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  • Essay / The Common Rule and Human Research - 1515

    Human research carried out in the United States today is regulated by the Common Rule. The Common Rule is a human subjects protection-themed policy created by a number of agencies, particularly the National Commission for the Protection of Human Subjects for Biomedical and Behavioral Research, developed in 1974 to combat detection serious mistreatment of human subjects from the syphilis study. at Tuskegee (Iltis, 2011). Some key requirements of the Common Rule are: ensuring compliance by research institutions, obtaining and documenting informed consent, Institutional Review Board (IRB) membership, function, operations, review or research and record keeping. It included additional safeguards for vulnerable subjects such as pregnant women and newborns, in vitro fertilization and fetuses, as well as protections for prisoners, children and people with intellectual disabilities (Department of Health and Human Services [HHS], 2009). The commission was best known for the Belmont Report, recognizing three ethical principles (respect, beneficence, and justice) that would serve as the basis for developing rules and conducting research. The Belmont Report or Title 45 contains the Code of Federal Regulations regarding the use of human subjects in research. It is this law under which St. Francis University operates. Federal regulations require each institution engaged in research involving humans to appoint members to form a review committee. This function of the Institutional Review Board (IRB) is to review all projects created by members of St. Francis University and verify that the criteria for each research project protect human rights under the laws federal and any other state- or institution-specific requirements (NIH, January 15, 2009).St. Eng...... middle of paper ...... medical care is that which incorporates compassion, responsibility, collaboration and trust. Each of these moral principles must be applied and understood by researchers to ensure the protection of all human subjects. Works CitedGuido, G. (2006). Introduction to ethics. In M. Connor (Ed.), Legal and ethical issues in nursing. (pp. 1-13). Upper Saddle River, NJ: Pearson Education Inc. NIH Office of Extramural Research. (2011). Protect human research participants. Retrieved from http://phrp.nihtraining.com: Ethical regulations and guidelines. (2011). Retrieved from http://ohsr.od.nih.gov/guidelines/belmont.html#gob1The American Heritage Dictionary (Ed.). (nd). The American Heritage Dictionary. New York, NY: American Heritage Publishing. Williams, A. (2000). “Health professionals have an ethical duty.” Journal of Medical Ethics, 26 (2), 87-88.