PPT-Research Involving Human Subjects

Q amp A Yvonne Lau OHRP Ann Hardy NIH Meredith TempleOConnor NIH 1 Case Study 1 An application describes the following proposed research activities The investigator receives autopsy specimens from a pathologist . 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. There are negative issues involving science and accidents do happen.. However in general the worst issues are because society makes unwise decisions on how scientific advances should be used in for instance armed conflicts.. NIH . Regional Seminar. Yvonne Lau, . MBBS, MBHL, . PhD. Director, Division . of Education and . Development (DED). Office for Human Research Protections (OHRP). Department of Health and Human Services (HHS). 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.. Steven J. Squires, MEd, MA, PhD. IACRN. Wednesday, September 16, 2015. Background and Disclosure. System Director of Ethics for Mercy Health. Ph.D. Health Care Ethics, M.A. in Biomedical Ethics and Health Care Policy, M.Ed. in College Student Personnel – Administration.. How Do Changing NIH Policies Impact Me?. LCOM Informational Sessions. Nov. 14, 16 2017. Jeralyn Haraldsen, PhD. Grant Proposal Manager . Office of the Vice President for Research. Introductions:. Research Protections Office. Synthetic . Nucleic Acid Molecules . (NIH Guidelines). Northern Arizona University. Office of Regulatory Compliance. Shelley Jones, Director of Biological Safety. Shelley.Jones@nau.edu. 928-523-7268. Human Research Protection Program (HRPP). HRPP COMPLIANCE AND QUALITY TEAM . Yale University. . Federal regulations (45 CFR 46 & 21 CFR 56) require institutions to establish written procedures for ensuring prompt reporting of any unanticipated problems involving risks to subjects or others (UPIRSOs) to the IRB, appropriate institutional officials, and the federal department or agency head.. UVM Research Protections Office. Unanticipated Problems (UAPs). The IRB is responsible per federal guidelines to review any unanticipated problems involving risks to subjects or others occurring in approved research (FDA: 21 CFR 56.108 (b)(1) & DHHS: 45 CFR 46.103(b)(5)(. 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. Esther K. Chung, MD, MPH. Professor of Pediatrics. IRB Chair. Children as a Vulnerable Population. Subject to coercion and undue influence. Potential population of convenience. Minimizing risk and distress. 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 .