Templates and Forms

• Protocol Templates
• Consent Form Procedures and Risks Language
• 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
• Reportable New Information Sheet
• 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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Consent Form Procedures and Risks Language

According to federal guidelines, language in ICFs should be suitable for the general public (i.e. language written at the 8th grade level). The following document contains plain language descriptions of procedures and their associated risk which can be incorporated into the ICF. This language has been vetted by the Institutional Review Board and may be used in ICFs to articulate study procedures, associated risks and various research elements. Additional resources that can help researchers translate commonly used scientific words into lay language which may be more easily understood can be found in the grey box below titled “Glossaries Of Lay Terms.”

• Consent Form Procedures and Risks Language

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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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Reportable New Information Form

• Reportable New Information Form
  • Must be used when reporting unanticipated problems, potential non-compliance, repeating protocol deviations and Data and Safety Monitoring Reports which required changes to the protocol documents. This form is not needed for deviation logs submitted at the time of continuing review unless there is a pattern of repeating deviations.

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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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