SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Institutional Review Board (IRB) 1

Question 1

Under which circumstance may an IRB grant a waiver of informed consent for research involving human subjects?

Accepted Answer

The research could not practicably be carried out without the waiver, involves minimal risk, and will not adversely affect subjects' rights or welfare

Answer

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?

Accepted Answer

A survey study of anonymous adult responses to publicly available educational curricula

Answer

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?

Accepted Answer

The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with its requirements

Answer

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?

Accepted Answer

Prisoners enrolled in studies examining conditions affecting the prison population

Answer

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?

Accepted Answer

Within the timeframe specified in IRB policy, generally promptly upon becoming aware of the event

Answer

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.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Institutional Review Board (IRB) 1