FDA Invites Comments on Guidelines for Informed Consent


The United States Food and Drug Administration is inviting comments on its new draft guidelines for informed consent. “This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA’s informed consent regulations,” states their introduction. “Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation.” The goal of the new guidelines, the FDA states, is “to enhance human subject protection and reduce regulatory burden.” Comments can be submitted to the FDA until September 15, 2014.

Instructions for providing comments are available at the FDA website.

Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors – Draft Guidance (US Food and Drug Administration, July 2014)

Support MIA

MIA relies on the support of its readers to exist. Please consider a donation to help us provide news, essays, podcasts and continuing education courses that explore alternatives to the current paradigm of psychiatric care. Your tax-deductible donation will help build a community devoted to creating such change.

Select Payment Method
Personal Info

Credit Card Info
This is a secure SSL encrypted payment.

Billing Details

Donation Total: $20 One Time