CIP Informed Consent Process & Documentation Flashcards

Which federal regulation establishes the basic requirements for informed consent in human subjects research in the US?

Answer: 45 CFR 46

45 CFR 46 (the Common Rule) establishes the foundational informed consent requirements for federally funded human subjects research.

What is the minimum required element of informed consent regarding duration?

Answer: A statement of the expected duration of the subject's participation

The regulations require disclosure of the expected duration of the individual subject's participation, not just the overall study timeline.

Under 21 CFR 50, which of the following is a basic element of informed consent?

Answer: A description of reasonably foreseeable risks or discomforts

Reasonably foreseeable risks and discomforts must be disclosed as a basic element under both 21 CFR 50 and 45 CFR 46.

When may an IRB waive the requirement to obtain a signed informed consent document?

Answer: When the research presents no more than minimal risk and involves no procedures for which consent is normally required

An IRB may waive signed consent when the research is minimal risk and involves no procedures ordinarily requiring written consent, per 45 CFR 46.117(c).

Which of the following best describes 'legally authorized representative' (LAR) in the context of informed consent?

Answer: An individual or judicial body authorized under applicable law to consent on behalf of a prospective subject

An LAR is defined by applicable law and may provide consent on behalf of subjects who lack decision-making capacity.

What must be included in a consent form when a study involves the collection of identifiable private information?

Answer: A statement describing the extent to which confidentiality of records will be maintained

Subjects must be informed about confidentiality protections, including any limits, as a basic required element of consent.