PPT-1 Research Involving Human Subjects

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. 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.. Dr. Jason Eberl, IRB Chair. Dr. Sam Pope, Biomedical Subcommittee Chair. Dr. Karen Spear, Social/Behavioral . Subcommittee Chair. Purpose of the IRB. Committee within an institution that reviews and . 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. Q & A. Yvonne Lau, OHRP. Ann Hardy, 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. . Basic hhs and nih requirements. Yvonne lau – Office of human research protections. Ann hardy – Nih Office of Extramural research. Dawn Corbett – NIH Office of extramural research. May 2017. Describe the role of the Office for Human Research Protections (OHRP) and the federal regulations on human research protections;. 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.. 111 Washington Ave Suite 104E. Lexington, KY 40536. 859.218.2023. Margaret.mcgladrey@uky.edu. The Institutional Review Board (IRB) at UK. What is the IRB and . Why Do I Need to Know About it?. Board responsible for monitoring protection of human subjects in research. 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. Office of Research Administration. Important to Note. These slides are not intended to replace the required CITI training on a long-term basis. Rather, they are being provided to researchers focused on COVID-19 research . 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.