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Forms and Instructions Forms Submission Guidelines Amendments Continuing Review Adverse or Unanticipated Events Ceded Review Study Closure Deadlines and Timelines Committee Meeting Dates Consent Requirements Information About Consent Required Consent Elements Conditions for a Waiver of Consent Study Management Tools Responsibilities of the Investigator Active-Study Record Management Post-Study Record Retention Policy and Procedures IRB Policy and Procedures HMS and Harvard University HIPAA at HMS Required Training CITI Human Subjects Training HETHR and Other Trainings Training Requirements Information for Students Student Information Student FAQ Student IRB Submission Information Special Requirements for Students Frequently Asked Questions FAQ What the IRB Reviews Who Needs to Submit an Application Why the IRB Conducts a Review Reference Federal and State Guidelines Countway Library Records Review Harvard University Links Definitions Presentation Library Faculty Information Research with Student Participants Information for Multi-Site Studies Information for International Studies Non-Full Time Faculty Information Information for IRB Members Reviewer Sheets Educational Materials Electronic Training Book Information for Participants Information about Research Your Rights as a Research Participant Sus Derechos como Participante de un Estudio de Investigación Who to Contact with Complaints or Comments Quality Assurance P-StAMP Program Information P-StAMP Policies and Procedures Contact Information	Educational Materials 2007 Educational Materials 2008 Educational Materials 2009 Educational Materials 2010 Educational Materials 2011 Educational Materials January 2011 Subpart B. Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research. Office for Protection from Research Risks. Human Subject Protections Emergency Medical Care. February 2011 Harvard Data Security Harvard University Research Data Security Policy The use and categorization of research information at Harvard CHS Initial Application Criteria and Procedures for Provost's Review of New Projects or Grants April 2011 Harvard University Human Subjects Payment Policy (log-in may be required) May 2011 PRIM&R Conference Hot-Topics Re-Cap Meyer, Michelle N. “Against One-Size-Fits-All Research Ethics.” Hastings Center Report 40.5 (2010): 10-11. Henry, James, Barton W. Palmer, Lawrence Palinkas, et al. “Reformed Consent: Adapting to New Media and Research Participant Preferences.” IRB: Ethics & Human Research Report 31.2 (2009): 1-8 Alessi, Edward J. and James I Martin. “Conducting and Internet-Based Survey: Benefits, Pitfalls, and Lessons Learned.” Social Work Research 34.2 (2010): 122-128 OHRP is hosting a National Research Community Forum "Protection of Human Subjects Research: Blending Regulatory Requirements and Best Practices" in Boston. Please visit the Forum homepage for registration information. June 2011 Office of Human Research Protections (2010). Guidance on IRB Approval of Research with Conditions. Johansson, Anna C., Steven J. Durning, Larry D. Gruppen, et al. "Medical Education Research and the Institutional Review Board: Reexamining the Process" Acad Med. 2011;86:809–817. August 2011 Office of Human Research Protections (2011). HHS announces proposal to improve rules protecting human research subjects Office of Human Research Protections (2011). Regulatory Changes in ANPRM Emanuel, Ezekiel J. and Jerry Menikoff. NEJM. (July 2011). Reforming the Regulations Governing Research with Human Subjects September 2011 Office of Human Research Protections (2011). Guidance on Reporting Incidents to OHRP October 2011 Reviewer Sheet - Children CHS Policy and Procedure Section 11.3 - Children November 2011 Scientific Review - CHS Policy Section 4.4 - 4.8 December 2011 Journal of the American Medical Association (2011). Protecting_Research_Participants_while_Reducing_Regulatory Burdens Journal of Clinical Research Best Practices (2011). An IRB Public Member's Education Updated: 15-Dec-2011
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