February 17, 2022
NOT-OD-10-019 - Update on the Requirement for Instruction in the Responsible Conduct of Researc
NOT-RR-11-005 - Modification of PAR-10-206: NCRR Science Education Partnership Award (SEPA) (R25)
NOT-OD-21-152 - Extension of COVID Flexibilities for Instruction in the Responsible Conduct of Research
NATIONAL INSTITUTES OF HEALTH (NIH)
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)
HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)
By way of this Notice, the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), and Health Resources & Services Administration (HRSA) reaffirm the principle that education in the responsible conduct of research is a fundamental element of research training and announce updates to their existing policy and guidance for such instruction. In particular, this Notice provides new recommendations on the format, frequency, and timing of instruction in the responsible conduct of research (RCR) and suggests additional topics for consideration.
Background and Related Information
NIH last updated its policy on RCR instruction in Fiscal Year 2010, with the publication of an NIH Guide Notice (NOT-OD-10-019) that reflected the evolution of biomedical research and incorporated experiences and lessons learned in the two decades since the introduction of the initial requirement for RCR instruction in National Research Service Award research training grants in 1990.
Since the 2010 update, both the 2018 NIH Strategic Plan for Data Science and the Federal Strategic Plan for STEM Education have underscored the need for further education and training in secure and ethical data use. More recently, in responding to the COVID public health emergency, universities have created new options for RCR instruction, leveraging advances in video conferencing and other technologies. Lastly, in late 2020, the Department of Health and Human Services (HHS) Office of Research Integrity gathered feedback from the research community about best practices, challenges, and needs related to teaching RCR and promoting research integrity.
Reflecting these developments, the HHS components that support research training and related activities are now providing new guidance on the format, frequency, and timing of RCR instruction, as well as additional topics for consideration. With the exception of the new recommendations for the RCR instructional components described below, the policy and guidance set forth in NOT-OD-10-019 remain in place.
Instructional Component Recommendations
Institutions are expected to begin to incorporate the changes described in this Notice into their plans for RCR instruction for the 2022-2023 academic year and in new and renewal applications for research training, career development, research education and dissertation research grants beginning with the September 25, 2022 due dates.
At the same time, institutions are reminded that as long as the COVID public health emergency continues, flexibilities in the method of instruction in the responsible conduct of research remain in place. RCR training may be completed fully online during the public health emergency and grant recipients need not seek prior approval to do so.
Francis D. Chesley, Jr., M.D.
Director, Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality