CHALLENGES TO THE INTEGRITY OF SCIENCE: THE FEDERAL MANDATE AND ISSUES FOR INSTITUTIONS
Since the publication of Betrayers of the Truth by Broad and Wade, many have given thoughtful consideration to the issues of protecting science against immoral and dishonest scientific practices while retaining appropriate sensitivity to the fragility of the scientific process and our healthy respect for the autonomy and personal responsibility of the individual researcher. Congress, through its passage of laws, higher education associations, through their advisory reports to institutions, and institutions have shown heightened concern both about the occurrence of instances of scientific fraud or misconduct, and about the handling of such cases.
The Federal Mandate
Federal regulation in the form of the Health Research Extension Act of 1985 (H.R. 2409) has now specified that "each entity which applies for a grant, contract, or cooperative agreement under this act for any project or program which involves the conduct of biomedical or behavioral research, shall submit in or with its application for such grant, contract, or cooperative agreement, assurances satisfactory to the Secretary that such entity 1) has established (in accord with regulations which the Secretary shall prescribe) an administrative process to review reports of scientific fraud in connection with biomedical and behavioral research conducted at or sponsored by such entity; and 2) would report to the Secretary any investigation of alleged scientific fraud which appears substantial."
Report language (June, 1985) further amplified that Congressional expectation indicating that "the Director of NIH should now take appropriate steps to establish a system for standardizing investigative procedures and post-investigatory sanctions in this area." The language goes on to state that "the NIH has a substantial interest in preserving the integrity of the research it supports and, accordingly, should become involved in misconduct inquiries as soon as there is reasonable evidence that an allegation of scientific fraud is substantive." Left to further clarification is the question of what it means for NIH to "become involved in misconduct inquiries" and further interpretation of the clause "reasonable evidence that an allegation of scientific fraud is substantive" (Committee on Energy and Commerce). Later report language from the Committee on Appropriations (June 23, 1988) further amplified legislative concerns by stating "The Committee also expects NIH to strengthen its internal investigative responsibility and fully explore the possibility of requiring the many peer review panels that evaluate research proposals to also, on a random basis, evaluate the results of that NIH-sponsored research with a focus on the broad area of scientific misconduct."
Currently in existence are interim Public Health Service policies and procedures for dealing with possible misconduct in science. Those interim policies list eleven features that should be included in policies and procedures adopted by institutions. Those were published in the NIH Guide for Grants and Contracts, Vol. 15, No. 11, July 18, 1986. Since these regulations are not yet final, they are still open for comment, and additional actions are under active consideration.
James B. MacRae, Jr., Acting Administrator and Deputy Administrator, Office of Information and Regulatory Affairs of the Office of Management and Budget, Executive Office of the President, wrote to the Department of Health and Human Services (April 29, 1988) encouraging further public comment on a number of important questions prior to the issuance of rules which, while aimed at strengthening the public confidence in the integrity of science, might at the same time have a chilling effect on the conduct of the science itself. Among the questions he raised was, "What is an appropriate definition of scientific fraud? …