# Presentation: 497910

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

## Custom-Fit Approach to Implementation of Diabetes Hypertension Guidelines
Best Precedents in Human Subjects Protection for Health Services Research 

- Best Precedents in Human Subjects Protection for Health Services Research

**Two Studies**

## 

43 sites
One-page survey of physicians
Use of secondary databases to obtain data on prescriptions of participating physicians

- 43 sites
- One-page survey of physicians
- Use of secondary databases to obtain data on prescriptions of participating physicians

**Guidelines Study**

## 
IRB applications included:
Written informed consent for physicians
Waiver of informed consent for patients
All application material was completed by staff at lead site.

- IRB applications included:
- Written informed consent for physicians
- Waiver of informed consent for patients
- All application material was completed by staff at lead site.

**Guidelines Study (cont’d)**

## 
19 months and 4680 hours later...
   (Duration and cost of study doubled from original budget.)

- 19 months and 4680 hours later...
-    (Duration and cost of study doubled from original budget.)

**Guidelines Study (cont’d)**

## 
1 Exemption
10 Expedited Reviews
31 Full Reviews
1 Disapproval

- 1 Exemption
- 10 Expedited Reviews
- 31 Full Reviews
- 1 Disapproval

**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

- 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

**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                   

- 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

**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.

- 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.

**Guidelines Study (cont’d)**

## 
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

- 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

**IRB Best Precedents Study**

## 
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

- 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

**IRB Best Precedents cont’d**

## 
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.

- 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.

**Conclusion**