Award Date

12-2011

Degree Type

Dissertation

Degree Name

Doctor of Philosophy in Educational Leadership

Department

Educational Leadership

First Committee Member

Gerald Kops, Chair

Second Committee Member

Cecelia Maldonado

Third Committee Member

Sterling Saddler

Fourth Committee Member

Patrick Carlton

Graduate Faculty Representative

LeAnn Putney

Number of Pages

315

Abstract

The Impact of Regulating Social Science Research with Biomedical Regulations Since 1974 Federal regulations have governed the use of human subjects in biomedical and social science research. The regulations are known as the Federal Policy for the Protection of Human Subjects, and often referred to as the "Common Rule" because 18 Federal agencies follow some form of the policy. The Common Rule defines basic policies for conducting biomedical and social science research. Almost from the inception of the Common Rule social scientists have expressed concerns of the policy's medical framework of regulations having its applicability also to human research in the social sciences. The purpose of this dissertation was to investigate the impact of regulating social science research with the framework of biomedical research regulatory standards.

Qualitative methodology is used to analyze the Office of Human Research Protection's Determination Letters, to facilitate in-depth interviews of human research protection program administrators, and to evaluate the Common Rule policy.

The researcher reviewed 763 letters with 43 letters determined to be associated with social science research projects. The 763 determination letters represented a time span of 10 years, from 2000 to 2010. The letters were reviewed for indications of noncompliance or deficiencies to regulations specified in the Federal Regulations 45 CFR 46, Subpart A, (the Common Rule). Noncompliance or deficiencies by the IRB and HRPP support staff represented the majority of determination letter findings.

In-depth interviews were conducted with HRPP administrators. The lack of flexibility of the Common Rule in its application to social science disciplines was a common theme in the responses of HRPP administrators. Evaluation of the Common Rule suggested the policy was effective and efficient for the IRB and its administrative support staff, but was less effective and not efficient for social science research projects.

The assessment of the impact of regulating social science with biomedical regulations highlights the need for additional education and training of IRBs and their administrative support staff to more effectively apply a biomedical model of research regulation to the review and approval of social science research activity. The assessment additionally suggests the need for an "update" of the Common Rule to address the specificity of new areas of social science research in which IRBs deliberate scrupulously with no regulatory guidance.

Keywords

Bioethics; Biomedical regulations; Common Rule; Common Rule (45 CFR 46); Complementary Analysis Research Method Application (CARMA); Education; Human research protection programs; Human research subjects; Institutional Review Board; Philosophy, religion and theology; Social sciences – Research – Law and Legislation; Social sciences – Research – Moral and ethical aspects; Social science research; Social science research compliance

Disciplines

Ethics in Religion | Higher Education and Teaching | Other Law | Philosophy | Public Policy | Social and Behavioral Sciences

Language

English


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