See the below web link for information about an FDA workshop on November 2 entitled: Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations http://www.fda.gov/BiologicsBlo... More

IRB SYMPOSIUM The City University of New York is presenting the seventh annual Fall IRB Symposium on September 29, 2010 in New York City. The event is designed to provide topics of interest to bot... More

Research Ethics Consulting Service Dr. Katrina Bramstedt is available as a research ethics consultant for matters pertaining to RCR curriculum development, as well as external protocol reviews. Wit... More

Huron Consulting Group has made its HRPP Toolkit available to the public at no charge. The Huron HRPP Toolkit represents a complete set of Standard Operating Procedures, templates, worksheets, checkli... More

For documents available on the web, see the IRB Links page.   Other IRB related documents that are not available on the web may be posted here by IRB Forum members, subject to approval.   In order to read documents in PDF format, you will need to first download the free Adobe Acrobat Reader. Selected Commentaries from IRB: Ethics & Human Research Published by The Hastings Center. Copyright 2001 (posted with permission).   (1) Robert M. Nelson, "Protocol 126 and "The Hutch"," IRB: Ethics & Human Research 23, no. 3 (2001):14-16.   (2) Robert M. Nelson, "Nontherapeutic Research, Minimal Risk, and the Kennedy Krieger Lead Abatement Study." IRB: Ethics & Human Research 23, no. 6 (2001):7-11. Children's Hospital of Philadelphia Investigator Training Modules   (1) The History and Ethics of the Protection of Human Participants in Research   (2) The Role of the Institutional Review Board   (3) Scientific Integrity, Conflict of Interest, and Compliance   (4) Good Clinical Practice in the Conduct of Research Powerpoint slides: Robert M. Nelson, MD PhD: Applying Ethical Principles to Pediatric Research (Presented to Conference on revised Declaration of Helsinki, Pretoria, South Africa, March 28, 2001. Recommended Publications:   Institutional Review Board: Management and Function. Edited by Robert J. Amdur and Elizabeth A. Bankert. ISBN: 0763716863. Price: $124.95 (U.S. List) Cover: Cloth. Pages: 622. Copyright: 2002   "Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness"  Developed by ECRI. Comparisons of ICH GCP Guidelines with FDA Regulations (courtesy of Paula Waterman)   "Informed Consent"   "Institutional Review Boards"