Late Breaking News
Is IRB A Four-Letter Word? Federal Medicine Needs Centralized System With Clear Guidelines
“Somewhere, something incredible is waiting to be known.” – Carl Sagan (1934-1996)
Editor-in-Chief, Chester ‘Trip’ Buckenmaier III, MD, COL, MC, USA.
I began my fascination with the scientific method and the process of research early in college. Decades later (more than I like to admit) as I look back, I am awed at the accelerating pace of medical discovery and dismayed at the concurrent explosion in the bureaucracy of research conduct known as the Institutional Review Board (IRB). Most of my medical research colleagues consider ‘IRB’ a four-letter word, and we all have personal horror stories of navigating procedural insanity imposed by IRBs, sometimes euphemistically referred to as the ‘office of preventative research,” in the name of human subject protection.
In fairness, IRBs are a vital component of the ethical conduct of sound research, ensuring that the safety and welfare of study participants is observed.
Sadly, history is rife with examples of gross ethical misconduct in the conduct of medical research. Atrocities perpetrated by Dr. Josef Mengele, the ‘Angel of Death’, at Auschwitz concentration camp will forever be synonymous with perhaps the most debased example of ethical failure in human research. Our own U. S. Public Health Service demonstrated flagrant disregard for the well-being of hundreds of poor African-Americans, mostly sharecroppers, in the Tuskegee syphilis study begun in 1932 and lasting until 1972. Investigators failed to inform study participants that they had syphilis or to effectively treat study participants with penicillin, even though that was known as an effective cure as early as 1940. Events of this type led the federal government to require IRB review of any studies conducted on human subjects using federal dollars. The need for this type of oversight appears self-evident and has likely been effective in limiting harm to patients due to unethical or improperly conducted medical research, which can carry significant risk to the subject.
Examples such as the Tuskegee study make the necessity of IRB approval for research involving human subjects easily understood. The problem arises when the same standards that should have been applied to the Tuskegee experiment, where the risk to the patient is clear, is applied to all human subject research, even when the study imposes little to no risk to the patient.
The absurdity of this ‘one IRB approach fits all human subject research’ environment that presently plagues federal medical research was highlighted in a committee report of the American Association of University Professors (http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm) in 2006. In this report some extreme examples of IRB missteps were described, such as the linguist who required subjects to sign and read a consent form in his study of preliterate tribes or the prevention of a Caucasion student from interviewing African-Americans for a study of career expectations of other PhD students because of concerns that it might be traumatic for them to be interviewed by a Caucasion. Some would suggest that these examples of non-medical research do not apply to the necessarily more stringent control required of federal medical research that carries more inherent risk to the patient. I vehemently disagree.
It is common to have extreme delays in the approval of even the most benign human subject research, where the risk of direct harm to the patient is hard to define or even to describe. I have spent the past seven months seeking approval to validate a new 0-10 pain scale using functional language. IRB concerns have included whether this validation study required consent (we ask this question daily in routine care) or if there is risk to the patient asking the pain question in a non-standard way (actually there are no standards for asking the question). In the federal system, it is routine to measure the time from submission of a research proposal to its final approval in terms of months and, in some cases, years.
To say the federal IRB system is inefficient is a crushing understatement. The layers of IRB approval and re-approval takes months of effort and occupies the majority of the workday for my research personnel (who have little time to actually do the research). The lack of a central coordinating IRB within the military renders multicenter studies next to impossible within our system, as revisions to proposals from multiple IRBs within each institution are often conflicting or completely at odds.
An important study looking into the pain management of wounded warriors between the DoD and VHA systems took more than three years to coordinate the competing IRB issues! I am fortunate to have an organization of dedicated professionals who are able to take the long view as they battle the current IRB bureaucratic morass. I am concerned about the many innovative research ideas that are severely damaged or eliminated by the inefficiency of our current processes.
How many promising new medical researchers have we disillusioned by current IRB methods and whose research energy is now lost to the federal system? Reform of our current IRB system is desperately needed and should be a top priority for federal medicine. An excellent start would be centralized, tri-service, regional IRB approval committees with clear guidelines on what should and should not be exempted from full human use review.
There truly are some incredible things just waiting to be known. For our wounded warriors’ sakes, can we really afford to waste any more time finding them out?