Forms & Tools

Through the menu on the left, please find all forms, resources, and tools that you may need for submitting to the IRB.

FAQs

OHR's Mission

The OHR's mission is to support The George Washington University research community in the conduct of innovative and ethical research by providing guidance, education, and oversight for the protection of human subjects.

The OHR assists the IRB with reviewing research projects that involve human subjects to ensure that two broad standards are upheld: first, that subjects are not placed at undue risk; second, that they give uncoerced, informed consent to their participation.

A human subjects research project is first reviewed in its proposal stage - even before subjects are recruited. Each approved project is re-evaluated at least annually. The OHR works with investigators to modify projects to ensure adequate protection for its subjects' rights and welfare. 

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.

Some frequently asked questions regarding student research:

  1. Who can serve as a Principal Investigator (PI)?
  2. Do my IRB forms need to be signed by the PI?
  3. How much time should I allow for an IRB approval of my research?
  4. Can I submit a hand written form?
  5. What does the study expiration date mean?
  6. Does a Quality Assurance/Quality Improvement (QA/QI) project that involves research need to be reviewed by an IRB?
  7. When can I get a Waiver?
  8. Is my research retrospective or prospective, and what is the difference?
  9. What are GW's FWA and IRB numbers?

Who can serve as a Principal Investigator (PI)?

All PIs must be Regular Service Faculty Members. The following MAY serve as PI: Full, Associate, or Assistant Professors; Research Scientists and Research Professors. The following 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 the 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)" for additional details or contact the OHR for additional information. 

Principal Investigator Considerations for Student Research

back to top

Do my IRB forms need to be signed by the PI?

Yes, all IRB forms require the signature of the PI.  Digital or electronic signatures are permitted.  If the PI is unable to sign the document, the document must be sent to OHR from the PI's GWU email address with a statement describing the reason they are unable to sign the document and verifying that they have reviewed and approved of all submitted documents.  The PI is asked to provide a physical signature as soon as possible in the future.

Additionally, all initial applications (new applications) require the signature of the PI and the PI's Department Chair (or the person to whom the PI reports).

If your PI has a 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.

back to top

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 to this office for review at a minimum of 4 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 completness of the application and complexity of the study. We cannot guarantee that we can accommodate your deadlines if you allow insuccifient 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 our office to ensure you are within their guidelines. (GSEHD, SPHHS)

back to top

Can I submit a hand written form?

No, hand written forms are not accepted by OHR. All of our forms are downloadable word documents and must be typed. The signature of the PI and PI's Department Chair are the only acceptable hand written elements for our forms.

back to top

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, use 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

back to top

When can I get a Waiver?

If your minimal risk study meets the criteria for either:

  • 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)

A study is not granted a waiver for convenience; you must provide justification for a waiver. Please see our Waivers of documentation and consent requirements and examples sheet for more information.

back to top

Is my research retrospective or prospective, and what is the difference?

Retrospective research is information that is already collected (already exists-or is "on the shelf") prior to the study submission.

Prospective research is information that has not yet been documented or collected at the time of study submission.

Please review the following Retrospective vs Prospective information slides for what examples and more information.

back to top

What are GW's FWA and IRB numbers?

OUR FWA (Federalwide Assurance) number is 00005945 and our IRB number is 00000169. You can find these at any time through the FWA search engine.

back to top

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 support@citiprogram.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.

 

 

Education, Outreach, & Training

Outreach

Classroom Outreach Requests