CTA Informed Consent Process 2 — Questions and Answers
Question 1: A participant who is illiterate wants to enroll in a clinical trial. Which approach is acceptable for obtaining informed consent?
- Skip the consent form since the participant cannot read it
- Have the participant sign an X and have a witness sign attesting to the verbal consent process (Correct answer)
- Allow a family member to sign the consent form on the participant's behalf without witness
- Obtain only verbal consent and document it in the medical record without a signature
Correct answer: Have the participant sign an X and have a witness sign attesting to the verbal consent process
For illiterate participants, an impartial witness must be present during the entire consent process and sign the form along with the participant's mark.
Question 2: What is the primary purpose of the 'cooling-off' period sometimes allowed between consent and enrollment?
- To allow the sponsor to review the consent form before the participant signs
- To give participants time to reconsider their decision and consult with others before committing (Correct answer)
- To allow the IRB to verify the participant's eligibility criteria
- To ensure the investigator has completed all required training
Correct answer: To give participants time to reconsider their decision and consult with others before committing
A cooling-off period gives participants adequate time to reflect on their decision and discuss participation with family or advisors without pressure.
Question 3: Under 21 CFR Part 50, which of the following constitutes a required element of informed consent?
- The total cost of the study drug to the sponsor
- A description of any reasonably foreseeable risks or discomforts (Correct answer)
- The names of all IRB members who reviewed the protocol
- The expected number of publications resulting from the study
Correct answer: A description of any reasonably foreseeable risks or discomforts
21 CFR 50.25(a)(2) requires disclosure of reasonably foreseeable risks or discomforts as a basic element of informed consent.
Question 4: A participant signs the consent form but then asks the study coordinator not to tell their spouse about their participation. How should the coordinator respond?
- Refuse enrollment since confidentiality cannot be guaranteed to the spouse
- Inform the participant that while their records are confidential, their personal health disclosures are their own choice (Correct answer)
- Contact the IRB immediately to report the participant's request
- Document the spouse as a legally authorized representative in the study records
Correct answer: Inform the participant that while their records are confidential, their personal health disclosures are their own choice
Confidentiality of study records is maintained by the research team; what participants share personally is their own decision.
Question 5: When must reconsent be obtained from a study participant?
- Only when the study drug is changed to a new manufacturer
- When a protocol amendment adds new risks or substantially changes the nature of participation (Correct answer)
- Every six months regardless of protocol changes
- When the principal investigator changes institutions
Correct answer: When a protocol amendment adds new risks or substantially changes the nature of participation
Reconsent is required when amendments introduce new information that could affect a participant's willingness to continue, such as new risks or significant procedural changes.
Question 6: Which statement best describes 'assent' in the context of pediatric clinical trials?
- Assent replaces parental permission for minors aged 7 and older
- Assent is the minor's affirmative agreement to participate, obtained in addition to parental permission (Correct answer)
- Assent is required only for adolescents aged 16 and older
- Assent is a legal document that grants the minor the same rights as an adult participant
Correct answer: Assent is the minor's affirmative agreement to participate, obtained in addition to parental permission
Assent is the child's affirmative agreement to participate and is obtained in addition to, not instead of, parental or guardian permission.
Question 7: A participant enrolled in a blinded study asks the investigator to reveal their treatment assignment. What is the most appropriate response?
- Immediately unblind the participant and document it as a protocol deviation
- Explain that unblinding is only done for medical necessity or at study end, per protocol procedures (Correct answer)
- Transfer the participant to a different site where their assignment can be revealed
- Notify the sponsor that the participant has withdrawn consent
Correct answer: Explain that unblinding is only done for medical necessity or at study end, per protocol procedures
Unblinding during a trial is generally reserved for medical emergencies or as defined by the protocol, and investigators should explain this to participants.
CTA Informed Consent Process 2
A participant who is illiterate wants to enroll in a clinical trial.
Which approach is acceptable for obtaining informed consent?