June 15, 2004 - ASM Comments on Public Health Service Policies on Research Misconduct

Federal Register Notice:  Public Health Service Policies on Research Misconduct; Proposed Rule

Chris B. Pascal, J.D. Director
Office of Research Integrity
11101 Wootton Parkway, Suite 750
Rockville, MD 20852

Re: RIN #0940-AA04 Public Health Service Policies on Research Misconduct Comments of the American Society for Microbiology

Dear Mr. Pascal:

The American Society for Microbiology (ASM) appreciates the opportunity to comment on the Public Health Service Policies on Research Misconduct: Proposed Rule published at 69 Federal Register 20778 (April 16, 2004). The ASM is the largest single life science Society with over 43,000 members, who work in university research, clinical and public health laboratories, in government service and in pharmaceutical, food, and environmental industries. The mission of the ASM is to promote the microbiological sciences and their application for the public good. The Society has a Committee on Ethical Practices with responsibility for assisting ASM in developing policies and procedures on issues involving scientific conduct. The Society also has a Code of Ethics to advance the profession and uphold its integrity.

This comment focuses on a specific and important provision in the Proposed Rule for policies related to research misconduct. In Section 93.502, the PHS proposes that a single Administrative Law Judge (ALJ) appointed from the Departmental Appeals Board (DAB) Administrative Law Judges conduct hearings on allegations of research misconduct and issue a recommended decision for review by the Assistant Secretary for Health. This procedure would constitute a substantial modification of the current process through which a Research Integrity Adjudications Panel (RIAP) consisting of three members conducts a hearing on charges of research misconduct. The ASM submits that hearings on allegations of research misconduct should continue to be conducted before a Research Integrity Adjudications Panel and that, at the request of either party, at least one member of the panel should be a scientist with research experience and knowledgeable in the scientific area focused on in the hearing.

Under the current procedure, one individual is designated as the Presiding Panel Member. Upon the request of either party, one of the other two Panel Members must be a scientist or other expert. The scientist or expert serves as a full member of the Panel, including attending the hearing, reviewing the evidence, and participating in the making and crafting of a decision. Under the proposed procedure, at the request of either party, the ALJ must retain a scientist or technical expert. Crucially, however, the expert would play only a consultative role and would not have any right or responsibility to participate in the deliberation concerning, or rendition of, a recommended decision on the allegations.

The ASM is not aware of any compelling evidence that use of a panel of adjudicators causes the hearing process to be ineffective. The ASM submits that inclusion of a scientist or technical expert in a formal, decision-making capacity rather than as a consultant does not complicate unduly the hearing process. Most importantly, inclusion of a scientist as a decisionmaker rather than as a consultant assures application of science in the process of reaching and writing a recommended decision on a charge of research misconduct.

Because such charges may turn upon issues uniquely related to scientific concepts and principles, it is important that the parties have the right to demand full participation by a scientist or expert in the adjudicatory process. For example, a charge that a scientist has manipulated materials or equipment so the research is not accurately presented may well present issues that are beyond the knowledge, expertise, experience, or background of an ALJ. Although an ALJ may utilize a scientist as a consultant on such matters, the scientist would not have a right to participate in the process of making and writing a decision. Thus, the accused or agency could rely only upon the ALJ’s willingness or ability to take into account expert assistance in arriving at a recommended decision. Further, the Assistant Secretary would be deprived of an analysis in the recommended decision prepared by an expert in the subject matter of the hearing.

For these reasons, the ASM submits that recommended decisions be issued by a RIAP and that, upon the request of either party, a scientist or technical expert participate fully as a member of the panel. With the appointment of a Presiding Panel Member, other procedures for expediting a fair and effective hearing may be utilized and the parties and Assistant Secretary may be assured that the recommended decision of the Panel reflects full participation of a knowledgeable expert.

Again, we appreciate the opportunity to comment on this important subject.

Sincerely,

Thomas Shenk, President, ASM
Gail H. Cassell, Ph.D., Chair, Public and Scientific Affairs Board
Julius Youngner, Ph.D., Chair, Committee on Ethics

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