Templates and Forms

• Protocol Templates
• Informed Consent Templates
• Short Form Informed Consent Templates (Non-English Speaking Subjects)
• HIPAA Forms
• Continuing Review Progress Summary Template
• MOD/MODCR Participant Notification Information Template
• External Team Member Form
• Responsible Participant Statement
• IRB Authorization Agreement Forms
• Radiation Safety 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
• 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 main protocol is a sponsor provided protocol
• Chart Review Protocol Template
  • Must be used for all chart review studies and submitted with along with a completed Waiver of HIPAA Authorization form

Back to top

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 Boiler Plate
  • Must be used for all studies utilizing the NCI CIRB

Back to top

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

The Procedure MG.O-004.03 Consenting Non-English Speaking Research Subjects Apr 30 2020 can be found here.

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) (new window)

Back to top

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
  • Must be used when requesting to access patient data for research purposes without the participants permission.

Back to top

Progress Summary Template

• Progress Summary for Continuing Review or Closure Application (CRA
  • Must be used when submitting continuing review and closure submissions.

Back to top

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.
  • For guidelines regarding re-consenting please see the Consideration for Re-consenting document.

Back to top

External Team Member Form

• External Team Member Form
  • Must be used when adding non-GU or MedStar study team members to a research study.

Back to top

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.

Back to top

IRB Authorization Agreement Forms

• IRB Authorization Agreement (IAA) Forms*
  • IAA (GU and any institution) Updated 2.1.2021
  • IAA (GU NOT IRB of Record) Updated 3.23.2021
• Individual Investigator Agreement (IIA) Form
  • IIA Updated 08.02.2018

^{*IAA forms are signed by the Institutional Official (IO) at each institution}

Back to top