RENEWING TRUST IN NIH

Michael Gottesman

Beginning last fall and continuing through this summer, we have been faced with allegations and revelations about lucrative consulting arrangements between NIH scientists and industry, some approved by NIH ethics officials and some not. These revelations have led to the perception that the integrity of NIH science and scientists may be compromised.

It is worth noting that the credibility of intramural scientists is of paramount importance to Congress and the public, who rely on us for unimpeachable information about basic research and crucial public health issues. It is therefore essential that NIH do whatever is necessary to restore public confidence in the work that is done here and the scientists who do it.

NIH Director Elias Zerhouni has appeared twice before the Oversight and Investigations Subcommittee of the House Committee on Energy and Commerce—the "Greenwood committee" (chaired by Rep. James C. Greenwood [R-Pa.])–to offer solutions to the current quandary.

In the first hearing, on May 18, he outlined steps that NIH had already taken, including creation of a central committee of scientists and ethics officials (the NIH Ethics Advisory Committee, or NEAC) chaired by Raynard Kington, NIH deputy director and deputy ethics counselor. This committee, which I co-chair, has brought uniformity and rigor to the review of requests for many different kinds of outside activities.

Dr. Zerhouni also reviewed the recommendations of a Blue Ribbon Panel on Ethics at NIH. But Greenwood committee members faulted some of the panel’s specific recommendations as being inadequate to prevent some abuses of concern to them. Subsequently, on June 22, Dr. Zerhouni outlined several significant changes in the ethics program at NIH that were received more enthusiastically by the Greenwood committee.

The principles behind these changes include:

Removing any ambiguity about which activities are acceptable and which are not to restore public trust and clarify policies for NIH staff

Increasing transparency in reporting outside activities

Allowing researchers at NIH to engage in certain types of consulting agreements with industry to expand the intellectual horizons of our scientists and their ability to contribute to the public health—but barring such activities for others, including NIH leadership, scientific directors, and clinical directors.

Creating a system that allows effective and efficient monitoring and oversight

The full testimony can be found here, which is part of the NIH website pertaining to ethics issues.

Highlights of Dr. Zerhouni’s specific plans to eliminate perception of conflict of interest at NIH and enhance public trust include:

Eliminating or reducing stock holdings in biotech and pharmaceutical companies

Verification of authenticity of research honors and awards

Limitations on the amount and nature of compensation for consulting activities (including disallowing stock or stock options)

Prohibitions on membership on corporate boards

Prohibitions on consulting with grantee institutions

Expanded public reporting of outside activities, including an increase in the number of NIH staff who file financial reports

Many of these changes in current policy require regulatory authority from the Office of Government Ethics, a process that takes many months. And specific details about how to implement these plans without causing undue hardship in individual cases are being worked out.

In the near future, NIH will be providing guidance about what activities may be possible while the new program is being developed.

The experience from NEAC suggests that many of the outside activities requested by NIH scientists are clinical care or academic—editing, writing, and teaching in a course—and most of these should continue to be approvable under the new rules.

Other outside activities, such as consulting with grantee organizations (for example, giving a scientific talk at a university or serving on an external advisory board to an NIH grantee), will not be allowed as outside activities, but can be conducted as official duty activities with approval from a supervisor and/or appropriate extramural staff, with or without sponsored travel, as appropriate.

The intent is to encourage intellectual exchanges with academia and industry as part of official duties, but to limit or prohibit compensation for such activities.

Much more information will be forthcoming as the new ethics program develops, and every effort will be made to inform the NIH community as new policies are formulated and implemented.

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