Templates and Forms

Protocol Templates
Protocol Template
Site Supplement to Sponsor Protocol Template

 

Informed Consent Templates
Georgetown Informed Consent Template (Biomedical and Social & Behavioral)
MedStar Health Research Institute - Georgetown Informed Consent Template
GHUCCTS Informed Consent Template
Assent Template

 

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 at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-english-speakers/index.html.
 

Financial Interest Review Form
Financial Interest Review Form

 

External Team Member Form
External Team Member Form

 

Responsible Participant Statement
Responsible Participant Statement

 

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)