By Norma Rodriguez, VP, QA & Regulatory, Greenphire
The FDA has issued a guidance document reinforcing the responsibility of the Institutional Review Board (IRB) as it relates to the assessment of clinical trial procedures, specifically emphasizing the importance of analyzing study participant payments in order to reduce the likelihood of coercion.
Within this guidance, the FDA notes the significance of the IRB’s role in reviewing the potential risks and benefits involved in a clinical trial. With a focus on protecting the interests of participants, the determined risks and benefits, including payment details, should be reasonable and clearly defined within the consent documentation to adequately inform participants of the study procedures.
The FDA identifies participant payments into two categories:
- Payment for study participation
- Study travel reimbursement