SOCRA - Society of Clinical Research Associates The Informed Consent Process Questions and Answers 2

Question 1

What are the eight required consent elements under 21 CFR 50.25(a)?

Accepted Answer

Purpose/procedures, risks, benefits, alternatives, confidentiality, injury compensation, contacts, voluntary participation

Answer

Only title and PI name

Answer

Only risks and benefits

Answer

Determined by each site

Question 2

What additional consent elements under 21 CFR 50.25(b)?

Accepted Answer

Unforeseeable risks, termination circumstances, additional costs, withdrawal consequences, new findings, and number of subjects

Answer

None exist

Answer

Only number of subjects

Answer

Never required

Question 3

How should consent be obtained from non-English speakers?

Accepted Answer

Certified translation or short form with witness and interpreter per 21 CFR 50.27

Answer

Cannot participate

Answer

Verbal consent sufficient

Answer

Family can translate

Question 4

When is re-consent required?

Accepted Answer

When significant new information arises that may affect willingness to continue

Answer

Never necessary

Answer

Only at completion

Answer

Only for safety events

Question 5

How should the consent process be documented?

Accepted Answer

A note documenting who obtained consent, that adequate time was given, and consent was voluntary

Answer

No documentation needed

Answer

Only signed form exists

Answer

Only if subject refuses

Question 6

What protections for subjects with diminished capacity?

Accepted Answer

LAR must consent, assent should be sought when possible, and additional safeguards in place

Answer

Cannot participate

Answer

No additional protections

Answer

Only investigator assessment