Contrary to current practices, under which consent documents are not freely accessible, the posting requirement subjects the documents to public scrutiny and provides a means for accessing useful consent models. The impetus for the requirement is to:
| Question | Instructions |
|---|---|
| Scope | ONLY applies to clinical trials conducted or supported by Federal Common Rule Agencies approved by the University of Kentucky (UK) Institutional Review Board (IRB) after January 22, 2019. (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. |
| Who? | The awardee |
| What? | Post one IRB-approved, blank informed consent form used to enroll subjects |
| When? | After the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol. |
| Where? |
On a publicly available Federal website:
|
| How? | See Office for Human Research Protections (OHRP) Guidance On Clinical Trial Informed Consent Form Posting |
| Redactions | If the Federal department or agency supporting or conducting the clinical trial determines that certain information should not be made publicly available on a Federal website (e.g., confidential commercial information), such Federal department or agency may permit or require redactions to the information posted. |
| Assistance | For University of Kentucky ClinicalTrials.GOV access, contact the Clinical Research Support Office (CRSO), Clinical Trials Compliance Administrator/UK PRS Administrator. |
