Institutional Review Board (IRB) Review and Oversight of Clinical Research at All Health First Facilities
All clinical research projects conducted at all Health First facilities must be reviewed and overseen by Western IRB (WIRB). This applies if any aspect of a human subject research project involves Health First facilities or services, whether the Principal Investigator is a physician, nurse, or staff member.
The Health First IRB is no longer reviewing protocols neither initial reviews nor continuing reviews. No meetings are scheduled, although it continues to have oversight over research protocols and will meet to address urgent matters of patient safety or noncompliance as these matters arise.
In the coming weeks, the Health First IRB will divest its oversight of clinical research studies entirely, and officially become “deregistered” by Health First .
If you wish to continue your clinical research at Health First you will no longer have the required IRB approval unless you take the necessary steps to transfer your project(s) to WIRB. Two major actions are required, one by Health First and the other by Investigators or their designees:
- Health First must transfer its IRB files of ongoing clinical research studies to WIRB.
- Investigators must follow the process for initial submission of clinical research protocols for WIRB.
This process must be completed by April 14th, 2008.
Important Western IRB Links
Western IRB Home Page
Western IRB's Initial Review and Submission Form - To be completed and submitted to WIRB as part of the transfer of IRB oversight to WIRB
Western IRB's Guide for Researchers - This handbook provides general information about conducting research and using WIRB for review of research
WIRB's Online Submission web site
Frequently Asked Questions
Click here for FAQ's
Additional Questions or Comments
Health First is working with members of Huron Consulting Group to facilitate this transition. Questions related to the closure of the Health First IRB and the transition to Western IRB you may be directed to the following Huron Consulting Group personnel:
Tom Bechert: (312) 479-8443 - Note that the area code is “312” not “321”
tbechert@huronconsultinggroup.com
Ofer Amit: (312) 451-5628
oamit@huronconsultinggroup.com
Linda Morrison (Western IRB): (360) 252-2443
Freqently Asked Questions
1. What has changed with respect to IRB submissions?
2. What are the timelines for this transition?
3. Who will be responsible for transitioning ongoing research to Western IRB
4. I recently received continuing review and approvals from the Health First IRB; Do I still need to re-submit my protocol materials to Western IRB?
5. How does the protocol submission process at Western IRB differ from the submission process for the Health First IRB?
6. Are there new forms to be completed when re-submitting ongoing research protocols to WIRB?
7. Do my existing protocol materials need to be significantly modified prior to re-submitting to Western IRB?
8. Who will pay for the transfer of existing protocols to WIRB?
9. Who will pay for the submission of new protocols to WIRB in the future? 10. Can Western IRB audit my research activities?
10. Can Western IRB audit my research activities?
1. What has changed with respect to IRB submissions?
Effective immediately, Health First will transfer IRB oversight of its existing and future human research to Western IRB (WIRB) at all three Health First hospitals. The decision to utilize WIRB was driven by Health First’s desire to provide human research protections coupled with world-class service to our community of research investigators.
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2. What are the timelines for this transition?
The transition is already under way. Investigators must ensure the transfer of their ongoing research to Western IRBby April 14, 2008.
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3. Who will be responsible for transitioning ongoing research to Western IRB?
There are two necessary steps to transfer ongoing clinical research to WIRB. The first step requires that Health First's IRB files be transferred to WIRB. Health First is taking the responsibility to complete this step. The second step is the Principal Investigator's responsibility. This step requires investigators to re-submit their active protocol(s) to WIRB through WIRB’s electronic submission portal.
Members of the Huron Consulting Group are available to assist researchers and staff during this transition, and may contacted by calling Tom Bechert at (312) 479-8443, Ofer Amit at (312) 451-5628, or the Health First IRB office at (321) 434-7291. Either of them will be available to walk you or your staff through the process.
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4. I recently received continuing review and approvals from the Health First IRB; Do I still need to re-submit my protocol materials to Western IRB?
Yes. Western IRB is becoming the IRB of Record for research conducted at Heath First facilities, and the Health First IRB will be de-registered with the federal government's Office of Human Research Protections (OHRP). Therefore, to maintain IRB approval of ongoing research, review and approval by Western IRB will be required even if continuing review was recently obtained from the Health First IRB.
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5. How does the protocol submission process at Western IRB differ from the submission process for the Health First IRB?
Western IRB offers a web-based submission process, which can be accessed from the WIRB website at http://www.wirb.com/onlinesubmissions/.
Investigators who prefer to submit paper submission may submit to the following address:
P.O. Box 12029
Olympia, Washington 98508-2029
USA
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6. Are there new forms to be completed when re-submitting ongoing research protocols to WIRB?
Yes. Western IRB's Initial Review and Submission Form will replace the Health First initial IRB review application form. This Initial Review and Submission Form must be completed and submitted to WIRB as part of the submission process.
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7. Do my existing protocol materials need to be significantly modified prior to re-submitting to Western IRB?
Overall, we don't anticipate that protocol submission materials previously reviewed by the Health First IRB will require significant modification prior to submission to Western IRB. However, protocol materials and informed consent documents that make reference to the Health First IRB will need to be modified to make reference to Western IRB where appropriate.
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8. Who will pay for the transfer of existing protocols to WIRB?
Health First will pay the fees associated with WIRB's review of all studies transferred to WIRB on or before April 14th, 2008.Please note that Health First expects corporate sponsors to reimburse Health First for these charges, and we ask your cooperation in explaining this to your sponsor contacts. Investigators and/or their practice groups are financially responsible for WIRB fees for studies transferred after April 14, 2008.
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9. Who will pay for the submission of new protocols to WIRB in the future?
Just as the Health First IRB charged fees for the review of protocol submission, so too does Western IRB. Investigators and/or their practice groups will be financially responsible for WIRB fees for new studies submitted to WIRB in the future. It is anticipated that investigators will arrange for payment of these fees by the research sponsor.
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10. Can Western IRB audit my research activities?
Western IRB periodically conducts on-site quality reviews of research activities related to WIRB-approved protocols in order to ensure that research activities are being conducted in accordance wit the protocol and in accordance with federal regulations. Western IRB typically tries to schedule such reviews on a biannual basis.
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