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The revised Common Rule (also referred to as the 2018 Requirements)1 at 45 CFR 46.116(h) requires that for each clinical trial conducted or supported by a federal department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the federal department or agency component conducting the trial. These instructions apply to clinical trials that are conducted or supported by HHS.
At this time, two federal websites have been identified as places where consent forms can be posted to satisfy 45 CFR 46.116(h): ClinicalTrials.gov2 and a designated docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).3 The awardee or the federal department or agency conducting the clinical trial may select either website to satisfy the posting requirement.
If ClinicalTrials.gov is selected, a consent form can only be uploaded if the clinical trial is also registered with that website. If the clinical trial is not already registered with ClinicalTrials.gov, then as part of ClinicalTrials.gov registration, information about the trial must be submitted4 and other requirements may be triggered. While the submission of information other than consent forms to ClinicalTrials.gov is not required by the Common Rule, the submission of this additional information is required by the ClinicalTrials.gov final rule, which implements the provisions of section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
As previously discussed, two federal websites have been identified as satisfying 45 CFR46.116(h): ClinicalTrials.gov and a designated docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).5Any clinical trial conducted or supported by HHS must use one of these websites to satisfy 45 CFR 46.116(h). Clinical trial consent forms may be posted to either location.
The 2018 Requirements state that a consent form must be posted to a designated federal website 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. While a consent form could be posted before a clinical trial closes recruitment, it does not satisfy the requirement at 45 CFR 46.116(h). If a consent form is posted before a clinical trial closes recruitment, it would have to be re-posted after the clinical trial closes recruitment in order for 45 CFR 46.116(h) to be satisfied.
A clinical trial could also close recruitment 61 or more days after the last study visit by any subject, as required by the protocol. This could happen, for example, if a clinical trial ends early because of safety concerns or because of low enrollment. The 2018 Requirements are silent on when a consent form must be posted in order to satisfy 45 CFR 46.116(h) in these circumstances. If a clinical trial closes recruitment 61 or more days after the last study visit by any subject as required by the protocol, OHRP recommends that posting should occur within 60 days of the clinical trial closing to recruitment.
In some circumstances, a clinical trial that an institution transitions to comply with the 2018 Requirements may have used a consent form that complies with the pre-2018 Requirements but not the 2018 Requirements in order to enroll subjects.9 Such consent forms may be posted to satisfy 45 CFR 46.116(h) so long as the form was used to enroll subjects.
If multiple awardees or multiple federal agency components are conducting the clinical trial, any one of these entities can post a clinical trial informed consent form to satisfy 45 CFR 46.116(h). In such scenarios, OHRP recommends that awardees or federal agency components reach agreement on which awardee or federal agency component will post a clinical trial informed consent form. As described previously, only one clinical trial informed consent form needs to be posted in order to satisfy 45 CFR 46.116(h).
Under 45 CFR 46.116(h)(2), if a federal department or agency conducting or supporting a clinical trial determines that certain information should not be made public on a federal website, the federal department or agency may permit or require redactions to the information posted. Redacted forms may be posted only if the federal department or agency conducting or supporting a trial has permitted or required the redactions.
The requirement for posting at 45 CFR 46.116(h) states that only one IRB-approved consent form used in subject enrollment must be posted for each clinical trial. More than one IRB-approved consent form used in subject enrollment may be posted, but only one is required.
Yes. Do not post any documents that have been signed by research subjects or that contain names of individual research subjects. No personally identifiable information (PII) or other patient information should be on the form.
45 CFR 46.116(h) requires that one IRB-approved consent form be posted for each clinical trial. Thus, for cooperative research where different versions of a consent form might be used at different sites, only one consent form must be posted. More than one IRB-approved informed consent form may be posted, but only one is required under the 2018 Requirements.
In this scenario, part of the clinical trial is being conducted by an HHS component. For this reason, 45 CFR 46.116(h) applies to the clinical trial as conducted at the HHS research institutions. Only one clinical trial consent form needs to be posted in order for the posting requirement to be satisfied for all HHS sites. The earliest that a consent form may be posted to satisfy 45 CFR 46.116(h) is when all HHS sites have closed to recruitment.
As previously described, under the 2018 Requirements it is up to the awardee or HHS component conducting the clinical trial to decide whether to post a clinical trial consent form to the designated docket folder on Regulations.gov or to ClinicalTrials.gov. (Note that additional posting locations might be identified in the future.)
One factor to consider in deciding where to post a form is whether the individual responsible for posting is the same as the responsible party who is required under the ClinicalTrials.gov final rule to update a clinical trial record. For example, if the cooperative research activity is industry-sponsored but involves an HHS research site or sites, the individual responsible for the ClinicalTrials.gov entry in accordance with the ClinicalTrials.gov final rule might not be associated with the HHS site(s). In that circumstance, the HHS research site(s) can use Regulations.gov to satisfy 45 CFR 46.116(h). Alternatively, the HHS research site(s) could work with the responsible party responsible for maintaining the ClinicalTrials.gov record to upload a consent form in accordance with 45 CFR 46.116(h) and the ClinicalTrials.gov final rule.
Yes. If a short form written consent procedure is used, then one copy of the short form and the study summary that was presented orally to subjects during subject enrollment (as required by 45 CFR 46.117(b)(2)) must be posted.
No. A clinical trial that is subject to the 2018 Requirements only because the institution has checked the box on its FWA is not required to comply with the consent form posting requirement at 45 CFR 46.116(h).
Candidate petitions are available to download and print at the links below, or in printed form through the Division of Elections. Printed petitions may be picked up by candidates or by another person on behalf of the candidate, or they can be mailed. Candidates requesting pre-filled forms should contact the Elections Division.
Petitions must be printed double-sided on 8.5 x 14 inch (legal size) paper so that:
The candidate consent form is a separate document from the candidate petition. The candidate must submit the consent form with the petitions when they are submitted to the Secretary of State. Each consent form is specific to the office being sought.
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