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Office of Regulatory Affairs

INSTITUTIONAL REVIEW BOARD (IRB)

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Forms for Biomedical Committees IRB-A & IRB-B




Educational Research
Is IRB review required?

IRB Forms and Cover Letters

Application for Biomedical IRB Review
(AB-1)
Continuing Review Form
(AB-2)
Request for Expedited Biomedical IRB Review
(AB-3)
Request for Biomedical IRB Review Exemption
(AB-4)
Amendment Cover Letter

Informed Consent From Templates and Guidelines

Georgetown University Informed Consent Form
Updated 11 August 2009
Required elements of a consent form
Code of Federal Regulations
Title 45 Public Welfare
Department of Health And Human Services
Part 46 Protection of Human Subjects
46.116 General requrements for informed consent
46.117 Documentation of informed consent
Joint MRI-GU Informed Consent Template
Updated 11 August 2009
GU-Merck Informed Consent Template
Treatment
Addendum Consent Form for Assent of Child < 12
Guidelines for Completing an Informed Consent Form
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)

Determination/Notification for IRB of Record for Human Subject Research Projects

Determination/Notification for IRB of Record for Human Subject Research Projects performed at both GU and Children's National Medical Center
* Determination/Notification for IRB of Record for Human Subject Research Projects performed at both GU and MedStar facilities
Determination/Notification for IRB of Record for Human Subject Research Projects (GU Stock Form)
* This form is for notification of IRB of Record for non-Oncology joint projects done at both Georgetown and a MedStar facility. This form is submitted to both the MedStar and the GU IRB chairs to decide if the project can be reviewed by only one IRB, instead of both. It is especially useful for a MedStar investigator doing the research at MedStar and only seeing subjects at the Georgetown GCRC and no other GU facility.
Note: Georgetown faculty are always required to submit to the Georgetown IRB regardless of study site.

Other Forms

Study Specific Disclosure Form    
GU Protocol Review Form for Reviewers
OHRP Investigator 101 Training Completion Form

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