Questioning Privacy Protections in Research (New York Times)

Dr. John Cutler, center, during the Tuskegee syphilis experiment. Abuses in that study led to ethics rules for researchers. Coto Report

Published: October 23, 2011

Hoping to protect privacy in an age when a fingernail clipping can reveal a person’s identity, federal officials are planning to overhaul the rules that regulate research involving human subjects. But critics outside the biomedical arena warn that the proposed revisions may unintentionally create a more serious problem: sealing off vast collections of publicly available information from inspection, including census data, market research, oral histories and labor statistics.

Organizations that represent tens of thousands of scholars in the humanities and social sciences are scrambling to register their concerns before the Wednesday deadline for public comment on the proposals.

The rules were initially created in the 1970s after shocking revelations that poor African-American men infected with syphilis in Tuskegee, Ala., were left untreated by the United States Public Health Service so that doctors could study the course of the disease. Now every institution that receives money from any one of 18 federal agencies must create an ethics panel, called an institutional review board, or I.R.B.

More than 5,875 boards have to sign off on research involving human participants to ensure that subjects are fully informed, that their physical and emotional health is protected, and that their privacy is respected. Although only projects with federal financing are covered by what is known as the Common Rule, many institutions routinely subject all research with a human factor to review.

The changes in the ethical guidelines — the first comprehensive revisions in more than 30 years — were prompted by a surge of health-related research and technological advances.

Researchers in the humanities and social sciences are pleased that the reforms would address repeated complaints that medically oriented regulations have choked off research in their fields with irrelevant and cumbersome requirements. But they were dismayed to discover that the desire to protect individuals’ privacy in the genomics age resulted in rules that they say could also restrict access to basic data, like public-opinion polls.

Jerry Menikoff, director of the federal Office for Human Research Protections, which oversees the Common Rule, cautions that any alarm is premature, saying that federal officials do not intend to pose tougher restrictions on information that is already public. “If the technical rules end up doing that, we’ll try to come up with a result that’s appropriate,” he said.

Critics welcomed the assurance but remained skeptical. Zachary Schrag, a historian at George Mason University who wrote a book about the review process, said, “For decades, scholars in the social sciences and humanities have suffered because of rules that were well intended but poorly considered and drafted and whose unintended consequences restricted research.”

The American Historical Association, with 15,000 members, and the Oral History Association, with 900 members, warn that under the proposed revisions, for example, new revelations that Public Health Service doctors deliberately infected Guatemalan prisoners, soldiers and mental patients with syphilis in the 1940s might never have come to light. The abuses were uncovered by a historian who by chance came across notes in the archives of the University of Pittsburgh. That kind of undirected research could be forbidden under guidelines designed to prevent “data collected for one purpose” from being “used for a new purpose to which the subjects never consented,” said Linda Shopes, who helped draft the historians’ statement.

The suggested changes, she said, “really threaten access to information in a democratic society.”

Numerous organizations including the Consortium of Social Science Associations, which represents dozens of colleges, universities and research centers, expressed particular concern that the new standards might be modeled on federal privacy rules relating to health insurance and restrict use of the broadest of identifying information, like a person’s ZIP code, county or city.

The 11,000-member American Anthropological Association declared in a statement that any process that is based on the health insurance act’s privacy protections “would be disastrous for social and humanities research.” The 45,000-member American Association of University Professors warned that such restrictions “threaten mayhem” and “render impossible a great deal of social-science research, ranging from ethnographic community studies to demographic analysis that relies on census tracts to traffic models based on ZIP code to political polls that report by precinct.”

Dr. Menikoff said references to the statutes governing health insurance information were meant to serve as a starting point, not a blueprint. “Nothing is ruled out,” he said, though he wondered how the review system could be severed from the issue of privacy protection, as the consortium has discussed, “if the major risk for most of these studies is that you’re going to disclose information inadvertently.” If there is confidential information on a laptop, he said, requiring a password may be a reasonable requirement.

Ms. Shopes, Mr. Schrag and other critics emphasized that despite their worries they were happy with the broader effort to fix some longstanding problems with institutional review boards that held, say, an undergraduate interviewing Grandma for an oral history project to the same guidelines as a doctor doing experimental research on cancer patients.

“The system has been sliding into chaos in recent years,” said Alice Kessler-Harris, president of the 9,000-member Organization of American Historians. “No one can even agree on what is supposed to be covered in the humanities and social sciences.”

Vague rules designed to give the thousands of review boards flexibility when dealing with nonmedical subjects have instead resulted in higgledy-piggledy enforcement and layers of red tape even when no one is at risk, she said.

For example Columbia University, where Ms. Kessler-Harris teaches, exempts oral history projects from review, while boards at the University of Illinois in Urbana-Champaign and the University of California, San Diego, have raised lengthy objections to similar interview projects proposed by undergraduate and master’s students, according to professors there.

Brown University has been sued by an associate professor of education who said the institutional review board overstepped its powers by barring her from using three years’ worth of research on how the parents of Chinese-American children made use of educational testing.

Ms. Shopes said board members at one university had suggested at one point that even using recorded interviews deposited at the Ronald Reagan Presidential Foundation and Library would have needed Reagan’s specific approval when he was alive.

Many nonmedical researchers praised the idea that scholars in fields like history, literature, journalism, languages and classics who use traditional methods of research should not have to submit to board review. They would like the office of human protections to go further and lift restrictions on research that may cause participants embarrassment or emotional distress. “Our job is to hold people accountable,” Ms. Kessler-Harris said.

Dr. Menikoff said, “We want to hear all these comments.” But he maintained that when the final language is published, critics may find themselves saying, “Wow, this is reasonable stuff.”


This article has been revised to reflect the following correction:

Correction: October 26, 2011

An article on Monday about federal officials’ plans to overhaul privacy rules that regulate research involving human subjects, and concerns raised by scholars, paraphrased incorrectly from comments by Linda Shopes, who helped draft a statement by historians about possible changes. She said that board members at a university (which she did not name) — not board members at the University of Chicago — suggested at one point that using recorded interviews deposited at the Ronald Reagan Presidential Foundation and Library would have needed Reagan’s specific approval when he was alive.