SOCRA - Society of Clinical Research Associates Institutional Review Board (IRB) Questions and Answers 1 — Questions and Answers
Question 1: According to 21 CFR 56, which of the following is a mandatory composition requirement for an Institutional Review Board?
- The board must include a physician, a lawyer, and a statistician.
- The board must consist entirely of members from the scientific community.
- At least one member must be primarily concerned with non-scientific areas. (Correct answer)
- A member of the study sponsor's executive team must be included for all industry-sponsored trials.
Correct answer: At least one member must be primarily concerned with non-scientific areas.
21 CFR 56.107(c) requires that each IRB include at least one member whose primary concerns are in non-scientific areas (e.g., a lawyer, ethicist, or member of the clergy) and at least one member whose primary concerns are in a scientific area. This ensures a diversity of viewpoints in the review process. There is no requirement for a specific combination of professions like physician/lawyer/statistician, nor can the board be composed entirely of scientists or require a sponsor representative.
Question 2: A principal investigator submits a minor amendment to an IRB-approved protocol. The change involves adding a new, non-invasive questionnaire to be administered during a scheduled study visit. This change does not increase the overall risk to participants. Which of the following is the most likely review pathway for this amendment?
- Full convened board review at the next scheduled meeting.
- Exemption from further IRB review.
- Review and approval by the institutional official only.
- Expedited review by the IRB chairperson or a designated experienced reviewer. (Correct answer)
Correct answer: Expedited review by the IRB chairperson or a designated experienced reviewer.
According to 21 CFR 56.110, an IRB may use an expedited review procedure for minor changes in previously approved research during the approved period. Adding a non-invasive questionnaire that does not increase risk typically qualifies as a minor change and can be reviewed by the IRB chair or a designated reviewer, rather than waiting for a full board meeting.
Question 3: What is the primary purpose of IRB continuing review for a previously approved, ongoing clinical trial?
- To re-evaluate the financial disclosures of the principal investigator.
- To ensure the study's scientific design remains innovative.
- To reassess the risk-benefit ratio and ensure continued protection of subjects. (Correct answer)
- To provide the sponsor with an annual summary of enrollment data.
Correct answer: To reassess the risk-benefit ratio and ensure continued protection of subjects.
The primary purpose of continuing review, which must occur at least annually for studies not qualifying for an exception under the revised Common Rule, is to re-evaluate the study to ensure that the rights and welfare of human subjects are still protected. This includes reassessing the risk-benefit ratio based on study progress, any new information, and reports of unanticipated problems or adverse events.
Question 4: During a clinical trial, a subject's study medication is accidentally swapped with another subject's medication. Although both subjects received the wrong dose for one day, neither experienced any adverse effects. This event was unexpected and not outlined in the protocol's risk section. This event should be promptly reported to the IRB as:
- An anticipated adverse event.
- A minor protocol deviation not requiring prompt reporting.
- An unanticipated problem involving risks to subjects or others (UAP). (Correct answer)
- A significant new finding to be shared only at continuing review.
Correct answer: An unanticipated problem involving risks to subjects or others (UAP).
An unanticipated problem involving risks to subjects or others (UAP) is any incident, experience, or outcome that is (1) unexpected, (2) related or possibly related to participation in the research, and (3) suggests that the research places subjects or others at a greater risk of harm than was previously known. A medication swap, even without immediate harm, fits this definition because it was unexpected and exposed subjects to potential risks not previously recognized, and must be reported promptly.
Question 5: Which of the following is an IRB required to prepare and maintain as part of its official records, according to 21 CFR 56.115?
- The personal medical records of all enrolled research subjects.
- Minutes of meetings that detail the vote on actions, including the number of members voting for, against, and abstaining. (Correct answer)
- A financial audit report of the research sponsor.
- A record of all conversations between the principal investigator and study subjects.
Correct answer: Minutes of meetings that detail the vote on actions, including the number of members voting for, against, and abstaining.
21 CFR 56.115 explicitly requires that an IRB prepare and maintain minutes of its meetings. These minutes must be detailed enough to show attendance, actions taken, the vote on those actions (for, against, abstaining), the basis for requiring changes or disapproving research, and a summary of the discussion on controversial issues.
Question 6: An IRB reviews a new research protocol and determines that the risks to subjects outweigh the potential benefits. According to 21 CFR 56.109, what is the IRB's authority in this situation?
- The IRB can only recommend changes but cannot stop the research from proceeding.
- The IRB can disapprove the research, preventing the investigator from conducting it at the institution. (Correct answer)
- The IRB must approve the research if the sponsor provides additional funding for subject safety monitoring.
- The IRB can approve the research on a probationary basis for 30 days.
Correct answer: The IRB can disapprove the research, preventing the investigator from conducting it at the institution.
According to 21 CFR 56.109(a), an IRB has the authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by the regulations. If the IRB determines the risks are not justified, it has the full authority to disapprove the study, and this decision is binding for the institution.
SOCRA - Society of Clinical Research Associates Institutional Review Board (IRB) Questions and Answers 1
According to 21 CFR 56, which of the following is a mandatory composition requirement for an Institutional Review Board?