Responsible Conduct of Research

NIH Policy on the Responsible Conduct of Research

Release date: November 24, 2009 (NOT-OD-10-019)
Last update: February 17, 2022 (NOT-OD-22-055)

The NIH Policy on Instruction in the Responsible Conduct of Research (RCR) provides specific requirements for RCR education plans, including ongoing monitoring and reporting on the fulfillment of the plans.

For access to Washington University RCR resources, please visit the Responsible Conduct of Research page.

Below is an overview of the NIH policy for RCR requirements. You may view the complete NIH policy OT-OD-10-019, and the notice from February 2022 with updated guidance in consideration of the pandemic.

General Requirements

NIH requires 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 receive instruction in responsible conduct of research.

New applications must include a plan for instruction in responsible conduct of research and must describe how participation will be monitored (requirements for individual applications vary).

Renewal applications, in addition to the criteria for new applications, the renewal application must describe past and future changes that address any weaknesses in the current instruction. All training faculty who have served as course directors, speakers, lecturers, and/or discussion leaders must be named in the application (requirements for individual applications vary.)

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.

Plan Components

Plans must address five specific instructional components:

1.  Format
Discussion-based instruction in the responsible conduct of research is expected and will include substantive face-to-face interaction among participants and faculty. Trainings with virtual “face-to-face” discussions may incorporate video conferencing options, provided they foster discussion, active learning, engagement, and interaction among participants. Video conferencing should not be the sole means for meeting the 8-hour requirement for RCR instruction, and a plan that employs only video conferencing will not be considered acceptable.

2.  Subject Matter
All RCR trainings must be centered on the ethics of conducting research responsibly
. The NIH identifies these subject areas for RCR:

  • conflict of interest – personal, professional, financial, and conflict of commitment, in allocating time, effort, or other research resources
  • policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices
  • mentor/mentee responsibilities and relationships
  • safe research environments (e.g., those that promote inclusion and are free of sexual, racial, ethnic, disability and other forms of discriminatory harassment)
  • collaborative research, including collaborations with industry and investigators and institutions in other countries
  • peer review, including the responsibility for maintaining confidentiality and security in peer review
  • data acquisition and analysis; laboratory tools (e.g., tools for analyzing data and creating or working with digital images); recordkeeping practices, including methods such as electronic laboratory notebooks
  • secure and ethical data use; data confidentiality, management, sharing, and ownership
  • research misconduct and policies for handling misconduct
  • responsible authorship and publication
  • the scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research

For more information, visit here​.

3.  Faculty Participation
Training faculty and mentors are highly encouraged to contribute.

4.  Duration of Instruction
Acceptable programs generally involve at least eight contact hours.

5.  Frequency of Instruction
Instruction must be undertaken at least once during each career stage. 

Compliance

NIH policy requires participation in and successful completion of instruction. It is expected that course attendance is monitored and that a certificate or documentation of participation is available upon course completion.