PPT-NIH-funded Human Subjects Research/Clinical Trials and the Transition to Forms E

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. 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?. 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. 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). Protocol=study plan which details what researchers will do in the study. It describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. . 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;. Manager. Tufts CTSI. Welcome and Introduction. Tufts CTSI’s Mission & . Purpose. Stimulate and expedite innovative clinical and translational research, with the goal of improving the public’s health. Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . “Putting it All Together. ”. 1. Why the changes to NIH-funded studies involving human subjects?. No policies existed to make sure that the public had access to results from unpublished NIH-funded research . 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. Great Plains . IDeA. -CTR Network. February 12, 2018. Bethany DeCarolis, CRA, Assistant Director. Sponsored Programs Administration. Agenda. “FORMS-E. ” application requirement. Selecting . the correct funding opportunity. October 25, 2017. Frances Payne Bolton School of Nursing. Center for Research & Scholarship. https://sites.google.com/a/case.edu/new-at-nih_10-25-17/. Summary of NIH Changes: 12.7.16 - . 1.25.18. Why it Matters, How it Affects Power and How to Generate a Randomization List. Brian . Ronayne. Research Statistician. nQuery. Webinar. Host. Agenda. Randomization in Clinical Trials. Common Randomization Strategies.