science

HS IRB Templates

Please click the links below to access available IRB templates that you may use for your study. These IRB templates are also available in the eIRB Library.

Every human subjects research study must have a protocol. When a study is sponsored by industry, a protocol is typically provided by the sponsor. If a protocol is not provided by the sponsor, or a study is initiated by the Principal Investigator (PI), the PI must create a detailed protocol for the study. If a protocol does not accompany the submission to the IRB, it will delay the review of the research.

To assist with the creation of a protocol, the IRB office has provided the following protocol templates:

  • HRP-503- Template Protocol – You can utilize either the form or the MS Word document for your study.
  • NIH and FDA Clinical e-Protocol Writing Tool – This is an electronic protocol building tool created by the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) for phase 2 and 3 IND/IDE studies.
  • HRP-508 - Site-Specific Appendix (SSA) – 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. You can utilize either the form or the MS Word document for your study. 
  • Form 7 (Request for Exemption) – Required for exempt research studies including medical record/chart/electronic database/specimen review and datasets created for research purposes. When submitting a Form 7, there is no need to submit a separate protocol; the Form 7 will serve as the protocol for these studies.
  • Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) This website provides recommendation of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol.  Included are a useful checklist (WORD | PDF) and example table of assessments (WORD | PDF).
  • Regulatory Binder Tabs
     
  • Subject Wallet Card
    This subject wallet contact information card has been approved by the Tufts Health Sciences IRB for use.
    Please consider providing this wallet card to subjects so they can easily access study contact information. This card has been approved by the Tufts Health Sciences IRB and can be used in a specific study without further IRB approval, provided the information on the card is restricted to the information in the template (contact name, phone #(s), address/location, e-mail address, and appointment reminder).  The size of the card and the font type can be altered without further IRB approval.  If you would like to include additional information or make further alterations on the card (beyond the allowed alternations described here), please submit it to the IRB for review and approval prior to use.

     
  • Research Participant Advocate Flyer
    Please consider distributing this flyer to subjects or displaying it.

eIRB Library

A complete list of policies, standard operating operating procedures, worksheets, checklists and templates is available on the eIRB library.

View the eIRB Library