For studies subject to the 2018 Requirements, if a VA research study is a clinical trial, one IRB-approved informed consent form used to enroll subjects, unless the IRB waived documentation of informed consent, must be posted by either the investigator or the Federal department or agency conducting or supporting the study. The informed consent form must be posted after the clinical trial is closed to recruitment and no later than 60 days after the last study visit by any subject as described in the IRB-approved protocol. For multi-site studies, it applies when the entire study has closed to subject recruitment. Any proprietary or personal information (such as names and phone numbers) must be redacted prior to posting the informed consent form.

• For any ORD-funded clinical trial, the applicable ORD funding service will be responsible for posting the informed consent form.
• For a clinical trial funded or supported by a Federal agency or department other than VA, the awardee is responsible for posting the informed consent form.
• For a clinical trial funded or supported by a non-Federal agency or department (e.g., university, industry, nonprofit organization) or not funded, the VA Investigator conducting the clinical trial is responsible for ensuring that the informed consent form is posted. If the clinical trial includes multiple sites engaged in the clinical trial, an agreement must exist specifying who is responsible for posting the informed consent form.