Student-Initiated Research
Student research, if it meets the definition of human subjects research, is reviewed the same as any other type of human subjects research at GW. Students are members of the GW community that are enrolled in courses as an undergraduate or graduate student, doctoral candidate, medical or law student, resident or intern.
Please review our Student Initiated Research Policy (HRP-817) for when a student project requires IRB review.
Frequently asked questions (FAQs) regarding student research:
- Who can serve as a principal investigator (PI)?
- Do my IRB forms need to be signed by the PI?
- How much time should I allow for an IRB approval of my research?
- Can I submit a hand written form?
- What does the study expiration date mean?
- Does a Quality Assurance/Quality Improvement (QA/QI) project that involves research need to be reviewed by an IRB?
- When can I get a waiver?
- Is my research retrospective or prospective, and what is the difference?
- What are GW's FWA and IRB numbers?
Who can serve as a principal investigator (PI)?
All PIs must be regular service faculty members. Individuals in the following roles MAY serve as PI: full, associate, or assistant professors; research scientists and research professors. Individuals in the following roles MAY NOT serve as PI: non-GW faculty (or other unaffiliated persons), students (graduate or undergraduate), residents, fellows, lecturers, adjunct professors, or limited service faculty. PI exceptions are permitted on a case-by-case basis; a PI Eligibility Exception Form must be completed and submitted to OHR for review with the IRB Application, along with the proposed PI's CV, letter of appointment, and any other necessary supporting documents. Review Policy: Principal Investigators (HRP-011) (DOC) for additional details or contact the OHR for additional information.
Principal Investigator Considerations for Student Research
Do my IRB forms need to be approved by the PI?
Yes, all IRB forms require the approval of the PI. The approval happens within the GW iRIS system. Applications are routed to the PI and department chair for approval, as appropriate.
All new study applications require the approval of the PI and the PI's department chair (or the person to whom the PI reports).
If your PI has a Medical Faculty Associates (MFA) appointment, the initial submission must be signed by either Dr. Wasserman or Dr. Simon. Please see Donna Embersit on the 8th floor of the MFA to obtain one of their signatures. MFA faculty applications missing this required signature will not be processed.
How much time should I allow for an IRB approval of my research?
We request that your exempt or expedited application and study materials be submitted for review a minimum of four weeks prior to your anticipated research start date. However, we cannot guarantee that all submissions will be approved in this timeframe, as the approval time is dependent on the completeness of the application and complexity of the study. We cannot guarantee that we can accommodate your deadlines if you allow insufficient time for IRB review. This approval timeframe assumes that all CITI training is complete, and all proper and completed paperwork has been submitted with the application. Missing information will delay the approval process.
Please note, some schools and departments have adopted their own policies and practices involving the submission of an IRB application. Please check with your PI and/or department's administrative office prior to submitting to OHR to ensure you are in compliance with their guidelines.
Can I submit a hand written form?
No, hand written forms are not accepted. As of June 1, 2018, most forms must be submitted using the online GW iRIS system. The system will route the submissions for review and approval by the appropriate parties and allow investigators to track the status of their submissions. Questions about the online submission process can be directed to [email protected].
Does a Quality Assurance/Quality Improvement (QA/QI) project that involves research need to be reviewed by an IRB?
Yes, in some cases IRB review is needed if the project meets the definition of human subjects research. If your project involves research and a QA/QI component, submit the standard IRB initial application form. If you are uncertain if your project qualifies as QA/QI project please contact OHR. Please also see the QA/QI Checklist.
When can I get a waiver?
A study is not granted a waiver for convenience; justification for a waiver must be provided. A waiver may be considered if your minimal risk study meets either of these criteria:
- waiver of documentation of consent (you would still obtain verbal consent)
- waiver of consent (no consent process; typically only granted in cases where you will not have contact with participants)
Please see our Waivers of documentation and consent requirements and examples sheet for more information.
Is my research retrospective or prospective, and what is the difference?
Retrospective research utilizes information that is already collected (i.e., data that already exists, or is "on the shelf") prior to the study submission.
Prospective research will utilize information that has not yet been collected or documented at the time of study submission.
Please review the Retrospective vs prospective information slides for examples and more information.
What are GW's FWA and IRB numbers?
GW's FWA (Federalwide Assurance) number is 00005945 and its IRB number is 00000169. You can find these at any time through the FWA search engine.
