Ethical Treatment of Human Subjects: History

¶ … ethical concerns when it comes to conducting human research. This paper presents those concerns and reviews the regulatory protocols that the United States employs in order to meet high ethical and legal standards.

How research involving human subjects works in the U.S.

In the Journal of Clinical Pathology author M.B. Kapp explains that the issue of ethics vis-a-vis human subjects in research isn't just a concern of clinicians and scientists; rather, these issues also have importance to lawyers, philosophers, and policy makers. And there definite legal provisions that are applied regarding "…participant safety, informed consent, and confidentiality" (Kapp, 2006). Of great interest when it comes to pathologists is how human tissue specimens are handled -- whether the tissues are to be used in the present or at some point in the future.

Kapp references what the writer calls "the most salient ethical values" that come into play when research involving human participants is being conducted. Those values are: a) "beneficence" (doing good); b) "non-malfeasance" (the absence of harmful actions); c) "fidelity and trust within the fiduciary investigator/participant relationship"; d) "personal dignity"; e) "autonomy pertaining to both informed, voluntary, competent decision making"; and f) the privacy of any and all personal information (Kapp, 336).

The writer explains that the U.S. Department of Health and Human Services (DHHS) published regulations in 1981 that applied to research protocols; and those regulations were based largely on the Belmont Commission (the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research) (Kapp, 336).

In fact the Belmont Commission boils the "basic ethical principles" down to three principals, similar but not exactly what Kapp has presented. Those three ethical principles from the Belmont Commission are: "the principles of respect of persons, beneficence and justice" (HHS, 1979). Within the "respect for persons" category the Belmont Report / Commission mentions two "convictions": one, that participants should always be treated as "autonomous agents"; and two, that individuals with "diminished autonomy are entitled to protection" (HHS).

Kapp goes on to explain that those institutions that have adopted the DHHS regulations also have accepted the "Common Rule" (also referred to as FDA regulations). The Common Rule means that as a protocol, certain requirements must be satisfied, and those are: a) physical and psychological risks to participants must be kept to a minimum; b) the physical and psychological risks must be part of a reasonable expectation of benefits to the participants, and moreover, there must be a reasonable expectation of "general knowledge" that will result from the research; c) there must be an equitable selection of participants; and d) consent to conduct the research must have been informed, including why the research is being conducted, how long it will take, and what risks may be involved along with what benefits can be expected (Kapp 336).