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)
“I’m no good at being noble, but it doesn’t take much to see that the problems of three little people don’t amount to a hill of beans in this crazy world. Someday you’ll understand that.”
—Julius J. Epstein, U.S. screenwriter, Philip Epstein, screenwriter, Howard Koch, screenwriter, and Michael Curtiz. Rick Blaine (Humphrey Bogart)
“Our brains are no longer conditioned for reverence and awe. We cannot imagine a Second Coming that would not be cut down to size by the televised evening news, or a Last Judgment not subject to pages of holier-than-Thou second- guessing in The New York Review of Books.”
—John Updike (b. 1932)
“... feminism is the attempt of women to grow up, to accept the responsibilities of life, to outgrow those characteristics of childhood—selfishness and unworldliness—that we require our boys to outgrow, but that we permit and by our social system encourage our girls to retain.”
—Henrietta Rodman (1878–?)
“For twenty-five centuries, Western knowledge has tried to look upon the world. It has failed to understand that the world is not for the beholding. It is for hearing. It is not legible, but audible. Our science has always desired to monitor, measure, abstract, and castrate meaning, forgetting that life is full of noise and that death alone is silent: work noise, noise of man, and noise of beast. Noise bought, sold, or prohibited. Nothing essential happens in the absence of noise.”
—Jacques Attali (b. 1943)