Common Rule Bulletin #5: Posting of ICFs

NIH OFFICE OF HUMAN SUBJECTS RESEARCH PROTECTIONS (OHSRP) GUIDANCE ON THE REVISED COMMON RULE

Common Rule Bulletin #5: Informed Consent Requirements – Posting of Informed Consents

The revised Common Rule (rCR), referred to as the “2018 requirements” or sometimes as “the Final Rule”, contains several new provisions that take effect for all new research reviewed on and after January 21, 2019. Note: This guidance is intended for use by the NIH Intramural Research Program (IRP) and may be superseded by future NIH guidance or policy, or guidance issued by the Office for Human Research Protections (OHRP).

A subset of the changes affects informed consent and this document aims to provide research teams with guidance on our current understanding of the new informed consent provisions and how to operationalize them so that informed consent procedures are compliant with the regulations.

This guidance is focused on the requirement under the rCR, that after the clinical trial is closed to new enrollment, one (1) copy of the IRB-approved informed consent used to recruit subjects to a clinical trial, be posted in a publicly available Federal website. [45 CFR 46.116(h)]

Summary of Informed Consent Posting Requirements

This new requirement is now included at 45 CFR 46.116(h) states:

For each clinical trial conducted or supported by a Federal department or agency:

1) One IRB-approved informed consent form used to enroll subjects must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available Federal Web site that will be established as a repository for such informed consent forms.

2) 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 Web site (e.g. confidential commercial information), such Federal department or agency may permit or require redactions to the information posted.

3) The informed consent form must be posted on the Federal Web site 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.

Background

By posting informed consent documents in the public domain, this new requirement is intended to increase transparency regarding informed consent language and organization and ultimately to improve the quality of informed consent documents for research subjects and their families.

The new requirement at 45 CFR 46.116(h) is required for protocols that meet the definition of a clinical trial, that are supported by a Federal agency. Under the regulation a clinical trial is defined as “…A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”

The regulation does not state which informed consent document should be posted, or that the final version of the informed consent document be posted, only that one (1) IRB-approved informed consent used to recruit subjects, must be posted. Further the regulation does not explain which informed consent document used on a multisite clinical trial must be posted, only that one (1) must be posted. There are no specifications that there be one posted per site, or by cohort, or which cohort.

The regulation allows for certain confidential information to be redacted at the time of posting. The example cites confidential commercial information. Note that the regulation does not allow for exceptions to the requirement for posting, only permitted or required redaction of certain confidential information by the agency.

The regulation requires that the PI or the institution must post the consent.

The informed consent document must be posted after the study is closed to recruitment, and within 60 days of the last study visit by any subject on the trial. In other words, after the study closes to enrollment of new subjects, and within 60 days of the first subject completing his or her last study visit, after enrollment has ceased. This should not be confused with study closure, which occurs for example, after all subject activities have ceased and the primary endpoint analysis is also completed. Also, if an Institutional Review Board terminates a protocol prematurely, or closes it to enrollment, then the clock starts for posting as described above.

The consent document must be posted on a Federal website that is intended as an informed consent document repository. OHRP has identified 2 sites that will meet this requirement, clinicaltrials.gov and regulations.gov.

How will these requirements be implemented at the NIH?

The NIH is a Federal agency, so all NIH clinical trials meeting the definition above, must post at least one (1) IRB-approved informed consent document used to recruit subjects to clinicaltrials.gov.

At the NIH, the PI is responsible to ensure that the consent is posted within the required timeframes. The PI should work with the IC, if there are questions.