 |
 |
 |
 |
 |
 |
|
|
||||||
|
|
||||||
|
|||||||
|
Education - RCRDepartmental ResponseFebruary 14, 2001 The Honorable W.J. "Billy" Tauzin Chairman, Committee on Energy and Commerce House of Representatives Washington, D.C. 20515 Dear Mr. Chairman: I am writing in response to your letter of February 5, 2001, in which you raise some concerns regarding the procedures used in adopting the "Public Health Service (PHS) Policy on Instruction in the Responsible Conduct of Research (RCR policy)." Enclosed are documents which we believe are responsive to your request. The RCR policy is the outgrowth of a longstanding sentiment in the scientific community that efforts to enforce rules against research misconduct should be coupled with programs to prevent such episodes from occurring in the first place. In turn, providing appropriate education and training on proper research practices is clearly a vital component of any such prevention effort. This perspective was memorialized in 1989 by the Institute of Medicine (IOM) which recommended that universities provide formal instruction in good research practices. The importance of education in this area was acknowledged in 1990 when NIH required all applicants for National Research Service Award Institutional Training Grants to have educational programs in the responsible conduct of research. The National Academy of Sciences also reaffirmed the importance of education in 1992 by recommending that research integrity issues be integrated into institutional curricula. Finally, in 1995, the Commission on Research Integrity recommended that every institution that applies for PHS funds submit an assurance that it will provide an educational program on the responsible conduct of research to all persons supported by PHS research funds. This recommendation was approved by the Secretary and publicly announced on October 22, 1999. The RCR education initiative also dovetails with the PHS misconduct regulations that require research institutions to "foster a research environment that discourages misconduct in all research... 42 C.F.R. ' 50.105. Providing education on responsible research practices to the research community would be a key component of any institutional effort to promote such an environment. The above history illustrates that the RCR policy fits into a pre-existing regulatory and policy framework that has been reaffirmed time and again by the research community. In keeping with this framework, on November 24, 1999, the Assistant Secretary for Health requested that the PHS agencies "implement a training requirement in the responsible conduct of research (RCR) for all staff at research institutions that are engaged in research or research training under PHS grants, contracts, and cooperative agreements" by FY 2001. In response to this request, the Office of Research Integrity (ORI) convened a working group of representatives from all the PHS agencies to develop an RCR policy. The PHS working group discussed various approaches to implementing the RCR education program, including whether to go through rulemaking, and opted to issue a PHS policy as it was a natural extension of the pre-existing RCR requirement for NIH training grants. By making the education program a condition of receiving PHS grant funds, this decision was consistent with the broad authority of the Secretary to "impose additional conditions prior to or at the time of any award when in the Secretary's judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of the public health, or the conservation of grant funds." 42 CFR ' 52.9. Moreover, by giving institutions broad discretion to determine how virtually every aspect of the educational program will be implemented, the RCR policy lacks the normative standards typically associated with a substantive rule. Institutions have the flexibility to decide the content, length, level and method of instruction and reasonable discretion to determine which "research staff" should receive it. Institutions can use PHS resources to provide education or develop their own approach. Institutions can decide whether to require recipients of instruction to demonstrate competency. Institutions can even determine the method for documenting that the RCR instruction has taken place. Thus, other than requiring that institutions have "a basic program of instruction," the policy does not impose the precise standards typically associated with a substantive rule. As a result of the considerable leeway given to the institutions, we believed that the RCR initiative was appropriately considered a policy. Nevertheless, ORI was certainly aware that the policy would have an impact on PHS-funded institutions and the research community; thus, their comments were solicited, welcomed, and largely incorporated into the policy. Indeed, extensive efforts were made to ensure that the extramural research community had ample notice and opportunity to comment on the draft RCR policy. A Federal Register Notice was published on July 21, 2000, announcing the intent to adopt the RCR policy, explaining how a copy of the draft policy could be obtained, and requesting comments. See 65 Fed. Reg. 45381 (July 21, 2000). A request for comment was also posted in the NIH Guide for Grants and Contracts, the ORI website, and in a direct notice to almost 2000 research institutions. In August 2000, the PHS held a meeting with representatives from approximately 25 scientific societies, associations, and research institutions to hear their opinions on the draft policy. Comments from this meeting, as well as over 100 written comments, raised some concerns about substantive aspects of the policy and requested extension of the comment period. As a result of this input, the comment period was extended from 30 to 60 days and the terms of the policy were substantially revised. The issuance of the final policy was announced in the Federal Register on December 7, 2000, which referred readers to the ORI website for the full text of the policy. 65 Fed. Reg. 76647 (December 7, 2000). Public notice of the RCR policy was also made through the NIH Guide for Grants and Contracts. In short, the public was afforded notice and an opportunity to comment, and those comments were substantially incorporated into the revised policy. We recognize, however, that you have questions and concerns regarding our decision to forego formal rulemaking. Even though we continue to believe that the RCR policy as described above was appropriately issued, in recognition of the recent White House directive calling for a period of review, we believe that its implementation should be delayed. Accordingly, we are in the process of publishing the enclosed notice in the Federal Register announcing that implementation of the RCR policy will be indefinitely suspended pending such review. In closing, thank you for bringing your concerns to our attention. We will be available to speak with you or provide further information upon request. A similar letter is being sent to Chairman-designate James C. Greenwood. Sincerely, Chris B. Pascal, J.D. Director Office of Research Integrity Enclosures cc: The Honorable John D. Dingell, Ranking Member
|
||||||||||||||||||||||||||||||||||||||||||
Page last updated on December 6, 2009
 U.S. Department of Health and Human Services Office of Research Integrity • 1101 Wootton Parkway • Suite 750 • Rockville, MD 20852 Directions to ORI Office Questions/suggestions about this web page? Contact ORI |
 |
 |
 |
Assurance
