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CTSA Regulatory Knowledge Working Group – OHSU Activities. Presented by: Kathryn G. Schuff, M.D. Date: September 12, 2007.
Presented by: Kathryn G. Schuff, M.D.
Date: September 12, 2007
A strong partnership between OHSU and Kaiser Permanente Center for Health Research, providing the opportunity for a wider array of research opportunities and collaborations among a wide array of basic, clinical and population scientists.
New services for non-industry sponsored studies:
IRB application creation/submission
Protocol design consultation
Grant budgeting and assembly
Regulatory Support Services
Drafting of Virtual Data Warehouse and Biolibrary protocols
Regulatory issues consultation
Interinstitutional regulatory assistance
Training on self-monitoring
Clinical trial registration education
Director: Kathryn Schuff, MD
Director: Susan Bankowski, MS, JD (CTSA Liaison)
The OHSU and KPNW IRBs and Privacy Boards have agreed to accept each other's:
* Training in human subjects protection (OHSU: Responsible Conduct
of Research (RCR); KPNW: Training in Bioethics and Human Subjects
* Training in HIPAA
* Disclosures of Conflicts of Interest in Research
For studies submitted to the OHSU IRB that include Kaiser personnel:
Search for Kaiser personnel below. Enter the first few letters of the
first or last name and click on the "Go" button. Create a screen shot
showing the name and date recertified (Alt-PrtScr, then paste into Word
document) and upload into the eIRB with your submission.
*Note: In cases where the person may have more than one certification
date, use the most recent date.
For additional information, please contact Jeannie Lee at Kaiser
Permanente Northwest's Research Subjects Protection Office at
503-335-6357 or Jeannie.Lee@kpchr.org.
For studies submitted to the KPNW IRB that include OHSU personnel, KPNW
IRB staff will verify training of OHSU personnel in the ORIO Compliance
All training and disclosures for all personnel must be current or the
submission will not be processed by either IRB.
Dr. PI from Institution A proposes a dietary evaluation of patients post MI and CABG to assess dietary intake of a new phyto-antioxidant and a dietary intervention to increase the level of the phyto-antioxidant. Would like to recruit post CABG patients from Institution A and Institution B by obtaining a list of subjects who have undergone CABG in the last 1 year to send them a letter inviting them to participate. Subjects will come to Institution A for dietary survey, multiple visits for baseline and follow-up labs and receive the dietary supplement, nutritional counseling.
Kaiser: If minimal risk, A would not cede
If minimal risk, B would cede
OHSU: If A, would not cede
If B, would cede but require letter
come from OHSU provider
VA-OHSU shared eIRB system