IRB Shopping
This is the first of a two-part blog inspired by a recent announcement by the Food and Drug Administration (FDA).
Institutional Review Boards (IRBs) are panels of scientists, health care professionals and community representatives charged with overseeing clinical trials. If the research involves a product regulated by the Food and Drug Administration, then the sponsor of the research must submit to an IRB. The original plan (known as the protocol) must be approved, including the consent form to be used when recruiting participants. Periodic reviews are conducted by, and adverse events are reported to, the IRB. If an IRB finds a problem with a clinical trial under its authority, it may suspend or terminate the research in the interest of the safety of the participants. Participants may ask the IRB to intervene in situations of serious disputes with the study team regarding the research. In short, an IRB can make or break a clinical trial.
While IRBs all follow common federal regulations governing research involving human subjects, there is ample opportunity for varying interpretation of the rules. IRBs often develop "personalities" based on the culture of the organization they are in. Some are quite deliberative and conservative in their decisions, while others are relatively quick and efficient. Where the safety and well-being of research participants are concerned, slow and conservative seem appropriate. But, with speed and efficiency being key attributes in the business world, which personality would you prefer if you were a company who wanted to test a product?
These perceptions led the federal government to question a few years ago whether research sponsors, such as pharmaceutical companies, search out or "shop" for the most lenient IRB they can find. Also in question was whether or not research protocols which had been disapproved by one IRB were routinely submitted to subsequent IRBs until one was found which would approve the research.
In 2002 the FDA published a request for comments on the question of IRB shopping - was it a real problem of any significant frequency and how might it be discouraged?
Next time: the FDA's recent decision on this issue...
-Joe
Related Topics: Drug Companies Offer More Details on Clinical Trials, Holes in US Drug Safety Net
Technorati Tags: FDA, IRB, clinical trials
Institutional Review Boards (IRBs) are panels of scientists, health care professionals and community representatives charged with overseeing clinical trials. If the research involves a product regulated by the Food and Drug Administration, then the sponsor of the research must submit to an IRB. The original plan (known as the protocol) must be approved, including the consent form to be used when recruiting participants. Periodic reviews are conducted by, and adverse events are reported to, the IRB. If an IRB finds a problem with a clinical trial under its authority, it may suspend or terminate the research in the interest of the safety of the participants. Participants may ask the IRB to intervene in situations of serious disputes with the study team regarding the research. In short, an IRB can make or break a clinical trial.
While IRBs all follow common federal regulations governing research involving human subjects, there is ample opportunity for varying interpretation of the rules. IRBs often develop "personalities" based on the culture of the organization they are in. Some are quite deliberative and conservative in their decisions, while others are relatively quick and efficient. Where the safety and well-being of research participants are concerned, slow and conservative seem appropriate. But, with speed and efficiency being key attributes in the business world, which personality would you prefer if you were a company who wanted to test a product?
These perceptions led the federal government to question a few years ago whether research sponsors, such as pharmaceutical companies, search out or "shop" for the most lenient IRB they can find. Also in question was whether or not research protocols which had been disapproved by one IRB were routinely submitted to subsequent IRBs until one was found which would approve the research.
In 2002 the FDA published a request for comments on the question of IRB shopping - was it a real problem of any significant frequency and how might it be discouraged?
Next time: the FDA's recent decision on this issue...
-Joe
Related Topics: Drug Companies Offer More Details on Clinical Trials, Holes in US Drug Safety Net
Technorati Tags: FDA, IRB, clinical trials
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