CIP IRB Administration & Management 4 — Questions and Answers
Question 1: An IRB determines that unanticipated problems involving risks to participants or others have occurred. Under 45 CFR 46, the institution must report this to:
- Only the study sponsor within 48 hours
- OHRP and any other applicable federal department or agency (Correct answer)
- The FDA only if the study involves an investigational device
- The IRB members by email within 5 business days
Correct answer: OHRP and any other applicable federal department or agency
Unanticipated problems involving risks to participants or others must be reported promptly to OHRP and any applicable federal department or agency head.
Question 2: When assessing the appropriateness of the research setting, an IRB administrator should consider all of the following EXCEPT:
- Adequacy of medical facilities to handle adverse events
- Qualifications and training of the research team
- The sponsor's projected profit margin for the intervention (Correct answer)
- Data security measures in place at the site
Correct answer: The sponsor's projected profit margin for the intervention
Sponsor profit margins are a business consideration, not an ethical criterion for IRB review of research setting adequacy.
Question 3: A study is approved under expedited review Category 6 (voice, video, digital, or image recordings). The IRB may approve it only if the only involvement of human subjects is:
- Collection of biological specimens and audio recordings simultaneously
- Collection of data through noninvasive procedures routinely employed in practice (Correct answer)
- Data collection via recordings where at least one script is pre-approved
- The recordings are used solely for training IRB staff
Correct answer: Collection of data through noninvasive procedures routinely employed in practice
Expedited Category 6 applies when the sole involvement of subjects is collection of data through noninvasive procedures routinely used in clinical practice, including voice/video/image recordings.
Question 4: An IRB administrator is preparing for an OHRP for-cause compliance oversight evaluation. Which document is MOST critical to have readily accessible?
- The institution's marketing strategy for research recruitment
- Minutes of all IRB meetings for the past three years (Correct answer)
- Personnel files for all research coordinators
- The principal investigators' CVs for all current studies
Correct answer: Minutes of all IRB meetings for the past three years
IRB meeting minutes are the primary record of the board's deliberations and decisions and are the first documents OHRP examines during a compliance evaluation.
Question 5: A non-affiliated IRB member (community member) serves a crucial role because they:
- Provide statistical expertise that other members lack
- Represent the perspective of research participants and the broader community (Correct answer)
- Can approve studies when the quorum of affiliated members is not met
- Are required to have medical training under federal regulations
Correct answer: Represent the perspective of research participants and the broader community
Non-affiliated/community members bring the perspective of potential research participants and the public, ensuring IRB deliberations reflect community values.
Question 6: A researcher asks the IRB to waive documentation of informed consent (i.e., no signed form) for an online survey involving sensitive mental health topics. Which criterion would SUPPORT granting this waiver?
- The researcher has published extensively on mental health topics
- The only record linking the subject to the research would be the consent document itself, creating a risk of harm (Correct answer)
- The study qualifies for exempt status under Category 3
- The survey takes less than 10 minutes to complete
Correct answer: The only record linking the subject to the research would be the consent document itself, creating a risk of harm
A waiver of documentation is appropriate when the signed consent form would be the only link between the participant and the research, and breach of confidentiality could cause harm.
Question 7: Which of the following best illustrates the principle of 'justice' as defined in the Belmont Report in the context of subject selection?
- Ensuring that benefits of research are maximized for all enrolled participants
- Distributing the burdens and benefits of research fairly across society, avoiding exploitation of vulnerable groups (Correct answer)
- Obtaining voluntary informed consent from every research participant
- Minimizing risks relative to anticipated benefits for each individual subject
Correct answer: Distributing the burdens and benefits of research fairly across society, avoiding exploitation of vulnerable groups
Justice in the Belmont Report refers to fair distribution of research burdens and benefits and preventing exploitation of vulnerable populations who are convenient to recruit but unlikely to benefit.
CIP IRB Administration & Management 4
An IRB determines that unanticipated problems involving risks to participants or others have occurred.
Under 45 CFR 46, the institution must report this to: