Cost of IRBs
Today, virtually all clinical trials are subject to oversight by Institutional Review Boards (IRBs). Members of the IRBs are experts in science, medicine and ethics and are responsible for reviewing the design of the clinical trials and for monitoring the way they are conducted as well as the results. While health care professionals and scientists employed by the institution served by the IRB usually make up the majority of the membership of that institution's IRB, there is also a requirement for participation by non-institutional members. Although most of the members are employees of the institution, they are frequently not paid extra for their service on an IRB. Rather, their service is considered a part of their duties as employees. Nevertheless, there are costs associated with maintaining IRBs.
A recent peer-reviewed study published in the journals IRB: Ethics & Human Research and Academic Medicine presents some idea of the costs of IRB oversight of clinical trials at US medical schools.
Half of the nation's 125 medical schools participated in the cost study, reporting their own costs. Of those, the authors of the study subsequently visited 10 of the responding schools to validate the accuracy of the self-reported costs.
The number of clinical trials conducted at the medical schools varied from a few to several thousand. The lowest reported total cast was $171,000 (per year). The highest was $4,700,000. Quite a difference. Much of that difference is due to the difference in size of the IRB operation at the institutions. When the costs were reported per clinical trial, the numbers varied from $300 to $500.
Probably the most significant question emerging from this study involves the difference in costs among institutions. Do some institutions spend more on reviewing clinical trials than others simply because they are less efficient in their review processes? Or does the quality of the reviews explain some of the differences? That is, do the institutions that spend more review the clinical trials more carefully? And, if so, does that greater attention to the research protocols translate into better safety records?
Those are questions for future research.
~Joe
Related Topics: Technorati Tags: Institutional Review Boards, IRB, clinical trials, health and wellness
A recent peer-reviewed study published in the journals IRB: Ethics & Human Research and Academic Medicine presents some idea of the costs of IRB oversight of clinical trials at US medical schools.
Half of the nation's 125 medical schools participated in the cost study, reporting their own costs. Of those, the authors of the study subsequently visited 10 of the responding schools to validate the accuracy of the self-reported costs.
The number of clinical trials conducted at the medical schools varied from a few to several thousand. The lowest reported total cast was $171,000 (per year). The highest was $4,700,000. Quite a difference. Much of that difference is due to the difference in size of the IRB operation at the institutions. When the costs were reported per clinical trial, the numbers varied from $300 to $500.
Probably the most significant question emerging from this study involves the difference in costs among institutions. Do some institutions spend more on reviewing clinical trials than others simply because they are less efficient in their review processes? Or does the quality of the reviews explain some of the differences? That is, do the institutions that spend more review the clinical trials more carefully? And, if so, does that greater attention to the research protocols translate into better safety records?
Those are questions for future research.
~Joe
Related Topics: Technorati Tags: Institutional Review Boards, IRB, clinical trials, health and wellness
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