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. 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.. 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. 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). Shannon Simmons, BA, CIP. March 14, 2014. Process Improvement Team. Vanderbilt Human Research Protections Program. Agenda. Review Investigator Responsibilities. Discuss FDA Warning letters . Q & A. 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.. of the . Clinical Research . Team. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. Learning Objectives:. Name the required and possible members of the research team. 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). NIH . Regional Seminar. Misti Ault Anderson, MS. , . MA. Senior Advisor for Public Health Education. Division . of Education and . Development. Office . for Human Research Protections (OHRP. ), HHS. Petrice Brown-Longenecker, PhD. 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). WMed HRPP . Investigator Responsibilities for . Clinical Trials Research . Introduction. This comprehensive, educational presentation for Clinical . Trials Research . is a resource tool provided by WMed Homer Stryker M.D. School of Medicine for researchers involved in sponsor- and/or investigator-initiated . 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;. 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.. What Every Investigator. (and his/her research staff). Should Know about. Conducting. Human Research Activities. *. Based on David Lettermen’s Top Ten . PI Responsibility #1. In designing the study, the investigator should take into consideration the three underlying ethical principles for conducting research with human subjects as delineated in the. 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..