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)
“The Settlement ... is an experimental effort to aid in the solution of the social and industrial problems which are engendered by the modern conditions of life in a great city. It insists that these problems are not confined to any one portion of the city. It is an attempt to relieve, at the same time, the overaccumulation at one end of society and the destitution at the other ...”
—Jane Addams (1860–1935)
“You don’t want a general houseworker, do you? Or a traveling companion, quiet, refined, speaks fluent French entirely in the present tense? Or an assistant billiard-maker? Or a private librarian? Or a lady car-washer? Because if you do, I should appreciate your giving me a trial at the job. Any minute now, I am going to become one of the Great Unemployed. I am about to leave literature flat on its face. I don’t want to review books any more. It cuts in too much on my reading.”
—Dorothy Parker (1893–1967)
“I am heartily tired of this life of bondage, responsibility, and toil. I wish it was at an end.... We are both physically very healthy.... Our tempers are cheerful. We are social and popular. But it is one of our greatest comforts that the pledge not to take a second term relieves us from considering it. That was a lucky thing. It is a reform—or rather a precedent for a reform, which will be valuable.”
—Rutherford Birchard Hayes (1822–1893)
“We have to ask ourselves whether medicine is to remain a humanitarian and respected profession or a new but depersonalized science in the service of prolonging life rather than diminishing human suffering.”
—Elisabeth Kübler-Ross (b. 1926)