Notice Number: NOT-HS-19-023

Key Dates
Release Date: October 11, 2019

Issued by
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)

Purpose

The purpose of this notice is to provide guidance to AHRQ grant applicants regarding posting of clinical trial informed consent forms, as required by the Final Rule amending the Federal Policy for the Protection of Human Subjects (Revised Common Rule) (Subpart A of 45 CFR 46). The HHS Office of Human Research Protections (OHRP) published the Final Rule in the Federal Register on January 19, 2017 and amended the Final Rule to delay implementation until January 21, 2019.

For clinical trials conducted by or supported by a Federal department or agency, Section 46.116(h) of the Revised Common Rule requires the posting of an IRB-approved consent form on a public federal website designated for posting such consent forms. The Office of Human Research Protection (OHRP) has identified ClinicalTrials.gov and Regulations.gov as the publicly available federal websites that will satisfy the consent form posting requirement (https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/)

To fulfill this requirement, recipients conducting AHRQ-funded clinical trials must submit one IRB-approved version of a consent form that has been used to enroll participants to either ClinicalTrials.gov, or the Regulations.gov website. AHRQ recipients submitting informed consent forms to Regulations.gov should maintain a copy of their receipt and tracking number. Additional instructions for posting clinical trial informed consent forms are available at https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/.

Institutions submitting documents to either ClinicalTrials.gov or Regulations.gov must protect participant privacy in accordance with applicable federal, state, and local laws and regulations (e.g., the HIPAA Privacy Rule, AHRQ Confidentiality Statute) and any applicable terms of their AHRQ award.

Resources

1. View an official version of the Final Rule in 45 CFR 46 at https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML.

2. OHRP webpage with information of the Revised Common Rule's clinical trial informed consent form posting requirement:

https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/

Inquiries

Please direct all inquiries to:

Hope Hongzhu He
Office of Extramural Research, Education, and Priority Populations (OEREP)
Telephone: 301-421-1905
Email:[email protected]