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Chapter II - Ethical and Regulatory Requirements For the Protection of Human Research Participants

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The Genetic Alliance IRB is committed to the protection of the research participant and the principles outlined in the ethical principles outlined in the Belmont Report. The Belmont Report, published in 1979 by the National Commission for the Protection of Human Participants of Biomedical and Behavioral Research, provides the ethical foundation for the federal regulations for the protection of human research participants. All personnel involved in the conduct and oversight of human participant research must abide by the fundamental principles set forth in the Belmont Report which include:

Individuals should be treated as autonomous agents afforded the right to make decisions for themselves. Those with diminished autonomy (e.g. minors, prisoners, persons who are mentally disabled) are entitled to additional protections. Application of this principle requires that human research participants are enrolled into research studies only under the conditions of effective informed consent. This involves a process in which participation in the research is acknowledged by the research participant (or by a legally authorized representative, LAR) as a voluntary act free from coercion or undue influence from the investigator or members of the research team.

The research study must be designed and implemented so as to maximize possible benefits and minimize possible harms. Application of this principle involves a risk/benefit analysis in which the risks to participants must be reasonable compared to the potential for benefit either to participants directly or to society. Risk evaluation must include the consideration of both the probability and magnitude of harm, including psychological, physical, legal, social, and economic harm.

The possibility for benefits and the potential burdens of the research should be equitably distributed among the potential research participants. Application of this principle requires
the close scrutiny of the enrollment process to ensure that particular classes (welfare patients, racial and ethnic minorities, or persons confined to institutions) are not selected for their compromised position or convenience to the research investigator.

These fundamental principles for the protection of human research participants are embodied in the federal regulations at 32 CFR 219, also called the Code of Federal Regulations, Federal Policy or the Common Rule.

The Common Rule underwent its first major revision since 1991 in 2017, and the final revised version was published in the Federal Register on January 19, 2017. The revisions aim to "modernize, simplify, and enhance" oversight for research with human participants in the  United States to address changes in the nature of research since the original publication of the Common Rule in 1991.

The Genetic Alliance IRB provides human research participants protection review, approval and oversight of protocols in accordance with the following federal regulations: Title 32, Code of Federal Regulations (CFR), Part 219, the “Common Rule;” 45 CFR 46, Subparts B, C and D; and 21 CFR 50 and 56 (see Appendix A). These federal regulations set forth the requirements for review of non-exempt human participants’ research by the IRB.

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