Jocelyn Kaiser's article "New law could open up lab books" (News of the Week, 6 Nov., p. 1023) presents a good picture of the perceived threat to the integrity of research laboratory and clinical data that could be wrought by the new law that would "require Federal awarding agencies to ensure that all data produced under an award [grant] will be made available to the public through the procedures established under the Freedom of Information Act [FOIA]." It is important to recognize, however, that the FOIA and subsequent court decisions establish protections that were used for many years when the National Institutes of Health (NIH) dealt with FOIA issues and policies, and that can still be helpful in guarding against disclosures.
First, the act provides several exemptions from disclosure, of which three covered most circumstances where NIH deemed it better not to apply mandatory disclosure (1):
1) "trade secrets and commercial or financial information obtained from a person and privileged or confidential";
2) "interagency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency"; and
3) " personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy."
Second, besides these and related exemptions from mandatory disclosure, various court cases have protected against disclosure of peer review evaluations to third parties. Supreme Court decisions have protected data from release when such release would harm the competitive position of the person supplying those data, and have denied third parties access, leaving it to the awarding NIH institute to determine whether to release certain data in a grant-supported clinical trial, even though the institute had earlier released those data to an appropriate scientific organization to confirm the validity of the findings and conclusions.
In all cases, NIH established an advantageous system under which persons requesting information had to specify the information or data requested to avoid "fishing expeditions," for instance, and sought advice from the persons supplying those data or information as to whether they wished to withhold parts of the requested data from disclosure under one or more of the allowable exemptions. Subsequent negotiations usually yielded some degrees of flexibility in releasing the information, at minimal risk or discomfort to the persons supplying it.
Adaptations of the above and other restraints in the FOIA and in niceties of responses should serve to protect government agency grantees, contractors, and intramural researchers against undue hardships and agony, as otherwise perceived by some who now face this new and sudden intrusion into their research lives. Time may have brought some subsequent changes into the basic act and corresponding agency regulations, and careful attention may still forestall the catastrophe that some researchers and their institutions now envision.
William H. Goldwater*
References
5508 Durbin Road,
Bethesda, MD 20814, USA.
E-mail: DEPMObg@aol.com
- Freedom of Information Act (1966, 1974), as amended by Public Law 93-502 (1974), exemptions (4), (5), and (6).
*Director of the Extramural Programs Management Office of the NIH Office of Extramural Research from 1984 to 1993.
Kaiser's article suggests that the new law which requires federally supported researchers to release their data upon FOIA requests will raise all kinds of problems for researchers. However, the law accomplishes two things: (i) it provides taxpayers, who paid for the research, access to the data; and (ii) federally supported scientists will not be able to shield their data from examination by other scientists.
The application of the law will be largely, if not entirely, limited to research that the government uses to justify regulations. Much of that research will involve human subjects, and appropriate safeguards are necessary and available to protect individuals' identity and privacy. Few federal research efforts are more politically charged than the U.S. Air Force's 20-year-long study of the health of the 1200 men who sprayed 90% of the Agent Orange used in Vietnam. Years ago, the Air Force researchers and the Department of Health and Human Services advisory panel to that study agreed to make all the data tapes available to anyone who requests them. The only alterations to the files are made by government experts who "scrub" out personal identifiers.
Data exchange is part and parcel of the practice of science.
Michael Gough
Director,
Science and Risk Studies,
Cato Institute,
1000 Massachusetts Avenue, NW,
Washington, DC 20001, USA.
E-mail: mgough@cato.org
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