Templates and Forms

• Protocol Templates
• Informed Consent Templates
• Short Form Informed Consent Templates (Non-English Speaking Subjects)
• Translation Certificate Template
• HIPAA Forms
• Continuing Review Progress Summary Templates
• MOD/MODCR Participant Notification Information Template
• Responsible Participant Statement

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
• Social and Behavioral Template
  • Must be used for all Social and Behavioral Studies; such as, surveys, interviews, focus groups, behavioral interventions, and educational practices
• Site Supplement Protocol Template
  • Must be used when GU is the IRB of record and the protocol is a sponsor provided protocol
• Secondary Use of Data Protocol Template
  • Must be used for all chart review studies

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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
• MedStar Health Research Institute-Georgetown Oncology ICF Template
  • Must be used for Oncology studies with investigational drugs, medical devices, special diets, radioactive materials, or other biomedical interventions or interactions
• GHUCCTS ICF Template
  • Must be used for GHUCCTS studies with investigational drugs, medical devices, special diets, radioactive materials, or other biomedical interventions or interactions
• Social Behavioral ICF Template
  • Must be used for all Social and Behavioral Studies; such as, surveys, interviews, focus groups, behavioral interventions, and educational practices
• GU-Assent Template
  • Must be used for studies involving children along with a parental consent form
• NCI CIRB ICF Boilerplate
  • 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)

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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)

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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.

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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.
• Waiver of HIPAA Authorization Form
  • May be requested by the IRB when the study team is requesting access patient data for research purposes without the participants permission.

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Progress Summary Templates

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

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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.

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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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