@GWOHRIRB

Student Initiated Research

Student Initiated Research page image (students jumping)

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 see Investigator Guidance and Policies page for more information.


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 do I know if I need to submit my human subjects research for review and IRB approval?
  4. How can I request assistance with the forms, IRB process, or my study submission?
  5. How much time should I allow for an IRB approval of my research?
  6. How do I know what I need to Submit?
  7. What if want to make changes to my study after I have IRB approval?
  8. What does the study expiration date mean?
  9. When can I close my study with the OHR?
  10. Can I submit a hand written form?
  11. CITI Questions
  12. Does a Quality Assurance/Quality Improvement (QA/QI) project that involves research need to be reviewed by an IRB?
  13. When Can I get a Waiver?
  14. Is my research retrospective or prospective, and what is the difference?

 

Who can serve as a Principal Investigator (PI)?


All PIs must be regular faculty members. Most commonly this is the student’s advisor, program director, or a mentor. The following CAN serve as PI: Full, Associate, or Assistant Professors; Research Scientists and Research Professors. The following CANNOT 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. Contact the OHR for additional information.

If you are a PI at your home institution, but wishing to use ongoing research for your student project, a GW PI is still required. If you are conducting research outside of GW, you will still need to have a GW affiliated PI. For example: Working at a local clinic conducting surveys of clients and providers. The clinic director or preceptor should not be listed as PI.

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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.
Additionally, all initial applications (new applications) require the signature of the PI and the PI's Department Chair (or the person the PI reports to).
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 do I know if I need to submit my human subjects research for review and IRB approval?


To assist you in determining if your study requires IRB review, OHR has created the “Human Subject Research Determination Worksheet." This is a self- evaluation tool provided so that the PI can make a determination if a project needs to be submitted for IRB review. If, after completion of the form, the PI is still unsure, please email the completed form to [email protected], and request that your worksheet be reviewed for a decision. A determination will be provided by email from an OHR staff member.

Generally, class requirements, CEs, oral histories, case studies, secondary (publicly available) data analysis, with no intent to publish or present outside of local context, would not be considered human subjects research and not require IRB review.

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How can I request assistance with the forms, IRB process, or my study submission?


We welcome your calls or emails at any point during your research process to answer any questions you may have. The OHR staff is available to meet with you Monday-Friday between the hours of 9am - 4pm, to discuss your project or in-process paperwork either in person or by phone.

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How much time should I allow for an IRB approval of my research?


We request that your 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 we can accommodate your deadlines if you allow less 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 as incomplete submissions will not undergo review until all requirements have been met.
Please note, some Schools (GSEHD, SPHHS) 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.

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How do I know what I need to Submit?

For all student lead projects involving human subjects research the following are required for review and approval:

  • New Study Application form (HRP-200) Forms Page
  • Student Investigator's Respoinsibilites form (HRP-290) Forms Page

The following documents may be required for review and approval depending on the type of research being conducted.

  • Consent document OR Waiver or Alteration of Consent Supplemental form (HRP-294) Forms Page & Research Tools Page
  • HIPAA Waiver (Partial HRP-281 or Full HRP-280) Forms Page
  • Research Team Personnel form (HRP-201) for studies with multiple team members beyone the PI and Primary Contact Forms Page
  • Data Collection Tools
  • Recruitment materials
  • Site Permission letters

All IRB forms must have the required signatures.

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What if want to make changes to my study after I have IRB approval?


All changes to IRB approved Expedited and Full Board studies require modification approval prior to implementing any approved changes. Please submit a Modification Form (HRP-203), indicating the change(s) you are making, and the justification. Changes to the protocol would include, but are not limited to: additions/removal of study staff, changes to procedures, or even additions/deletions/changes to a survey or questionnaire.
Exempt studies require modification approval only when; the changes may increase the risk to subjects, there is a change in PI, or when you want to start collecting identifiers.

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What does the study expiration date mean?


After the approval of Expedited and Full board studies a continuing review of the study must occur at least annually. The expiration date is generally one year from the approval date. You are first notified of your expiration date in your initial approval letter. The study becomes expired after 12:01 AM the eve of the expiration date. If your study is expired you will receive a notification from OHR and ALL research activities must be stopped. If we do not receive a request for continuance prior to expiration, your study must be re-submitted in its entirety.
To avoid your study expiring the continuing review request form (HRP 202) must be completed, signed by the PI, and submitted to OHR at least 30 days prior to the expiration date. As a courtesy, OHR will send you two reminders 60 & 30 days prior to the study expiration.

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When can I close my study with the OHR?


An IRB approved study can be closed in the OHR when all data collection and subject interaction has been completed, all private identifiable information has been stored, de-identified, or destroyed in accordance with IRB approved protocol. This is applicable to all Expedited and Full Board studies. Please submit the Study Closure Form (HRP-206) when these criteria have been met. Closure Forms are not required for Exempt studies.

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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 dowloadable 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.
If your study expires but you wish to continue the study you must complete a new application and re-submit your study documents as a new study.

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CITI Questions


In order to conduct human subjects research at GW there are certain education or training requirements that must be met. GW has partnered with the Collaborative Institutional Training Initiative (CITI) to provide that training. Please see OHR's CITI information pages for more details (CITI Courses & CITI Accounts & Information). Note: ALL research team members must have CITI training complete and up-to-date for study approval.
You may also want to check out OHR's CITI FAQ page and Step-by-Step Instructions for registering your CITI account, selecting courses, steps for refresher courses, and obtaining completion reports.

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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 Waiveror Alteration of Consent Supplemental form 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 Retropective vs Prospecitive information slides for what examples and more information.

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