Notice Number: NOT-OD-10-019
Update: The following update relating to this announcement has been issued:
Release Date: November 24, 2009
NOT-OD-22-055 - FY 2022 Updated Guidance: Requirement for Instruction in the Responsible Conduct of Research.
PA-22-051 - AHRQ Mentored Career Enhancement Awards for Established Investigators in Patient-Centered Outcome Research (K18)
PA-22-050 - AHRQ Patient-Centered Outcomes Research (PCOR) Mentored Clinical Scientist Career Development Award (K08)
PA-22-049 - AHRQ Patient-Centered Outcomes Research (PCOR) Mentored Research Scientist Career Development Award (K01)NOT-OD-16-122
National Institutes of Health (NIH), (http://www.nih.gov)
The purpose of this Notice is to update NIH policy on instruction in the responsible conduct of research, convey some of the consensus best practices that have evolved in the research training community over the past two decades, and to provide access to additional information that may be useful to institutions and individuals in meeting their obligations under NIH policy. Specifically this Notice: 1) develops principles based on 20 years’ experience of providing instruction in responsible conduct of research by the scientific research community; 2) is more specific about who should participate, how often instruction should occur, and the form that instruction should take; 3) addresses issues that have arisen as the practice of biomedical, behavioral and clinical science has evolved; and 4) provides guidance to applicants, peer reviewers and NIH staff in determining how well specific plans for instruction in responsible conduct of research compare with the best practices accumulated over the past two decades by the research training community.
This Notice applies to all NIH Institutional Research Training Grants, Individual Fellowship Awards, Career Development Awards (Institutional and Individual), Research Education Grants, Dissertation Research Grants, or other grant programs with a training component that requires instruction in responsible conduct of research as noted in the Funding Opportunity Announcement.
In 1989, the NIH published its first Notice of policy concerning instruction in responsible conduct of research in the NIH Guide (Volume 18; Number 45. December 22). This Notice required that institutional training grant applications include a description of activities related to instruction about responsible conduct of research. A subsequent Notice (NOT-OD-94-200 NIH Guide Volume 23, Number 23, June 17), published in 1994, updated all previous Notices and required that applications for institutional research training grants lacking a plan for instruction in responsible conduct of research be returned without review, established review procedures, and established the minimum requirements for an acceptable plan. Similar requirements were subsequently adopted for instruction via research education grants, individual fellowships, and career awards as funding opportunity announcements for these programs were published.
In the ensuing years, there have been a number of developments related to instruction in responsible conduct of research. The scientific community has responded by developing innovative courses, workshops, research projects on instruction in responsible conduct of research, and instructional materials. Congress has enacted laws establishing the Office of Research Integrity to promote integrity in biomedical and behavioral research supported by the U.S. Public Health Service. The NIH Institutes and Centers (ICs), NIH peer review committees, and the scientific communities participating in NIH research have all evolved standards for what constitutes responsible conduct of research and an acceptable plan for instruction in this area. Legislation in this area initially focused on activities that fall under the formal definition of Research Misconduct. Federal Regulations define Research Misconduct as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results (http://ori.hhs.gov/documents/42_cfr_parts_50_and_93_2005.pdf). It does not include honest error or honest differences in interpretations or judgments of data. However, it is well appreciated by all that responsible conduct, as opposed to misconduct, encompasses many other aspects of ethical behavior in the practice of scientific research.
The practice of biomedical research continues to evolve in terms of the interaction of participants (team research) and participating disciplines, emerging technologies in both the laboratory and in the publishing arena, and in the interactions of academic, medical, and for-profit enterprises. Acknowledging these changes, and drawing on the experiences of the past two decades, this Notice clarifies and updates NIH policy on instruction in responsible conduct of research.
For the purpose of this Notice, responsible conduct of research is defined as the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.
The following principles are based on several key concepts about responsible conduct of research and best practices that have evolved over the past two decades’ experiences:
NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research. This policy will take effect with all new and renewal applications submitted on or after January 25, 2010, and for all continuation (Type 5) applications with deadlines on or after January 1, 2011. This Notice applies to the following programs: D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R. This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.
NIH recognizes that instruction in responsible conduct of research occurs formally and informally in educational settings and that informal instruction occurs throughout the research training experience. The guidance provided below is directed at formal instruction in responsible conduct of research. It reflects the accumulated experiences and the best practices of the scientific community over the past two decades. These practices have been incorporated into many of the best regarded programs of instruction in responsible conduct of research.
While courses related to professional ethics, ethical issues in clinical research, or research involving vertebrate animals may form a part of instruction in responsible conduct of research, they generally are not sufficient to cover all of the above topics. Additional detail regarding subject matter is available under Resources.
Special Considerations by Type of Award
Institutional training and institutional career development programs (for example, T15, T32, T34, T90/R90, TL1, K12, or K30 programs): Institutional programs are encouraged to provide instruction in responsible conduct of research for all individuals associated with the program of training regardless of their source of support.
Short-term training and research education programs (for example, T35 and R25 programs lasting six or fewer months, short-term trainees supported on T15, T32 and T34 programs, and short-term participants in R25 programs): The NIH recognizes that the duration of an institutional training or research education program should be considered in the design, implementation, and review of plans for instruction in responsible conduct of research. The duration of such instruction within short-term institutional programs should be appropriate for the total duration of the program and should be justified in the application. This is an instance where on-line instruction could be appropriate. Such programs may also use innovative strategies to incorporate instruction in responsible conduct of research and to relate instruction in responsible conduct of research to the scientific focus of the short-term program.
Individual awards: In keeping with the individual nature of these programs, fellows and scholars, along with their institutions and sponsors/mentors, are encouraged to tailor instruction in responsible conduct of research to the needs of the individual. Thus, instruction may go beyond formal institutional courses and provide opportunities for the individual to develop their own scholarly understanding of the ethical issues associated with their research activities and their impact on society. An individualized plan would also be appropriate in the rare instance where an institution does not have an established formal mechanism for such instruction.
Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process or not reviewed.
Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address the five Instructional Components (Format, Subject Matter, Faculty Participation, Duration and Frequency) taking into account the characteristics of institutional programs or the unique circumstances outlined for short-term training programs, individual fellowships, career awards, and research education programs. The review will be guided ultimately by the principles set forth at the beginning of this Notice.
The plan for instruction in responsible conduct of research and the past record of instruction in responsible conduct of research, where applicable, will be discussed after the overall determination of merit of the application at large; the review panel’s evaluation of the plan will not be a factor in the determination of the impact/priority score. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. The results of the review of the plan for instruction in responsible conduct of research and the past record of instruction in responsible conduct of research, where applicable, will be reported as an administrative note in the summary statement and will explain how the review panel determined its rating. Regardless of the impact/priority score, applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan. Institute or Center staff will apply the principles set forth at the beginning of this Notice to determine the acceptability of the revised plan.
For Institutional Training, Education, and Institutional Career Development Awards:
Continuation (Type 5) applications must describe the nature of the instruction in responsible conduct of research and the extent of trainee and faculty participation as required in the PHS 2590. This report must include a description of any enhancements and/or modifications to the five instructional components from the plan described in the awarded application. Specific training faculty members who were contributors to formal instruction in responsible conduct of research during the last budget period must be named.
For Individual Fellowships:
Continuation (Type 5) applications must report specifically on instruction for the fellow in responsible conduct of research. This report must include subject matter covered, format, frequency and duration of instruction, or indicate when during a previous or future budget period instruction in responsible conduct of research did or will take place. The report should discuss both formal and/or informal instruction in responsible conduct of research and should note the extent to which the sponsor or senior fellow participated in these activities.
For Individual Career Development Awards:
Continuation (Type 5) applications must include a description of instruction in responsible conduct of research as required in the PHS 2590. This report should describe instruction, or participation as a course director, etc. in the case of senior career awardees, in both formal and informal instruction in responsible conduct of research in the past budget period, if applicable. If instruction, or participation as a course director, etc., occurred in a prior budget period, the PI should note the date of occurrence. Any activities undertaken to individualize instruction appropriate to the career stage of the PI should be discussed.
For Dissertation Awards (R36):
Continuation (Type 5) applications must report on instruction in responsible conduct of research under a separate heading. This section should describe participation in both formal and informal instruction in responsible conduct of research in the past budget period, where applicable. If instruction occurred in a prior budget period, the PI should note the date when formal instruction was last completed. Any activities undertaken to individualize instruction appropriate to the career stage of the PI should be discussed. The report will describe how the mentor participated in these activities.
NIH policy requires participation in and successful completion of instruction in responsible conduct of research by individuals supported by any NIH training/research education/fellowship/career award. It is expected that course attendance is monitored and that a certificate or documentation of participation is available upon course completion. NIH does not require certification of compliance or submission of documentation, but expects institutions to maintain records sufficient to demonstrate that NIH-supported trainees, fellows, and scholars have received the required instruction.
The NIH Research Training website (http://grants.nih.gov/training/extramural.htm) includes additional information on instruction in responsible conduct of research and links to the Office of Research Integrity (http://ori.hhs.gov/), links to instructional materials, and examples of programs that have been regarded as good models for instruction in responsible conduct of research (http://bioethics.od.nih.gov/researchethics.html). The National Academy Press has just published the 3rd. edition of the classic, On Being a Scientist, and is available online at http://books.nap.edu/catalog.php?record_id=12192.
Questions concerning this Notice should be directed to:
Division of Biomedical Research Workforce
Office of Extramural Programs
Office of Extramural Research