The Common Rule and Human Research

1515 Words7 Pages
Human research done in the United States nowadays is regulated by the Common Rule. The Common Rule is a policy on the topic of Human Subject Protection created by a number of agencies specifically the National Commission for the Protection of Human Subjects for Biomedical and Behavioral Research developed in 1974 to address detection of serious maltreatment of human subjects from the Syphilis Study at Tuskegee (Iltis, 2011). Some key requirements of the Common Rule are: assuring 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 neonates, in vitro fertilization and fetuses, protection of prisoners, children and the mentally disabled (Department of Health and Human Services [HHS], 2009). The commission’s was best known for the Belmont Report, recognizing three ethical principles (respect, beneficence, and justice) which would serve as the foundation in developing rules and conduct of 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 the St. Francis University functions. The Federal regulation requires each institution engaged in research involving humans subject appoint members to form a review board. This Institutional Review Board (IRB) function is to review all projects created by any members of St. Francis University and verify the criteria in each research project protects the human rights under the federal and any other requirements specific to state or institution (NIH, January 15, 2009). St. Fran... ... middle of paper ... ...hical care is that which incorporates compassion, accountability, collaboration and trust. Each of these moral principles must be applied and understood by the researchers to ensure protection of all human subjects. Works Cited Guido, G. (2006). Introduction to Ethics. In M. Connor (Ed.), Legal & Ethical Issues in Nursing. (pp. 1-13). Upper Saddle River, NJ: Pearson Education Inc. NIH Office of Extramural Reserach . (2011). Protecting Human Research Participants. Retrieved from http://phrp.nihtraining.com : Regulations and Ethical Guidelines . (2011). Retrieved from http://ohsr.od.nih.gov/guidelines/belmont.html#gob1 The American Heritage Dictionary (Ed.). (n.d.). The American Heritage Dictionary.New York, New York : American Heritage Publishing . Williams, A. (2000). “Health professionals have an ethical duty”. Journal of Medical Ethics, 26 (2), 87-88.
Open Document