Tufts Medical Center/Tufts University Health Sciences
Institutional Review Board
Check List for Investigators: Human Research Protocol Submissions
Submit ONE (1) original paper submission application to the IRB office (Box 817 or 15 Kneeland St, 1st floor).
Original signatures are required on the paper submission. Please also submit all documents electronically (e.g.,
on a flash drive or CD; flash drives will be returned). The original application will consist of the following, as
needed: IRB forms, protocol, site-specific appendix, grant, and all supporting documents. Please call the IRB
office at (617) 636-7512 if you have questions regarding a study submission.
FORM I – Application for investigation in humans. Required for all new (expedited and greater than minimal risk)
protocols submitted to the IRB for initial review.
SITE-SPECIFIC APPENDIX – Required for all new and continuing review submissions if the protocol does not
already detail aspects of the study as they will occur specifically at this site (e.g., consent process, specific location
of document storage, operational details of recruitment methods). This form will typically be used for those studies
that are multi-center or industry sponsored and the protocol document cannot be tailored to this site.
FORM II – Drug/Substance/Biologic information for approved and investigational drugs/substances. Include
supporting documentation, as needed, e.g., package insert, Investigator’s Brochure.
INVESTIGATOR’S BROCHURE – If the drug is investigational submit the Investigator’s Brochure.
FORM III – Device information. Include supporting documentation, e.g., user manual, information sheets. If
510(k) status has been granted, attach FDA documentation.
FORM IV – RESEARCH-RELATED RADIATION EXPOSURE (including Radiation Safety Officer’s Signature)
FORM RSC – RADIATION SAFETY COMMITTEE. Procedures involving radiolabelled agents in humans.
Contact the Radiation Safety Committee at (617) 636-6168.
FORM V – CONTINUING REVIEW of a previously approved protocol. Used for previously approved ongoing
research that is to continue; research must be reviewed on an annual basis at a minimum, or more frequently if
specified by the IRB. May also require a Site-Specific Appendix (see above).
FORM VI – SAMPLE BANKING FORM (required for any sample banking)
INFORMED CONSENT FORM(S) (ICF)
Please refer to the IRB website or contact the IRB office for assistance in
preparing an assent form for minors (under 18 years of age) or if the study will enroll other vulnerable populations (e.g.,
persons with impaired decision making capacity).
PROTOCOL
GRANT APPLICATION (if applicable)
PSYCHOLOGICAL TESTS/QUESTIONNAIRES/ INTERVIEW QUESTIONS/ ADVERTISEMENTS/
SUBJECT DIARIES/RECRUITMENT FLIERS/SCRIPTS/CONTACT LETTERS, ETC.
Health Insurance Portability and Accountability Act (HIPAA) Form(s) (as applicable) Research
Authorization Form (RAF), as applicable, Request for Waiver of Research Authorization, Data Use Agreement Form, Review
Preparatory to Research Form, Research on Decedents Form, or Case Report Authorization Form.
Check if either facility will be used:
Clinical and Translational Research Center (CTRC)
(If yes, contact the CTRC Administrator at (617) 636-5973).
Human Nutrition Research Center on Aging (HNRCA)
(If yes, a copy of above material should also be sent to the HNRCA, 711 Washington Street).
PROJECT TITLE:
PRINCIPAL INVESTIGATOR:
CONTACT PERSON:
TELEPHONE: