WELCOME to OHR and the GWU IRB!

            The Office of Human Research (OHR) is the administrative support office for the George Washington University Institutional Review Board (IRB). The GW IRB is responsible for the review of all research activities that involve human subjects (in accordance with federal regulations). The OHR provides institutional oversight for all human subjects research activities conducted by GW affiliates (faculty, students, or employees), under the auspices of the George Washington University.

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 The OHR's mission:

To support the GW research community in the conduct of

innovative and ethical research by providing guidance, education

and oversight for the protection of human subjects.

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If this is your first time visiting or you are already familiar with our website, take a moment and browse the information we have provided on the IRB, human subjects research guidance, application preparation and submission process, and education and outreach services available to all GW researchers.

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*ANNOUNCEMENTS*

IRB Forum: February 22, 2012 10AM-11AM (room TBA):

Protecting Vulnerable Subjects Part One: Pregnant Women and Children

IRB Forum Certificates of Attendance:

These will be available at each Forum unless otherwise indicated. Attendees will receive one credit hour. Two credits can be applied to future CITI training Refresher courses requirements. Please note: these certificates must be included in all study submissions in order to statsify CITI requirements.

New Researcher Training:

"Introduction for New Researchers"

A new training workshop is now being offered here in our office. These sessions will target basic essentials of submission requirements, administrative processes, and general information for submitting research (IRB) applications. Sessions will take place as requested, and we will post here as we receive requests. All are welcome!!

Classroom Outreach Requests:

Please submit requests for an OHR representative to visit your department or classroom at least a month in advance (if able). This allows ample time to tailor the outreach to your specific needs. You can send your request to ohrirb@gwumc.edu with the subject line of "Outreach request".

FOR YOUR INFORMATION

Please Note:

1. All new research Submission forms MUST include the signatures of the Principal Investigator AND the Department Chair. Generally, submissions will not be moved forward until the application signatures have been received by our office.

2. No hand-written forms will be accepted. This is a measure to ensure that submission documents can be easily read, scanned and stored for future reference. This also assists in making modifications to the forms when needed.

3. CITI Training requirements must be met prior to study approval being sent out.

4. The newly revised Exempt Registration Form Instructions sheet is now available to reference for completion of the Exempt Registration Application Form.

Study Renewal Requests:

Federal regulations require that all Expedited and Full Board research must receive (at least) annual IRB approval to continue. To comply with this, all renewal requests must be received in this office within 30 days prior to the study expiration date.

Please submit study renewal at least three weeks prior to the IRB expiration date, to prevent your study from expiring while it is in process of review. We cannot guarantee your study will receive approval in time if appropriate OHR/IRB review time has not been given. Please refer to the Forms section for the current Renewal Request submission form.

* If your renewal has not received IRB approval by the expiration date, all enrollment and study procedures must stop until IRB approval to continue has been obtained.

Forms:

Please download IRB submission forms only when you are ready to use them. The use of previous form versions may delay your submission process, and potentially trigger a request for completion of a current form. This is necessary so we are provided with the best information regarding your proposed research, and you are provided the most efficient approval turn-around time. We greatly appreciate your assistance.

Changes to IRB Approved Research:

All studies are required to have IRB approval prior to the implementation of any changes. Please submit the completed Modification Form, and include all applicable documents that are being modified.

Study Closures:

For all Expedited and Full Board research, please submit a closure form and closure materials to the OHR. Studies can be closed when subject enrollment is closed, all follow-up research activities have been completed, and the analysis of identifiable data has been completed. Please be sure that all data has been de-identified, unless the IRB has approved keeping the data.

CITI Training:

All Principal Investigators and key members of the research team are required to have completed CITI training prior to IRB review and conducting human subjects research at GW. This training is to be kept current until your study is closed through this office. Please see our CITI instructions page for details.

Determining IRB Reveiw Requirement:

When deciding if your research will require IRB review and oversight, we have a worksheet that can help guide you in your decision process. Please refer to the “Human Subject Research Determination Worksheet”, found on the forms page.

IRB Number:

An IRB number will be assigned at the time of your study submission. You may request a number prior to submission if required by an external institution, by emailing your request to: ohrirb@gwumc.edu. Please include the name of the principal investigator, title of the research project/study protocol, and sponsor (if applicable).

Full Board Review Process:

Please be advised that the OHR will conduct a pre-review of all submissions prior to full board review. This pre-review process may include requests for additional information and clarifications, and the OHR requests prompt responses to these to ensure that your submission will go to the meeting date which you are requesting. Any delay in the pre-review process may cause your submission to be moved to the next IRB meeting.

Submission Process:

Please submit all IRB application packets to the OHR. Upon receipt, your study will be registered in our database, assigned to an IRB Analyst for review, and assigned an IRB number if applicable. An Analyst will be in touch with you within a week of receipt to communicate any issues that may need to be addressed.

Hours of Operation: Monday through Friday, 8:00 a.m. to 5:00 p.m.

Office Walk-in Hours: Monday through Friday, 9:00 a.m. to 5:00 p.m. 

The Office of Human Research
2300 Eye St., NW, Ross Hall, Room 613
 Washington, DC 20037
Phone: 202.994.2715
Email: ohrirb@gwumc.edu