Templates and Forms

Please note, when uploading study documents in to the IRB system, a standard naming convention should be used for study documents such as Study Protocol_V1 and Main ICF_V2.

Protocol Templates

• Biomedical Protocol Template
  • Must be used for investigational drugs, medical devices, special diets, radioactive materials, or other biomedical interventions or interactions
  • Must be used for all Social and Behavioral Studies; such as, surveys, interviews, focus groups, behavioral interventions, and educational practices
  • Must be used when GU is the IRB of record and the main protocol is a sponsor provided protocol
  • Must be used for all chart review studies

  Informed Consent Form (ICF) Templates

  • Georgetown ICF Template
    • Must be used for investigational drugs, medical devices, special diets, radioactive materials, or other biomedical interventions or interactions
    • Must be used for Oncology studies with investigational drugs, medical devices, special diets, radioactive materials, or other biomedical interventions or interactions
    • Must be used for GHUCCTS studies with investigational drugs, medical devices, special diets, radioactive materials, or other biomedical interventions or interactions
    • Must be used for all Social and Behavioral Studies; such as, surveys, interviews, focus groups, behavioral interventions, and educational practices
    • Must be used for studies involving children along with a parental consent form
    • Must be used for all studies utilizing the NCI CIRB. Note, for studies already approved a modification must be submitted with the current version.
      • GU / MedStar Boilerplate language (05.24.2024) (English) for NCI CIRB studies (New)
      • GU / MedStar Boilerplate language (05.24.2024) (Spanish) for NCI CIRB studies (New)

      Informed Consent Guidelines
      Code of Federal Regulations
      Title 45 Public Welfare
      Department of Health And Human Services Part 46 Protection of Human Subjects
      46.116 General requirements for informed consent
      46.117 Documentation of informed consent

      Glossaries Of Lay Terms
      Glossary of Lay Terms (Medical terms in lay language, from Stanford)
      Lay Language for Medical Terms (University of Kentucky)
      Lay Terminology (North Shore Long Island Jewish Health System)
      Simplification Guide to Medical Terms (University of Michigan)

      Short Form Consent Templates

      • Sample Short Form – English
      • Sample Short Form – Spanish
      • Sample Short Form – Russian
      • Sample Short Form – Arabic
      • Sample Short Form – Korean
      • Sample Short Form – Simplified Chinese
      • Sample Short Form – Vietnamese
      • Sample Short Form – Amharic

      Procedure MG.O-004.03 Consenting Non-English Speaking Research Subjects outlines the procedures for obtaining and documenting informed consent for non-English speaking participants.

      Translation Service: Chris Elznic, Client Success Manager, chris@ad-astrainc.com, Office number: +1 301.408.4242 Ext. 106, Ad Astra Inc., 8701 Georgia Ave Suite 808, Silver Spring, MD 20910, www.ad-astrainc.com (new window)

      Translation Certificate Template

      • Translation Certificate Template
        • This form can be used when documents are translated from English to another language by study team member and a translation service is not utilized.

        HIPAA Forms

        • HIPAA Authorization Form
          • The HIPAA Authorization form has been incorporated into the ICF template. There is no longer a need for a separate HIPAA Authorization Form unless otherwise instructed due to special circumstances, such as relying on an external IRB.
          • May be requested by the IRB when the study team is requesting access patient data for research purposes without the participants permission.

          For more information regarding HIPAA regulations click here.

          Progress Summary Templates

          • Progress Summary For CR or Closure Template without p-Sites
            • Must be used for continuing review or closure submissions
            • Must be used for continuing review or closure submissions when GU is the IRB of Record and there are approved p-Sites

            Participant Notification Form

            • MOD/MODCR Participant Notification Information Template
              • Must be used for modification submission to inform the IRB how participants will be notified of changes to the study.
              • Consideration for Re-consenting document provides guidelines on participant notification and re-consent.

              Responsible Participant Statement

              • Responsible Participant Statement
                • Must be used for student lead research. All students conducting research projects are required to list their advisors/mentors in the IRB application under Responsible Participant. The Responsible Participant is considered to be a member of the research team and must complete a Study Specific Disclosure Form and fulfill all required training. In addition, a Responsible Participant Statement must be signed by the Responsible Participant and attached to “Other Attachments” in the IRB application. A study cannot be reviewed until the Responsible Participant is added to the study as a Study Team Member and the Responsible Participant Statement is signed and attached to the application.

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                © 2024 Georgetown Research Services

                37th and O Streets, N.W.
                Washington DC 20057

                © 2024 Georgetown Research Services