1 / 12

IRB Reviews of Multi-Site, Low Risk, Health Services Research

IRB Reviews of Multi-Site, Low Risk, Health Services Research. Two Studies. Custom-Fit Approach to Implementation of Diabetes Hypertension Guidelines Best Precedents in Human Subjects Protection for Health Services Research. Guidelines Study. 43 sites One-page survey of physicians

julian-kline
Download Presentation

IRB Reviews of Multi-Site, Low Risk, Health Services Research

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. IRB Reviews of Multi-Site, Low Risk,Health Services Research

  2. Two Studies • Custom-Fit Approach to Implementation of Diabetes Hypertension Guidelines • Best Precedents in Human Subjects Protection for Health Services Research

  3. Guidelines Study • 43 sites • One-page survey of physicians • Use of secondary databases to obtain data on prescriptions of participating physicians

  4. Guidelines Study (cont’d) • IRB applications included: • Written informed consent for physicians • Waiver of informed consent for patients • All application material was completed by staff at lead site.

  5. Guidelines Study (cont’d) • 19 months and 4680 hours later… (Duration and cost of study doubled from original budget.)

  6. Guidelines Study (cont’d) • 1 Exemption • 10 Expedited Reviews • 31 Full Reviews • 1 Disapproval

  7. Guidelines Study (cont’d) • Delays: • Obtaining information from site R&D offices • Finding and retaining a site PI • Getting signatures from site PI • Correspondence with committees and staff regarding requests for revisions • Obtaining notification and documentation of review results

  8. Guidelines Study (cont’d) • Length of Time (Days) for Submission and Approval Process Med Min Max Submission to first notification from committee 49 14 196 Submission to approval 133 30 506 Identification of site PI to receipt of approval letter 286 52 798

  9. Guidelines Study (cont’d) • Interesting Anomalies • Disapproval by one IRB who found the study was too risky. • Review by one IRB for two different sites: approved as minimal risk for one site, rejected pending revision for second site. • Request for names of participating physicians at annual review, despite assurances of confidentiality in application and consent.

  10. IRB Best Precedents Study • 20 multi-site, health services research studies funded during 2001-2003 • 15 reviewed thus far • 78 sites (mean = 5.2 sites/study) • 7 intervention, 8 observational

  11. IRB Best Precedents cont’d • Number of studies with discrepant types of reviews (i.e., full review vs. expedited vs. exempt): 11 • Lots of requests for changes to consent forms that don’t seem to have anything to do with local environment/culture

  12. Conclusion • We need to find a way to reduce the time and costs associated with review and approval of low-risk, multi-site HSR studies. • Balance risk of these studies with cost of impeding the research process. • Reduce variability in IRB reviews and responses. • Remove or revise site PI requirement in cases where site PI has no responsibility other than signing forms.

More Related