PPT-Informed Consent and Ethical Considerations in Clinical Trials

Jon Mark Hirshon MD MPH PhD Professor Department of Emergency Medicine Senior ViceChairman IRB University of Maryland Baltimore Disclosures Commercial Pfizer Sickle Cell Disease Council for Change amp Advisory Board. Ricardo Perez, DO, JD. Assistant Professor of Medicine. UMDNJ-SOM. Ethical and Legal Issues in the Treatment of Older Adults. This . Care of the Aging Medical Patient in the Emergency Room. . (CAMP. th. Anniversary. An IRB . Infoshort. December 2013. Purpose. A statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. kathleen.omalley@jefferson.edu. Why is it so important?. Why is it referred to as a process?. 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. . Ethical . Issues in Clinical Psychology. APA Code of Ethics guides the behavior of clinical psychologists. Relevant issues include. Confidentiality. Informed consent. Multiple relationships. Competence. MS-3 Case Based Series. 1. Updated . May. 2012. Objectives. Review ethical principles. Review principles of informed consent. Understand the role of confidentiality in patient care. Describe legal and ethical issues in the care of minors. 1. Leonard Sacks. Office of Medical Policy. CDER. FDA. The Clinical Trial. How did clinical trials escape from the computer age?. Was the problem FDA’s regulations on record keeping . Was it industry’s nervousness to try anything new?. . Protocol. K-SADS part 1 . 10:45 Coffee break. 11:00 K-SADS . part . 2. . Good Clinical Practice. . Study medications & logistics . Laboratory . procedures . & MRI. 12:30 Lunch. Agenda - morning. Before participants . can enrol in a clinical trial, they . must:. be recruited,. screened. , and . give their informed consent.. The . process of enrolling in clinical trials is carefully regulated in order to protect the participants and maintain the clinical trial’s . Ashley E. Ross MD PhD. Executive Medical Director. Mary Crowley Cancer Research Centers. NASPCC Annual Meeting 2019. Objectives. Define GCP (Good Clinical Practice) and its applications for patients and research.. Anne Roussell, RN. Office of Clinical Research. QA Study Audits. The purpose:. provide . principal investigators (PI) and study teams . early . detection regarding study conduct . issues; . provide . Dr. Haider Raheem Mohammad. Research ethics and clinical trials . in therapeutic . research. All medicines employed in pharmacy are subjected to two linked phases of activity: discovery and validation. Some botanical species like the opium poppy were discovered by chance to have medicinal value some 2000 or more years ago and validated by simple trial and error. The vast majority of the more potent and selective drugs used in the UK today have been subjected to systematic processes of discovery, evaluation, testing and approval. Since the introduction of voluntary assessment by the Committee on Safety of Drugs in the UK in 1964, formal regulatory approval of all medicines has become rigorous and mandatory.. of. human . challenge trials. Nele Berthels. FAMHP Vaccine Symposium. , . BRUSSELS, . 9 September 2017. Disclaimer. This presentation . reflects . my . personal point of . view, . and . not necessarily the . Jane Perlmutter. The Gemini Group. CTTI. John Adams. PKU and Allied Disorders. Best Medicines Coalition. Antoine Daher. Casa Hunter. Brazilian Federation of Rare Disease Associations. ICH E6 . June 4, 2020.