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FUNDAMENTALS OF ETHICAL CONDUCT IN RESEARCH

As discussed throughout this book, behavioral intervention research has multiple goals. First and foremost is to develop a meaningful intervention to address a targeted problem area and population at risk, to determine its efficacy and effectiveness, and to obtain the best outcomes for individuals, families, and/or their communities. Other goals include determining safety, cost-effectiveness, feasibility, and acceptability of an intervention and its implementation potential. Implicit in the conduct of intervention research is that ethical protocols are used to achieve these goals. A basic principle is that ethical goals do not justify unethical research practices to reach those goals even if the outcomes are beneficial in the long run. In fact, compromising ethics in any aspect when conducting a study to reach a larger ethical goal creates more ethical questions including whether the outcomes should be used or considered in decision making surrounding clinical practice or published in the literature (O’Mathuan, 2014). As noted by Beecher (1966) in his classic paper on ethics in clinical research, “An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means. There is no ethical distinction between means and ends” (p. 372). This is a key point that needs to guide all actions related to behavioral intervention research.

As noted, there are numerous policies and guidelines governing research ethics, and a detailed discussion of these policies is beyond the scope of this chapter. International guidelines include the Declaration of Helsinki, The Council for International Organizations of Medical Sciences (CIOMS), International Ethical

Guidelines for Biomedical Research Involving Human Subjects, and the World Health Organization (WHO) and International Classification of Health (ICH) Guidelines for Good Clinical Practice. These guidelines are intended to facilitate and support ethical review worldwide and are intended to ensure that the dignity, rights, safety, and well-being of research participants are maintained and that the results of investigations are credible.

The Belmont Report (U.S. Department of Health and Human Services, 1979) is one of the most important documents guiding the ethical conduct of research in the United States. It is a statement of basic ethical principles and guidelines to assist in resolving the common and tricky ethical issues that arise during the conduct of research with human study participants. The report includes three important principles: (a) Respect for Persons: individuals should be treated as “autonomous agents,” and those with diminished autonomy are entitled to protection; (b) Beneficence: do not harm individuals and maximize possible benefits and minimize possible harm; and (c) Justice: benefits to which an individual is entitled must not be denied without good reason or a burden being unnecessarily imposed.

This report was highly influential in the establishment of the current U.S. regulations for protection of human research participants (U.S. Department of Health and Human Services, 2009). These regulations include five subparts: subpart A, also known as the “Federal Policy” or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; subpart D, additional protections for children; and (more recent) subpart E, registration of IRBs that conduct review of human research studies conducted or supported by Health and Human Services (HHS). The main elements of the Common Rule include requirements for assuring compliance by research institutions; requirements for researchers’ obtaining and documenting informed consent; and requirements for IRB membership, function, operations, review of research, and record keeping. Investigators are typically introduced to, and receive training in, relevant policies when completing their institutional human subjects training.

 
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