Risks and Benefits
Institutional Review Boards (IRBs) are responsible for determining whether or not a clinical trial may be conducted and under what conditions. Hospitals, clinics, academic medical centers and the institutions that host clinical trials all rely on their IRBs to carefully consider what is being proposed, including who the research participants will be. One of the most important considerations involves comparing the risks and benefits of the proposed research - also known as the "risk:benefit ratio."
While this may sound very exact and quantitative, typically no calculations are involved. Rather, several aspects of the proposed clinical trial are examined to compare the benefits and risks of each.
First, is the science solid enough to reasonably lead to an advance in our understanding of the biomedical phenomenon being studied? Is the protocol (the way the clinical trial is designed) logically constructed? That is, are the costs or risks of doing the research justified by an expected yield of significant new information?
Second, are the discomforts and risks to the research participants reasonable when compared with the likely benefits to the participants and to society at large? Time spent, uncomfortable clinical tests and obnoxious side effects all contribute to the overall risk. Individual participants may benefit from closer health monitoring and potential improvement of their medical condition. Knowledge about curing or preventing the clinical condition being studied is a potential benefit to society.
The risk:benefit ratio cannot be reliably predicted for the individual research participant, however. (If it could, there would be no reason to do the research.) In fact, for an individual, the side effects of a medication being tested may be so severe that the individual perceives her participation to present a very unfavorable risk:benefit ratio.
The role of the IRB is to make sure the clinical trial is designed in such a way that the overall benefits are worth the overall risks. And if they are not, then the IRB must disapprove the clinical trial.
As for the individual - she must decide for herself whether the benefits are worth the risks. And she often doesn't have enough information to do that until her participation in the clinical trial has finished.
-Joe
Related Topics: Technorati Tags: clinical trial, risk benefit ratio, institutional review board, IRB, health and wellness
While this may sound very exact and quantitative, typically no calculations are involved. Rather, several aspects of the proposed clinical trial are examined to compare the benefits and risks of each.
First, is the science solid enough to reasonably lead to an advance in our understanding of the biomedical phenomenon being studied? Is the protocol (the way the clinical trial is designed) logically constructed? That is, are the costs or risks of doing the research justified by an expected yield of significant new information?
Second, are the discomforts and risks to the research participants reasonable when compared with the likely benefits to the participants and to society at large? Time spent, uncomfortable clinical tests and obnoxious side effects all contribute to the overall risk. Individual participants may benefit from closer health monitoring and potential improvement of their medical condition. Knowledge about curing or preventing the clinical condition being studied is a potential benefit to society.
The risk:benefit ratio cannot be reliably predicted for the individual research participant, however. (If it could, there would be no reason to do the research.) In fact, for an individual, the side effects of a medication being tested may be so severe that the individual perceives her participation to present a very unfavorable risk:benefit ratio.
The role of the IRB is to make sure the clinical trial is designed in such a way that the overall benefits are worth the overall risks. And if they are not, then the IRB must disapprove the clinical trial.
As for the individual - she must decide for herself whether the benefits are worth the risks. And she often doesn't have enough information to do that until her participation in the clinical trial has finished.
-Joe
Related Topics: Technorati Tags: clinical trial, risk benefit ratio, institutional review board, IRB, health and wellness
1 Comments:
Hi Joe, I was an IRB member for five years at at state university medical center. I finally resigned after realizing that the high risk study participants were not identified (only about 5% of all studies reviewed), nor was there any attempt to determine if they had really been informed about the risks of the study for which they had enrolled. It seemed like the primary goal was to protect the massive flow of "indirect" money from the drug company sponsors of the majority of the studies to the institution and the discretionary (slush) funds of the "investigators" who rarely had any part in the study design or analyses. What is your impression?
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