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HHS Policy for Protection of Human Research Subjects Code of Federal Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 46 Revised January 15, 2009 • In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: • Risks to subjects are minimized • Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. • Selection of subjects is equitable. • Informed consent will be sought from each prospective subject or the subject's legally authorized representative, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.111
A good place to start! For help writing a research protocol http:www.cc.nih.gov/cc/proto mechanics/index.html For studies with <strong>com</strong>plex ethics or regulatory considerations contact your IRB Chair OHSR (301-402-3444) The clinical Center’s Department of Bioethics (301– 496-2429) This booklet is available from NIH 50 copies will be at the Ethics Committee table at the AmSECT Committee Fair this Saturday
Page 1 and 2: David S Edgell, BA, MHSc, CCP, CPC
Page 3 and 4: Objectives • Improve understandin
Page 5: Nuremberg Code - 1947 •“Doctors
Page 9 and 10: Perfusion projects lend themselves
Page 11 and 12: When Do I Require Ethics Approval?
Page 13 and 14: Scientific Misconduct takes various
Page 15 and 16: A significant proportion of journal
Page 17 and 18: What about our benchmark journals?
Page 19 and 20: Case from the literature “Gene Th
Page 21 and 22: What has this got to do with Perfus
Page 23 and 24: Heart Ache • “We are just resea
Page 25: Conclusion •Ethical research prac

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