The Maintenance Of Adopted by the Executive Council of the Copyright 1982 by the Association of American Medical Colleges. All material subject to this copyright may be photocopied for the noncommerical purpose of scientific or educa Foreword In January 1982, the Association of American Medical Colleges appointed an Ad Hoc Committee on the Maintenance of High Ethical Standards in the Conduct of Research. The committee was chaired by Julius R. Krevans, M.D., Dean of the University of California, San Francisco. The decision to establish this committee resulted from concerns that the wide attention received by several instances of misconduct by biomedical investigators would call into question the integrity of the whole research enterprise. The Association believes that faculties and their institutions have the primary responsibility to maintain high ethical standards in research and to investigate promptly and fairly when misconduct is alleged. The committee report was adopted by the Executive Council on June 24, 1982, as a guide to faculties of the medical schools and teaching hospitals who are responsible for the integrity of the biomedical research enterprise. John A.D. Cooper, M.D. Association of American Medical Colleges Introduction The principles that govern scientific research have long been established and have been applied by faculties and administrators of academic medical centers and teaching hospitals for the discovery of the new knowledge that is needed to promote the health and welfare of mankind. The maintenance of high ethical standards in research based on these principles is a central and critical responsibility of faculties and administrators of academic medical centers. Recently, however, there have been a number of instances of misconduct, including fraud, in research and in reporting of research data which have received wide attention. Validity and accuracy in the collection and reporting of data are intrinsically essential to the scientific process; dishonesty in these endeavors runs counter to the very nature of research, that is, the pursuit of truth. The responsibility of the scientific community to the public is acknowledged. The maintenance of public trust in this pursuit is vital to the continuing vigor of the biomedical research enterprise. Loss of this trust because of isolated instances of dishonest behavior on the part of a few researchers could cause great harm by calling into question in the mind of the public the validity of all new knowledge and the integrity of the scientific community at large. In short, it is in the best interest of the public and of academic medicine to prevent misconduct in research and to deal effectively and responsibly with instances where misconduct is suspected. The primary goal of this document is to set forth guidelines and recommendations that will be useful to medical schools and teaching hospitals in designing their individual institutional approaches to dealing with alleged misconduct by researchers. Although the guidelines and recommendations that follow principally address fraud (i.e., the intentional fabrication, falsification, or "stealing" of research data) they may also be useful in institutional efforts to deal with the violation of existing administrative procedures and ethical codes for the treatment of human and animal subjects of research and other problems that may arise in The Prevention of Research Fraud The primary responsibility for taking steps to prevent research fraud rests with the scientific community. In academic institutions, it can best be executed by the faculties. In a free society, and particularly in the academic milieu where creativity and individual thought are qualities to be fostered and not stifled, aberrant behavior of individuals cannot be completely controlled. It is unrealistic, therefore, to assume that research fraud can be entirely prevented. On the other hand, faculties can create a climate that promotes faithful attention to high ethical standards. This climate should enhance the research process and should not inhibit the productivity and creativity of scientists. It is recognized that the principal deterrent in research fraud is the overwhelming probability that fraudulent data will be detected soon after their presentation. Virtually all experimentation leading to scientific findings of significance will be repeated, and the likelihood that falsified, fabricated, or plagiarized data will go unquestioned is exceedingly slim. Despite the selfcorrecting nature of science, however, instances of research fraud have occurred and faculties should explore additional measures to decrease further the likelihood that a researcher will risk the odds and commit fraud. Faculties and institutional officials should consider the following: ● Having in place a conspicuous and understandable mechanism for dealing with instances of alleged fraud. • Adopting institutional policies that define misrepresentation of research data as a major breach of contract between the faculty or staff member and the institution. (This policy should particularly be articulated in the faculty handbook.) • Articulating institutional policies that foster openness of research. • Encouraging faculties to discuss research ethics to heighten awareness and recognition of these issues. Establishing institutional policies to provide: 1) an appropriate and clearly defined locus of responsibility for the conduct of research; 2) assurance that individuals charged 2 |