The Common Rule and Human Research Essay - 1512 Words

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†¦show more content†¦One should also recognize the possibility of other potential reviewing entities. St. Francis must approve all proposals without any exceptions if human subject or animals are involved. All students must have a faculty mem ber sponsoring the research in order to supervise the student’s proposal. If the research proposal has been reviewed by any other entity a copy needs to be with the proposal to St. Francis University’s IRB. Although the IRB reviews all research involving humans there are review categories that research may be eligible for if the Principal Investigator ( PI ) requests. This decision is determined by the IRB not the PI the request must be submitted requesting exemption status if one of the following are present: 1. Research conducted in established or commonly accepted education environment that does research one a regular basis. 2. Research using tests, surveys, interviews, observation of public behavior without any identification of the participants. 3. Research utilizing existing data if without any identifiers 4. Research that is conducted by the approval of federal or state agency heads to evaluate public benefit. 5. Food quality and evaluation only with the using or without food ingredients at or below the level found to be safe. Research that is classified exempt is not subjected to the continued review but it is important to be aware that Exempt does not mean no review. ExpeditedShow MoreRelatedExamination Of Past And Present Ethical Guidelines On Biomedical Research1368 Words   |  6 PagesEilidh Cowan Ethics of Biomedical Science Research Ioan Alexandru Beldean Examination of past and present ethical guidelines on biomedical research Ethics can be defined as a set of moral values informing one’s decisions. But this set of moral values can be influenced by many different things, such as various cultures, religions, and even technological advancements. 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