Challenges to the Integrity of Science: The Federal Mandate and Issues for Institutions. (1989)

CHALLENGES TO THE INTEGRITY OF SCIENCE: THE FEDERAL MANDATE AND ISSUES FOR INSTITUTIONS Since publication of Betrayers of Truth by Broad and Wade, many have given thoughtful consideration to issues of protecting science against immoral and dishonest scientific practices while retaining appropriate sensitivity to fragility of scientific process and our healthy respect for autonomy and personal responsibility of 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 occurrence of instances of scientific fraud or misconduct, and about handling of such cases. Federal Mandate Federal regulation in form of 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 conduct of biomedical or behavioral research, shall submit in or with its application for such grant, contract, or cooperative agreement, assurances satisfactory to Secretary that such entity 1) has established (in accord with regulations which 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 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. language goes on to state that the NIH has a substantial interest in preserving integrity of research it supports and, accordingly, should involved in misconduct as soon as there is evidence that an allegation of scientific fraud is substantive. Left to further clarification is question of what it means for NIH to become involved in misconduct inquiries and further interpretation of clause reasonable evidence that an allegation of scientific fraud is substantive (Committee on Energy and Commerce). Later report language from 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 possibility of requiring many peer review panels that evaluate research proposals to also, on a random basis, evaluate results of that NIH-sponsored research with a focus on 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 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 Office of Management and Budget, Executive Office of President, wrote to Department of Health and Human Services (April 29, 1988) encouraging further public comment on a number of important questions prior to issuance of rules which, while aimed at strengthening public confidence in integrity of science, might at same time have a chilling effect on conduct of science itself. Among questions he raised was, What is an appropriate definition of scientific fraud? …