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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	Submission Guidelines All applications submitted to the CHS office receive a pre-review by a CHS staff member. The staff member will communicate to the Investigator any issues or recommended changes to the study or study documents based on the regulations or CHS policies. The staff member who pre-reviews a research proposal sees that proposal through the initial approval and any subsequent submissions (such as continuations and amendments) to the office. And, the CHS staff member who reviews one research proposal for an Investigator will review all subsequent proposals for that Investigator. Submission Guidelines For New Applications Please submit one original copy (including requisite signatures) of the Initial Application Materials (appropriate application with supplemental forms) to the CHS office along with the following materials, as applicable: CVs/Biosketches for the Investigator and research personnel with human studies responsibilities (including members of the team who interact with participants or handle data/specimens containing participant identifiers); Disclosure Statements for the Investigator and research personnel. Human Subjects Protection Training certification for all research personnel with human studies responsibilities (including members of the team who interact with participants or handle data/specimens containing participant identifiers); IRB approvals from appropriate institutions, or letter of support if the institution does not require IRB review, as applicable; All funding application/s (including grants, subcontracts and clinical trial agreements) supporting the research; The full protocol; The sponsor protocol (when one exists); The complete DHHS-approved protocol (when one exists); Recruitment materials (cover letters, fliers, brochures, email notices); Study materials (telephone scripts, question guides, written questionnaires and surveys); Educational materials (information sheets, study guides); Consent materials, including any requests for waivers; HIPAA materials (including any waiver requests and proposed authorizations); Investigator’s Brochure (or package insert or pages from the Physicians Desk Reference, if a marketed drug). Students will also need to submit: Mentor letters (HMS faculty and on-site supervisor). Application should be signed by student and mentor HMS faculty mentor's Human Subjects Protection Training certificate Updated: 25-Aug-2010
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