PPT-© HRP Consulting Group Investigator Responsibilities in Human Subjects Research

Jeffrey M Cohen PhD CIP Chief Executive Officer HRP Consulting Group Overview History Human Research Protection Program Investigator Responsibilities 2 HRP Consulting Group History 3. Faculty Advisor or Principal Investigator Supervision versus Student Investigator or Study Coordinator . Responsibilities. Gwenn Snow, MS, RD, CIP. IRB Program Manager. Office of Human Research Protection. 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?. Ethics and Conflict of Interest—NIH Rules. Title IX Sexual Harassment. New Intellectual Property Assignment Procedures. ETHICS AND CONFLICT OF INTEREST CHANGES AND NEW PHS-NIH RULES. Montana State University. Jan Zolkower, MSHL, CIP, CCRP. January 13, 2012. Review Investigator Responsibilities. Discuss recent FDA Warning letters and OHRP Determination letters. Review of Advanced Notice of Proposed Rulemaking (ANPRM). 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). (IRB). Research Methods Professional Development Institute. December 3, 2015. About Our Speaker. Katherine (Kathi) J. . Conger, . Professor of Human Development and Family Studies, . Department of Human Ecology, University . 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.. Stephen Workman, MPH. September 2016. Thomas Jefferson University. Investigator responsibilities. Sponsor assessment of PI performance . What TJU does well. How PIs can be more impressive to sponsors. GW Office of Human Research IRB Forum July 2015 New Forms and Policies Updated Documents IRB Application (HRP-200) Merges the previous Exempt from IRB Review Request and Human Subjects Research Synopsis form; Overview of Good Clinical Practices (GCP) . Investigator and Study Team Responsibilities. Miles McFann. IRB Administration. Training and Outreach. 2. Good Clinical Practice is the compilation of accepted ethical and scientific standards governing clinical research that ensure the integrity of data obtained and the protection of human research subjects.. Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Purpose:. To . provide an overview of Investigator Responsibilities and GCP. to study sites. Presented by the . Research Quality Compliance Network.  . PRESENTERS. Ginger Bair, CCRP – QA/QC Coordinator, Office of Quality Compliance and CTSI. Josh Fessel, MD, PhD . –. . Senior Clinical Advisor, Division of Clinical Innovation, NCATS and NIH. 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..