HHS JURISDICTION[index]

Does HHS have jurisdiction to propose findings of scientific misconduct against Professor Light or Dr. Tsara? The first question is whether HHS has any relationship with the scientists.

As with all Federal agencies, HHS can only do what Congress has enabled it to do by passing a specific statute. The enabling legislation for scientific misconduct reviews does not give HHS a roving commission to be watchdog over all scientific inquiry. HHS may only investigate scientists who are apply for HHS funds, receive HHS funds directly, or indirectly benefit from HHS funds received at their institution, or otherwise.

When HNEW applies for funds based on Dr. Light's work, both will be subject to HHS review. Once an application is made, the applicant cannot escape review by withdrawing the application. The wrongdoing is seeking federal money with an application that involves misconduct. That deed is complete when the application is submitted.

Dr. Tsara is already subject to HHS review because she was working on a project funded in part by HHS. Yet this funding need not be a direct grant to the investigator:

"'Funded by' means the provision of monetary support for grants, cooperative agreements, fellowships, contracts, or interagency agreements, and includes subgrantees, subcontractors and individuals who work on the funded research project even though they do not receive compensation from the Federal funds."

If you work on any part of a project that draws some part of its funds from HHS, you are subject to review. When one realizes that this could include an entire institution if the institution applies HHS money to general activities, it is arguable that anyone at a major medical research institution will be subject to HHS scientific misconduct review.

Once it has been determined that the individual has been funded by HHS, the question shifts to whether scientific misconduct has been committed:

"Scientific misconduct" is defined as, "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 interpretation or judgment of data." (Policies and Procedures for Dealing with Possible Scientific Misconduct in Extramural Research, 56 Federal Register 27384, 1991.)

The two fundamental limits on HHS's jurisdiction are that (1) the subject matter of HHS proceedings be "scientific misconduct" as defined above, and (2) HHS act within constitutional and other legal constraints on federal agency actions.

A. Legal Constraints

The First Amendment to the U.S. Constitution bars government from interfering with a citizen's right to free speech. HHS may not violate a scientist's free speech rights through its misconduct investigations. There is a special recognition of First Amendment rights in scientific research because "academic freedom" is as much a part of the scientific method as of free expression in literature or political science. The gravamen of academic freedom is to permit inquiry into even the most unlikely and unpopular ideas, no matter how absurd they may seem to the rest of us.

This means, first, that HHS may not determine that it is misconduct to apply for money to work on politically unpopular projects, as long as the application does not otherwise fall afoul of the definition of scientific misconduct. Once a project is funded, however, HHS is free to find that any deviation from the specific terms of the grant, including a change of research topics, is misconduct.

Since "academic freedom" is not limited to political ideas, this also means that HHS may not determine that it is scientific misconduct to apply for money to support research that cannot be rationalized by existing scientific theories. There may be other reasons for supporting such research, but "scientific misconduct" is not one of them because exercising academic freedom does not deviate from commonly accepted practices within the scientific community.

The scope of speech protected by the First Amendment is, of course, limited. While speech is more than just talking and writing, the protections for other actions have been limited to what the courts call symbolic speech. This doctrine has been found to protect nude dancing, but it is unlikely to extend to laboratory work. Thus we need not worry about whether just publishing an article can be misconduct: the article will either be based on improperly conducted science, or will be an improper report of the science funded by HHS. Irrespective of the free speech aspects of the article, it will violate the contractual terms of the grant by misreporting the results. It is this misreporting, and not the article itself, that is the misconduct.

Basically then, researchers are entitled to investigate whatever hypotheses they want, but their First Amendment rights do not protect communication of fabricated or falsified data. Furthermore, there is no First Amendment right protecting the communication of false data, even if the communication is done with a good faith belief that the data is accurate and correct.

Therefore, researcher's First Amendment rights do not protect any other communication of incorrect information resulting from "serious deviations from commonly accepted practices."

B. The Definition of Scientific Misconduct

In addition to the constitutional and other legal constraints, HHS's jurisdiction to propose findings of misconduct against scientists is limited to situations involving "practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research." Exercising academic freedom does not deviate from commonly accepted practices within the scientific community. Since it is not "scientific misconduct" to exercise academic freedom, academic freedom links the legal constraints on HHS jurisdiction with those imposed by the meaning of "scientific misconduct."

If Professor Light can be sanctioned for proposing or reporting studies that cannot be explained by accepted scientific theories, science is frozen in concrete.

Should Professor Light receive a grant? The answer should be strictly a scientific matter. However, it is important to recognize that, without the preliminary data, Professor Light would have no chance, whereas, with valid data, he has a substantial chance. The threshold question, therefore, is the accuracy of the preliminary data, and that is strictly a scientific issue. The collateral issue, "misconduct," arises only if the data is not reproducible, and there is sufficient evidence of fabrication or falsification or some other serious deviation from commonly accepted practices.

On the other hand, the primary issue in Dr. Tsara's case is "misconduct." If Dr. Tsara knew the data was false, her behavior amounts to misconduct. But even if Dr. Tsara did not know the data was false, she is not off HHS's hook. If her use of the data was a serious violation from commonly accepted practices, her behavior amounts to misconduct. However, if Dr. Tsara can be sanctioned for failing to notice that data submitted through her administratively is false, the administration of research will soon be out of touch with those doing it. Therefore, Dr. Tsara's initial defense is that HHS has no jurisdiction to propose findings of misconduct against scientists for "honest error or honest difference in interpretation or judgment of data." If Dr. Tsara's administrative error is not "scientific misconduct," she is entitled to the same defenses as any other data base user.

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