As the federal government considers an overhaul to rules governing scientific research involving human subjects, the National Research Council is urging officials to be more exacting in determining which types of social and behavioral science research should receive oversight.
A report released by the council on Thursday outlines a wide range of recommendations for how to protect human subjects while making social and behavioral research more effective. A committee of National Research Council-appointed researchers drafted the document -- described as “a consensus report” -- after holding a workshop with researchers earlier this year and reviewing empirical literature on protecting human subjects.
The report is a response to the federal government’s proposal, released in 2011, to make sweeping changes to the regulations governing human subjects, known as the Common Rule, for the first time in more than two decades. The Department of Health and Human Services has proposed to, among other things, create a new category of “excused” research that would subject certain kinds of research posing minimal risks to lower levels of scrutiny from institutional review boards.
Some social science and humanities researchers have complained that the current review process is too burdensome, especially since their research typically possess minimal risk to participants.
In its report released Thursday, the National Research Council report endorses that approach, but also urges the government to refine its definition of what types of research ought to be overseen by an institutional review board in the first place.
The Department of Health and Human Services should clarify that only “human subjects research” is subject to the Common Rule and IRB procedures, the report says. Only research that involves direct interaction with a living individual or involves obtaining identifiable information about an individual should fall into that category, the committee wrote.
Research that relies on publicly available information or information that can be observed in public contexts should not be considered “human subjects research,” the report says. Neither should studies that collect or rely on some personally identifiable information so long as there is no reasonable expectation of privacy, the report adds.
“If you’re analyzing the phone book -- or the 21st century version thereof -- you shouldn’t have to consider it to be human subjects research,” said Susan Fiske, a professor of psychology and public affairs at Princeton University, who led the committee.
“So much of what people are doing now with Big Data includes observation of people in public places like the Internet,” Fiske said. “If you’re tweeting, the pattern of your tweets is certainly not expected to be private.”
The report also makes recommendations about which types of human subjects research should enjoy the lesser scrutiny of being deemed “excused research.” Excused research should include projects that involve human subjects in benign or familiar activities, such as educational tests, surveys and focus groups.
As part of the new “excused” research category, the government had proposed that researchers should have to develop a data protection plan that adhered to standards similar to those required for health care providers handle patient data under the federal Health Insurance Portability and Accountability Act.
The committee also rejected that approach, arguing that the standard would, in the research context, overprotect some types of data and not provide subjects with sufficient protection in other areas. The report calls for data protection approaches to be dynamic and adapt to the specific needs of an investigator.
Zachary M. Schrag, a professor of history at George Mason University, who has been critical of the IRB system, praised the report’s thoroughness and call for empirical research, but said it not address some underlying problems with how social and behavior science is overseen by review boards.
“The only time the word freedom appears in the report is freedom for IRBs,” he said, adding that the current federal rules can be an impediment to social scientists who want to explore controversial topics.