Department Chair and Special Routing Sign Off

In section 3.5 of the INSPIR application, add the names of all the people required to sign off on your study, including your Department Chair and all required Special Routing Signatures as listed below. Also, for each name, select their corresponding Signature Role from the drop down list.
 
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, please add the corresponding NAME(S) to this section (3.5):
  • Human Gene Therapy Committee: HE, WEI  (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: HE, WEI (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: MATRASCIA, LU (Research involving subjects from any of the Maternal Child areas or patients of the Maternal Child Department of Boston Medical Center)
  • Biomedical Engineering: PIEPENBRINK, JAMES (Study uses devices that are not FDA approved for the indication in this study.)
  • Cancer/oncology research from ANY department (not just Oncology): FALLER, DOUGLAS (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: DAVIDOFF, RAVIN (Signs off on studies where medical residents are specifically recruited)
  • Dean Medical School: ANTMAN, KAREN (Signs off on studies where medical students are specifically recruited)
  • Office of Research – Dental School: PYKE, BARBARA (Protocols that specifically recruit dental students require this sign-off on behalf of the Dean of the School of Dentistry)
  • Dean of the School of Public Health: MEENAN, ROBERT (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: BETANCES, JOSEALBERTO (Study will be conducted in this clinical area.)
  • Division of Psychiatry: CIRAULO, DOMENIC (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: ROTH, MARY-TARA (Study takes place in GCRU or uses its resources.)
  • Nursing Department: GRIFFIN, MARTHA (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.)
  • Investigational Pharmacy Services: ZALEWSKI, STEPHEN (Study uses drugs or biologics where the agent is received, stored and/or administered at BUMC.)
  • Radiation Safety: DER HAGOPIAN, HAROUTUNE (Study involves radiation exposure for subjects specifically for research purposes, either from x-rays, dexascans or from isotopes.)
  • Radiology: NORBASH, ALEXANDER (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: PIPENBRINK, JAMES (Biomedical Engineering), TRAINOR, SHAWN (Deputy Laser Safety Officer, Clinical Lasers), TATKOWSKI, WITOLD (Director Medical Physics and Radiation Safety), and KURKOMELIS, JOHN (Laser Safety Officer).
  • 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.

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