The NIH Revitalization Act of 1993 authorizes the creation of the Commission on Research Integrity ("CRI") to advise the Secretary of Health and Human Services ("HHS") on issues of research misconduct and integrity. The 12-member panel issued its 75-page report, "Integrity and Misconduct in Research" ("CRI Report") around Thanksgiving, but widespread distribution was frustrated by the government shutdown caused by squabbling over the balanced budget amendment. The CRI Report followed the fiascoes leading to the charges against several prominent scientists described in earlier installments of this EBM series (Charles Walter & Edward P. Richards, Engineering and the Law: Research Misconduct: Catching the Desperadoes and Restraining the Zealots, 13(1) IEEE ENGINEERING IN BIOLOGY AND MEDICINE MAGAZINE 142 (1994); Charles Walter & Edward P. Richards, Engineering and the Law: News Fraud Fuels Science Fraud, 13(2) IEEE ENGINEERING IN BIOLOGY AND MEDICINE MAGAZINE 278 (1994); Charles Walter & Edward P. Richards, Engineering and the Law: Pillorying Well-Stocked Scientists, 14(1) IEEE ENGINEERING IN BIOLOGY AND MEDICINE MAGAZINE 96 (1995)), various congressional investigations into these HHS proceedings, and the 1992 National Academy of Sciences ("NAS") study, "Responsible Science: Ensuring the Integrity of the Research Process."
The CRI is chaired by Kenneth Ryan, Distinguished Kate Macy Ladd Professor in the department of obstetrics, gynecology, and reproductive biology at Harvard Medical School, and comprises outstanding professionals who are both knowledgeable and sympathetic to the problem of safeguarding research integrity such as Thomas Devine, legal director of the Government Accountability Project, C.K. Gunsalus, associate vice chancellor for academic affairs at the University of Illinois, Karl Hittleman, associate vice chancellor for academic affairs at the University of California, San Francisco, Drummond Rennie, deputy editor of JAMA, and Priscilla Shaffer, a virologist from the Harvard Medical School.
In its First Annual Report ("Initial Report"), CRI concludes that the culture underlying research fraud and misconduct is a subject of widespread concern in the scientific community well beyond the few highly publicized cases. CRI lists four areas in need of urgent attention:
The definition of "research misconduct" currently used by the Public Health Service ("PHS") is:
"fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research. It does not include honest error or honest differences in interpretations or judgments of data."
The National Science Foundation ("NSF") uses a similar definition. In 1992, the NAS study recommended limiting the definition to "fabrication, falsification and plagiarism" ("FFP"):
"Misconduct in Science is defined as fabrication, falsification, or plagiarism in proposing, performing or reporting research. Misconduct in science does not include errors of judgment, errors in the recording, selection, or analysis of data; differences in opinions involving the interpretation of data; or, misconduct unrelated to the research process.
As we pointed out in a previous article in this EBM series (Charles Walter & Edward P. Richards, Engineering and the Law: Scientific Misconduct, Part 5--Making Scientific Regulation Work, 11(4) IEEE ENGINEERING IN BIOLOGY AND MEDICINE MAGAZINE 102 (1992)), research professionals are burdened with the vague "other practices" language in the PHS definition because scientific research is without articulated professional standards of conduct. Without a professional code, it is impossible to write down all the ways a research professional can violate the standards of his or her profession.
The final CRI Report was the result of fifteen commission meetings over a period of one and one-half years. The definition proposed by the CRI eliminates both FFP and the "other practices" clause. The new definition would include a preamble,
"It is a fundamental principle that scientists be truthful and fair in the conduct of research and the dissemination of its results. Violation of this principle is scientific misconduct."
The preamble would be followed by the specific definition of "research misconduct",
"Specifically, research misconduct is significant misbehavior that improperly appropriates the intellectual property or contributions of others, that intentionally impedes the progress of research, or that risks corrupting the scientific record or compromising the integrity of scientific practices. Such behaviors are unethical and unacceptable in proposing, conducting, or reporting research, or in reviewing the proposals or research reports of others."
This definition would be followed by specific examples,
"Examples of research misconduct include but are not limited to the following:
"1. Misappropriation: An investigator or reviewer shall not intentionally or recklessly
"a. plagiarize, which shall be understood to mean the presentation of the words or ideas of another as his or her own, without attribution appropriate for the medium of presentation; or
"b. make use of any information in breach of any duty of confidentiality.
"2. Interference: An investigator or reviewer shall not intentionally and without authorization take or sequester or materially damage any research-related property of another, including without limitation, the apparatus, reagents, biological materials, writings, data, hardware, software, or any other substance or device used or produced in the conduct of research.
"3. Misrepresentation: An investigator or reviewer shall not with intent to deceive, or in reckless disregard for the truth,
"a. state or present a material or significant falsehood; or
"b. omit a fact so that what is stated or presented as a whole states or presents a material or significant falsehood.
"These behaviors are a subset of the professional misconduct that is the responsibility of institutions where research is conducted.
There is no doubt that dishonest behavior in the course of federally-funded research is going to be dealt with, and that the sanctions will not be limited to FFP. The only question is: Will the sanctions come from self-governance or will they be imposed by governmental edict? Many in the research community believe that the proposed NAS definition of "scientific misconduct" will impede the development of a code of professional responsibility for researchers, whereas the proposed CRI definition will encourage the establishment of such a code by researchers. Thus, the effect of adopting the NAS definition is likely to be an ever-growing menu of professional misconduct with sanctions imposed by nonscientists (probably lawyers), whereas the effect of adopting the CRI definition will be self-governance through a code developed by researchers to protect themselves from any vagueness in the broader definition of misconduct.
Some scientists prefer the CRI definition because they believe that non-FFP misconduct is widespread. For example, John Bailar, a medical statistician at the University of Chicago Medical School who is interested in data manipulation, is quoted as follows.
"'[T]he big problems are not with FFP, but with other aspects of how scientists go about their job. . ."'I'm thinking of violations of high standards; not telling readers everything they need to know to evaluate a piece of work fairly. For example, repeating an experiment until you get the 'right' result and only reporting that is misconduct. [Doing] 20 statistical tests until one is significant and only reporting that is misconduct.
"'None of these things fall under FFP, but they have become so widespread that they are a substantially greater threat to progress than relatively infrequent occurrences of FFP.'
Many in the research community with vested personal interests in retaining their status as grant authors for grantee institutions, do not like any definition of "research misconduct" that might hold them accountable for non-FFP conduct. Others, most of whom would never do any act contrary to the proposed CRI definition, continue to display paranoia in their response to CRI's proposal for professional responsibility to safeguard research integrity. Both groups are the enemy of federally-funded research, because, accountability for federal funds is necessary, and if this group prevails, the accountability will be through governmental edict rather than self-regulation.
For example, the Federation of American Societies for Experimental Biology ("FASEB") is a prestigious federation of 45,000 research scientists from ten constituent societies formed to bring members of the constituent societies together, to enhance their function as a group, and to disseminate research results. FASEB FEDERATION CONSTITUTION AND BYLAWS, Art. II. The hierarchy of FASEB continues to object to a definition of "research misconduct" that would hold research professionals accountable for non-FFP conduct that seriously deviates from practices that are commonly accepted within the scientific community for proposing, conducting or reporting research. In response to CRI's Initial Report, Dr. Samuel C. Silverstein, then President of FASEB, wrote to Dr. Ryan that proposed sanctions should be limited to existing problems in research, thereby suggesting that FFP was the only form of research misconduct at the present time. If this were correct, of course, there would be no need for concern about sanctions for non-FFP conduct.
Subsequently, FASEB received a copy of the proposed CRI definition of "research misconduct" developed at the end of July at a meeting in Elkridge, Maryland. In a letter purporting to be "on behalf of the 45,000 members of the 10 Federation Societies," the view's of FASEB's hierarchy that the proposed definition was "totally unsatisfactory" were transmitted without consultation with its members in a letter to Dr. Ryan from FASEB President, Dr. Ralph Bradshaw. Perhaps, most embarrassing is Dr. Bradshaw's statement,
"Moreover, the definition and accompanying material reflect a lack of understanding of the process of basic scientific research and the operations and attitudes attempting to understand complex biological phenomena.
Dr. Bradshaw urged that CRI adopt the NAS definition. This will be viewed as another attempt by scientists to avoid accountability because the NAS definition addresses only FFP and what is not misconduct; the whole issue of misconduct that is not FFP but is related to research is not addressed. If "FASEB" had asked this member, the response would have been that the CRI definition perceives the scientific research process very well, and would promote its goal by weakening vested interests that dilute federal tax support for the retention of personal status, without threatening those conducting research for the advancement of science, whereas the NAS definition disingenuously fails to address most of what is misconduct, and invites the perception that research professionals are unwilling to be accountable for misconduct.
The Law, Science & Public
Health Law Site
The Best on the WWW Since 1995!
Copyright as to non-public domain materials
See DR-KATE.COM for home hurricane and disaster preparation
See WWW.EPR-ART.COM for photography of southern Louisiana and Hurricane Katrina
Professor Edward P. Richards, III, JD, MPH - Webmaster