2000 Draft policy issued by the Office of Research Integrity of the Public Health Service (PHS).
The Office of Research Integrity (ORI) of the Public Health Service (PHS) seeks comments on this draft. Comments must be received by ORI at 5515 Security Lane, Suite 700, Rockville, MD, 20852,
or by E-mail to firstname.lastname@example.org, no later than September 21, 2000 (extended deadline).
July 17, 2000 Draft
PHS Policy on Instruction in the Responsible Conduct of Research (RCR)
Agencies of the Public Health Service (PHS) strongly believe in promoting the responsible conduct of research and preventing research misconduct, and other violations of responsible research, through education and awareness. Since 1990, NIH has required recipients of National Research Service Award research training grants to develop a program of instruction in the responsible conduct of research for trainees. With this policy, PHS extends the requirement to all staff at extramural institutions engaged in research or research training with PHS funds, or who work on PHS-supported research projects. A similar requirement will cover PHS intramural staff engaged in research or research training.
It is the view of the PHS that all researchers, from the inexperienced to the expert scientist, should be afforded educational opportunities that contribute to the development of the whole researcher and encourage the proliferation of life-long attitudes toward conducting research in a responsible manner. This document sets forth the terms of the PHS policy requiring RCR educational opportunities for all staff engaged in research or research training.
It is the policy of the PHS that all staff engaged in research or research training with PHS support shall successfully complete a program of instruction in the responsible conduct of research, as described in this document. The policy pertains to all research, including animal, human, or basic research, or research training, conducted with grant, contract, or cooperative agreement support from any agency, or office, of the PHS. Ensuring research integrity requires an institutional commitment. Although the mandatory aspects of this policy apply only to staff involved in research that is supported by PHS funds, it is strongly recommended that the program of instruction apply to all individuals engaged in research at the institution, including those supported by institutional, private, or other non-PHS sources of support.
"Program of Instruction" means completion of any educational activity, including a formal course, workshop, seminar, CD-ROM, Internet activity, self-study guide, discussion series, or other educational activity that is consistent with the goals and core areas of instruction outlined in this document.
"Institution" means the public or private entity or organization that is applying for, or is a recipient of, financial support from the PHS, including grants, contracts, or cooperative agreements. The organization assumes legal and financial accountability for the awarded funds and for the performance of the supported activity.
"RCR" means the responsible conduct of research.
The policy applies to all staff who conduct research or receive research training with PHS funds, or who otherwise work on a PHS-supported research project even if the individual does not receive PHS support. "All staff" includes principal investigators, co-principal investigators, senior investigators, institutional officials who approve PHS grants, contracts, or cooperative agreements, tenure-track investigators, students, postdoctoral fellows, technicians, staff scientists, data management staff, subcontractors, consultants, clinicians, research nurses, research associates, research assistants and anyone else involved in conducting the research or who receives research training at the institution, or under the direction of the institution. PHS recommends that departmental and sponsored research staff, secretarial, and other support staff receive instruction in RCR relevant to their jobs and roles in the research enterprise. This does not limit the authority of the institution to impose more detailed or broader requirements for RCR education on research staff.
The goals of the PHS-required RCR program of instruction are to:
To the extent applicable to the research programs at the institution, any RCR program of instruction shall contain the following core areas of instruction:
The Core Instructional Areas are described as follows:
Each institution that applies for or receives PHS funds for research or research training, beginning on October 1, 2000, must certify that: