SOCRA The Informed Consent Process 5

Question 1

A sponsor wants to use a subject's biological specimens collected during a trial for future unspecified research. What must the informed consent include?

Accepted Answer

A specific statement about whether specimens may be used for future research and whether subjects will be asked again for consent

Answer

21 CFR 50.25(b)(8) requires disclosure if specimens may be used for future research and whether subjects will be contacted for additional consent.

Question 2

Under the HIPAA Privacy Rule, what authorization is typically required alongside informed consent in federally regulated research?

Accepted Answer

A HIPAA Authorization for use and disclosure of Protected Health Information (PHI) for research purposes

Answer

HIPAA requires a separate authorization (or IRB-approved waiver) for research use of PHI, which is typically combined with but distinct from the informed consent.

Question 3

Which of the following best describes the role of a 'witness' to the informed consent process under FDA regulations?

Accepted Answer

The witness attests that the consent was explained to the subject and that the subject appeared to understand and voluntarily agreed

Answer

A witness attests to the authenticity of the consent process, confirming the subject received the information, understood it, and signed voluntarily.

Question 4

When pregnant women are enrolled in research under 45 CFR 46 Subpart B, whose consent is generally required?

Accepted Answer

Consent of the pregnant woman alone is sufficient

Answer

45 CFR 46 Subpart B generally requires consent of the pregnant woman alone for research involving pregnant women; father's consent is only required in limited specific circumstances.

Question 5

What is the significance of 45 CFR 46.116(c) 'broad consent' provision added in the 2018 Common Rule revisions?

Accepted Answer

It permits prospective consent for future, unspecified research use of stored identifiable biospecimens and data

Answer

Broad consent allows researchers to prospectively obtain subject permission for future, unspecified secondary research use of their stored identifiable biospecimens and data.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA The Informed Consent Process 5