US requires informed consent forms for clinical studies to be posted online
12 March 2019. Related: Research studies, Other news.
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))
https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html
Revised common rule educational materials
https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html
Revised common rule Q&As
https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html