Faculty of Medicine CHS

Home \| Contact Information \| Site Map \| FWA00007071 \| AAHRPP Accredited

Home Forms and Instructions Forms Ceded Review Deadlines and Timelines Committee Meeting Dates Consent Requirements Consent Templates Required Consent Elements Conditions for a Waiver of Consent Investigator Manual Policy and Procedures IRB Policy and Procedures HMS and Harvard University HIPAA at HMS Department Assignments ESTR Information ESTR Assistance Human Research Required Training CITI Human Subjects Training HETHR and Other Trainings Training Requirements Study Management Tools Definitions Reference Federal and State Guidelines Countway Library Records Review Harvard University Links Research with Student Participants Information for Multi-Site Studies Information for International Studies Information for Students Information for IRB Members Reviewer Sheets Educational Materials Quality Improvement Program (QIP) Information Contact Information	Educational Materials 2007 Educational Materials 2008 Educational Materials 2009 Educational Materials 2010 Educational Materials January 2010 OHRP Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010) February 2010 Reviewer Sheets – Full Committee, and Pregnant Women and Children Forms - Disclosure Statement Forms, CHS Initial Application, and Form F - Consent Waiver, Sample Consent Form for Adults Review Confirmation Sheet (available upon request) Clinical Trials Agreement (available upon request) March 2010 OHRP Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards (March 24, 2009) IRB Ethics & Human Research (2010). Genomic Research Data: Open vs. Restricted Access April 2010 Human Embryonic Stem Cell Research Advisory Committee, National Research Council and Institute of Medicine of the National Academies (2008). 2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research June 2010 Office for Human Research Protections (2007). Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events September 2010 Office of Human Research Protections (2010). Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues. October 2010 Office of Human Research Protections. (2010). Clarification of "noninvasive" in expedited review category 3 & Categories of Research that May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure. Office of Human Research Protections. (2010). Revised Frequently Asked Question Regarding Engagement in Research. Menikoff, Jerry. NEJM (October 2010) The Paradoxical Problem with Multiple-IRB Review. The New England Journal of Medicine. November 2010 Guidance on Continuing Review (OHRP) Updated: 24-Nov-2010
	For questions or comments about this website, please email: orsp@hms.harvard.edu Copyright © 2011 by the President and Fellows of Harvard College (Trademark Notice). All rights reserved. This site is best viewed on Internet Explorer 8.0/Firefox 3.0 or higher.