Topic > The Common Rule and Human Research - 1515

Human research conducted in the United States today is governed by the Common Rule. The Common Rule is a human subjects protection policy created by a number of agencies, most notably the National Commission for the Protection of Human Subjects for Biomedical and Behavioral Research, developed in 1974 to address the detection of serious mistreatment of human subjects. humans from the Tuskegee syphilis study (Iltis, 2011). Some key requirements of the Common Rule are: ensuring compliance by research institutions, obtaining and documenting informed consent, membership, function, operations, review or research with the Institutional Review Board (IRB), and record keeping. It included additional safeguards for vulnerable individuals such as pregnant women and newborns, in vitro fertilization and fetuses, and protection of prisoners, children, and the mentally disabled (Department of Health and Human Services [HHS], 2009). The commission was best known for the Belmont Report, which recognized 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 functions. Federal regulation requires each institution engaged in research involving human subjects to nominate members to form a review board. The function of the Institutional Review Board (IRB) is to review all projects created by any member of St. Francis University and verify criteria in each research project that protects human rights under federal law and any other specific requirements by state or institution (NIH, January 15, 2009).St. Fran...... middle of paper ......health care is one that 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. (pages 1-13). Upper Saddle River, NJ: Pearson Education Inc.NIH Office of Extramural Research. (2011). Protection of human research participants. Retrieved from http://phrp.nihtraining.com: Regulations and Ethical Guidelines. (2011). Retrieved from http://ohsr.od.nih.gov/guidelines/belmont.html#gob1The American Heritage Dictionary (ed.). (n.d.). The American Heritage Dictionary.New York, New York: American Heritage Publishing.Williams, A. (2000). “Healthcare workers have an ethical duty.” Journal of Medical Ethics, 26 (2), 87-88.