SOCRA CCRP Exam - Topic 1 Question 13 Discussion

For IRB/IEC submissions, investigators must disclose subject-related information that may impact voluntariness or fairness of participation.

21 CFR 56.111(a)(3): The IRB must ensure that subject selection is equitable.

21 CFR 50.25(a)(3): Requires disclosure of ''any compensation and/or medical treatments available if injury occurs.''

ICH E6(R2) 4.8.10(n): Informed consent should describe ''any compensation and/or reimbursement to subjects.''

Thus, compensation amounts must be reviewed by IRB/IEC to ensure they are not coercive or excessive. Budgets (A), marketing plans (C), and contracts (D) are administrative and not part of IRB submission requirements.

Correct answer: B (The amount of payments and compensation to subjects).

21 CFR 50.25(a)(3).

ICH E6(R2), 4.8.10(n).