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 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, the Sterling IRB Submission Application requires investigators to verify 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). Each of these individuals should be listed in Section A of the Submission Application.
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 Section A of the Sterling IRB Submission Application lists the following internet links, which offer online training information for human research participant protection: Guidance on Good Clinical Practice (GCP)Other online training information can be found at any of the following internet links: Human Participant Protections Education for Research Teams (provided by the National Institute of Health, NIH)3. Recommended Books Protecting Study Volunteers in Research: A newly updated and expanded educational resource suggested by NIH and FDA (source; NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2002). This comprehensive manual addresses current and emerging issues that are critical to our system of human research participant protection oversight, CME and Nursing Contact hours available. Written by: Cynthia McGuire Dunn, M.D. and Gary Chadwick, Pharm.D., MPH, CIP with the University of Rochester Medical Center.Ensuring a HIPAA - Compliant Informed Consent Process: CenterWatch has an excellent book that discusses the elements of authorization: 4. Foundations and Associations Association of Clinical Research Professionals (ACRP): 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: 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 pre-eminent 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): 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.The Walter B. Morley Research Foundation, Inc.: The Morley Foundation is a non-profit organization that provides training and education to professionals in clinical research and the industry. Programs include training for: Investigator Coordinators (CRC), Monitors, and Project Management. Services include QA Audits, SOP development and site consulting. call 1-888-636-1062 (toll-free) or email . |
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© Sterling Institutional Review Board