Notice Number: NOT-HS-19-008

Key Dates
Release Date: January 11, 2019

PA-20-070
PA-20-072
NOT-HS-18-014
NOT-HS-19-023
NOT-HS-20-005
NOT-HS-21-002
RFA-HS-20-002
RFA-HS-20-003 - Novel, High-Impact Studies Evaluating Health System and Healthcare Professional Responsiveness to COVID-19 (R01)

Issued by
Agency for Healthcare Research and Quality (AHRQ)

Purpose

The purpose of this notice is to provide guidance to the extramural research community regarding the implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Revised Common Rule). 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 the general compliance date until January 21, 2019.

As of January 21, 2019, studies initiated on or after that date, ongoing studies that voluntarily transitioned to the Revised Common Rule, 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 for the remainder of the study. For such studies, please note the following changes in AHRQ policies and procedures:

1. AHRQ will no longer require IRB review of grant applications or other funding proposals. However, certification of IRB review will still be required for all AHRQ-supported non-exempt human subjects research studies, and recipients must still provide certification to AHRQ that the research protocol has been reviewed and approved by the IRB.

2. For AHRQ-funded or supported clinical trials, informed consent documents must be posted on a public federal website after recruitment closes and no later than 60 days after the last study visit. For additional guidance, refer to the OHRP Revised Common Rule Q&As on Informed Consent at https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html#informed-consent.

3. Applications or proposals that include studies to which the Revised Common Rule applies should take note of changes to categories of research qualifying for exemption and take care to select the appropriate category. For additional guidance, refer to the OHRP Revised Common Rule Q&As on Exemptions at https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html#exemptions.

4. For applications submitted for due dates on or after January 25, 2019, AHRQ will transition from E (e.g. E4) to "X codes (e.g. X4) to reflect categories of exempt research. Those submitting applications for due dates on or after January 25, 2019 will have the option of selecting exemption 7 or 8, if applicable. Applicants may see these changes in applications, summary statements, and progress reports.

5. Unless otherwise specified in the Funding Opportunity Announcement or solicitation, AHRQ will no longer require continuing review for studies unless continuing review is required by the Revised Common Rule or other federal, state, or local regulation or policy.

Additional details, including requirements and processes for adopting the new provisions, can be found in the Final Rule (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html).

Inquiries

Please direct all inquiries to:

Hope Hongzhu He, JD, MPA, MA
Human Protections Administrator (HPA)
Agency for Healthcare Research and Quality (AHRQ)/ HHS
Office of Extramural Research, Education, and Priority Populations (OEREP)
E-mail: HopeHongzhu.He@ahrq.hhs.gov