PPT-Research Ethics, Human Subjects and Data Management

Or Why Bad Cases Make Tough Laws Objectives By the end of this lecture 1 You will have stopped wondering why there are so many conflicting results out there 2 You will have stopped wondering why there are so many hoops to jump through in order to do research. Wilna. . Venter, M.A., M.Ed.. Cluster Manager: Strategic Support. University of Cape Town Research Office. Content. Historical . background . Definition . of research . integrity and ethics. Responsible conduct of . Research ethics. All research has . ethical . implications. Research activities can affect the health and wellbeing of subjects and of society as a whole. There is . often a . tradeoff between protection of subjects and the potential social value of the research. “Conforming to the standards of conduct of a given profession or group”. Agreements shared by researchers about what is proper & improper in the conduct of scientific inquiry. ASA Code of ethics. Subjects. Freda E. Yoder. Division of Education and Development. Office for Human Research Protections (OHRP). Department of Health and Human Services (HHS). Ann M Hardy, . Dr.P.H. .. NIH Extramural Human Research Protection Officer. Julie M. Aultman, Ph.D.. Chair, Institutional Review Board. Associate Professor, Family and Community Medicine. Northeast Ohio Medical University. Important Questions. What is research?. What is human subjects research?. Or, . Why Bad . Cases Make Tough Laws!. Objectives: By the end of this lecture..... 1. You will have . stopped . wondering why . there . are so many conflicting results out there.. 2. You will have stopped wondering why there are so many hoops to jump through in order to do research.. Jeffrey M. Cohen, Ph.D. CIP. Chief Executive Officer. HRP Consulting Group. Overview. History. Human Research Protection Program. Investigator Responsibilities. 2. © HRP Consulting Group. History. 3. Office of Research Policies, Compliance, and Committees (. ORPCC). Updated March 2011. HISTORICAL . EVENTS:. Nuremberg Code. In . 1947, the Nuremberg Tribunal condemned experiments that 23 German physicians and administrators were performing on concentration camp prisoners.. Agreements shared by researchers about what is proper & improper in the conduct of scientific inquiry. ASA Code of ethics. Defining Ethics. Forewarned is forearmed. Balancing risk of harm to subjects vs. potential benefits of research. Presented by:. Joanne Muratori & . Patria Davis. Agenda. Objective. Review . history, role, and function of the Institutional Review Board. Review federal definition of human subjects research and levels of review. Julio F. . Turrens. , Ph.D. . (. jturrens@usouthal.edu. ). Professor of Biomedical Sciences. Associate Dean, College of Allied Health . Professions. and Jack Shelley-Tremblay. Professor of Psychology. Susan L. Rose, Ph.D.. Office for the Protection of Research Subjects (OPRS). Panoramic View of OPRS. Flexibility . Coalition. Webpage. Inclusion/ exclusion Criteria. California Coalition. Quality Improvement activities. HHS Office for Human Research Protections (. OHRP. ). Division of Education and Development (. DED. ). Disclaimer. The opinions expressed are those of the presenter and do not necessarily reflect the policy of the U.S. Department of Health and Human Services.. Psychiatry. A. J. Allen, MD, PhD. Sr. Med. Fellow, Bioethics & . Peds. Capabilities. Eli Lilly and Company. E-learning series. AACAP. A. J. Allen/Allenaj@Lilly.com/Dec. 11, 2013. Disclosures of Potential Conflicts.