SOCRA The Informed Consent Process 3 — Questions and Answers
Question 1: Which condition must be met for an IRB to approve a waiver of informed consent for research under 45 CFR 46.116(f)?
- The research must involve only healthy volunteers
- The research could not practicably be carried out without the waiver (Correct answer)
- The sponsor must request the waiver in writing
- The study must be double-blinded
Correct answer: The research could not practicably be carried out without the waiver
One key criterion for a consent waiver is that the research could not practicably be carried out without the waiver of informed consent.
Question 2: What is 'therapeutic misconception' in the context of informed consent?
- When subjects believe placebos will cure their disease
- When subjects confuse research participation with receiving individualized medical care (Correct answer)
- When investigators withhold treatment information
- When sponsors misrepresent study benefits in advertising
Correct answer: When subjects confuse research participation with receiving individualized medical care
Therapeutic misconception occurs when subjects fail to understand that the goal of research is to generate generalizable knowledge, not to optimize their individual care.
Question 3: Under FDA regulations, how long must signed informed consent documents be retained?
- 2 years after the study ends
- 3 years after completion of the study
- At least 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued (Correct answer)
- 5 years after the last subject's last visit
Correct answer: At least 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued
21 CFR 312.62 requires retention of consent documents for at least 2 years after approval of a marketing application or 2 years after the investigation is discontinued.
Question 4: A CRC discovers that an enrolled subject did not fully understand the risks when signing consent. What is the most appropriate immediate action?
- Withdraw the subject from the study immediately
- Notify the sponsor and await instructions
- Re-consent the subject with a thorough explanation of all risks before any further study procedures (Correct answer)
- Document the finding and continue study procedures
Correct answer: Re-consent the subject with a thorough explanation of all risks before any further study procedures
The ethical obligation requires re-consenting the subject and ensuring full comprehension before any further study-related procedures are conducted.
Question 5: Which of the following is an example of undue influence in the consent process?
- Providing a subject with a bus pass to cover travel costs
- A physician-investigator implying poorer care will result if the patient refuses to enroll (Correct answer)
- Offering fair market value compensation for study participation
- Explaining all risks clearly in simple language
Correct answer: A physician-investigator implying poorer care will result if the patient refuses to enroll
Undue influence occurs when a person in authority implies negative consequences for non-participation, compromising truly voluntary consent.
Question 6: In emergency research under 21 CFR 50.24, what must occur within how many days after enrollment without consent?
- The subject or LAR must be informed within 5 business days
- The IRB must be notified within 3 working days
- The community must be notified within 30 days of study closure
- The subject or LAR must be asked for consent as soon as feasible (Correct answer)
Correct answer: The subject or LAR must be asked for consent as soon as feasible
Under 21 CFR 50.24, consent from the subject or LAR must be sought as soon as feasible once the emergency situation allows.
Question 7: When must an investigator obtain re-consent from a study subject?
- Only when the study sponsor requests it
- When there is a protocol amendment that materially affects subject risk or willingness to participate (Correct answer)
- Re-consent is never required once initial consent is obtained
- Only when the IRB conducts a continuing review
Correct answer: When there is a protocol amendment that materially affects subject risk or willingness to participate
Re-consent is required when protocol changes or new information significantly impact subject risk or could affect a subject's decision to continue participating.
SOCRA The Informed Consent Process 3
Which condition must be met for an IRB to approve a waiver of informed consent for research under 45 CFR 46.116(f)?