by James E. Lewis, PhD, an independent consultant and formerly a columnist for the Association of American Medical Colleges blog, Wing of Zock
A little known, but intentional, loophole in the federal regulations allows activities involving human subjects to be labeled “innovative care.” In spite of all that has been done since World War II to protect human subjects in clinical research, this ambiguity offers a mechanism through which unscrupulous individuals can avoid the ethical and regulatory obligations for the protection of human research subjects and the norms of professional and scholarly behavior. Recent cases demonstrating this dilemma can be found on the internet, but my purpose here is not to review any specific case but rather to bring broader attention to the generic question: “when is what appears to be human subjects research not research?” and the fundamental question: “how is it possible for such activities to occur without oversight?”
Let’s start by considering a hypothetical worst case scenario: A clinician, eager to investigate a self-generated hypothesis, decides to ignore everything anyone has ever said about protecting human subjects and undertake and fund an activity at his/her own discretion. The “innovative treatment” the physician is planning to implement is brought to the attention of the hospital and they determine, at the appropriate administrative level, that, based on the very limited information they’ve been provided, the activity does not meet the definition of human subjects research and does not require IRB approval. However, the hypothetical research subjects die. FDA is going to investigate. The Centers for Medicare and Medicaid Services is going to investigate because the subjects were Medicare eligible for inpatient coverage.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.