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  • Certificate of Translation
  • Clinical Research Recruitment Website Form
    Submit for all Tufts Medical Center studies that utilize an Informed Consent Form. This is a Tufts MC institutional requirement and must be submitted in order to receive IRB approval.  This form for posting studies on this recruitment website is optional for Tufts University studies.
  • ClinicalTrials.gov Form
    Submit for all new studies that utilize an Informed Consent Form. This is an institutional requirement and must be submitted in order to receive IRB approval.
  • Conflict of Interest Form
    The PI and each research team member are to complete this form. The PI is to submit his/her completed COI form to the IRB office. Any form(s) from research team members with “YES” responses are also to be submitted to the IRB office by the PI. The PI is to retain in his/her study files the completed form(s) for research team members who answer “no” to all Please refer to the Tufts University Conflict of Interest Policy or the Tufts Medical Center Policy on Industry Conflicts of Interest.
  • Form 1 (New Study)
    Required for all new studies submitted for full IRB review or expedited review.
  • Form 2 (Drug)
    Required for a new study or continuing review application that involves a drug, substance, biologic, or nutrient administered for research purposes. Ancillary or supportive drugs administered in a study require a Form 2 if the drug and dose are specified in the protocol.
  • Form 3 (Device)
    Required for a new study and continuing review that involves a device in as part of the research study. A separate Form 3 is required for every device employed in a research study. A user manual, operations manual, etc., must be submitted for each device.e.
  • Form 4 (Research Radiation)
    Required for a new study and continuing review if a research study involves radiation exposure solely for research purposes. The form must be reviewed and signed by the Radiation Safety Officer (RSO) prior to submission to the IRB office. At the time of continuing review, if the amount of radiation exposure has not changed since the Form 4 was last reviewed and signed by the RSO, a copy of the most recent RSO-signed Form 4 and a letter signed by the PI stating that there has been no change in radiation exposure may be submitted to the IRB office in place of a newly signed Form 4.

    • Typical Exposure Document
      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 radiolabelled agents are to be used, please complete and submit the above form to the Radiation Safety Office.

HIPAA Forms

  • Request for Waiver of Research Authorization:
    Databases where PHI is placed, processed and stored that are used as resources for future research require a HIPAA Research Authorization or a HIPAA Waiver. Since the definition of Research is the same under HIPAA and the Common Rule, these databases also require IRB approval. Complete a Form 7 when requesting a HIPAA Authorization or a HIPAA Waiver.
  • Waiver of Research Authorization Tracking Form:
    This form is used to help you fulfill HIPAA accounting requirements when you are granted a research authorization waiver. I f 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.
  • Data Use Agreement Form:
    The Tufts Medical Center/TUHS IRB/Privacy Board may permit the use and disclosure of PHI as a Limited Data Set under a Data Use Agreement between a Data User and Tufts Medical Center/TUHS. The PI should complete the Data Use Agreement Form to ensure that the request for Limited Data Set under a Data Use Agreement includes all of the necessary information regarding the uses and disclosures. The following elements should be included in the agreement:
  1. Establish the permitted uses and disclosures of the limited data set by the recipient, consistent with the purposes of the research.
  2. Limits on who can use or receive the data
  3. Requires appropriate safeguards to prevent the use or disclosure of the information other than as provided for in the data use agreement
  4. Requires reporting of unauthorized uses or disclosures to the HIPAA Privacy Officer. This information should also be reported to the IRB.
  5. Prohibits contacting subjects or identifying information of subjects
  • Review Preparatory to Research Form:
    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:
    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:
    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.