Faculty of Medicine CHS

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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	Ceded Review To avoid duplication of review, the CHS will consider accepting review responsibilities, or ceding its review to another IRB, ordinarily when the following conditions are met: 1. Accepting Review Responsibilities for another Institution The CHS will accept reviewing responsibilities on a case-by-case basis, including but not limited to the following situations: When the primary work involving participants takes place on Faculty of Medicine property under the jurisdiction of an Investigator from the Faculty of Medicine and the secondary institution ’s involvement is primarily financial or limited to minimal risk activities, or When the study involves a secondary institution or institution’s personnel but is initiated by an Investigator from the Faculty of Medicine. Such studies may include but are not limited to: clinical rotation curriculum of students, program evaluations, surveys and questionnaires, and research conducted at international sites. 2. Ceding Review to other Institutions The CHS may cede reviewing authority to another IRB under one or more of the following conditions: The Faculty of Medicine acts solely as the funding recipient of an award and no research activities will be taking place at HMS or HSDM facilities; The Faculty of Medicine is the recipient of a prime funding award and provides a subcontract for human studies work to be performed at another institution that either has or will have IRB approval for the human studies work; The involvement of the Faculty of Medicine Investigator is limited to data or specimen analysis collected through the other institution, or other minimal risk, engaged activities. The other institution’s reviewing IRB is more properly constituted to review a certain scope or topic of work, or may have knowledge of the local research context. The CHS will ordinarily not cede review if any research activities conducted at HMS or HSDM require direct intervention or interactions with study participants. 3. Required Documentation for Ceded Review The following documents must be submitted to the CHS for consideration of ceding review to another IRB: Catalyst Cede Review Form (for partnering with Joslin, Dana-Farber Cancer Institute, Children's Hospital Boston, Beth Israel Deaconess Medical Center, or Partners-Massachusetts General Hospital and Brigham and Women's Hospital) Designation Request Form (for partnering with any institutions not listed above) Funding application (grant, contract and/or subcontract), if funding is awarded to the Faculty of Medicine IRB approval letter from the reviewing IRB (if ceding review is requested) Please see the CHS Policies and Procedures (Section 7) pertaining to ceded review, particularly where it relates to continuing review, amendments, serious and/or continuing non-compliance and unanticipated problems involving risks to research participants and/or others. Updated: 05-Oct-2011
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05-Oct-2011