by Joan P. Schwartz, Ph.D., NINDS, and Philip Chen, Ph.D., OD

The increasing interest and concern about cases of misconduct in science not only on the part of scientists, but also members of Congress and the press, make ethics in science a timely subject. Ethics in science is the code of behavior that governs the manner in which scientists relate to each other and the process by which they acquire their data and ideas and communicate them to other scientists and to the public at large. Most of us strongly believe that good science demands high ethical standards. The Office of Intramural Research wants to develop better mechanisms both for educating intramural researchers about these ethical standards and for dealing with issues of misconduct in science. We hope that this forum will serve an educational function, and we would like to include contributions from intramural scientists about their viewpoints on -- and their real-world experiences with -- ethical issues in science.

Misconduct in science, as currently defined by the Office of Research Integrity (ORI), includes "fabrication, falsification, plagiarism, and any other practice that seriously deviates from what is commonly accepted in the scientific community ..." It does not include honest error or differences in interpretation or judgment of data, authorship disputes, human- or animal-subject protection issues, discrimination, or criminal activities, each of which is handled by another specific process. However, some of these other issues fall into the category of "questionable research practices ... in areas such as allocation of credit, the treatment of research data, respect for intellectual property, and mentorship responsibilities" [Alberts & Shine, Science 266, 1660 (1994)]. The ORI definition of misconduct in science is currently undergoing review by the Public Health Service Commission on Research Integrity.

ORI has issued a set of guidelines on how to handle allegations of scientific misconduct (entitled Scientific Misconduct in Intramural Research, available from ORI, (301) 443-3400). Basically, three sequential steps are involved when an allegation is raised in the NIH intramural program.

1. The process begins when a Lab or Branch Chief or Scientific Director receives an allegation of scientific misconduct. After consultation with Philip Chen, the NIH Agency Intramural Research Integrity Officer (AIRIO), an "allegation assessment" is carried out by the Scientific Director, with the cooperation of the Lab or Branch Chief.

2. If this assessment suggests that there is sufficient evidence or information to support the need for further evaluation, the Deputy Director for Intramural Research (DDIR) notifies ORI and establishes a committee to carry out a formal inquiry. At this point, all notebooks, records, and data related to the case are secured for review by the Inquiry Committee. The purpose of the inquiry is information gathering and fact finding to determine if the alleged conduct is within the definition of misconduct in science and substantial enough to allow a specific finding of scientific misconduct. However, the Inquiry Committee does not make a finding of misconduct in science.

3. If the Inquiry Committee recommends that an investigation be carried out, the case is turned over to ORI, which carries out a formal investigation.

Given this overall process, what principles should underlie how the NIH Intramural Program deals with cases involving misconduct in science, as well as other ethical issues in the conduct of science? Three principles seem paramount: timeliness, confidentiality, and fairness to all parties involved. To ensure that cases are dealt with expeditiously and in a completely impartial way, the Office of Intramural Research plans to establish an NIH Committee on Scientific Conduct and Ethics. Members will be named from each Institute, Center and Division to ensure that a broad range of scientific disciplines is represented. This committee will help refine the ORI guidelines, as well as the intramural guidelines on research conduct, if necessary. Procedures for the protection of the rights of both "whistleblowers" and scientists accused of misconduct in science will be developed by this group. A subcommittee would be formed immediately, from members of the committee, to address each case that arises involving allegations of misconduct in science or disputes concerning authorship or publication practices, record keeping, sharing of materials and data, and mentoring and supervision. Arbitration may be offered as a settlement mechanism in some cases. Finally, the Office of Intramural Research is drafting a confidentiality statement to be given to any person with a "need to know" about a case, reminding that person of the importance of keeping allegations and other information confidential. We believe that these mechanisms will allow a timely, fair, and confidential evaluation of every case that comes to the attention of the Office of Intramural Research.

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