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. Jeri R. . Barney. , JD, . MS . . Michele . Antisdel, . MBA/CCRP. HRPP Compliance Manager IRB Regulatory Analyst. Human Research Protection Program (HRPP). May 16, 2013. Discussion. Consent Process. 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?. An IRB . Infoshort. , June 2013. Informed Consent: Basis. The federally mandated requirements for informed consent are grounded in the Belmont Report.. . Respect for Persons:. “Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. Consultation and Unity Conference, March 15, 2017. Gillian Paul. , . OKT LLP. 1. Introduction. On the threshold of some big changes on how Aboriginal people are engaged. Consultation is not working. Moving from an “Aboriginal Consultation” to an “Aboriginal Consent” Framework . Susan Sonne, . PharmD. , BCPP. Associate Professor of Psychiatry. Chair, IRB II. Presentation slides were adapted from . citiprogram.org. Introduction. Final Rule to revise the current regulations at 45 CFR 46, Subpart A (Common Rule) was published by HHS on . 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. Session Overview. Process and Documentation. Vulnerable Populations. Informed Consent of Non-English Speakers. Illiterate Subjects. Alteration/Waiver of Informed Consent. Informed Consent Process. Informed Consent is not just a form; it is an ongoing process of information exchange that may include:. Jeri R. . Barney. , JD, . MS . . Michele . Antisdel, . MBA/CCRP. HRPP Compliance Manager IRB Regulatory Analyst. Human Research Protection Program (HRPP). May 16, 2013. Discussion. Consent Process. 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.. Waiver of Consent, Alteration of Consent, and Waiver to Document Consent . Definitions. Waiver of consent – the IRB waives all consent requirements (process, document, signature). Alteration – the IRB waives some or alters some of the elements of informed consent (document, signature).