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

Question 1

According to 21 CFR 56, which of the following is a mandatory composition requirement for an Institutional Review Board?

Accepted Answer

At least one member must be primarily concerned with non-scientific areas.

Answer

The board must include a physician, a lawyer, and a statistician.

Answer

The board must consist entirely of members from the scientific community.

Answer

A member of the study sponsor's executive team must be included for all industry-sponsored trials.

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?

Accepted Answer

Expedited review by the IRB chairperson or a designated experienced reviewer.

Answer

Full convened board review at the next scheduled meeting.

Answer

Exemption from further IRB review.

Answer

Review and approval by the institutional official only.

Question 3

What is the primary purpose of IRB continuing review for a previously approved, ongoing clinical trial?

Accepted Answer

To reassess the risk-benefit ratio and ensure continued protection of subjects.

Answer

To re-evaluate the financial disclosures of the principal investigator.

Answer

To ensure the study's scientific design remains innovative.

Answer

To provide the sponsor with an annual summary of enrollment data.

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:

Accepted Answer

An unanticipated problem involving risks to subjects or others (UAP).

Answer

An anticipated adverse event.

Answer

A minor protocol deviation not requiring prompt reporting.

Answer

A significant new finding to be shared only at continuing review.

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?

Accepted Answer

Minutes of meetings that detail the vote on actions, including the number of members voting for, against, and abstaining.

Answer

The personal medical records of all enrolled research subjects.

Answer

A financial audit report of the research sponsor.

Answer

A record of all conversations between the principal investigator and study subjects.

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?

Accepted Answer

The IRB can disapprove the research, preventing the investigator from conducting it at the institution.

Answer

The IRB can only recommend changes but cannot stop the research from proceeding.

Answer

The IRB must approve the research if the sponsor provides additional funding for subject safety monitoring.

Answer

The IRB can approve the research on a probationary basis for 30 days.