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 ohrirb
gwu [dot] edu (ohrirb[at]gwu[dot]edu).
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.
Collaborative IRB Training Initiative (CITI)
Please note: GW does not own, maintain or otherwise create CITI material. If you require assistance with your CITI account, including certificates of completion, please contact citiprogram.org. GW IRB does not maintain CITI completion certificates for any GW affiliated research personnel.
All GW investigators and non-GW investigators conducting research under the auspices of the GW IRB must demonstrate and maintain sufficient knowledge of the ethical principles and regulatory requirements for protecting human subjects, through the completion and periodic renewal of the web-based human subject protection training called Collaborative Institutional Training Initiative (CITI). CITI training requirements apply to research staff that are interacting with potential or enrolled subjects, to include, but not limited to the following: obtaining consent, recruiting, data collection and intervention; or viewing, obtaining, analyzing or otherwise handling identifiable research data.
Research team members should select the training modules (either Biomedical or Social/Behavioral) that are most applicable to their research. This training must be completed prior to submission of all new human research study applications and is valid for two years. After two years, research team members must take the CITI Refresher Course. Current training of all research team members must be maintained throughout the life of the study.
Please visit CITI Accounts and Information for more information about registering for a CITI account.
Username and Password Information
If you have forgotten your username or password, please contact the CITI Support Desk. Do NOT create a new account!
CITI Support Desk: 888-529-5929 or supportcitiprogram [dot] org (support[at]citiprogram[dot]org)
Registration & General Information
To register an account with CITI please go to the CITI website (be sure to affiliate your account with GW!)
Principal Investigators are responsible for ensuring all research staff has completed the GW required CITI courses. It is the responsibility of the PI and research staff to keep track of CITI completion reports. These reports can be obtained by logging into your account viewing the course you've completed and selecting the "Print Completion Report" button. CITI completion reports do not need to be submitted to the OHR for any GW faculty, staff, or students who have completed CITI at GW. Researchers must correctly answer 75% of the questions in each section to successfully pass. If a course section is failed, the researcher will immediately be given the opportunity to retake that section’s exam. HRP-800 Principal Investigator Obligations
Need to take CITI for your program or to graduate?
OHR does not track program CITI requirements for CEs, Practica, or Graduation; you will need to contact your department to determine which course(s) you will need to take.
CITI completed at another Institution?
If you have taken CITI training or some other form of human subject protections training at another institution, please submit documentation of training to OHR. We will review the completed training, when it was last completed, and if it meets GW training requirements.
If CITI training was completed through another institution, we recommend that you “Affiliate” your CITI account with GW to enable GW OHR staff to view your completed training directly.
Please note, that because every institution can design their CITI modules differently all course work does not always transfer over, and could make it appear as though your courses are incomplete. It will be best to keep the completion reports from your original institution saved and submit them with any IRB paper work you plan to submit to our office even after affiliating with GW.