CRA IRB & Informed Consent 2 — Questions and Answers
Question 1: A sponsor requests that the IRB waive documentation of informed consent for a minimal-risk telephone survey. Under 45 CFR 46.117(c), this waiver is permissible only if:
- The only record linking the subject to the research would be the consent document and the principal risk is a breach of confidentiality (Correct answer)
- The research involves deception and the subjects cannot be debriefed until study completion
- The sponsor provides written assurance that subjects are not members of a vulnerable population
- The study is conducted entirely outside the United States
Correct answer: The only record linking the subject to the research would be the consent document and the principal risk is a breach of confidentiality
Under 45 CFR 46.117(c)(1), the IRB may waive the requirement for a signed consent form when the only record linking subject to research is the consent document and the main risk is a confidentiality breach.
Question 2: During continuing review, the IRB discovers that enrollment has exceeded the approved maximum by 12 subjects. The most appropriate immediate action is to:
- Issue a protocol deviation report and determine whether a suspension of enrollment is warranted (Correct answer)
- Allow the overage because the additional subjects are already enrolled
- Require the PI to withdraw the excess subjects from the study immediately
- Grant automatic approval for the additional subjects as a minor amendment
Correct answer: Issue a protocol deviation report and determine whether a suspension of enrollment is warranted
Enrollment exceeding approved limits is a protocol deviation that must be reported and assessed; the IRB must determine whether enrollment should be suspended pending review.
Question 3: Which element of informed consent specifically addresses the possibility that participation may involve risks that are currently unforeseeable?
- A statement that participation may involve risks to the subject or embryo/fetus if the subject is or may become pregnant
- A statement that the research may involve unforeseeable risks to the subject or to others (Correct answer)
- A disclosure of the expected duration of the subject's participation
- A description of the procedures to be followed including those that are experimental
Correct answer: A statement that the research may involve unforeseeable risks to the subject or to others
45 CFR 46.116(b)(1) requires disclosure of any reasonably foreseeable risks, and 46.116(b)(2) notes that a statement about unforeseeable risks must be included when applicable.
Question 4: An IRB uses expedited review for a study because it qualifies under an expedited review category. Who may conduct this expedited review?
- The IRB chairperson or one or more experienced reviewers designated by the chairperson (Correct answer)
- Any two members of the full IRB voting independently
- The entire convened IRB via an email vote
- The study sponsor's medical monitor in lieu of an IRB member
Correct answer: The IRB chairperson or one or more experienced reviewers designated by the chairperson
Under 45 CFR 46.110, expedited review is conducted by the IRB chairperson or one or more experienced IRB members designated by the chairperson.
Question 5: A research coordinator notices that subjects in a Phase II trial are experiencing unexpected adverse events not listed in the consent form. The coordinator's first responsibility is to:
- Notify the PI immediately so the events can be reported to the IRB and sponsor as required (Correct answer)
- Reassure subjects that unexpected events are normal and continue the study
- Unilaterally revise the consent form to include the new risks before telling the PI
- Wait until the scheduled continuing review to raise the issue with the IRB
Correct answer: Notify the PI immediately so the events can be reported to the IRB and sponsor as required
Unexpected adverse events must be reported to the PI immediately, who is then responsible for timely reporting to the IRB and sponsor per protocol requirements.
Question 6: Under the revised Common Rule (2018), a broad consent template may be used for:
- Storage, maintenance, and secondary research use of identifiable private information or biospecimens (Correct answer)
- Any federally funded research that qualifies for exempt status
- Emergency research where subjects cannot consent in real time
- Research conducted entirely outside the United States on non-U.S. citizens
Correct answer: Storage, maintenance, and secondary research use of identifiable private information or biospecimens
The 2018 Common Rule introduced broad consent specifically for storage, maintenance, and secondary research use of identifiable private information or biospecimens.
Question 7: A subject who signed an English-language consent form later reveals they do not read English well. The research team administered a short-form oral consent. According to 45 CFR 46.117(b)(2), which additional requirement applies?
- A witness must be present during the oral presentation and sign the short form and a summary (Correct answer)
- The PI must re-consent the subject in writing in their native language within 72 hours
- The IRB must be notified within 5 business days of the oral consent
- The subject must provide a written statement confirming their understanding
Correct answer: A witness must be present during the oral presentation and sign the short form and a summary
When a short-form consent is used orally, a witness must be present and must sign both the short form and the written summary provided to the subject.
CRA IRB & Informed Consent 2
A sponsor requests that the IRB waive documentation of informed consent for a minimal-risk telephone survey.
Under 45 CFR 46.117(c), this waiver is permissible only if: