science

HS IRB Forms

Overview of key forms for working with the HS IRB.

Forms

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

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.