Problems With IRB Review of Social Science
While the federal regulations and Belmont principles were formulated with biomedical and social-behavioral research in mind, the enforcement of the regulations, the examples used in typical presentations regarding the history of the regulatory requirements, and the extensiveness of written guidance have been predominantly focused on biomedical research.
Numerous complaints by investigators about the fit between the federal regulations and its IRB review requirements as they relate to social science research have been received. Broad complaints range from the legitimacy of IRB review, the applicability of the concepts of risk as it pertains to social science (e.g., possibly unneeded, over-burdensome requirements), and the requirements for the documentation of participants' consent, i.e., consent forms). Often these concerns are based on an IRB misunderstanding the social science and/or failing to apply the flexibility permitted in the regulatory framework. Social scientists have appropriately criticized biomedical IRBs for failing to adequately understand their research methods (such as ethnography). In 2003, OHRP, in conjunction with the Oral History Association and American Historical Association, issued a formal statement that taking oral histories, unstructured interviews (as if for a piece of journalism), collecting anecdotes, and similar free speech activities often do not constitute "human subject research" as defined in the regulations and were never intended to be covered by clinical research rules.
Other federal agencies supporting social science have attempted to provide guidance in this area, especially the National Science Foundation. In general, the FAQ assures IRBs that the regulations have some flexibility and rely on the common sense of the IRB to focus on limiting harm, maximizing informed consent, and limiting bureaucratic limitations of valid research.
Read more about this topic: Institutional Review Board
Famous quotes containing the words problems with, problems, review, social and/or science:
“She has problems with separation; he has trouble with unity—problems that make themselves felt in our relationships with our children just as they do in our relations with each other. She pulls for connection; he pushes for separateness. She tends to feel shut out; he tends to feel overwhelmed and intruded upon. It’s one of the reasons why she turns so eagerly to children—especially when they’re very young.”
—Lillian Breslow Rubin (20th century)
“It’s so easy during those first few months to think that the problems will never end. You feel as if your son will never sleep through the night, will always spit up food after eating, and will never learn to smile—even though you don’t know any adults or even older children who still act this way.”
—Lawrence Kutner (20th century)
“As I review my life, I feel I must have missed the point, either then or now.”
—Mason Cooley (b. 1927)
“Both gossip and joking are intrinsically valuable activities. Both are essentially social activities that strengthen interpersonal bonds—we do not tell jokes and gossip to ourselves. As popular activities that evade social restrictions, they often refer to topics that are inaccessible to serious public discussion. Gossip and joking often appear together: when we gossip we usually tell jokes and when we are joking we often gossip as well.”
—Aaron Ben-Ze’Ev, Israeli philosopher. “The Vindication of Gossip,” Good Gossip, University Press of Kansas (1994)
“In the new science of the twenty-first century, not physical force but spiritual force will lead the way. Mental and spiritual gifts will be more in demand than gifts of a physical nature. Extrasensory perception will take precedence over sensory perception. And in this sphere woman will again predominate.”
—Elizabeth Gould Davis (b. 1910)