Guides: Research in the Health Sciences: IRB

Georgetown IRB Quick Links

Reference Shelft

Writing a Protocol
Bartrum EA, Karp BI. Writing a protocol. In: Principles and Practice of Clinical Research. Elsevier; 2018:219-229. doi:10.1016/B978-0-12-849905-4.00016-2

Moving through the IRB Process...

The IRB, or Institutional Review Board, provides an approval process for all biomedical, social, and behavioral research conducted at Georgetown. In order to protect human subjects and comply with Federal law and institutional policy, the Board requires the following criteria for IRB Approval:

The risks to subjects are minimized as much as possible.
The risks to subjects are reasonable in relation to anticipated benefits.
The informed consent is adequate.
Where appropriate, the research plan makes provisions for the safety of the subjects during the data collection process.
Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data.
Appropriate safeguards are included within the study to protect the rights and welfare of the vulnerable subjects.

(List taken from http://ora.georgetown.edu/irb/)

Many researchers dread the IRB Process, but having information helps your approval move more smoothly & quickly!

Some research may be exempt from the IRB approval process, if it meets certain criteria.

Preparing for the GUMC IRB!

Human Subject Protection Training
Before submitting to the IRB, all researchers must complete specific Human Subject training modules.
HIPAA Training
Once you've completed the basic module within the online CITI training, you can also take the HIPAA section.
IRB Forms
Various IRB forms must be submitted, depending on your specific research focus. Includes a template for Informed Consent.
IRB Manuals
In order to make your IRB process smoother, be sure to read the appropriate IRB Manuals.

IRB Contacts

There are five individual IRB Committees at GUMC. The links below provide current membership listings & scheduled meeting dates.

IRB Reference Resources

NCCN Informed Consent Language (ICL) Database
"The NCCN Informed Consent Language (ICL) database is a comprehensive resource to assist researchers and clinical operations personnel with writing and amending informed consents for study participants. It currently contains more than 2,300 standardized lay language descriptions of risks and events associated with clinical research. The database content was developed through collaboration with two NCCN Member Institutions, namely, Dana-Farber Cancer Institute and The University of Texas MD Anderson Cancer Center."

The Graduate Health & Life Sciences Research Library at Georgetown University Medical Center