IRB Knowledge Center
IRB Basic Information
What is the IRB:
The Institutional Review Board (IRB) is responsible for the review and monitoring of all research involving human subjects taking place at Georgetown University. As part of this review process, the IRB balances both ethical considerations and scientific validity to protect the rights and welfare of human research subjects. IRB is an acronym for Institutional Review Board. The IRB is responsible for the review and approval of all research involving human subjects, as well as scientific validity and ethical review
When do I have to submit to the IRB?
If you plan to conduct human subjects research, you must submit to the IRB and receive approval prior to beginning any research.
How is my submission reviewed?
Upon your formal submission, the GU IRB office will conduct a pre-review of your submission. During the pre-review process, the GU IRB office will confirm the following:
1. Inclusion of Georgetown protocol and sufficient information provided
2. Inclusion of subject facing documents
3. Determine the appropriate level of IRB oversight
4. Confirm completion of Human Subjects Research training and necessary Ancillary Reviews
After pre-review is completed, your submission will undergo the appropriate level of IRB review.
Not Human Subjects Research
IRB oversight is limited to human subjects research. Therefore, research that is not human subjects research is not within the scope of IRB review.
Human subject is defined by the Common Rule as meaning “a living individual about whom an investigator (whether professional or student) conducting research:
i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
ii) Obtains, uses studies, analyzes, or generates identifiable private information or identifiable bio specimens. (45 CFR 102(e)(1))
Research is defined as “means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46.192(l))
If you are not certain whether your research project is human subject research or you would like for the IRB Office to make a formal determination, please complete and submit a IRB submission with the protocol attached in the Georgetown-MedStar IRB system.
Formal IRB determinations and Not Human Subjects Research letters will only be provided through the review process in the Georgetown-MedStar IRB system. Formal determinations will not be provided through email or Virtual Office Hours. Upon submission, if the IRB does not agree with you that your research project is not human subject research, you will be asked to submit a full IRB application in the Georgetown-MedStar IRB system. Do not assume that your research project is not human subjects research.
Quality Improvement Projects
Quality improvement (QI) projects can be similar to the type of human subjects research that the IRB needs to review. QI projects often include activities such as conducting surveys, reviewing identifiable data, drawing conclusions about problems, and suggesting methods for improvement. Federal regulations require human subjects research to be reviewed and approved by the IRB, while activities that are solely QI do not require IRB oversight. However, some QI activities may also fall under human subjects research and therefore need IRB approval.
If you are not certain whether your quality improvement project is human subject research, please complete and submit the IRB application with the protocol attached in the Georgetown-Medstar IRB system. DO NOT assume that your quality improvement project is not human subjects research.
Exempt Research
The Common Rule allows for a certain subset of human subjects research to be exempt from IRB oversight. There is not a separate application for this type of research and the IRB office will request the appropriate necessary information during the pre-review process. This research must be submitted to the IRB for a formal letter of exemption prior to the beginning of any research. Please note that exempt research still requires adherence to GU institutional policy surrounding research. Per GU policy, the IRB is the only entity who can make a determination of exemption.
For details regarding what research may qualify for an exempt determination, please see:
Expedited Review
Human subjects research can fall under what the Common Rule refers to as expedited review. Expedited review requires review by a single expedited reviewer rather than review by the entire IRB committee. Research that is determined to qualify for expedited review during the pre-review process will be forwarded to an appropriate IRB reviewer.
For details regarding what research may qualify for expedited review, please see:
Full Board Review
Human subjects research that does not fall under any other category will go to full board review. Upon submission to the IRB, the IRB Office will determine the appropriate committee that will review the submission.
For details regarding each committee, please see:
- How is my study reviewed:
- Not Human Subjects Research / QI
- Exempt
- Expedited
- Full Board
- Reportable New Information (RNI)
- HIPAA
- Other