OHRP Releases Information on Clinical Trial Consent Form Posting, GDPR Guidance
As part of the revisions to the Common Rule (the set of regulations that govern research involving human participants) going into full effect in January 2019 (see COSSA’s coverage for more details), clinical trials covered by these regulations must publicly post copies of the consent forms used to enroll participants. The Office of Human Research Protections (OHRP) has announced that these consent forms must be posted either on clinicaltrials.gov or to a docket folder on regulations.gov (docket ID: HHS-OPHS-2018-0021).
OHRP has also made available guidance related to the European General Data Protection Directive (GDPR) to assist stakeholders conducting human subjects research in the E.U. The compilation is available on the OHRP website.