CIP CIP Informed Consent Process & Documentation 2

Question 1

Which of the following situations requires reconsenting a research participant?

Accepted Answer

New information arises that may affect a subject's willingness to continue

Answer

Subjects must be reconsented when new information emerges that could materially affect their decision to continue participation.

Question 2

In an emergency where a subject is unable to consent, research involving greater-than-minimal risk may proceed without consent if:

Accepted Answer

The IRB has approved an exception from informed consent (EFIC) and FDA requirements are met

Answer

FDA's 21 CFR 50.24 allows exception from informed consent in life-threatening situations when specific IRB approval and community consultation requirements are satisfied.

Question 3

A subject who does not speak English must be consented using:

Accepted Answer

A short form consent document in the subject's language with an interpreter and a witness

Answer

When consent cannot be obtained in English, a short form in the subject's language paired with an oral presentation and witness signature is an accepted approach under 45 CFR 46.117(b)(2).

Question 4

Which additional element of informed consent must be included when a study involves research on biospecimens?

Accepted Answer

Whether the research will (if known) or might include whole genome sequencing of the biospecimen

Answer

The revised Common Rule added disclosure of the potential for whole genome sequencing of biospecimens as an additional consent element.

Question 5

What is 'broad consent' as introduced in the 2018 revised Common Rule?

Accepted Answer

Consent for future unspecified use of identifiable private information or biospecimens

Answer

Broad consent allows institutions to obtain a single consent for future, yet-to-be-specified secondary research use of stored specimens or data.

(CIP) Certified Institutional Review Board Professional Practice Test

(CIP) Certified Institutional Review Board Professional Practice Test

CIP CIP Informed Consent Process & Documentation 2