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Policy Reminder

What happens if I do not submit a continuing review (renewal) or a final report?

All non-exempt research must be reviewed on a continuing basis. Most commonly, the Human Research Protection Office (HRPO) reviews a non-exempt research study on an annual basis. If IRB approval lapses, all research activities must stop.

To allow adequate time for review, it is very important to submit your continuing renewal paperwork 6 weeks prior to the date of IRB approval expiration. If your study requires additional reviews prior to coming to HRPO you should account for this review time. If you are ready to close your study a final report must be submitted.

Your study will be closed due to non-compliance if HRPO has not received continuing review paperwork or a final report and 30 days have passed since the expiration date of IRB approval. If HRPO closes your study and you want to continue the research activities a new study must be submitted. The closed study will not be re-opened.

A pattern of allowing studies to lapse and subsequently be closed by HRPO may be determined to be continuing noncompliance and reported to federal regulatory bodies/sponsors.

If you have any questions or for more information please contact:

Jeanne Velders, HRPO Associate Director, at 633-7443 or veldersj@wusm.wustl.edu

IRB Registration with the FDA

Click here for a letter that documents HRPO’s registration with the FDA.

Focus On...

Behavioral Research:
Many of the Behavioral Forms have been revised and NEW guidelines developed. Read on for details.

Priority Reviews

American Recovery & Reinvestment Act (ARRA):
You may qualify for a priority review if receiving funds under ARRA/Stimulus package. To appropriately flag your study for review the HRPO Priority Review cover letter should be printed and included with your submission packet. Additional information is needed to prioritize your study. Please follow the steps as outlined on the cover letter. If this information is not provided with the submission it may delay the review of your study.

A priority review is only applicable when there is a good indication that the study will be funded under ARRA, (e.g. receiving the Just In Time (JIT) Request or a Notice of Intent to Fund).

It is the responsibility of the Research Coordinators/ Supporting Staff to consult with the Principal Investigator/Project Director or Department/Grant Administrator (i.e. DA) to obtain the necessary information and paperwork required to qualify for a priority review....read on

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