November 29, 1999 Dr. Sybil Francis Senior Policy Analyst Office of Science and Technology Policy Executive Office of the President Washington, DC 20502 Dear Dr. Francis: We appreciate the opportunity to comment on the proposed new definition and procedures for federal research agencies regarding the issue of research misconduct as described in the October 14, 1999 Federal Register notice. In 1992, the National Academies' Committee on Science, Engineering, and Public Policy (COSEPUP) issued a report entitled Responsible Conduct: Ensuring the Integrity of the Research Process. The COSEPUP panel, chaired by Dr. Edward E. David, formulated 12 recommendations that defined scientific misconduct and proposed uniform mechanisms by which research institutions and federal funding agencies could deal with specific instances. The panel recommended that these uniform guidelines be adopted by all federal agencies. After reviewing the federal register notice, we believe that, in general, the proposal as outlined in the notice adopts the approach outlined in that report. In particular, we strongly support the new definition of misconduct and the decision wherein the "other serious deviations clause" contained in some agencies' definition was deemed unnecessary. Establishing a uniform definition of research misconduct across the Federal agencies will provide the opportunity for consistent policies for responding to allegations of misconduct. In addition, we strongly support the decision that agencies and research institutions are partners who share responsibility for the integrity of the research process. We also support the view that research institutions bear primary responsibility for prevention and detection of research misconduct, and for the inquiry, investigation, and adjudication of allegations of research misconduct while keeping in mind that federal agencies have the ultimate oversight authority for federally-funded research. We do, however, have a number of comments that we believe will help clarify the definition and procedures as described in the notice. They include the following: 1. Research Misconduct Definition: We wholeheartedly support the definition as it is outlined including the addition of "reviewing" as part of the activities where the misconduct definition should apply. However, we suggest the addition of the word "data" in the definition of fabrication, so it would read as follows (suggested addition in capital letters): "Fabrication is making up DATA OR results and recording or reporting them." Similarly, we believe it is important to indicate what research misconduct does not include. The revised definition should read as follows: "Research misconduct does not include honest error, honest differences in opinion, or MISCONDUCT UNRELATED TO THE RESEARCH PROCESS." The definitions for falsification and plagiarism go beyond those in the COSEPUP report. We find these additions acceptable. 2. Research Definition: In defining research, you indicate it includes all fields of science, engineering, and mathematics. We believe it should also include medicine, so that the revised definition would read as follows: "Research, as defined herein, includes all basic, applied, and demonstration research in all fields of science, engineering, MEDICINE, and mathematics." Some would include medicine within science, but since the same is true for mathematics, it seems best to be clear. 3. Questionable Research Practices: The COSEPUP report defined questionable research practices as follows: "Questionable research practices are actions that violate traditional values of research enterprise and that may be detrimental to the research process. However, there is at present neither broad agreement as to the seriousness of these actions nor any consensus on standards for behavior in such matters." The report went on to outline examples of what types of activities questionable research practices include Failing to retain significant research data for a reasonable period; Maintaining inadequate research records, especially for results that are published or are relied on by others; Conferring or requesting authorship on the basis of a specialized service or contribution that is not significantly related to the research reported in the paper; Refusing to give peers reasonable access to unique research materials or data that support published papers; Using inappropriate statistical or other methods of measurement to enhance the significance of research findings; Inadequately supervising research subordinates or exploiting them; Misrepresenting speculations as fact or releasing preliminary research results, especially in the public media, without providing sufficient data to allow peers to judge the validity of the results or to reproduce the results. As indicated in the COSEPUP report, we believe that scientists and their institutions should act to discourage questionable research practices through a broad range of formal and informal methods in the research environment. They should also accept responsibility for determining what questionable research practices are serious enough to warrant institutional penalties. But the methods used by individual scientists and research institutions to address questionable research practices should be distinct from those for handling misconduct in science or other misconduct. Our concern with the procedures as outlined is that they might imply that institutions and scientists are not permitted to have even additional standards than those outlined in the federal register notice. The final policy should make clear that there is no prohibition for the institution to have an additional standard. Insertion of a phrase such as the following would be adequate: "Nothing in this policy should be seen as preventing a research institution from setting additional standards for actions that they believe are sanctionable." 4. Confidentiality: The issue of confidentiality, although addressed, is not very clear as there is no clear delineation of who is in a "need to know" situation and who has access to records. In particular, in the section on "Guidelines for Fair and Timely Procedures" one person who should be in a "need to know" situation is the accused. They should have access to information collected by the investigation group either in the institution or in a government agency. One concern is that the exemption from disclosure under the Freedom of Information Act has obvious advantages for confidentiality, but could be used in such a way as to limit access by the accused or his/her representatives. Therefore, we believe a specific statement such as the following should be added to the section on "safeguards for the subject of the allegation": "The accused will have access to all relevant accusations and the data supporting them." and in the section on Confidentiality "The exemption from the Freedom of Information Act will not limit the access of the accused to all relevant accusations and the data supporting them." On the opposite extreme, in the section entitled "other reasons to notify the agency" in the previous section on "Responsibilities of Federal Agencies and Research Institutions," the reasons identified for access are very broad. Only at the end of section 4 is the issue of confidentiality addressed where it clearly states "knowledge about the identify of subjects and informants is limited to those with a need to know." Therefore, we also believe a sentence such as the following should be added to set a limit on the broad definition in the "other reasons" section: "All inquiries should be confidential unless exceptional circumstances warrant agency notification." In summary, we believe that the proposed common definition of misconduct and the procedures outlined for handling such allegations are a major step forward. We greatly appreciate the years of effort have gone into development of this policy. By clarifying, as outlined above, the definitions and procedures a bit further, we believe the proposed policy can thoughtfully respond to the challenge of developing a policy that allows for the creativity of the research process while requiring adherence to high standards of conduct. Sincerely, Bruce Alberts President National Academy of Sciences Kenneth I. Shine President Institute of Medicine Wm. A. Wulf President National Academy of Engineering