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IRB Forms

HIPAA Forms

  • Request for Waiver of Research Authorization
    • Version Date: 03/17/2008
  • Waiver of Research Authorization Tracking Form
    • Version Date: 03/17/2008
  • Data Use Agreement Form
    • Version Date: 03/17/2008
  • Review Preparatory to Research Form
    • Version Date: 11/28/2016
  • Research on Decedent Form
    • Version Date: 03/17/2008
  • Case Report Authorization Form
    • Version Date: 01/20/2011
  • Certificate of Translation
    • Version Date: 05/02/2016
  • Clinical Research Recruitment Website Form
    • Version Date: 03/18/2015
      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. [Please refer to the List of Conditions when completing this form]
  • ClinicalTrials.gov Form
    • Version Date: 02/23/2017
      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
  • Form 1 (New Study)
    • Version Date: 01/10/2019
      Required for all new studies submitted for full IRB review or expedited review.
  • Form 2 (Drug)
    • Version Date: 03/21/2016
      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.
    • To locate current drug labeling - package inserts go to: http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
  • Form 3 (Device)
    • Version Date: 08/29/2016
      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.
  • Form 4 (Research Radiation)
    • Version Date: 03/24/2016
      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
    • 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 5 (Continuing Review)
    • Version Date: 01/01/2019
      Required for continuing review submissions only. For additional information about completing the Continuing Review, please refer to the Continuing Review page.
  • Form 6 (Tissue Banking)
    • Version Date: 06/28/2016
      Required for a new study and continuing review if a research study involves sample banking. A separate optional sample banking informed consent form (ICF) must also be submitted with Form 6.
  • Form 7 (Request for Exemption)
    • Version Date: 02/11/2019
      Required for any new study submitted for exemption. Can be submitted for medical record/chart/specimen review studies. If completed thoroughly, Request for Exemption  is designed to eliminate the need for a separate protocol, ICF, and HIPAA documentation
  • Form 8 (WIRB)
    • Version Date: 08/14/2018
      Required for WIRB submissions. Please click here for more information.
  • Form 9 (Central IRB Network)
    • Version Date: 05/15/2017
      Required for Central IRB Networks: NCI CIRB, NIH StrokeNet, PETAL cIRB, and CEGIR CCHMC IRB submissions. Click here for more information
  • Form 10
    1. Form 10A - Request to Assume Oversight
      Version Date: 01/15/2019
      This document 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: 01/15/2019
      This document 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: 01/15/2019
      This document 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: 04/03/2018
      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).
  • Reportable New Information (HRP-214)
    • Version Date: 03/24/2016
  • Short Forms
    • Version Date: 01/09/2018
  • Site-Specific Appendix    
    • Version Date: 8/10/2018
      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.
  • Study Close Out (Cover Letter)
    • Version Date: 07/20/2016
      Use this letter template to close out your study with the IRB.

HIPAA Forms

  • Request for Waiver of Research Authorization:
    • Version Date: 03/17/2008
      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:
    • Version Date: 03/17/2008
      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.
  • Data Use Agreement Form:
    • Version Date: 03/17/2008
      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:
    • Version Date: 11/28/2016
      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: 03/17/2008
      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.