Templates and Forms
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- Protocol Templates
- Informed Consent Templates
- Short Form Informed Consent Templates (Non-English Speaking Subjects)
- HIPAA Forms
- Financial Interest Review Form
- External Team Member Form
- Responsible Participant Statement
- IRB Authorization Agreement (IAA) Forms
- Individual Investigator Agreement (IIA) Form
- NCI CIRB ICF Boiler Plate
- Radiation Safety Forms
- COVID-19 Contingency Plan Template
- Continuing Review Progress Summary Template
- MOD/MODCR Participant Notification Information Template
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
- COVID-19 Contingency Plans Template
Informed Consent Templates
- GU-Assent Template
- NCI CIRB ICF Boiler Plate
- GU-HRP-502 – Social Behavioral ICF Template
- GU-HRP-502 – MedStar Health Research Institute-Georgetown Oncology ICF Template
- GU-HRP-502 – Georgetown ICF Template
- GU-HRP-502 – GHUCCTS ICF Template
Informed Consent Guidelines
Code of Federal Regulations
Title 45 Public Welfare
Department of Health And Human Services Part 46 Protection of Human Subjects
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
Guidance for obtaining and documenting informed consent of subjects who do not speak English can be found at the OHRP website.
HIPAA Forms
PLEASE NOTE: Along with the implementation of the new IRB system and associated documents, 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.
For more information regarding HIPAA regulations click here.
Financial Interest Review Form
External Team Member Form
Responsible Participant Statement
IRB Authorization Agreement (IAA) Forms
- Review IRB of Record Forms Webpage
For more information regarding the request to act as the IRB of Record (reviewing on the behalf of other participating sites), deferral of IRB oversight to another institution (relying site or ceded review), and/or reliance agreements (IAAs and IIAs), please click here.