November 5, 2020
NOT-HS-20-005 - AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114 (b)
NOT-HS-19-008 - AHRQ Implementation of Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule)
NOT-HS-18-014 - AHRQ Implementation of the Burden-Reducing Provisions of the 2018 Common Rule
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)
The purpose of this Notice is to provide information to the extramural research community regarding AHRQ's implementation of the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP)’s determination of Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
Applicants, offerors, and recipients proposing or conducting AHRQ-funded research studies subject to the 2018requirements for the Federal Policy for the Protection of Human Subjects (also known as the "Common Rule") and its cooperative research provision (45 CFR 46.114(b)) and that are ongoing or initially reviewed by the Institutional Review Board (IRB) during the Coronavirus Disease 2019 (COVID-19) public health emergency, as declared by the Secretary of the Department of Health and Human Services athttps://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx, may request an exception to the use of a single IRB.
On October 8, 2020, as permitted by 45 CFR 46.114(b)(2)(ii), the Office for Human Research Protections (OHRP) issued its determination of Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (OHRP COVID-19 Exception Determination) (https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-exception-determinations/october-2020-exception-determination/index.html). The determination states that, for studies that are conducted or supported by HHS and subject to the 2018 Requirements, and for purposes of 45 CFR 46.114(b)(2)(ii), an exception to the requirement to use a single IRB is appropriate for the following category:
1. that is ongoing or initially reviewed by the IRB during the Coronavirus Disease 2019 (COVID-19)
public health emergency, as declared by the Secretary of Health and Human Services at
2. where reliance on a single IRB would not be practical; and
3. for which the HHS division supporting or conducting the research approves of the use of this exception.
For as long as the OHRP's determination is in place, AHRQ will not require use of a single IRB for AHRQ-funded research that qualifies for an exception as outlined in the OHRP COVID-19 Exception Determination and for which the use of the exception is approved by AHRQ. Approved exceptions apply for the duration of the AHRQ-conducted or supported research.
Requesting an Exception to Use of a Single IRB
AHRQ will consider exception requests for studies subject to the 2018 requirements. To request an exception to use of a single IRB, eligible applicants, offerors, or recipients for AHRQ-conducted or supported cooperative research must submit an exception request to AHRQ, including justification as to why the study meets the exception criteria defined by OHRP. Applicants, offerors, and recipients must include the name of the site(s) for which an IRB other than the single IRB of record is proposed to review the study for the site(s).
Pre-Award Exception Requests
Applicants who wish to seek an exception must provide the exception request and accompanying justification in section 3.2, titled, "Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site" under G 500- PHS Human Subjects and Clinical Trials Information in the grant application (https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general/g.500-phs-human-subjects-and-clinical-trials-information.htm#3.2). Applicants should name the PDF document ‘SIRBexceptionrequest.pdf.’ and follow instructions in section 3.2 for AHRQ applicants to submit an exception request, instead of a single IRB plan.
Offerors shall follow the instructions that are contained in the Request for Proposal (RFP) for submitting an exception request, instead of a single IRB plan.
Note that the proposed budget in the application or contract proposal must reflect all necessary single IRB costs without an approved exception. Applicants and offerors should not assume that an exception will be granted when considering what single IRB costs to include in the budget.
Post-Award Exception Request
Grant and cooperative agreement recipients seeking an exception to use of single IRB post-award should submit a prior approval request in writing, to the AHRQ Grants Management Specialist (GMS) listed on the Notice of Award (NOA), no later than 30 days before the proposed change, and signed by the Authorized Organization Representative (AOR).
AHRQ contract recipients are not eligible for post-award exceptions and may not submit such requests.
Notice of Approval or Disapproval of Request
AHRQ applicants, offerors, and recipients will be notified of the final decision by AHRQ's Division of Grants Management or the Contracting Officer (CO), prior to award. Applicants and offerors should not assume an exception is granted unless notified of approval. For both grant applications and contracts, the award budget may need to be adjusted if an exception is approved.
Note: This exception does not prevent, nor should it be viewed as discouraging, the voluntary use of a single IRB in cooperative research subject to the 2018 Requirements.
Hope Hongzhu He, JD, MPA, MA
Human Protections Administrator
Agency for Healthcare Research and Quality
Telephone: (301) 427-1905