PPT-Research Involving Human Subjects

Q amp A Misti Ault Anderson OHRP Petrice BrownLongenecker NIH Meredith TempleOConnor NIH 1 Case Study 1 An application describes the following proposed research activities The investigator receives autopsy specimens from a pathologist . 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.. 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.. 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. 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. 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 . 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)(. 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. For VA Personnel Conducting Expanded Access Program Activities for the Treatment of Patients with Monkeypox. (May be Used in Lieu of CITI Modules for ORD-Required Training in Human Subjects Ethical Protections). 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 . Psychiatry. A. J. Allen, MD, PhD. Sr. Med. Fellow, Bioethics & . Peds. Capabilities. Eli Lilly and Company. E-learning series. AACAP. A. J. Allen/Allenaj@Lilly.com/Dec. 11, 2013. Disclosures of Potential Conflicts.