A perspective piece published in the New England Journal of Medicine addressed the controversy surrounding a clinical trial under investigation for allegedly violating the “ethical safeguards” of human subject research.

In 2016, William Halford, PhD, of Southern Illinois University reportedly administered a live attenuated herpes simplex virus vaccine to 17 participants at an off-campus hotel without approval from an institutional review board (IRB). Dr Halford had failed to submit a new drug application to the Food and Drug Administration (FDA) and did not obtain informed consent from participants, according to investigative journalists. Sponsored by a company known as Rational Vaccines, the clinical trial is now under criminal investigation by the FDA, as well as separate investigations from Southern Illinois University and the government of St. Kitts and Nevis.

Although 1 participant of the trial has reported “decreased…frequency and intensity” in herpes outbreaks, 3 others have sued Rational Vaccines. The Halford case has reignited debate among medical ethicists as to the appropriate level of trial regulation from the IRB.

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Some maintain that patients should be afforded the autonomy to participate in trials without IRB interference, and that modern regulations “[stifle]…innovative new treatments.” Many also assert that FDA and IRB regulations exist primarily to protect the “vested interests” of research institutions and are prohibitive to the development of new clinical trials. Supporters of Dr Halford’s decisions also note that many patients may seek untested treatments out of frustration for the lack of available therapies and information. According to perspective author Bernard Lo, MD, of the Greenwall Foundation and the University of California, San Francisco, supporters of evidence-based trials must clarify to the public that they are “addressing patients’ needs” to quell worries about the respective roles of the IRB and FDA.

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Although the FDA and IRB exist to protect patient safety, controversy surrounding the Halford case highlights the potential inadequacies of these institutions. To move forward, Dr Lo asserts that supporters of evidence-based standards must address patient concerns, including personal autonomy and lack of existing treatments for certain conditions, to restore public faith in research regulations.


Lo B. A parallel universe of clinical trials. N Engl J Med. 2018;379:101-103.