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As of January 1, 2020, the IRB transitioned to an electronic IRB (eIRB) system.  To apply for new study approval or to submit a continuing review, modification or reportable new information (RNI), please do so through eIRB at https://eirb.tuftsmedicalcenter.org.

  • Below are supplemental forms that you may be required to complete and upload to your eIRB application. These forms are also available on the eIRB Library.
  • Please also refer to Documents to Upload with eIRB for guidance on which documents to include with your submission and where they should be uploaded in eIRB.

IRB Forms

  • Certification of Translation
    • Version Date: 05/02/2016
  • Drug Decision Tree
  • Device Decision Tree
    • Version Date: 08/29/2017
      Use this decision tree to help identify whether your study uses a device that is subject to FDA regulations.
  • Form 4 (Research Radiation)
    • Version Date: 11/18/2019
      Required for a new study and continuing review if a research study involves radiation exposure solely for research purposes. The form may be reviewed and approved by the Radiation Safety Officer (RSO) through the “Manage Ancillary Review” function of eIRB prior to submission.
    • Typical Exposure Document
      • Version Date: 12/2011
        This document lists typical effective whole body radiation doses from common medical imaging procedures, including their related increase in lifetime cancer risk and the period of natural background radiation that delivers the equivalent radiation dose.
    • Radiation Safety Committee Form
      • If radiolabeled agents are to be used, please complete and submit the above form to the Radiation Safety Office.
  • Form 6 (Tissue Banking)
    • Version Date: 12/19/2019
      Required for a new study and continuing review submissions if a research study involves sample banking for future unspecified research. A separate optional sample banking informed consent form (ICF) must also be submitted with Form 6.
  • Form 7 (Request for Exemption)
    • Version Date: 12/10/2019
      Required for any new study submitted for exemption. Can be submitted for exempt studies and uploaded as the protocol for those through eIRB. If completed thoroughly, this form is designed to eliminate the need for a separate protocol.
  • Form 8 (WIRB)
    • Version Date: 10/07/2019
      Required for WIRB submissions. Please click here for more information.
  • Form 10
    1. Form 10A – Request to Assume Oversight
      Version Date: 5/13/2020
      This form is required for requesting that Tufts Health Sciences IRB assume (take on) IRB oversight for research at another institution.
    2. Form 10B – Request to Cede Review
      Version Date: 5/13/2020
      This form is required for requesting that Tufts Health Sciences IRB cede (give up) oversight for research to another IRB.
    3. Form 10C – Request for Independent/Institutional Agreement
      Version Date: 5/13/2020
      This form is required for requesting that Tufts Health Sciences IRB assume (take on) IRB oversight for research for an independent investigator or institution that does not have an FWA.
  • Form 11 (Adding Tufts Medical Center Satellite Locations to an IRB Approved Study)
    • Version Date: 11/22/2019
      Use this form to add a participating site (or multiple sites) that are fully owned by Tufts Medical Center and operating as a Tufts Medical Center location, and are covered by the Tufts Medical Center Federalwide Assurance (FWA00004449).
  • Institutional Profile Form (HRP-815)
    • Version Date: 04/02/2020
      Use this form to request that an institution be added to eIRB, allowing you to select it as an external IRB or a relying site.
  • Short Forms
  • Site-Specific Appendix (SSA)
    • Version Date: 01/09/20
      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 including who conducts the consent interview, 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.

Other Forms

HIPAA Forms

  • Tracking Form for Disclosure of PHI from Research Records
    • Version Date: 02/10/2020
      This form is used to help you fulfill HIPAA accounting requirements when you are granted a research authorization waiver. If you access 50 or fewer records, you must record the names of the records you have accessed. If you access 51 or more records, you may create a profile of the study population (e.g., men over age 70 with glaucoma and a history of hypertension). In either case, it is the responsibility of the PI to report the names or profile to his/her institution’s HIPAA Privacy Officer for Research.
  • Review Preparatory to Research Form
    • Version Date: 12/03/2019
      This form is required when you plan to access PHI for purposes preparatory to research (such as preparing a research protocol, assessing feasibility of a research study, developing a hypothesis, or identifying prospective participants who would meet eligibility criteria for a proposed project). The PI will confirm the following on the Review Preparatory to Research Form:

      1. The use of the PHI is solely for purposes preparatory to research.
      2. The review is necessary for preparation.
      3. No PHI is removed from the covered entity during the course of the review.
  • Research on Decedent Form
    • Version Date: 11/15/2019
      This form is required if you plan to conduct research on decedents (a person who has died). The PI will confirm the following on the Research on Decedent Form:

      1. The PHI accessed is solely for research of the PHI on the decedent.
      2. The PHI accessed is necessary for research.
      3. Documentation of death is available upon request.
  • Case Report Authorization Form
    • Version Date: 01/20/2011
      This form is for use when a case report may directly or indirectly identify a patient. An analysis of more than 3 clinical cases meets the definition of research that must receive IRB approval before starting. These cases also require HIPAA authorization from the patient. Please refer to the case report policy for more information.