Methodist Healthcare System San Antonio Institutional Review Board home page
All IRB policies, procedures and guidelines are now posted on the site. Some of them have the "In approval" watermark, but all have been signed by the Chief Medical Officer and all are now approved. I will be replacing the watermarked documents with clean ones as soon as possible. Email Philip at Philip.Oilepo@MHShealth.com if you need verification of this for a sponsor. Stay tuned!
For the most part, all the guidelines, policies and procedures are the same as those previously posted on www.SAHealth.com. For this web page, I've broken them into smaller sections, so that it will be easier to find the information you need for a specific question. The documents are the same as those posted on the MHS Policy Tech web site, which will soon be available to all MHS employees.
How to Use This Site
All of the MHS IRB guidelines, policies and procedures are listed in the left hand side of this page. They are grouped by general categories. If you click on any of the links, you will be directed to a page with an attachment. Click on "view" or "download" to view the document. (Note that on some MHS computers, the "view" function may not work - use the "download" function instead.)
Within each document, there will be links to other sections of our guidelines, policies and procedures. If you are on an MHS computer, and have access to PolicyTech, the links within the document will take you to the Policy Tech page for that link. Note that these links will not work if your computer cannot access Policy Tech.
For those users who do not have access to Policy Tech, there are links provided on the page associated with each attachment. Those links will take you to other sections of the guidelines, policies and procedures on this web site. You can also search the "sidebar" on the left side of this page if you want to move to another section of the guidelines, or use the "search this site" engine at the top of this page.
IRB Contact Information:
IRB Director: Philip Oilepo MBA, CIP (210) 575-6910
IRB Assistant: Sandie Laird (210) 575-4918
MHS IRB Information:
FederalWide Assurance: 00000435 - Expires 11/01/2017
IORG number: IORG0000867 - Expires 2/14/2015
IRB Registration Number: 00001230
Methodist Healthcare System Institutional Review Board (MHS IRB) is duly constituted, has written procedures for initial and continuing review of clinical trials; prepares written minutes of convened meetings, and retains records pertaining to the review and approval process. MHS IRB is in compliance with the ICH Good Clinical Practice Guidelines insofar as those guidelines are consistent with the U.S. Food and Drug Administration regulations (21 CFR Parts 50 and 56) and the Department of Health and Human Services regulations (45 CFR 46) pertaining to the protection of human subjects in research. MHS IRB is registered with OHRP/FDA. Our IRB registration number is IRB00001230.
Before your first submission:
All new protocol submissions must be cleared by the MHS Clinical Trials Office before you submit them to the IRB. The Clinical Trials Office (CTO) will determine whether the MHS facilities can support the research. The CTO will also facilitate contracts, data use agreements, and hospital permissions. The number to call is (210) 575-4238, or you may email Sherri Shade at Sherri.Shade@mhshealth.com
IRB Education tools
Below are links to documents that help explain some of the IRB guidelines and procedures. Check this section for updates! Current entries include guidance on Exempt Review, Women of Childbearing Potential, Tips for using central IRBs, and Assessing Adverse Events.
Publications of Interest to the Research Community