CRU research proposals may be submitted by any University of Iowa faculty or professional and scientific staff. Studies conducted in the CRU must be approved by the University of Iowa Institutional Review Board (IRB) or Western IRB (WIRB) and the CRU Advisory Committee. You should prepare and submit IRB and CRU applications simultaneously.
Investigator-Initiated Protocols should be sent to the appropriate UI IRB and a CRU application should be submitted.
IRB CRU Application (you must have MS Word 6.0 or higher to read these files)
Industry-Initiated Protocols should be sent to WIRB and a CRU application should be submitted along with the copies of the Informed Consent Document and Sponsor Protocol.
WIRB CRU Application (you must have MS Word 6.0 or higher to read these files)
CRU Application Submission Directions
- Click on CRU Application above, and save it to the appropriate folder.
- When you are ready to complete the CRU application, open the file with Word and use your arrow key, tab key or mouse to move from line to line or box to box and complete the required information. Click on a box and an “X” will indicate you have chosen it. To remove the “X” click the box again.
- Fill out the application and the Research Safety Plan.
- It is recommended that you do not unprotect this form as the results are unpredictable.
- Please e-mail your CRU application to Mary McDermott
For more information, please contact the CRU secretary at 384-8305.
Important Facts Regarding the Preparation of a ICTS Clinical Research Unit Application
- 1. Please email your CRU application to mary-mcdermott@uiowa.edu.
- 2. Every CRU protocol must be approved an Institutional Review Board (IRB). The IRB-01 reviews investigator-initiated studies and the Western IRB reviews protocols that are industry-initiated. We recommend that CRU and IRB applications be submitted simultaneously.
- 2. The CRU supports patient oriented research in adults, children and infants. Most studies will take place in the CRU, but studies can be done in other sites in the hospital with the assistance of a CRU flexible nurse.
- 3. The CRU grant will cover bed, clinic or nursing charges unless your protocol is industry-initiated. Delineate your anticipated expenses clearly on the GCRC application and plan to discuss your budget with the Program Administrator before your protocol is submitted.
- 4. The CRU dietitians are experienced in formulation of research diets, assessment of nutritional intake, anthropometry, and resting energy expenditure measurements. Their services are provided at no charge to investigators.
- 5. Your protocol will be reviewed by the CRU biostatistician and we encourage you to work with him/her in designing the study and in performing your data analysis. All appointments should be scheduled with Professor Zimmerman through Ms. Ann Weber in the Department of Biostatistics. Ms. Weber's hours are from 9 am to 1 pm, Monday through Friday, and all appointments should be scheduled with her by phone, (319) 384-8085, or via email, ann-weber@uiowa.edu.
- 6. Industry-initiated protocols that are designed to answer specific scientific questions may be performed in the CRU, but the CRU grant cannot pay for any expenses associated with these protocols.
- 7. The Regulatory Knowledge and Support Key Function of the ICTS assists investigators in the preparation of the required Safety Plan. Please direct any inquiries or questions regarding research protocols and research safety to Janet Schlechte, M.D., Director of Research Safety and Investigator Support. She may be reached via emailjanet-schlechte@uiowa.edu or by phone at (319) 384-8305. Questions or inquiries regarding IND processes and/or FDA regulations should be directed to Larry Fleckenstein, Pharm.D., Associate Director of Investigator Support. He may be reached via email l-fleckenstein@uiowa.edu or by phone at (319) 335-8804.
