Extension Evaluation Matters: 2nd Edition

HUMAN SUBJECTS RESEARCH

The Common Rule for the protection of research participants is codified in the Code of Federal Regulations (45 CFR Part 46). These regulations are grounded in the Belmont Report of 1979. A PDF of the report is available here. This report was written in response to abuses of people in the name of research, as with medical experiments in Nazi Germany, and with such infamous cases as the Tuskegee Syphilis Study and the case of Henrietta Lacks, whose cells were harvested without her knowledge.

The Belmont Report provides three ethical guidelines that researchers should adhere to:

1. Respect for persons: Individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. This ethical guideline is applied through informed consent and voluntary participation in the research. 2. Beneficence: Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. This guideline is applied through participants understanding the risks and benefits of the research. 3. Justice: Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." This principle is applied through the fair selection of research participants.

Most universities require that researchers participate in some type of training about human subjects research. A common training program is the Collaborative Institutional Training (CITI).

Your university has an Institutional Review Board (IRB) that ensures that researchers are following these regulations. This video provides a short introduction to the work of IRBs. Link: https://youtu.be/U8fme1boEbE

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