The Institutional Review Board (IRB)
They used to be called 'Ethics Boards,' and they were tasked with deciding when a particular patient would not be resuscitated, which patient was next in line to receive a kidney transplant, and how a hospital's policy defined 'brain death.' Hospitals and other medical facilities had them -- and used them to make the tough decisions. As clinical research became a more organized practice, evolving from simply trying a new procedure on a particularly (usually terminally) ill patient to detailed protocols involving many ill participants matched with healthy ones, one of the more demanding tasks of the Ethics Boards became reviewing proposed research before it was allowed to be conducted at an institution. The result was a subcommittee of sorts, which came to be called the Institutional Review Board or IRB.
Typically, the early IRBs comprised the most senior physicians at an institution, a top level administrator or two, perhaps the institution's attorney and chaplain, and a couple of physicians who conducted research -- often the very research the IRB was charged with reviewing. We've come a long way since these early IRBs. Now there is much greater standardization and regulation of the IRB's composition and responsibilities. And because of conflict of interest concerns, clinical investigators are not usually allowed to participate as IRB members reviewing their own clinical trial protocols. IRBs are populated with physicians, scientists, ethicists, patient advocates, and members of the communities in which the clinical research will be conducted. They must possess sufficient expertise to be able to adequately review the science and the medicine of the proposed research. Detailed written records of the IRB's discussions, decisions and actions are maintained. And they are responsible not only for determining whether or not a protocol will be approved, but the conditions to be imposed on it, as well as for monitoring the progress of the clinical trial, including changes, adverse events, and results. Finally, the IRB is the institution's ultimate decision-maker when it comes to shutting down a clinical trial or dealing with the aftermath of a clinical trial that unexpectedly harms participants.
Are IRB's perfect? Definitely not. They are sometimes understaffed, inexperienced or overburdened with a large volume of clinical trials to review. But they are better now than they have ever been and they are improving steadily. It is uniformly accepted that the IRB's primary concern should be for the protection of participants, even when that concern may create administrative hurdles for potential physician investigators or prevent the institution from accepting funding for certain clinical research. In that sense, today's IRB still provides an 'ethical check' on clinical trials conducted in hospitals, universities and medical institutions.
-Joe
Related Topics: Stem Cell Research, Organ Transplants
Typically, the early IRBs comprised the most senior physicians at an institution, a top level administrator or two, perhaps the institution's attorney and chaplain, and a couple of physicians who conducted research -- often the very research the IRB was charged with reviewing. We've come a long way since these early IRBs. Now there is much greater standardization and regulation of the IRB's composition and responsibilities. And because of conflict of interest concerns, clinical investigators are not usually allowed to participate as IRB members reviewing their own clinical trial protocols. IRBs are populated with physicians, scientists, ethicists, patient advocates, and members of the communities in which the clinical research will be conducted. They must possess sufficient expertise to be able to adequately review the science and the medicine of the proposed research. Detailed written records of the IRB's discussions, decisions and actions are maintained. And they are responsible not only for determining whether or not a protocol will be approved, but the conditions to be imposed on it, as well as for monitoring the progress of the clinical trial, including changes, adverse events, and results. Finally, the IRB is the institution's ultimate decision-maker when it comes to shutting down a clinical trial or dealing with the aftermath of a clinical trial that unexpectedly harms participants.
Are IRB's perfect? Definitely not. They are sometimes understaffed, inexperienced or overburdened with a large volume of clinical trials to review. But they are better now than they have ever been and they are improving steadily. It is uniformly accepted that the IRB's primary concern should be for the protection of participants, even when that concern may create administrative hurdles for potential physician investigators or prevent the institution from accepting funding for certain clinical research. In that sense, today's IRB still provides an 'ethical check' on clinical trials conducted in hospitals, universities and medical institutions.
-Joe
Related Topics: Stem Cell Research, Organ Transplants
1 Comments:
Dear Joe, It's been my experience that IRBs primarily exist for the protection of the tens of millions of dollars of overhead income given to the institution by the drug companies whose "me too" drugs are being tested. The medical institution's IRB is populated by the VP for Research, and those members who complain too much about the protocols submitted to the IRB are made unwelcome.
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