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IRB Creep Threatens Innovative Treatment in California
In light of research abuses committed in the 20th Century such as the Tuskegee Syphilis Study conducted by the U.S. Public Health Service between 1932 and 1972, and radiation experiments conducted during the Cold War, Congress passed the National Research Act of 1974. The Act was followed by the "Belmont Report" which made recommendations regarding the regulation of human subjects research. Today, the Code of Federal Regulations (45 CFR Part 46) provides standards for Institutional Review Board (IRB) approval when human subjects research is contemplated. IRB review is not, however, required in cases where innovative treatment is isolated and not intended as part of a research design. Despite the latter limitation, fear of government action has resulted in assumed or expanded authority for IRB's. This new phenomena is known as "IRB Creep".
In California, innovative treatment of as few as three patients has been deemed "research" requiring IRB consultation and approval. In other states, however, as many as 200 patients have been treated with untested, untried procedures under the rubric of innovative care, with subsequent federal approval. In the latter cases, patients suffering a debilitating and sometimes fatal condition known as clostridium difficile colitis or "C-Diff" had third-party fecal matter introduced into their gastrointestinal tract by colonoscopie to stem the disease, notwithstanding the fact that the standard of care would normally prohibit introducing such infectious material in this manner. Dr. Colleen Kelly, M.D., an originator of this unique approach at Brown University, found the treatment highly successful. She made no application for IRB or FDA approval. Her method was considered innovative care. She was awarded a research grant by the Nationaol Institute of Health to continue the effort. Today, a "fecal pill" is used instead of the colonoscopy injection, and has become the standard of care for treating C-Diff. (Huffington Post, 7-10-13).
In contrast to Dr. Kelly's work on C-Diff treatment, California physicians seeking to utilize innovative, untested therapies to treat aggressive, usually fatal cancers have not fared nearly as well. The Medical Board of California, through the opinions of its experts, has suggested that treating three or even a single patient with innovative care in critical cases, without first consulting an Institutional Review Board and possibly the FDA for prior approval, may be grounds for disciplinary action. Clearly the standards being used to determine IRB review are inconsistent. What is deemed innovative treatment one day may be standard of care a few months later. Where no human research intent or design applies, what is the proper role of the IRB?
Until these issues are clarified by statute or regulation, physicians must exercise great caution when pursuing innovative, untested treatment in potentially fatal cases, especially in an institutional setting. Fear of negative action by the Center for Medicare Services (CMS) or general wariness of hospital liability has made many medical facilities cautious to the point of wanting IRB approval for any treatment deemed non-routine. In the case of otherwise terminal conditions this can mean that the standard of care for the patient becomes hospice and death without the opportunity for innovative treatment because IRB review takes time. The result of IRB creep is that the government, rather than the physician and patient, makes this most critical and personal decision for the patient.