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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 January 2007 - Engagement Comparison Table: OHRP’s Proposed Revised Guidance Document Versus OHRP’s 1999 Guidance Documents (OHRP) February 2007 - CHS Reviewer Sheets (above) March 2007 - International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS) April 2007 - Marshall, Eliot (2007). Sequencers of a Famous Genome Confront Privacy Issues. Science, Vol. 315 Issue 5820, 1780. Guidance on Continuing Review (OHRP) May 2007 - Detection and Disclosure of Incidental Findings in Neuroimaging Research (NINDS) June 2007 - Issues to Consider in Intervention Research with Persons at High Risk for Suicidality (NIMH) Research Protocols and Suicide Risk (UCLA OPRS) Pennisi, Elizabeth (2007). DNA Study Forces Rethink of What It Means to Be a Gene. Science, Vol. 316, Issue 5831, 1556-1557. July/August 2007 - Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (OHRP) September 2007 - Policies and Procedures of the Harvard Medical School/Harvard School of Dental Medicine Committee on Human Studies (6 July 2007). Section 14: Non-compliance with 25 CFR § 46, HU or CHS Policies/Procedures. Pgs. 106-112 (full-text) October 2007 - Campbell, Eric, et al. (2007). Institutional Academic-Industry Relationships. Journal of the American Medical Association, Vol. 298, Issue 15, 1779-1786. November 2007 - Phillips, Michael R, et al. (2002). Risk factors for suicide in China: a national case-control psychological autopsy study. The Lancet, Vol. 360 Issue 9347, 1728-1736. December 2007 - Policies and Procedures of the Harvard Medical School/Harvard School of Dental Medicine Committee on Human Studies (6 July 2007). Section 13: Adverse Events and Unanticipated Problems. Pgs. 102-106 (full-text) Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events (OHRP) Frost, Norman, and Robert Levine. (2007). The Dysregulation of Human Subjects Research. Journal of the American Medical Association, Vol. 298 Issue 18, 2196-2198 2008 Educational Materials 2009 Educational Materials 2010 Educational Materials 2011 Educational Materials Updated: 28-Mar-2011
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