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Mason recently established the PHS Executive Committee on Scientific Misconduct. The Committee met for the first time this Spring and will meet several times per year to address.general strategy and policy issues and to make recommendations and decisions on the adoption of any proposed PHS policies, guidelines, or regulations. Committee members include highlevel officials from NIH, ADAMHA, the Centers for Disease Control, the Food and Drug Administration, the Office of the General Counsel, OSIR, OSI, and other PHS components.

In addition to the Executive Committee, the PHS will propose to Secretary Sullivan that an Advisory Committee on Scientific Integrity be established to review and evaluate the efficacy of policies and procedures of the Department in detecting, deterring, and investigating allegations of scientific misconduct, and to provide advice to the Assistant Secretary for Health on Improving these policies and procedures. This committee could be a very important source of contact between the PHS and the broad scientific community. It is essential that the scientific Integrity programs of the PHS be developed in close

cooperation with the scientists and Institutions effected by such

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programs. A variety of viewpoints would be represented on the committee to address adequately the problems and concerns of

the institutions at which research is taking place and the

scientists conducting such research.

Of equal Importance to the Investigation of scientific misconduct Is the promotion of responsible conduct of science. This is a responsibility shared by grantee and applicant Institutions,

professional and academic associations, and all PHS

components supporting research. As the research community continues to develop policies and procedures that deal

effectively with allegations or suspicions of scientific

misconduct, the PHS will be able to focus more on its primary responsibilities in this area, and to address a number of

Important unresolved issues. In particular, we will work closely with other organizations such as the institute of Medicine of the National Academy of Sciences to develop prevention and education activities. Issues such as the responsibility of authors In multi-author collaborative research publications, the protection of whistleblowers, and measures to reduce the pressure for excessive publication will be addressed in the future. For

example, the Office of the Assistant Secretary for Health has begun planning for a conference on the issues surrounding data derived from PHS supported research, Including the ownership and retention of such data. We also need to encourage further discussion within the scientific community about the sharing of data among scientists and appropriate funding components.

In closing, I would like to stress that the policies and activities of the PHS in the arena of scientific misconduct must be guided by the recognition that good science is characterized by honest error. A worthy and productive endeavor of science is the disproving of hypotheses and their replacement with ones that describe nature more effectively. Science is also characterized by legitimate differences of opinion among scientists. Some of the driving forces behind scientific progress and discovery are competition and differences of opinion in the scientific community. Policies developed and Implemented by the PHS must account for these positive features of scientific controversy, must not confuse scientific error with misconduct,

have a chilling effect on scientific progress essential for the enhancement of public health and well-being.

The attention of the Congress, the public, the scientific and academic communities, and the Federal funding agencies has been focused on this crucial issue. I am confident that the

many parties whose vital Interests are served by valld, reliable, and significant scientific research can work together to deter, detect, and investigate scientific misconduct effectively. The Public Health Service accepts a major responsibility in this endeavor, and I believe that the programs and policies we have put in place, and will be implementing in the near future, are a major step toward maintaining public confidence in the scientific research supported by this agency.

Thank you for this opportunity to speak to you on this

Important Issue. At this point, I will be glad to respond to any questions you or other members of the committee may have.

Chairman ROE. Thank you, Dr. Bivens.
The Chair recognizes Dr. William Raub.

TESTIMONY OF DR. WILLIAM F. RAUB, DEPUTY DIRECTOR, NATIONAL INSTITUTES OF HEALTH, BETHESDA, MD

Dr. RAUB. Thank you, Mr. Chairman.

We appreciate this opportunity to describe the progress that has been made in establishing the Office of Scientific Integrity.

Mr. Chairman, I have an extended statement that with your permission we will submit for the record.

Chairman ROE. No objection, so ordered.

Dr. RAUB. And I will confine my oral remarks today to some highlighting of particular facets of that testimony.

Within the Public Health Service, the Office of Scientific Integrity is the focus for several activities. First, it is the site for receiving allegations or other information about possible misconduct in science from public and Federal sectors.

Second, it is responsible for monitoring misconduct inquiries and investigations by applicant and awardee institutions.

Third, it is responsible for conducting investigations of possible scientific misconduct in extramural research projects when that is necessary.

Fourth, it is responsible for conducting investigations of possible scientific misconduct in intramural research projects; that is, within our own laboratories and clinics.

The Office of Scientific Integrity also will be a leading entity within the Public Health Service for promoting responsible conduct in research and for developing policies and procedures that relate to misconduct in science and the responsible conduct of research. As Dr. Bivens indicated, we strongly believe that the primary responsibility for investigating allegations or other indications of misconduct should rest with the institutions that receive and request research support from the Public Health Service. That is as the Congress intended in its 1985 amendments to the Public Health Service Act and in fact was NIH and PHS policy prior to that time. 16

The strategy described therein and its effectiveness clearly will depend upon the success of institutions in conducting investigations that are expert, expeditious, and fair and upon the success of the Office of Scientific Integrity in fulfilling its responsibilities in communicating effectively with institutions and facilitating institutional investigations.

Major roles of the OSI will be to monitor institutional investigations for thoroughness and objectivity and to conduct its own independent investigations when necessary. We do not envision the OSI as a police force with the authority to disrupt the creative scientific environments of institutions, but rather as a collaborator in the process that is in 17 everyone's mutual advantage to conduct properly.

16 See Appendix 5, Evolution of the Public Health Service Misconduct Policy. 17 Dr. Raub changed the word "in" to "to."

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