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

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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.

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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)

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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.

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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

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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.

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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.

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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.

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