Tufts University 20 Professors Row

Office of the Vice Provost for ResearchMedford MA, 02155

Institutional Review Board(617) 627-3417

FWA #

Social, Behavioral & Educational Research IRB

INDIVIDUAL INVESTIGATOR AGREEMENT

This Form Must be Typed and All Sections Must be Fully Completed

Name of Principal Investigator: / Protocol Number:
Full Title of Protocol:
Name of Individual Investigator: / Title:
Responsibility in Project: / E-mail:
Institution, if any: / Department:
Address: / Phone:
Certification
As a member of the study staff on this protocol, I certify the following:
I am aware of the resources available for review of: 1) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; 2) the U.S. Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46; 3) the Federal Wide Assurance (FWA) and terms of the FWA; and 4) the relevant institutional policies and procedures for the protection of human subjects.
I will comply with all other applicable federal, international, state, and local laws, regulations, and policies that may provide additional protections for human subjects participating in the research conducted under this agreement.
I will abide by all determinations of the Institutional Review Board (IRB) and will accept the final authority and decisions of the IRB, including but not limited to directives to terminate participation in designated research activities.
I will complete the online CITI exam or include written documentation that I have completed Human Subjects Research training at another institution.
I will not to enroll subjects in research prior to the research being reviewed and approved by the IRB.
I will report promptly to the IRB any proposed changes in the research and I will not initiate changes in the research without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to subjects.
I will report immediately to the IRB any unanticipated problems involving risks to subjects or others in the research.
When responsible for enrolling subjects, I will obtain, document, and maintain records of informed consent for each such subject or each subject’s legally authorized representative as required under HHS regulations at 45 CFR part 46 (or any other international or national procedural standards selected in the FWA for the institution referenced above) and stipulated by the IRB.
I will cooperate with the IRB in its initial and continuing review, record keeping, reporting, and certification for the research.
I will provide all information requested by the IRB in a timely fashion.
I understand that this Agreement does not preclude me from taking part in research not covered by this Agreement.
I acknowledge that I am primarily responsible for safeguarding the rights and welfare of each research subject, and that the subject’s rights and welfare must take precedence over the goals and requirements of the research.

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Individual Investigator’s Signature

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Printed Name of Individual Investigator Date

IRB Administrator Signature Date

Revised: 06/20151This form and all SBER IRB forms can be located at:

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