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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	Who Needs to Submit an IRB Application All research activities supported directly or indirectly by faculty, staff and students of HMS and HSDM are covered under the policies and procedures of the CHS, which extend uniformly to all research, development, or related activities involving human participants carried out under the aegis of HMS or HSDM. Research that falls under one of the following categories is subject to the review and approval by the CHS: The research is funded by or through HMS or HSDM; The research is conducted by HMS-based and HSDM-based faculty, acting in their capacities as such; The research is conducted by students of HMS or HSDM acting in their capacity as such; The research is conducted by non-faculty employees of HMS or HSDM acting in their capacities as such; The population from which participants will be drawn is exclusively or substantially composed of individuals who are patients, students or employees of HMS or HSDM; The Research makes substantial use of the property or facilities of HMS or HSDM or is otherwise significantly associated with, or likely to be perceived as being associated with, HMS or HSDM; The Research involves the use of HMS or HSDM non-public information for the purposes of the research, or to identify or contact prospective participants. Additionally, the CHS follows the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) Guidance on Engagement of Institutions in Human Subjects Research, which states “In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.” No funds (federal, foundation, private, corporate, departmental, or other) may be expended for research involving human participants unless the requirements for review and approval have been satisfied and a CHS approval or exemption has been documented. Updated: 03-Mar-2010
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