PPT-1 Updating the Common Rule Governing Human Subjects Research Protections

Jerry Menikoff 2 2 Disclaimer The views expressed in this presentation and those of the presenter and do not necessarily represent the views of the Department of Health and Human Services or any subdivision thereof. Dr Beth Perry. Senior Research Fellow, Centre for Sustainable Urban and Regional Futures, University of . Salford. Director . of Greater Manchester Local Interaction Platform. b.perry@salford.ac.uk. Waves of Governance.... 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?. Zhichao Zhu and Guohong Cao. Department of Computer Science and Engineering. The Pennsylvania State University, University Park, PA 16802. {zzhu, gcao}@cse.psu.edu. outline. Introduction. Preliminaries. Susan Loess-Perez, MS, CIP, CCRC. Director of Research Compliance. Office of Research Services. Graduate Thesis and Dissertation Conference. February 6, 2016. Purpose of IRB. What Requires Review. Levels of Review. 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. . 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. 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. . Contrasts in Governing. Central America and Caribbean have history of different governing traditions.. Limited government – everyone, including government must obey laws. Constitutions, statements of citizens’ rights, laws define limits. Gillian Allcroft. Deputy Chief Executive. National Governance Association . NGA is a membership organisation. NGA is an independent charity representing and supporting governors . and trustees in maintained schools and academies in England. Kristina Borror, PhD. Director of Policy and Education. VHA Office of Research Oversight. 1. Overview. Background. Exemptions and Subpart Applicability. Exemptions. Limited IRB Review. Broad Consent. for People with DisabilitiesSTATES AND TERRITORIESNo current organ transplant protections for people with disabilitiesNotes HB 58 2020 Reg Sess Ala 2020 failed in 2nd Committee SB 225 2019 Reg Sess Al 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..