary concern should be:
- Whether the payment exceeds IRS reporting thresholds for research compensation
- Whether the payment constitutes undue inducement that compromises voluntariness (Correct answer)
- Whether the payment is sufficient to attract an adequate sample size
- Whether the payment must be disclosed as a conflict of interest by the researcher
Correct answer: Whether the payment constitutes undue inducement that compromises voluntariness
The IRB must evaluate whether the magnitude of compensation is so large relative to the risk and burden that it impairs subjects' ability to freely weigh participation, constituting undue inducement.
CIP Human Subjects Protection & Safety 5
Which of the following is the PRIMARY purpose of requiring IRB review of research?