SOCRA - Society of Clinical Research Associates The Informed Consent Process Questions and Answers 2 — Questions and Answers
Question 1: What are the eight required consent elements under 21 CFR 50.25(a)?
- Only title and PI name
- Purpose/procedures, risks, benefits, alternatives, confidentiality, injury compensation, contacts, voluntary participation (Correct answer)
- Only risks and benefits
- Determined by each site
Correct answer: Purpose/procedures, risks, benefits, alternatives, confidentiality, injury compensation, contacts, voluntary participation
The eight elements: research description, risks, benefits, alternatives, confidentiality, injury compensation, contacts, voluntary participation.
(1) Research description with procedures, (2) foreseeable risks, (3) expected benefits, (4) alternative treatments, (5) confidentiality provisions, (6) compensation for injury, (7) contact information, (8) voluntary participation statement.
Question 2: What additional consent elements under 21 CFR 50.25(b)?
- None exist
- Unforeseeable risks, termination circumstances, additional costs, withdrawal consequences, new findings, and number of subjects (Correct answer)
- Only number of subjects
- Never required
Correct answer: Unforeseeable risks, termination circumstances, additional costs, withdrawal consequences, new findings, and number of subjects
Six additional elements: unforeseeable risks, termination, costs, withdrawal consequences, new findings, and number of subjects.
(1) Unforeseeable risks, (2) investigator-initiated termination circumstances, (3) additional costs, (4) consequences of withdrawal, (5) significant new findings will be provided, (6) approximate number of subjects.
Question 3: How should consent be obtained from non-English speakers?
- Cannot participate
- Certified translation or short form with witness and interpreter per 21 CFR 50.27 (Correct answer)
- Verbal consent sufficient
- Family can translate
Correct answer: Certified translation or short form with witness and interpreter per 21 CFR 50.27
Either a certified translation of the full form or a short form in their language with a witness.
Full translation: entire form translated, subject signs translated version. Short form: form in subject's language states elements were presented orally, witness attends entire presentation, both sign. IRB approval needed.
Question 4: When is re-consent required?
- Never necessary
- When significant new information arises that may affect willingness to continue (Correct answer)
- Only at completion
- Only for safety events
Correct answer: When significant new information arises that may affect willingness to continue
Required when new information could affect willingness, including safety findings, protocol amendments, or risk/benefit changes.
Required for protocol amendments changing procedures/risks, new DSMB safety information, IND safety reports, and IB updates. Process: IRB approval, identify affected subjects, discuss, document, and sign updated form.
Question 5: How should the consent process be documented?
- No documentation needed
- A note documenting who obtained consent, that adequate time was given, and consent was voluntary (Correct answer)
- Only signed form exists
- Only if subject refuses
Correct answer: A note documenting who obtained consent, that adequate time was given, and consent was voluntary
Best practice: document who conducted the discussion, that questions were answered, and consent was voluntary.
Include who conducted discussion, date/time, adequate time given, questions answered, subject appeared to understand, consent was voluntary, and any concerns raised. Supports the signed form as evidence of a meaningful process.
Question 6: What protections for subjects with diminished capacity?
- Cannot participate
- LAR must consent, assent should be sought when possible, and additional safeguards in place (Correct answer)
- No additional protections
- Only investigator assessment
Correct answer: LAR must consent, assent should be sought when possible, and additional safeguards in place
LAR consent required, assent sought when feasible, and additional safeguards such as independent advocates may be needed.
Protections: capacity assessment, LAR consent, seeking assent, information in understandable format, IRB review, possible independent advocates, enhanced monitoring, and re-assessment if capacity improves.
SOCRA - Society of Clinical Research Associates The Informed Consent Process Questions and Answers 2
What are the eight required consent elements under 21 CFR 50.25(a)?