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Institutional Biosafety Committee (IBC) Cede Review Request
- Request that one IBC review multi-site protocols on behalf of all involved IBCs
- Request single IBC review when adding new site(s) to existing protocols
- Useful for reducing the complexity of the IBC review process for multi-site clinical and laboratory research studies involving recombinant or synthetic nucleic acids molecules, biological agents, and other biological materials conducted at an institution
- Available to clinical research and laboratory research investigators and study staff
The IBC Cede Review Application is used when a study involves recombinant or synthetic nucleic acids molecules, biological agents, and/or other biological materials. In our continued efforts to reduce regulatory burdens for Harvard investigators, the Harvard Catalyst Regulatory Foundations, Ethics, and Law Program and Institutional Biosafety Committees (IBCs) for 15 Harvard-affiliated institutions developed this form to facilitate consolidated review of biological research (in the laboratory or with human subjects). It may be used for any multi-site clinical or laboratory research study that involves at least one Harvard-affiliated schools or institutions.
Investigators conducting research at more than one site may submit this application to request review by a single IBC. The request will be considered by the relevant IBCs and a decision will be made on a case-by-case basis. Each participating IBC makes the decision whether to rely on the review of another IBC (to cede the review) or to conduct its own full review.
When to use this form:
- Investigators should use this form before submission of an IBC application but after their research plans have been finalized.
- This form does not replace the requirement for filing an IBC application and receiving approval prior to commencing work.
- For research that has previously been reviewed and approved, this form may also be used to request review by a single IBC when adding a new site to an existing protocol.
We suggest preparing the following required information before filling out the form:
- The name and contact of the institution where the overall principal investigator (PI) is “primarily employed.” Although investigators may have appointments at multiple institutions, they are usually considered an “employee” or a “workforce member” of only one institution. The institution from which the overall PI receives his/her paycheck is generally considered the institution of primary employment. For Harvard University employees, this would be the school at which their primary appointment is held.
- Which IBC is being requested to review and the reason(s) why.
- Title and brief description of your research.
- The sites where the research will be conducted.
- The activities which will be conducted at each site.
- The contact information for the site investigators.
Download the IBC Cede Review Application
When the form is complete, please email it to all IBC contacts for the participating sites.
Institutional IBC Cede Review Form Contacts:
Boston Children’s Hospital: Despina Felis (email@example.com)
Dana-Farber Cancer Institute: Karen Byers (Karen_byers@dfci.harvard.edu)
Forsyth Institute: Kathy Eklund (KEklund@forsyth.org)
Harvard Committee on Microbiological Safety (COMS): Rebecca Caruso (Rebecca_caruso@hms.harvard.edu)
Please note that Harvard COMS conducts IBC review for the following institutions: Beth Israel Deaconess Medical Center, Joslin Diabetes Research Center, Harvard Medical School, Harvard School of Dental Medicine, Harvard School of Public Health, Harvard University Faculty of Arts and Sciences, Massachusetts Eye and Ear, and Schepens Eye Research Institute.
Mass General Brigham IBC: Ryan Schlimgen (RSchlimgen@partners.org)
Please note that Mass General Brigham IBC conducts IBC review for the following institutions: Brigham and Women’s Hospital, Inc., Massachusetts General Hospital, McLean Hospital Corp., and Spaulding Rehabilitation Hospital Network.
To request any of the above documents be made accessible please email firstname.lastname@example.org.