CIP CIP Informed Consent Process & Documentation 2 — Questions and Answers
Question 1: Which of the following situations requires reconsenting a research participant?
- New information arises that may affect a subject's willingness to continue (Correct answer)
- The IRB undergoes a change in membership
- The study's funding source changes
- The PI changes institutions but continues the study
Correct answer: New information arises that may affect a subject's willingness to continue
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:
- The IRB has approved an exception from informed consent (EFIC) and FDA requirements are met (Correct answer)
- Any available family member verbally agrees
- The PI certifies the emergency in writing afterward
- The sponsor provides written authorization
Correct answer: The IRB has approved an exception from informed consent (EFIC) and FDA requirements are met
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:
- A short form consent document in the subject's language with an interpreter and a witness (Correct answer)
- English-only documentation if an interpreter is present
- A translated full consent form approved by the sponsor only
- Any bilingual staff member without a formal translated document
Correct answer: A short form consent document in the subject's language with an interpreter and a witness
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?
- Whether the research will (if known) or might include whole genome sequencing of the biospecimen (Correct answer)
- The cost of storing the biospecimen
- The names of repositories where the biospecimen will be stored
- Contact information for the biobank
Correct answer: Whether the research will (if known) or might include whole genome sequencing of the biospecimen
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?
- Consent for future unspecified use of identifiable private information or biospecimens (Correct answer)
- Consent covering all studies at a single institution
- Consent obtained from a subject's family for group-level data
- General permission for any research activity at a clinical site
Correct answer: Consent for future unspecified use of identifiable private information or biospecimens
Broad consent allows institutions to obtain a single consent for future, yet-to-be-specified secondary research use of stored specimens or data.
Question 6: Under the Common Rule, how long must researchers retain signed consent documents?
- At least 3 years after completion of the research (Correct answer)
- At least 1 year after the last subject interaction
- For the life of the subject
- Until the IRB's next continuing review
Correct answer: At least 3 years after completion of the research
45 CFR 46.115(b) requires IRBs to retain records, including consent documents, for at least three years after completion of the research.
CIP CIP Informed Consent Process & Documentation 2
Which of the following situations requires reconsenting a research participant?