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.html
- Be sure to maintain a copy of your Regulations.gov receipt.
Refer to the Posting Informed Consent webpage for additional resources.
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