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Investigator/SMO Training and Education 1. Introduction Training and education in the ethical conduct of human research is essential in protecting the rights and welfare of humans participating in research studies. In recognition of this principle, Sterling IRB requires investigators to ensure that each key member of the research team has successfully completed training in human research participant protection. This training includes, but is not limited to, the following topics:
Key study personnel include the principal investigator, the sub-investigator(s), and the study coordinator(s). |
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Sterling IRB accepts training completed in a variety of formats and from a variety of sources. The most common training formats include online training modules, live lectures and seminars, self-study texts that provide CEU and CME credit, and college courses. The various sources through which one may obtain training include government entities, professional organizations, non-profit institutions, and commercial businesses. Human research participant protection training may be reported to Sterling IRB in the form of training certificate copies (if applicable) and/or a brief written explanation of the training received. Copies of training certificates and/or written training explanations should be submitted as attachments to the Submission Application (except in the case of training explanations that are written directly on the Submission Application). 2. Internet Links Online training information can be found at any of the following internet links: Guidance on Good Clinical Practice (GCP) The Belmont Report HIPAA Guidance Human Participant Protections Education for Research Teams (provided by the National Institutes of Health, NIH) Human Subject Assurance Training (provided by the Office for Human Research Protections, OHRP) FDA and Good Clinical Practice Guidance: GCP in FDA-regulated Clinical Trials FDA Information Sheet Guidances HIPAA Guidance: http://www.hhs.gov/ocr/hipaa http://privacyruleandresearch.nih.gov http://www.hhs.gov/ocr/combinedregtext.pdf (Summary of the HIPAA Privacy Rule) Research with Medical Devices: http://www.fda.gov/cdrh/ (FDA Center for Devices and Radiological Health, CHRH) Title 21 CFR (Code of Federal Regulations): http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199921 Federal regulations governing the proper conduct of clinical research and the makeup of institutional review boards (IRB). Elements of informed consent documents are also discussed. Title 45 CFR (Code of Federal Regulations): http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199945 Federal regulations governing the proper conduct of clinical research and the makeup of institutional review boards (IRB) pertaining to federally funded research. Elements of informed consent documents are also discussed. Government Agencies and Commissions: Center for Drug Evaluation and Research, CDER Contains important information concerning the conduct of FDA-regulated studies. U.S. Food and Drug Administration, FDA Provides a wealth of information on all aspects of the drug and device approval processes, including the protection of human research participants. National Institutes of Health, NIH Dedicated to the latest information regarding health issues and ongoing scientific research and special reports. Office for Human Research Protections, OHRP Provides guidelines for human research participant protection. International Conference on Harmonisation, ICH Provides access to all available guidance issued by the ICH organization. The President's Council on Bioethics, PCB Offers current information on national meetings regarding research participant protection with the use of biologic materials as well as other ethical dilemmas. 3. Recommended Books Protecting Study Volunteers in Research www.centerwatch.com In addition to addressing current and emerging issues that are critical to our system of human subject protection oversight, Protecting Study Volunteers in Research has been expanded to include a chapter on how to implement the HIPAA Privacy Rule in research. Protecting Study Volunteers in Research is a suggested educational resource by NIH and FDA (source: NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2003, page 47342) and was designed to help organizations provide the highest standards of safe and ethical treatment of study volunteers. This manual is referenced routinely for ethical considerations and insights and for a comprehensive review of regulations and guidelines not conveniently found elsewhere. 4. Foundations and Associations Association of Clinical Research Professionals (ACRP) www.acrpnet.org ACRP offers the training you need to be successful in clinical research today. Whether you are new to clinical research or a seasoned professional, ACRP's educational offerings aim to meet your needs. With fundamental and intermediate level training for monitors and coordinators, GCP's for physicians, timely audio-conferences on hot topics, SOP writing, budgeting, negotiation skills, accompanied site visits, FDA audit preparation, certification exam review and many other relevant and timely courses, ACRP offers you the training you need to be successful in clinical research today. PRIM&R - Public Responsibility in Medicine and Research www.primr.org PRIM&R is dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research. For thirty years, PRIM&R has been the preeminent source for education, professional development, and resource sharing in all areas pertaining to the ethical, regulatory, and societal aspects of the research enterprise. PRIM&R serves governmental officials, academics, human research protection programs, medical and legal professionals, pharmaceuticals and biotechnology leaders, and the full array of representatives of research institutions and related professions. Drug Information Association (DIA) www.diahome.org With more than 27,000 members worldwide, the Drug Information Association (DIA) is the premier member-driven organization encompassing the full continuum of disciplines in the pharmaceutical and related industries. The mission of DIA is to serve and develop members by providing a neutral, global forum that promotes the exchange of information critical to their professional performance and achievement. The goal of DIA is to be the most effective means for members to obtain the knowledge they need to advance their career, their profession, and their organization. To learn more or if you have any questions, call 1-888-636-1062 (toll-free) or email us. |
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