CRS Institutional Review Board Procedures 2

Question 1

Which federal regulation primarily governs IRB review of human subjects research at institutions receiving federal funding?

Accepted Answer

45 CFR Part 46

Answer

45 CFR Part 46, known as the Common Rule, is the primary federal regulation governing human subjects protections and IRB review.

Question 2

A researcher wants to conduct a minimal-risk survey of adults about their dietary habits. Which IRB review category is most appropriate?

Accepted Answer

Exempt review

Answer

Anonymous surveys on non-sensitive topics with minimal risk typically qualify for exempt review under 45 CFR 46.104(d)(2).

Question 3

What is the maximum period for which an IRB can grant approval before requiring continuing review under the pre-2018 Common Rule?

Accepted Answer

1 year

Answer

Under the pre-2018 Common Rule, IRB approval expires after one year unless the IRB grants a shorter approval period.

Question 4

Which of the following research activities is explicitly excluded from IRB review under the revised 2018 Common Rule?

Accepted Answer

Scholarly and journalistic activities

Answer

The 2018 Common Rule explicitly excludes scholarly and journalistic activities, along with public health surveillance and certain other activities, from its scope.

Question 5

An IRB member has a financial interest in a company sponsoring a study under review. What must occur?

Accepted Answer

The member must recuse themselves from the review

Answer

IRB members with conflicting interests must recuse themselves from the discussion and vote for that study.

(CRS) Certified Research Specialist Practice Test

(CRS) Certified Research Specialist Practice Test

CRS Institutional Review Board Procedures 2