Joint FDA-OHRP Draft Guidance Details ‘Key Information’ in Informed Consent

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

By signing up for a tour of the Thompson FDA Compliance Expert Suite, you are also registering to receive email offers and product updates from us. Simply click unsubscribe at the bottom of any email if you would like to discontinue delivery.

Joint FDA-OHRP Draft Guidance Details ‘Key Information’ in Informed Consent

J.W. Schomisch

March 11, 2024 at 11:42 AM EST

The FDA and the Department of Health and Human Services’ Office for Human Research Protections (OHRP) released joint draft guidance March 1 addressing the revised Common Rule requirement to begin informed consent with “key information” to aid subject understanding. The draft guidance provides recommendations for developing a key information section for clinical trials or stud... Read More

My Research Folders

You are not Logged in yet, Please login to see Your research folders.

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

Joint FDA-OHRP Draft Guidance Details ‘Key Information’ in Informed Consent

My Research Folders

THOMPSON FDA

COMPLIANCE EXPERT

RESOURCES

HELP

CONTACT