Nevertheless, the OSI is prepared to recommend strong actions against individuals and institutions when the public's trust has been betrayed.

Having been established within the Office of the Director of the National Institutes of Health on April 10, 1989,18 the OSI represents a major change from the way the Public Health Service previously discharged its responsibilities with regard to misconduct in science. Before that time each agency within the Public Health Service had separate administrative and oversight responsibility for dealing with misconduct. Now, operational responsibility for all of these activities is centralized in the OSI. This enables greater consistency and efficiency in handling misconduct cases, and it clarifies for the Public Health Service staff, the public, and the biomedical research community the central focus of responsibility and authority for dealing with possible misconduct.

As a first order of business for the Office of Scientific Integrity, we established 10 objectives for it to complete by the end of this summer. Those can be summarized, Mr. Chairman, essentially by saying that we have moved quickly to recruit a cadre of highly skilled staff on an interim basis while we undertake the arrangements for longer term staffing arrangements.

At the same time, a variety of activities are either complete or well along for ensuring that all active cases are receiving prompt and appropriate attention, and we have as an immediate objective that of 19 creating a smoothly functioning unit both with respect to its own internal procedures as well as with respect to its interactions with other organizations, such as the Office of Scientific Integrity Review, other institutes within the Public Health Service, and of course the awardee institutions with whom we deal.

Much of this agenda already has been accomplished, and every part of it is otherwise well underway.

If we look beyond the end of summer, the Office of Scientific Integrity has 10 further longer term objectives that it is designed to accomplish within the next year. I will highlight four that I believe have particular importance.

First is the objective of bringing all active cases transferred to the Office of Scientific Integrity from ADAMHA and the NIH to completion. Prompt resolution clearly is in everyone's interest and, as often said, justice delayed is justice denied.

Second, the Office is intent upon developing a much more proactive, collaborative role for its staff with institutions right from the outset of investigations, especially complex ones. We believe this will ensure that strategies are developed that will address all of the important issues.

The OSI as designed can and will be a concentrator of experience with cases, and we believe we can share that experience effectively with our institutional clientele.

Third, the OSI will give special attention to the issues associated with the protections of whistleblowers within its operational and outreach responsibilities. We will look to identify and implement

18 "Statement of Organization, Functions and Delegations of Authority," 54 Fed. Reg. 1108011081, March 16, 1989. See Appendix 5-G.

19 Dr. Raub deleted the words "that of."

standard policies and procedures. At the moment anonymity remains the single best protection for the whistleblower.

And finally among these highlights, the OSI will explore further ways to interact with the community of scientific publishers and ensure that as the results of research come before those responsible for the refereed scientific literature we will have the most appropriate interactions in those instances where real or apparent misconduct may have occurred.

Finally, Mr. Chairman, the OSI will take a prominent role in the PHS-wide efforts designed to promote proper conduct in research and to prevent wrongdoing. This will be done in collaboration with the Office of Extramural Research at the NIH, the Office of Intramural Research at the NIH, the Office of Extramural Programs at ADAMHA, and of course the Office of Scientific Integrity Review.

At the same time there will be broad, continuing consultation with organizations such as the National Academy of Sciences, the American Association of Universities, and other Federal entities such as the National Science Foundation.

Among these many issues, perhaps the most important in the short run will be, as Dr. Bivens indicated, further efforts to achieve consensus within the research community on those topics related to the retention of and access to primary data and the ownership of that data.

I am pleased to say, Mr. Chairman, that our interim staffing at OSI is in place, competent and enthusiastic. Our initial strategy has been to recruit a cadre of full-time individuals on a detail basis as we proceed with the longer term, more regular arrangements. Dr. Suzanne Hadley currently is the Acting Deputy Director of that office. She not only has substantial research and program administrative experience, but also was the misconduct policy officer for the National Institute of Mental Health for several years.

My colleague, Dr. Brian Kimes, who is with me today, is the Acting Director of the OSI. He has 14 years of research grant and contract program experience within the National Cancer Institute.

Mr. Chairman, we are optimistic about the prospects for this endeavor. I assure you and your colleagues that it will have whatever resources it needs to achieve the objectives we have set for it, and at the appropriate time later this morning we will be glad to respond to any comments or questions you might have.

FOR RELEASE ON DELIVERY

STATEMENT

BY

WILLIAM F. RAUB, PH.D.

DEPUTY DIRECTOR

NATIONAL INSTITUTES OF HEALTH

DEPARTMENT OF HEALTH AND HUMAN SERVICES

BEFORE THE

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

OF THE

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

HOUSE OF REPRESENTATIVES

JUNE 28, 1989

Mr. Chairman, members of the subcommittee, I am William Raub, Deputy Director of the National Institutes of Health. Thank you

for providing this opportunity to describe the progress that has been made in establishing the Office of Scientific Integrity or "OSI." Within the Public Health Service, this office is the focus for (1) receiving allegations or other information about possible misconduct in science from the public and Federal sectors, (2) monitoring misconduct inquiries and investigations by applicant and awardee institutions, (3) conducting investigations of possible scientific misconduct in extramural research projects (when necessary), (4) conducting investigations of possible scientific misconduct in intramural research projects. The OSI will be a leading entity within the PHS for promoting responsible conduct in research and for developing policies and procedures that relate to misconduct in science and the responsible conduct of research. With respect to instances of misconduct by scientists and institutional processes for dealing with these matters, the OSI will be the principal contact and point of interaction for all institutions and investigators supported under the Public Health Service Act. As Dr. Bivens has noted, the office of Scientific Integrity Review, or "OSIR" will be active primarily in overseeing and developing general policies and procedures of the PHS related to misconduct in science, reviewing "OSI" investigations and recommendations for

2.

Assistant Secretary for Health in translating the results of OSI investigations into sanctions when scientific misconduct has been established by the evidence.

We believe that the strength of this country's biomedical

Nevertheless,

research establishment has depended and will continue to depend substantially on the support and trust of the public. We also believe that the institutions that have received this support and trust have amply rewarded us all by providing major health benefits to our people and by making the United States the indisputable world leader in biomedical research. when there are allegations of misconduct in science, there must be swift, thorough and fair investigation of individuals or institutions accused or suspected of misconduct; and, when the public trust, in fact, has been broken, there must be sanctions commensurate with the scope of the wrongdoing. Of equal importance, we believe that the Public Health Service and the biomedical research community must work together to strengthen biomedical research by promoting standards and establishing oversight for the responsible conduct of science. The OSI has a central role in these areas.

We strongly believe that the primary responsibility for investigating allegations or other indications of misconduct