NIH Draws Up New Guidelines

As researchers at Harvard's Medical School have struggled to deal with the consequences of two messy scandals over the past year, the National Institutes of Health (NIH) is preparing to implement new regulations designed to forestall similar occurrences.

NIH, which gave out research grants amounting to more than $5.5 billion last year, says the new rules governing possible scientific misconduct--combined with another set of proposed changes in conflict-of-interest guidelines--will increase the accountability of the scientific community.

Last year the Med School was rocked by the discovery that Dr. Shervert H. Frazier, former head of psychiatry at the Harvard-affiliated McLean Hospital, plagiarized an article he had written early in his career.

If grant-receiving academic institutions do not change their policies to conform with the NIH specifications--slated to go into effect on November 8--they risk losing all funding from the government agency.

Misconduct is defined in the new statute 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 interpretations or judgments of data."

Here are a few of the major components of the new rules required of research institutions:

. The institution must have a written policy with guidelines defining misconduct, as well as procedures for violation of these guidelines.

. Specific requirements must be met pertaining to time limits on reporting violations, confidentiality when investigating violations and documenting investigations.

. Each year, the organization must give a report to the Office of Scientific Integrity at NIH assuring them that all procedures and policies are being followed.

Other restrictions on scientific research are not covered by these new rules, such as conflict of interest between industry and academic researchers. Another department of NIH is currently finalizing proposals requiring researchers to disclose financial interests and outside professional activities.

These proposals sparked controversy at Harvard because of the University's Medical Science Partnership (MSP), a venture capital fund for marketing new technology that comes out of Medical School research.

Tougher rules on conflict of interest could be a direct threat to MSP, which markets professors' research while ensuring a percentage of the profits go back to the University.

While some institutions will have to scramble to create new policies from scratch in accordance with the new misconduct guidelines, Harvard should have no such problems with its existing procedures, says Dr. Suzanne W. Hadley, deputy director of the Office of Scientific Integrity.