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Department Chair and Special Routing Sign Off

In section 3.5 of the INSPIR application, ONLY add the name of your Department Chair or Section Chief and select their corresponding Signature Role from the drop down list. Please note that you no longer need to add any “Special Routing” Signatures here since the INSPIR system will automatically route Initial Reviews to any additional “Special Routing” signatures depending on what you answered in your submission.
 
Department Chair Signature – Each IRB application requires a department chair’s signature. This signature indicates that the protocol is appropriate to be conducted in the department, that the PI has adequate expertise in the subject matter and in research, that the research staffing is appropriate, that the research will not interfere with patient care, that the standard of care described in the protocol reflects the standard of care in the department, and that the chair agrees that the research can and should be conducted within his/her department.
 
Special Routing – For BUMC Investigators only. If your protocol requires review by any of the following departments or committees, the INSPIR system will automatically route it to the corresponding NAME(S) listed below:
  • Human Gene Therapy Committee: SAJAL GHOSH  (This protocol must be routed to the Gene Therapy Committee if you will be introducing anything foreign of biological origin, i.e. microbial, human cells, recombinant DNA, directly into humans OR if your research will involve the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human research participants (human gene transfer))
  • Institutional Biosafety Committee: SAJAL GHOSH (Studies that use rDNA, cDNA, laboratory use of human blood, human tissues or cells, human body fluids, biohazards, and infectious agents including, but not limited to HIV-1 and HTLV – for a complete list of agents requiring IBC approval, please refer to the IBC website.
  • Maternal Child Department: OLIVERA VRAGOVIC (If this study involves human research subjects from Labor & Delivery, the post-partum inpatient floors, the neonatal intensive care unit (NICU), or the Well Baby Nursery of Boston Medical Center, the study must be routed to the Perinatal Research Review Committee for sign-off)
  • Biomedical Engineering: MADISON MOREAU (Study uses electrically powered devices (AC or battery) that are not FDA approved for the indication in this study.)
  • Cancer/oncology research from ANY department (not just Oncology): MATTHEW KULKE (This includes trials that are recruiting patients with cancer for treatment of disease or symptoms; studies pertaining to cancer prevention or detection; and studies of cancer survivors, i.e. people who have had a previous diagnosis of cancer.)
  • Chief Medical Officer: RAVIN DAVIDOFF (Signs off on studies where medical residents or fellows are specifically recruited. This is also the signatory if any Boston Medical Center faculty, staff, laboratory personnel, or trainees are targeted for recruitment)
  • Dean Medical School: KAREN ANTMAN (Signs off on studies where medical students are specifically recruited)
  • Office of Research – Dental School: BARBARA PYKE (Protocols that specifically recruit dental students require this sign-off on behalf of the Dean of the School of Dentistry. This is also the signatory if any students or residents from the Goldman School of Dental Medicine will be involved in the design or conduct of the study)
  • Dean of the School of Public Health: SANDRO GALEA (Protocols that specifically recruit students from the School of Public Health require sign-off from the Dean of the School of Public Health)
  • Division of Ambulatory Pediatrics: EILEEN COSTELLO (Study will be conducted in this clinical area.)
  • Division of Psychiatry: DAVID HENDERSON (this signoff is required if your study 1) involves subjects who are being recruited from the psychiatry or behavioral health services at Boston Medical Center or mental health clinical programs affiliated with Boston Medical Center; 2) will be utilizing data of patients who are or have been treated at Boston Medical Center or its affiliates; or 3) will require the assistance of staff or faculty of the Division of Psychiatry at Boston Medical Center or its affiliates.)
  • GCRU: RIDIANE DENIS (Study takes place in GCRU or uses its resources.)
  • Nursing Department: PAMELA COREY (If this study requires inpatient or outpatient nursing care, other than by nurses who work for the investigator or the GCRU, to help conduct the research (e.g., assessing physical/mental status of subjects, administering medications, checking vital signs, performing nursing procedures, completing data forms for implementation of the study) then the study must be routed for nursing department sign off. Failure to do so will result in the lack of resources and/or delay the study. Also, any study where the PI is a nurse will require this sign off)
  • Investigational Pharmacy Services: NITASHA SANIL (Study uses drugs or biologics where the agent is received, stored and/or administered at BUMC.)
  • Radiation Safety: ALISON ERRICO (Study involves radiation exposure for subjects specifically for research purposes, either from x-rays, Radiation therapy machines, dexascans or from isotopes.)
  • Radiology: JORGE SOTO (Study involves more radiological imaging studies than would be required as part of standard care.)
  • For all IRB protocols dealing with Lasers, Light Emitting Diodes, Photon Induced Photo Acoustic Streaming (PIPS), and Low level Light Therapy (LLLT) must be submitted for review and sign-off to: MADISON MOREAU (Biomedical Engineering), SHAWN TRAINOR (Deputy Laser Safety Officer, Clinical Lasers), ALISON ERRICO (Director Medical Physics and Radiation Safety), and ALISON ERRICO (Laser Safety Officer).
  • BMC Clinical Trials Office: MICHAEL PORRECA, AMY CHUNG, or BRYANT SHIELDS (study involves the provision of any of Boston Medical Center (BMC) clinical services or use of BMC infrastructure. Also for studies that were entered in BMC’s VelosCT)
  • BMC Pathology: ELIZABETH DUFFY or ERIN NORBERG (Studies that involve procuring and/or processing samples, i.e. tissue or slides, through Pathology at BMC)
  • BMC Laboratory Medicine: ELIZABETH DUFFY or ERIN NORBERG (Studies that include activities that require the involvement of Laboratory Medicine services at BMC including but not limited to specimen procurement, lab testing, phlebotomy, point of care testing such as urine pregnancy, use of lab CLIA, etc)
  • Other Special Routing (Other clinical services from which subjects will be recruited or whose resources will be used in the research. You must obtain a letter of approval from the appropriate supervisor and attach it in the Study Attachments Section.)

Please note: If your protocol requires the review of one or more of the options marked in red under “Special Routing” above, the protocol will require an independent review and approval by these committee(s). Their sign off on this protocol in INSPIR does not constitute their approval but rather an acknowledgement of this study. The PI is responsible for pursuing approval from these committees before starting his/her study even if the IRB had approved it for the human subject part of the research.