US requires informed consent forms for clinical studies to be posted online

Simon Collins, HIV i-Base

US studies now require informed consent sheets for clinical studies to be available on as US Federal website as open access documents.

This is an important move for greater transparency in clinical research that should be routinely adopted for all studies.

This change is mainly for new studies (enrolling after 19 January 2019).

The new requirements were published in the electronic Code of Federal Regulations on 20 December 2018.

Unfortunately, this requirement only becomes mandatory after studies have closed to recruitment and no later than 60 days after the last study visit by any participant. It is a good move, but  is still a long way from full transparency.

References and further information

Clinical trial informed consent form posting (45 CFR 46.116(h))

Revised common rule educational materials

Revised common rule Q&As

Links to other websites are current at date of posting but not maintained.