CIP CIP Informed Consent Process & Documentation 1 — Questions and Answers
Question 1: Which federal regulation establishes the basic requirements for informed consent in human subjects research in the US?
- 45 CFR 46 (Correct answer)
- 21 CFR 11
- 45 CFR 164
- 21 CFR 50
Correct answer: 45 CFR 46
45 CFR 46 (the Common Rule) establishes the foundational informed consent requirements for federally funded human subjects research.
Question 2: What is the minimum required element of informed consent regarding duration?
- A statement of the expected duration of the subject's participation (Correct answer)
- A statement of the total study duration
- A statement of each visit's length
- A statement of the follow-up period only
Correct 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.
Question 3: Under 21 CFR 50, which of the following is a basic element of informed consent?
- A description of reasonably foreseeable risks or discomforts (Correct answer)
- A guarantee of confidentiality
- An explanation of the sponsor's funding source
- A list of all investigators on the study
Correct 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.
Question 4: When may an IRB waive the requirement to obtain a signed informed consent document?
- When the research presents no more than minimal risk and involves no procedures for which consent is normally required (Correct answer)
- When the PI determines it is impractical
- When the study is federally funded
- When the sample size exceeds 500 participants
Correct 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).
Question 5: Which of the following best describes 'legally authorized representative' (LAR) in the context of informed consent?
- An individual or judicial body authorized under applicable law to consent on behalf of a prospective subject (Correct answer)
- Any adult family member of the subject
- The subject's primary care physician
- The IRB chair acting on behalf of vulnerable subjects
Correct 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.
Question 6: What must be included in a consent form when a study involves the collection of identifiable private information?
- A statement describing the extent to which confidentiality of records will be maintained (Correct answer)
- The names of all IRB members who reviewed the protocol
- The complete protocol synopsis
- A copy of the IRB approval letter
Correct 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.
CIP CIP Informed Consent Process & Documentation 1
Which federal regulation establishes the basic requirements for informed consent in human subjects research in the US?