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Human subjects requirements and economic education researchers.

Article Excerpt
I. Introduction

All academic institutions that receive funding from the United States federal government are required to enforce regulations that govern the use of human subjects by their researchers. When a study meets the government's definition of research, the principal investigator must submit a proposal outlining the methodology and procedures to an internal Institutional Review Board (IRB) prior to engaging in any research project that includes collecting and/or analyzing data from human subjects. The local IRB must certify that the design is in conformity with the federal regulations before any research project using human subjects may begin. Thus, virtually all university professors in the U.S. who use their students for research into the scholarship of teaching and learning must be familiar with the IRB regulations and practices.

Although many classroom-based educational projects either do not meet the regulation's definition of research or are explicitly exempted from the human subjects protocols, the IRB system may still impose significant costs on project directors. The underlying rationale for the federal regulations and the IRB process is to protect human subjects from potential harm that may result as a consequence of participating in a research project. For some types of research studies, such as medical drug trials, the personal risks may be obvious and potentially serious. However, for classroom-based studies that normally rely on surveys and tests, the risks of personal harm are minimal or non-existent.

In recent years, a small number of high profile cases where careless procedures were employed in medical studies caused universities to tighten their oversight of all human subjects research. These cases included the deaths of two research volunteers, one at the University of Pennsylvania and another at Johns Hopkins University (Brainard 2005). The increased scrutiny and the burdens of conforming to the IRB policies led to public complaints by social scientists and educators whose typical research procedures do not pose significant risks to their human subjects. The 2002 Annual Report of The Journal of Economic Education (Becker 2002) calls into question the necessity of imposing the same IRB regulations that protect human subjects in medical studies to the area of classroom teaching. Risk-averse university officials, observing lawsuits filed against universities for human subjects violations in medical experiments, may "overreact when confronted with human subject committee members' arguments to expand their policing function to classroom teaching." It is argued that overly stringent IRB requirements create unnecessary burdens and hurdles for economic education researchers, and thus, less classroom-based research will be conducted. (1)

This paper investigates the extent of knowledge held by economic education researchers about the federal regulations that govern human subjects research, the perceived costs of these regulations, and whether the regulations significantly affect the quantity and quality of research done in economic education. Our analysis is based on information obtained through a web-based survey directed to those who recently conducted and published research in economic education and those likely to do so. After a brief background review of human subjects' protocols in social science research, we will discuss the survey results and the implications of our findings.

II. Background

The current federal regulations that govern human subjects research evolved from the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research which was formed by Congress in 1974. This commission's final report, released in 1979 and popularly known as the "Belmont Report," (2) identified and defined the basic ethical principles on which today's regulations are based. The commission categorized these principles into the following three areas: 1) Respect for persons: To ensure the honor for the personal dignity, autonomy, and right to privacy of individual human subjects. 2) Beneficence: The obligation to minimize the risks of potential harm to human subjects while seeking to maximize the benefits of research to humanity. 3) Justice: To ensure that all benefits and costs of human subjects research are fairly and equitably distributed. These principles serve as the foundation for the Federal Policy for the Protection of Human Subjects (Code of Federal Regulations Title 45-Part 46) which institutionalizes the IRB process. Currently, seventeen federal departments and agencies that support and conduct human subjects research enforce this policy, which is often referred to as the Common Rule. (3)

The specific policies of the Common Rule are extensive but surround a small set of key issues. Primary among these issues is the requirement to obtain informed consent from all experimental participants in a research project. All human subjects must be free to both volunteer and withdraw from participation. Researchers are required to determine the potential risks, both physical and mental, that may result from participation in a project and to inform all human subjects about these risks prior to requesting their consent to participate. Furthermore, researchers are required to estimate all of the potential benefits and costs of the research project and to equitably select human subjects from the pool of individuals most suitable for the research questions being asked. The Common Rule also contains policies specifically designed to protect the rights of children and prisoners. While the regulations establish the roles and responsibilities of the local IRBs, they also provide institutions with a substantial degree of flexibility in how the boards are organized and operated.

If an academic institution receives federal financial support for any purpose, all investigative projects conducted at that institution must adhere to the Common Rule policies whenever human subjects are involved. Two major caveats to this rule exist. First, a project must meet the Common Rule's definition of "research" in order to be...

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