I read with great interest the commentary by John D. Lantos on the
SUPPORT study controversy. Dr. Lantos makes a compelling argument that the
OHRP was misguided in its criticism of SUPPORT, primarily because both
arms of the trial were within standard of care.1-2
Eligible infants whose parents refused to participate in SUPPORT
received the same medical care, but instead of randomization via protocol,
they were subject to "idiosyncratic clinical judgments in the absence of
good evidence."1 That is a frightening concept. How can it be easier for a
physician to change clinical practice on a whim than it is for her to
study those very same differences in practice using the scientific method?
I agree that the informed consent process needs to change, but I
propose that we change the entire system. If both intervention arms of a
clinical trial are within standard practice, the IRB should not require
written informed consent at all. "In such situations," according to Dr.
Lantos, "there may be no incremental risk to being in a study. There may
even be some benefit." 1 Of course, these studies would continue to
require verbal assent from parents and prior approval from the IRB, but
shifting to an opt-out rather than an opt-in regime would significantly
benefit the progress of medicine. Indeed, some institutions outside of the
United States have already adopted this policy.3
No one wants to get rid of oversight for clinical research entirely,
but too much oversight has had a measurable and significant chilling
effect on scientific advancement.4 In my opinion, there is no doubt that
the obstacles to initiating and conducting clinical research would be more
navigable without the burden of universal written informed consent.
REFERENCES 1. Landtos JD. Learning the right lessons from the SUPPORT
study controversy. Arch Dis Child Fetal Neonatal Ed. 2013;epub ahead of
print. 2. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal
Research Network. Target ranges of oxygen saturation in extremey preterm
infants. N Engl J Med. 2010;362:1959-1969. 3. Reignier J, Mercier E, Le
Gouge A, et al. Effect of not monitoring residual gastric volume on risk
of ventilator-associated pneumonia in adults receiving mechanical
ventilation and early enteral feeding: a randomized controlled trial.
JAMA. 2013;309:249-56 4. O'Herrin JK, Kudsk K, Frost N. Health insurance
portability Accountability Act (HIPAA) regulations: effect on medical
record research. Ann Surg. 2004;239:772-776.
Conflict of Interest:
None declared
I read with great interest the commentary by John D. Lantos on the SUPPORT study controversy. Dr. Lantos makes a compelling argument that the OHRP was misguided in its criticism of SUPPORT, primarily because both arms of the trial were within standard of care.1-2
Eligible infants whose parents refused to participate in SUPPORT received the same medical care, but instead of randomization via protocol, they were subject to "idiosyncratic clinical judgments in the absence of good evidence."1 That is a frightening concept. How can it be easier for a physician to change clinical practice on a whim than it is for her to study those very same differences in practice using the scientific method?
I agree that the informed consent process needs to change, but I propose that we change the entire system. If both intervention arms of a clinical trial are within standard practice, the IRB should not require written informed consent at all. "In such situations," according to Dr. Lantos, "there may be no incremental risk to being in a study. There may even be some benefit." 1 Of course, these studies would continue to require verbal assent from parents and prior approval from the IRB, but shifting to an opt-out rather than an opt-in regime would significantly benefit the progress of medicine. Indeed, some institutions outside of the United States have already adopted this policy.3
No one wants to get rid of oversight for clinical research entirely, but too much oversight has had a measurable and significant chilling effect on scientific advancement.4 In my opinion, there is no doubt that the obstacles to initiating and conducting clinical research would be more navigable without the burden of universal written informed consent.
REFERENCES 1. Landtos JD. Learning the right lessons from the SUPPORT study controversy. Arch Dis Child Fetal Neonatal Ed. 2013;epub ahead of print. 2. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Target ranges of oxygen saturation in extremey preterm infants. N Engl J Med. 2010;362:1959-1969. 3. Reignier J, Mercier E, Le Gouge A, et al. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013;309:249-56 4. O'Herrin JK, Kudsk K, Frost N. Health insurance portability Accountability Act (HIPAA) regulations: effect on medical record research. Ann Surg. 2004;239:772-776.
Conflict of Interest:
None declared