SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Institutional Review Board (IRB) 1 — Questions and Answers
Question 1: Under which circumstance may an IRB grant a waiver of informed consent for research involving human subjects?
- The research involves greater than minimal risk but the investigator prefers not to obtain consent
- The research could not practicably be carried out without the waiver, involves minimal risk, and will not adversely affect subjects' rights or welfare (Correct answer)
- The sponsor has determined that consent is unnecessary for operational efficiency
- The IRB chair has sole authority to waive consent without full board review
Correct answer: The research could not practicably be carried out without the waiver, involves minimal risk, and will not adversely affect subjects' rights or welfare
Federal regulations (45 CFR 46.116) permit an IRB to waive or alter informed consent when the research involves no more than minimal risk, the waiver will not adversely affect subjects' rights and welfare, the research could not practicably be carried out without the waiver, and subjects are debriefed where appropriate.
Question 2: Which of the following categories of research is most likely to qualify for exempt status under federal regulations?
- A phase II clinical trial of an investigational drug in cancer patients
- A survey study of anonymous adult responses to publicly available educational curricula (Correct answer)
- Research involving pregnant women as a specifically targeted population
- A study collecting identifiable biological specimens for genetic analysis
Correct answer: A survey study of anonymous adult responses to publicly available educational curricula
Anonymous surveys using existing educational tests or curricula with no risk of harm to participants commonly qualify for exempt status under 45 CFR 46.104(d)(2). Phase II drug trials, pregnant women studies, and identifiable biospecimen collection involve higher risk or vulnerable populations requiring at least expedited or full review.
Question 3: What authority does an IRB have when it determines that unanticipated problems pose serious risks to participants or others?
- The IRB may only recommend modifications; only the sponsor can halt the study
- The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with its requirements (Correct answer)
- The IRB must defer to the FDA before taking any enforcement action
- The IRB can issue a warning letter but must allow the study to continue until federal review
Correct answer: The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with its requirements
Per 45 CFR 46.113, an IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants. This is a core institutional safeguard.
Question 4: Which population requires additional regulatory protections beyond the standard informed consent process under Subpart D of the Common Rule?
- Adults with limited English proficiency
- Prisoners enrolled in studies examining conditions affecting the prison population (Correct answer)
- Children enrolled in minimal-risk survey research
- Healthy adult volunteers in phase I pharmacokinetic studies
Correct answer: Prisoners enrolled in studies examining conditions affecting the prison population
Subpart C of 45 CFR 46 establishes additional protections for prisoners because their voluntariness may be compromised by their circumstances. Subpart D covers children. Adults with limited English proficiency require translated documents but are not a separately regulated vulnerable subgroup under Subpart C or D.
Question 5: When must an investigator report an unanticipated problem involving risks to participants or others to the IRB?
- Only at the time of annual continuing review
- Within the timeframe specified in IRB policy, generally promptly upon becoming aware of the event (Correct answer)
- Only if the problem results in a serious adverse event requiring hospitalization
- At the end of the study in the final report to the sponsor
Correct answer: Within the timeframe specified in IRB policy, generally promptly upon becoming aware of the event
Unanticipated problems that involve risks to participants or others must be reported to the IRB promptly — typically within a specified window (often 5–10 business days for serious events) per institutional policy and OHRP guidance. Waiting until annual review or study completion is not acceptable.
Question 6: How long must an IRB retain records of research activities, including minutes of convened meetings, under federal regulations?
- One year after study completion
- At least three years after completion of the research (Correct answer)
- Five years from the date of initial IRB approval
- Indefinitely, with no minimum retention period specified
Correct answer: At least three years after completion of the research
45 CFR 46.115(b) requires that IRB records, including minutes, membership rosters, and study files, be retained for at least three years after completion of the research. This ensures accountability and the ability to reconstruct IRB decisions during audits or investigations.
SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Institutional Review Board (IRB) 1
Under which circumstance may an IRB grant a waiver of informed consent for research involving human subjects?