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Library > Fact Sheets > IRB Main Page
IRB MAIN PAGE
Posted 8/6/2012
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Institutional Review Board Mission
The mission of the Wright-Site IRB is to safeguard the rights and welfare of human research subjects.
Submission Requirements
The following checklist is provided to assist you in assembling your protocol package:
Link to Investigator Submission Checklist (.pdf) 49 kb
Please Note: Your protocol will not be reviewed until this checklist is completed in its entirety and all documents have been received by the IRB office. Once the protocol is submitted to the IRB, a 60 day suspense is established to complete the remainder of the requirements.
Templates and instructions for these forms can be found under "Forms and Templates". Please follow the format and instructions of these templates exactly as they will ensure that the IRB has all of the necessary information to approve your research. It is also possible to link to these forms from the Submission Checklist.
Please submit the protocol and informed consent document in Microsoft Word format via email to one of the IRB administrators (see "Contact Us"). Any document with a signature must be submitted to the IRB office as a hard copy. All other supporting documentation can be submitted by email.
All primary investigators, associate investigators and key personnel listed on the protocol must have completed the CITI training module (or equivalent) prior to submission of a protocol. The CITI training module and instructions can be found under "Training". If your initial training has been completed, annual refresher training must be current at the time of submission.
The Directorate Cover Letter must be signed to ensure that your protocol has been read and signed off by a statistical consultant (or a member of the research team qualified to perform statistical analyses), Medical Consultant (If you need a medical consultant, please contact the IRB administrator.), Program Manager, Branch Chief, Division Chief, and Director/ Commander prior to submission. you have any questions regarding these signature requirements, please contact the IRB office.
All institutions engaged in research under a particular protocol must have an Assurance of Compliance on file with the Air Force Surgeon General's Research Compliance office. If your research is being conducted or supported by an agency other than the AFRL you will likely need to have an Assurance. Please refer to the "Assurance" section for Assurance templates. For additional guidance on assurances and what it means to be engaged in research, please refer to the "Assurance" section or contact the IRB office.
Submission Deadlines
New protocol:
A new protocol, and all submission requirements, must be submitted to the IRB administrator no later than close of business 4 weeks prior to the date of the IRB meeting. Protocols submitted after this deadline will be put on the following month's agenda if they require full board review. Exceptions to this rule will require justification from the Division Chief of the PI. There are provisions for "just in time" approval of protocols when circumstances dictate. All exempt and expedited protocols are reviewed in a rolling fashion as soon as all requirements are received.
Continuing Review:
All approved protocols must be reviewed and approved on at least an annual basis. The review schedule for this IRB is on an 11 month (one month prior to the expiration date of your protocol) cycle. The expiration date is one year from the day of the IRB meeting at which your protocol was approved or the IRB approval date listed on your approval letter. This will ensure that protocols are reviewed and approved prior to expiration so that there is no lapse in approval or research.
The continuing review process will consist of the following notifications and requirements:
- Notification by email, 60 days prior to expiration, PI will have 30 days to submit:
- a progress or final report
- amendments to the protocol
- all original signed informed consent documents (PI retains a copy)
If the required documents are not received by the IRB prior to the expiration date, IRB approval will be suspended.
IRB Meeting
The IRB meeting is held the third Wednesday of every month at 1300. It is located in the second floor conference room of building 441.
Investigators are asked to have a seat in the waiting area in the hallway outside of the conference room until called in for presentation of their protocol. The conference room will have a computer and projector available for Power Point presentations.
Pictures of facilities and equipment are encouraged! The IRB asks that presentations be limited to 5 minutes and follow the format outlined under "Forms and Templates".
If your protocol requires presentation to the convened board, we kindly request that the primary investigator is available to present in person. If the PI is unable to present in person, please contact an IRB administrator as soon as possible to arrange for a VTC or teleconference.
Adverse Event Reporting
Any adverse experience associated with the study that is both serious and unexpected must be reported to the IRB immediately (within 24 hours).
There is a template letter and instructions available for reporting adverse events under "Forms and Templates". AFI 40-402 Attachment 5 has more detailed guidelines on completing this report. For any adverse event or suspected adverse event please consult with the medical monitor for evaluation of the subject and how to categorize the event.
Do not hesitate to contact the IRB Chairperson or Administrator as soon as an adverse event is suspected or confirmed.
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