The Informed Consent Process Flashcards
7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 The Informed Consent Process flashcards as text
A sponsor wants to use a subject's biological specimens collected during a trial for future unspecified research. What must the informed consent include?
Answer: A specific statement about whether specimens may be used for future research and whether subjects will be asked again for consent
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.
Under the HIPAA Privacy Rule, what authorization is typically required alongside informed consent in federally regulated research?
Answer: A HIPAA Authorization for use and disclosure of Protected Health Information (PHI) for research purposes
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.
Which of the following best describes the role of a 'witness' to the informed consent process under FDA regulations?
Answer: The witness attests that the consent was explained to the subject and that the subject appeared to understand and voluntarily agreed
A witness attests to the authenticity of the consent process, confirming the subject received the information, understood it, and signed voluntarily.
When pregnant women are enrolled in research under 45 CFR 46 Subpart B, whose consent is generally required?
Answer: Consent of the pregnant woman alone is sufficient
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.
What is the significance of 45 CFR 46.116(c) 'broad consent' provision added in the 2018 Common Rule revisions?
Answer: It permits prospective consent for future, unspecified research use of stored identifiable biospecimens and data
Broad consent allows researchers to prospectively obtain subject permission for future, unspecified secondary research use of their stored identifiable biospecimens and data.
A subject who signed consent 3 months ago now asks for a copy of their consent form. What must the investigator do?
Answer: Provide the subject with a copy; subjects are entitled to a copy of the signed consent document
21 CFR 50.27 and ethical principles require that subjects receive a copy of the signed consent form, and this right persists throughout the study.
Under FDA regulations, which of the following is NOT one of the eight required basic elements of informed consent per 21 CFR 50.25(a)?
Answer: The name and contact information of the study sponsor's CEO
The eight basic elements of informed consent in 21 CFR 50.25(a) do not include the sponsor CEO's name; they focus on study-relevant information subjects need to decide about participation.