March 18, 1999
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Scientists Challenge New Disclosure Law

By William J. Cromie

Gazette Staff

Douglas Dockery, a School of Public Health researcher who has worked on the Six Cities Study since 1975, checks a device that collects air pollutants.

In 1963, Harvard researchers published a study that found air pollution in the United States was shortening the lives of millions of people, possibly by as much as two years in the most polluted areas. In 1999, the same study has led to what scientists all over the country consider to be threats of choking restrictions on their work.

In 1997, the U.S. Environmental Protection Agency (EPA) cited the research, called the Six Cities Study, as evidence that a significant toughening in air pollution standards was necessary. Seeing this as a hazard to their financial health, industry, particularly the petroleum industry, demanded that Harvard and the EPA release more details of the study. The request was refused on several grounds, including the fact that the data included confidential medical information on 8,000 people who volunteered to participate in the study.

Harvard proposed that an independent organization be appointed to review the data and provide the information requested by industry and Congress without compromising confidentiality. That proposal was accepted by the EPA and put into place in 1998. However, it was not enough for U.S. Sen. Richard Shelby, a Republican from Alabama. Last year, he inserted a little-noticed law in an appropriation bill that Congress approved. That law has every university, hospital, and nonprofit institution that receives federal funds worried about the future of its research programs.

The provision requires that every scrap of data produced by researchers with federal grants be made available to the public under the Freedom of Information Act (FOIA).

"This measure was long overdue," Shelby claims. "It represents a first step in ensuring that the public has access to all studies used by the federal government to develop federal policies."

Supporters of the law say that, if the public pays for a study, any taxpayer should be able to examine the data it produces. They argue that agencies like the EPA should not be able to change regulations that have a significant impact on the nation's economy and health without releasing all the information on which the change was based.

That sounds logical enough, but the devils are in the details. At present, researchers make their data available through reports published in journals, after the information is reviewed by a jury of their peers. The new law could make additional information available, including laboratory and field notebooks, patient questionnaires, computer tapes, and even e-mail.

The inclusive wording of the law worries every researcher. Says Kevin Casey, Harvard's director of federal and state relations: "It raises concerns of patient confidentiality, intellectual property rights, viability of partnerships with industry sponsors, the integrity of long-term research programs supported by multiple grants over many years, and could chill recruitment of research volunteers when they know that information about themselves may become property of the federal government, and that it would be made available to anyone who asked for it."

"This is a meat-ax approach to access of data when it's actually a fine scalpel that's required," Mary Ellen Sheridan, assistant vice president for research at the University of Chicago, told a meeting of the American Association for the Advancement of Science last month.

Repeal Effort

Scientists' concerns have been heard by the White House Office of Management and Budget (OMB), which must administer the law. The agency has asked for comments from involved bodies and is seeking to narrow the scope of Public Law 105-277 (PL 105-277), as Shelby's legislation is known. (Comments are being accepted through April 5.) The OMB itself has proposed limiting the data to information directly related to published research findings and to that which is used to establish federal policies.

Many scientists don't think that's enough. They see only problems if federal agencies, at the request of the public or industry, can figuratively look into their filing cabinets, desk drawers, and research diaries and extract selected material to support their vested interests or viewpoints. The loss of privacy could limit, even prevent, valuable research from being done.

The Six Cities Study led to other successful investigations of environmental tobacco smoke, acid rain, and the effects of pollutants on asthma. Companies whose bottom lines are affected by such research results could use PL 105-277 against the conduct of such investigations.

Researchers have expressed their fear of being harassed by certain industries. Tobacco, chemical, and petroleum companies might try to delay or quash research that could subject them to costly new health and environmental regulations.

Drug and biotechnology companies take a different view of the law, of course. Their researchers often collaborate with university scientists funded by federal dollars. Any release of proprietary information to their competitors could be very costly in time and money.

Additionally, research institutions would need to establish elaborate and costly bureaucratic mechanisms to make data on any project available on demand. "The financial commitment and administrative burden of such a requirement could be staggering," comments Jane Corlette, Harvard's associate vice president for government, community, and public affairs.

Scientists worry that, no matter how OMB chooses to resolve their concerns, any narrowing of the law's provisions could be challenged in court. "Because of this, it is our hope that Congress will revisit PL 105-277 and convene a process whereby these and other issues can be discussed in a deliberative and public process," says Harvard Provost Harvey Fineberg.

Instead of surgically carving out "infected" parts of the law, other scientists call for junking it outright. Support for that has come in a bill filed by U.S. Rep. George Brown, a California Democrat, to repeal the Shelby law.

That could be difficult. PL 105-277 supporters include Senate Majority Leader Trent Lott and others who insist that the public should have access to data that goes into regulations that affect their lives. Even some scientists insist that the researcher community has not paid enough attention to sharing the results of tax-funded investigations.

On the other hand, "the unforeseen negative consequences of complete disclosure could be enormous," Corlette points out. She cites the Six Cities Study as an example. The investigation began in the early 1970s and surveyed 8,000 adults and 14,000 children in Watertown, Mass.; Steubenville, Ohio; Harriman, Tenn.; Portage, Wis.; Topeka, Kansas; and St. Louis, Mo. Another Harvard study covered 552,000 adults living in 151 cities. "It would cost an enormous sum to gather all the data on such studies and reproduce it for the government," Corlette notes. "Added to this are the problems of diverting scientists from their research and the almost inevitable violations of the confidentiality of the participants."

For all these reasons and more, Harvard is asking OMB to cut the broad mandate of PL 105-277 to a narrower one that protects the public's right to know without trespassing on the rights of researchers.

"Depending on how the word 'data' is defined in any final ruling, demanding more information than is necessary or prudent to fulfill the public's right to know will have the unintended consequence of misinterpretation, misunderstanding, or harassment of researchers," says Casey.

"The United States has created a research capacity that is the envy of the world," Fineberg notes. "Certainly, the Congress has a responsibility to encourage scientifically sound research. PL 105-277, as presently crafted, could do unforeseen damage to a process that has served the public interest well for many decades."


Copyright 1999 President and Fellows of Harvard College