Regulatory Institutions and Policies

Federal Regulations

National Institutes of Health (NIH)

Requirement for Instruction in the Responsible Conduct of Research in National Research Service Award and Institutional Training Grants , NIH Guide, Volume 21, Number 43

The National Institutes of Health requires that all applicants for Institutional National Research Service Award (NRSA) Research Training Grants (T32, T34) include explanation of an educational program in the responsible conduct of research. Applications that do not include a plan for RCR instruction are considered incomplete. The NIH suggests that the RCR instructional program include the following topics: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human participants and animal subjects, and data management. The proposed plan must include the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. Public Health Service (PHS)

PHS Policy on Instruction in the Responsible Conduct of Research (RCR)

In December of 2000, the Public Health Service issued a policy requiring all researchers supported by PHS funding to complete a program of instruction in the responsible conduct of research. Congress has suspended the policy and has asked the PHS to review the format and content of the policy. The Office for Research Integrity (ORI) is currently revising the policy and plans to re-release the policy in the future. The suspended policy required PHS supported researchers to engage in education on the following topics: data management and integrity, mentor/trainee responsibilities, publication practices and responsible authorship, peer review, collaborative science, human subjects, research involving animals, research misconduct, and conflict of interest and commitment. Research institutions nationwide are taking steps to implement RCR educational programs prior to the re-release of the policy.