Where to Post Informed Consent Forms for NIH-Funded Clinical Trials

The revised Common Rule requires that an IRB-approved version of an informed consent form be posted on a public federal website for all NIH-funded clinical trials. This must be done after enrollment ends and within 60 days of the last study visit. See Guide Notice NOT-OD-19-050. NIH has just released additional guidance regarding which federal websites allow for the posting of these informed consent forms.   ClinicalTrials.gov You can upload an IRB-approved version of the form to the ClinicalTrials.gov study record. Note that ClinicalTrials.gov does not accept non-English documents. Be sure to follow the Protocol Registration and Results System (PRS) instructions for document uploads at https://prsinfo.clinicaltrials.gov/results_definitions.html#DocumentUpload Regulations.gov You can upload an IRB-approved version of the form to Regulations.gov Docket ID: HHS-OPHS-2018-0021.Instructions for uploading can be found on the OHRP website at https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.htmlBe sure to maintain a copy of your Regulations.gov receipt. Refer to the Posting Informed Consent webpage for additional resources.
Source: NIH Extramural Nexus - Category: Research Authors: Tags: Policy Top Stories Clinical Trials Clinicaltrials.gov informed consent regulations.gov Source Type: funding