CIP Human Subjects Protection & Safety 5

Question 1

Which of the following is the PRIMARY purpose of requiring IRB review of research?

Accepted Answer

To protect the rights and welfare of human research subjects

Answer

The fundamental mission of the IRB is to protect the rights and welfare of human subjects, as established by the National Research Act of 1974 and subsequent regulations.

Question 2

A researcher discovers mid-study that a commonly used drug interaction causes a serious adverse event not listed in the protocol. This finding must be reported to the IRB as:

Accepted Answer

An unanticipated problem involving risks to subjects or others

Answer

New information revealing previously unrecognized serious risks related to study procedures or interventions qualifies as a UPIRTSO requiring prompt IRB reporting.

Question 3

Under the Common Rule, which criterion for IRB approval requires that subject selection be equitable?

Accepted Answer

45 CFR 46.111(a)(3) — Equitable selection of subjects

Answer

45 CFR 46.111(a)(3) specifically requires IRBs to determine that the selection of subjects is equitable, with attention to the justice principle.

Question 4

A study involving collection of blood samples and survey data from adults is reviewed by the IRB. Which expedited review category would MOST likely apply?

Accepted Answer

Category 6 — collection of data using noninvasive procedures, and Category 7 — research involving surveys and interviews

Answer

Blood collection from healthy adults via venipuncture within safe limits (Category 2) and survey data collection (Category 7) are both listed expedited categories commonly applicable to this study type.

Question 5

The National Commission for the Protection of Human Subjects produced the Belmont Report in 1979 primarily in response to:

Accepted Answer

The Tuskegee Syphilis Study and other historical research abuses

Answer

The Belmont Report was commissioned following public outcry over the Tuskegee Syphilis Study and other abuses that demonstrated the need for formal ethical principles in human subjects research.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Human Subjects Protection & Safety 5