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The term research refers to a systematic investigation designed to develop or contribute to generalizable knowledge by testing and proving or disproving specific hypotheses. The knowledge gained through research may be important as a basis for the formulation of social policy or the improvement of practice in medicine, education, social services, or other areas. Research may produce information as the result of experimentation that involves introducing some new variable (e.g., a test drug or method of treatment) into the situation and seeing what difference, if any, that new variable makes. Alternatively, research may entail gathering data and drawing conclusions by observing things happening naturally (i.e., a natural experiment). In both the experimental and observational methods, research may involve using human beings as participants who serve as the sources of data from which the generalizable conclusions are drawn. Especially when human participants are involved, research must be conducted in an ethical manner, including assurances that the participants have given informed consent for their involvement.
Principles regarding the proper conduct of research involving human participants have been incorporated into over thirty different international guidelines and ethical codes. The first of these was the Nuremberg Code, adopted in 1947 for Nazi war-crime trials in which defendant physicians tried to justify their horrible actions as scientific experiments. Subsequent ones were spurred on by various scandals involving the mistreatment of human subjects, such as the forty-year Tuskegee (Non-Treatment of) Syphilis Study, the deliberate hepatitis infection of residents at Willowbrook (New York) state hospital between 1956 and 1971, and injection of live cancer cells into patients in 1963 at the Jewish Chronic Disease Hospital in Brooklyn, New York. In the United States, Congress in 1974 enacted the National Research Act, establishing the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research (popularly referred to as the Belmont Commission). In 1981 regulations embodying some of the Belmont Commission’s recommendations were issued by the federal Department of Health and Human Services (DHHS, but at the time called the Department of Health, Education, and Welfare). These regulations have been adopted by other federal agencies as a Common Rule to protect human participants in any research protocol those agencies sponsor. Also, any research concerning the testing of investigational drugs or medical devices is regulated simultaneously by the federal Food and Drug Administration (FDA).
Research to which these regulations apply must be reviewed and approved by an interdisciplinary
Institutional Review Board (IRB) and is subject to continuing IRB oversight. Conducting a research protocol without IRB approval or over IRB objection subjects the investigator and sponsoring institution to the loss of any future government funding for the conduct of research.
For any proposed research protocol, the IRB must ensure (among other things) that informed consent will be obtained from each potential participant. Potential participants must be informed of the following:
- the purposes of the research, its expected duration,and the procedures involved;
- anticipated risks or discomforts, as well as benefits,of participation and all reasonable alternatives to participation in the research protocol;
- the extent to which research records will be keptconfidential;
- the availability of any compensation and/ortreatment for research-related injuries;
- the right not to participate and to discontinueparticipation at any time without penalty.
The IRB also must ensure that participants’ informed consent is appropriately documented.
The IRB must police the requirement that no human subject is involved in research unless ethically sufficient informed consent has been obtained and the prospective participant has had the chance, without coercion or undue influence (i.e., voluntarily), to really consider whether or not to participate. The regulatory provisions for informed consent in research are basically a codification and extension of the common law (i.e., the judgemade law that evolves on a case-by-case basis) in the diagnostic and therapeutic setting. Under the common law, valid consent requires that the individual’s agreement be voluntary, informed, and given by a person with adequate cognitive and emotional capacity. Individual IRBs are themselves monitored by the Office for Human Research Protections within DHHS.
Some states have enacted their own, additional laws, which vary quite a bit, concerning conditions for protection of research subjects. Moreover, private civil malpractice lawsuits may be brought by an individual participant against researchers and protocol sponsors for violation of common law standards regarding the obtaining of informed consent or other deviations from the acceptable standard of care under the circumstances.
Ethical researchers owe a heightened obligation to make certain that meaningful informed consent has been obtained for research involving especially vulnerable participants, particularly when the research consists of risky experimental interventions. Especially vulnerable persons in this context include persons with mental disabilities that impair decision-making capacity, prisoners, children, and pregnant women. Racial factors must also be taken into account when considering the need for special protections for vulnerable groups, because it has been common historically for researchers to both take undue advantage of members of racial minority groups by including them disproportionately in very risky studies, and to deny them the potential benefits of research participation by unfairly excluding them from certain studies. When a potential research participant is unable to give valid voluntary, informed consent personally, a surrogate acting on behalf of the person’s best interests may act as decision-maker.
- Coleman, Carl H., Jerry A. Menikoff, Jesse A. Goldner, and Nancy N. Dubler. 2005. The Ethics and Regulation of Research with Human Subjects. Newark, NJ: Matthew Bender.
- DeRenzo, Evan G., and Joel Moss. 2006. Writing Clinical Research Protocols: Ethical Considerations. Burlington, MA: Elsevier.
- Noah, Barbara A. 2003. The Participation of Underrepresented Minorities in Clinical Research. American Journal of Law and Medicine 29 (2–3): 221–245.
- Title 45, Code of Federal Regulations, Part 46: Protection of Human Subjects. 2003. Washington, DC: U.S. Government Printing Office.
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