Authors

  1. Issel, L. Michele

Article Content

"Protection of human subjects" might sound biomedical, legal, or paternalistic to some, whereas to others, it might sound humanitarian or morally right. Regardless of how it sounds, the Department of Health and Human Services' regulations concerning the conduct of research with human beings is codified under 49 CFR 46. This set of regulations, informally known as the "Common Rule," is the United States' Federal Policy for the Protection of Human Subjects.

  
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I served as a member of the university institutional review board for several years. So, I am familiar with the rules, the eight elements of informed consent, and the Belmont Report of 1978. I am also familiar with the various ways researchers, whether naively or maliciously, seek to conduct research with people, human beings. The institutional review board on which I served reviewed research from the social sciences and that were not biomedical in nature. We received proposals to conduct research with and about employees of an organization, such as teachers in a school district or health care providers in a clinic. Many of these proposals were considered exempt from meeting the regulatory requirements, most often meeting the exemption of using existing, publicly available de-identified data sets. Other proposals involved collecting primary data from employees about themselves, their work, their managers, their organization, or their co-workers. These human subjects deserve protection just as much as patients in Phase 2 clinical trials, only protection provided in ways that match the research environment.

 

In particular, confidentiality or anonymity and voluntary participation require researchers to be sensitive and attentive to the employee's perspective and concerns. A few small details revealed about an individual make it possible to identify that person, particularly in small work units or organizations. The extent to which a researcher takes precautions to assure confidentiality or anonymity can enhance the validity of responses from those employees. I also realize it might discourage some employees from participating, jeopardizing the response rate. Nonetheless, careful attention to the ethical elements of the research makes for better science.

 

Researchers from nations other than the United States have the same moral obligations and often similar legal obligations to protect research subjects. Many nations have mechanisms comparable with the 45 CFR 46, or they have formal agreements to follow the United States' rules. Nationality is not a criterion for being exempt from protection.

 

Manuscripts submitted to Health Care Management Review are inconsistent in describing how human subjects were protected. Adding a few sentences about this adds value in two ways. Describing a novel or creative approach to assure anonymity (for example) becomes a teaching/learning opportunity, with the creator getting intellectual credit. That's one value of communicating about how human subjects were protected. The other value is more societal in nature; it conveys the value and importance of the research subjects. In my experience, most people are willing to participate in research because they want to make a contribution to science. Protecting them as they make their contribution is a sign of respect; communicating about that protection is a sign of researcher's integrity.