CIP Ethical & Regulatory Compliance 5

Question 1

The Federal Wide Assurance (FWA) is an agreement between an institution and which federal agency?

Accepted Answer

The Office for Human Research Protections (OHRP)

Answer

An FWA is a formal agreement filed with OHRP in which an institution commits to comply with federal regulations for the protection of human research subjects under 45 CFR 46.

Question 2

Which of the following IRB composition requirements is mandated by federal regulations?

Accepted Answer

At least one member whose primary concerns are non-scientific and at least one member not affiliated with the institution

Answer

45 CFR 46.107 requires IRBs to include at least one member whose primary concerns are in nonscientific areas and at least one member who is not affiliated with the institution and is not part of the immediate family of an affiliated person.

Question 3

A study is classified as 'exempt' from IRB review. This means:

Accepted Answer

The research meets specific categories defined in regulations where full IRB review is not required, though institutional review may still be needed

Answer

Exempt research falls into specific categories defined in 45 CFR 46.104 where the risk to subjects is low; however, someone authorized by the institution must still determine that the research qualifies for exemption.

Question 4

Under the revised Common Rule (2018), broad consent is a new mechanism that allows subjects to consent to future research use of:

Accepted Answer

Stored identifiable biospecimens and identifiable private information for unspecified future research

Answer

The 2018 revised Common Rule introduced broad consent as an option allowing prospective subjects to consent to storage and use of their identifiable biospecimens and data for future unspecified research studies.

Question 5

When an IRB reviews a protocol and determines it meets criteria for approval, which of the following is NOT among the required findings under 45 CFR 46.111?

Accepted Answer

The research has potential to generate revenue for the institution

Answer

45 CFR 46.111 lists required criteria for IRB approval including risk minimization, equitable subject selection, and informed consent, but does not include institutional financial benefit as a consideration.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP Ethical & Regulatory Compliance 5