PPT-Ethics and Safety in Human Subjects Research

Steven J Squires MEd MA PhD IACRN Wednesday September 16 2015 Background and Disclosure System Director of Ethics for Mercy Health PhD Health Care Ethics MA in Biomedical Ethics and Health Care Policy MEd in College Student Personnel Administration. 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. how health research is reviewed. This presentation has been developed to form part of the lesson ‘Research ethics and how health research gets reviewed’ - www.nuffieldbioethics.org/education. ‘Clinical research’ - What is it?. Colleen M. Gallagher, PhD, FACHE. Chief & Executive Director, Section of Integrated Ethics. Associate Professor, Department of Critical Care. Definition of Research. Research is designated as an . Q & A. Misti. Ault Anderson, . OHRP . Petrice Brown-Longenecker, NIH. Meredith Temple-O’Connor, NIH. 1. Case Study 1. An application describes the following proposed research activities:. The investigator receives autopsy specimens from a pathologist. . 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. 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. September 4, 2015. IRB Basics. What is an IRB?. I. nstitutional . R. eview . B. oard (responsible to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated) . 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.. Chris . Sylvester, M.A.. Senior Grant Administrator (AO). Grants and Contracts. 617-414-2879. christopher.sylvester@bmc.org. A research study in which one or more human subjects are prospectively assigned . Theories and approaches to Ethics. Ethics and Culture/Religion. Arguing Ethics. Threats to ethics and ethical problems in knowledge. Under the influence of ethics—. ’wrong’ . ethics, ethics in history..