Protection of Human Subjects
Revised Common Rule
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). A final rule was published in the Federal Register (FR) on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018, and June 19, 2018. The revised Common Rule is effective July 19, 2018. A Final Rule was issued on June 18, 2018 to delay the general compliance date of the Revised Common Rule until January 21, 2019. The Final Rule provides regulated entities with the option to implement three burden-reducing provisions during the delay period (July 19, 2018, through January 20, 2019). Go to AHRQ Guide Notice at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-18-014.html.
The general compliance date of the revised Common Rule remains January 21, 2019. This means that HHS-conducted or supported research initiated on or after January 21, 2019, and studies that voluntarily implemented the three burden-reducing provisions during the delay period (July 19, 2018, through January 20, 2019), are expected to comply with all Revised Common Rule requirements.
View an official version of the 2018 Requirements in 45 CFR 46 of the July 19, 2018, edition of the e-Code of Federal Regulations.
Posting Clinical Trial Informed Consent Form (45 CFR 46.116(h))
The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available Federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision.
Refer to the Office for Human Research Protections (OHRP)’s guidance on Clinical Trial Informed Consent Form Posting (45 CFR 46.116(h)).
AHRQ Guidance on Posting Informed Consent Forms for AHRQ-Funded Clinical Trials.
Single IRB Requirement
The Revised Common Rule, at 45 CFR 46.114 (b) (cooperative research), requires all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency rely upon approval by a single IRB for the portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. Reliance on a single IRB of record in cooperative research is required beginning January 20, 2020, unless the study meets the criteria for an exception described in §46.114(b)(2) of the Revised Common Rule.
For more information on exceptions that apply to HHS supported or conducted research protocols, refer to HHS’ exception determinations at https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/114b-exception1/index.html.
OHRP's guide on the single IRB requirement.
AHRQ Guide Notices
AHRQ Implementation of the Burden-Reducing Provisions of the 2018 Common Rule.
AHRQ Guidance on Posting Informed Consent Forms for AHRQ-Funded Clinical Trials.
Pre-2018 Requirements
OHRP Guidance on the Federal Policy for the Protection of Human Subjects
OHRP Guidance on the Federal Policy for the Protection of Human Subjects (the Common Rule).
On April 9, 2020, OHRP issued "OHRP Guidance on COVID-19." The guidance responds to questions OHRP received from the research community regarding how the Department of Health and Human Services (HHS) human subjects protection regulations (45 CFR part 46) apply to actions taken by institutions and investigators in response to the COVID-19 outbreak. OHRP offers guidance on the following topics: (i) Public Health and Clinical Activities; (ii) Excluded Public Health Surveillance Activities; (iii) Legally Required Reporting; (iv) Research Changes to Eliminate Apparent Immediate Hazards; (v) Proposing and Reviewing Study Changes; and (vi) Whether Suspensions of Research Must be Reported. The guidance document can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html.
