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Conclusions and Comments[index]

Misappropriation of HHS Funds and the ALERT System

HHS' recent decision to remove the names of individuals who have been found to have misappropriated federal research funds from the PHS ALERT System raises the question, "Is the misappropriation of federal research funds a practice that seriously deviates from commonly accepted practice within the scientific community for conducting research?"

Admittedly, misappropriated funds may not have been taken for the direct "personal" benefit of the individual stealing them. A common motive is to enhance underfunded state teaching programs or support unfunded research projects or activities. However, there is usually substantial professional benefit to the individual who misappropriates federal funding to other projects or activities. Further, it is the senior, respected scientists who have greatest access to the type of federal funds that are most easily shifted about (training grants, departmental grants, core grants, and the like). Misappropriation by respected scientists, many of whom have administrative responsibilities, does substantial damage to younger, more idealistic scientists who have not yet learned to "play the game." To the uninitiated, the misappropriation of federal money to pay for unfunded research or underfunded institutional activities looks more like money-laundering or pushing drugs, creating local dependencies on federal funds, than honest conduct.

Protecting Whistleblowers

Part of the Director's responsibility for coordinating the development of research integrity policies is to ensure that subjects of investigations and whistleblowers are treated fairly. We believe that what this means is that neither the public nor researchers will know who accused a researcher of misconduct. The average citizen might say, "Whoa, even criminals have the right to confront their accusers; what's going on here?" Does the fact that the police have secret informers justify ORI having them too?

The problem facing scientists accused by ORI is that scientific misconduct isn't a crime. HHS is an administrative agency. A violation of an HHS regulation is an administrative matter, controlled by principles of administrative law. Under well-established principles of administrative law, one must exhaust all administrative remedies by obtaining what is called a "final agency action" before seeking relief in a court of law.

However, vindication in a court of law is not so easy following a final agency action. The courts give great deference to final agency actions because administrative hearings save the courts time and effort. However, if, after exhausting all administrative remedies, a debarred researcher can prove that the HHS hearing was clearly wrong or patently unfair, relief is probably not more than three years away. If the ex-researcher can afford $100,000 in legal costs even though unemployed, there is a light at the end of the tunnel. Most likely, it is a train.

The New Order

In the May, 1994 issue of EMB Magazine, we asked how Dr. Bivens reconciled his outrageous treatment of researchers like Robert Gallo with his implicit obligation to undertake diligent efforts to restore the reputations of scientists who have been exonerated of ORI charges. We received no answer to that question, but we may have received an answer to another, even more fundamental question. Consider the facts.

During the eighteen month period before scientists could appeal ORI findings of misconduct to DAB panels, ORI won sixteen misconduct cases against scientists. Then scientists were given the opportunity to appeal to DAB panels, introduce their own evidence and witnesses, and cross-examine ORI investigators and witnesses. During the next year and a half, every scientist who appealed won or ORI dropped the charges, and Dr. Bivens claimed that ORI and DAB were in "fundamental disagreement" over the importance of honesty in science.

The bottom line is that ORI is now an independent entity in DHHS, its Director now reports directly to the Secretary and Dr. Bivens is still the Director.

More ominously, Dr. Bivens' newly independent ORI now develops policies, procedures and regulations within HHS without limitation. HAG is an independent fiefdom for developing the definition of "scientific misconduct," developing procedures for charging scientists with it, investigating, prosecuting and judging the charges, and publishing "guidelines" for procedures used by the panels hearing scientists' appeals of those charges. If this arrangement doesn't resolve the "fundamental disagreement" between HAG and the appeals panels, nothing will.

There are numerous questions that are not even addressed by the present regulations. For example, what quantum of evidence is required for HAG to propose a finding of misconduct? Since ORI was unable to prove four out of four of its past misconduct findings by a preponderance of the evidence (See this Engineering and Law series in the March 1994 issues of the EMB Magazine at 142-145), it is clear that ORI has been proposing findings of misconduct based on a quantum of evidence that is substantially less than that required for an actual finding of misconduct. It seems likely that the newly independent HAG will continue to do likewise. What will the lesser standard be? A mere suspicion? In criminal indictments, charges are brought when there is "probable cause" to believe the accused is guilty. Whatever standard HAG uses, it should be disclosed and discussed outside HHS. There is a great deal at stake for society and for the accused when HHS proposes a finding of misconduct. Was ORI's standard sufficient to deny society the benefits of Robert Gallo's research for several years? Or is it insufficient to protect society from a researcher who claims that a worthless drug is beneficial? And since it is society--not just funding that HHS administers--that is really at stake, why doesn't the same standard apply to all research that impacts society, however funded? Why aren't scientists in private laboratories scrutinized in the same way?

How to Avoid Trouble

How does a researcher get caught in the HHS administrative net? It is obvious that receiving an HHS grant places a researcher under the control of HHS. Less obvious is the fact that electing to be associated with HHS funding, even ever so slightly, also subjects one to HHS's rules. [9]

It's a lot simpler to earn an honest living practicing law to support one's research and writing articles for this series in the EMB Magazine.

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