Downloaded from http://fn.bmj.com/ on June 6, 2015 - Published by group.bmj.com
PostScript
The trouble with informed consent
REFERENCES
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 randomisation 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 USA 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.
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Lantos JD. Learning the right lessons from the SUPPORT study controversy. Arch Dis Child Fetal Neonatal Ed 2014;99:F4–F5. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med 2010;362:1959–69. 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. O’Herrin JK, Kudsk K, Frost N. Health Insurance Portability Accountability Act (HIPAA) regulations: effect on medical record research. Ann Surg 2004;239:772–6.
Matthew B Wallenstein Correspondence to Dr Matthew B Wallenstein, Department of Pediatrics, Stanford University School of Medicine, 725 Welch Road, Palo Alto, CA 94304, USA; [email protected] Competing interests None. Provenance and peer review Not commissioned; internally peer reviewed. To cite Wallenstein MB. Arch Dis Child Fetal Neonatal Ed 2014;99:F251. Accepted 30 November 2013 Published Online First 19 December 2013 Arch Dis Child Fetal Neonatal Ed 2014;99:F251. doi:10.1136/archdischild-2013-305621 Arch Dis Child Fetal Neonatal Ed May 2014 Vol 99 No 3
F251
Downloaded from http://fn.bmj.com/ on June 6, 2015 - Published by group.bmj.com
The trouble with informed consent Matthew B Wallenstein Arch Dis Child Fetal Neonatal Ed 2014 99: F251 originally published online December 19, 2013
doi: 10.1136/archdischild-2013-305621 Updated information and services can be found at: http://fn.bmj.com/content/99/3/F251.1
These include:
References Email alerting service
This article cites 3 articles, 0 of which you can access for free at: http://fn.bmj.com/content/99/3/F251.1#BIBL Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
PostScript
The trouble with informed consent
REFERENCES
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 randomisation 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 USA 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.
2
1
3
4
Lantos JD. Learning the right lessons from the SUPPORT study controversy. Arch Dis Child Fetal Neonatal Ed 2014;99:F4–F5. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med 2010;362:1959–69. 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. O’Herrin JK, Kudsk K, Frost N. Health Insurance Portability Accountability Act (HIPAA) regulations: effect on medical record research. Ann Surg 2004;239:772–6.
Matthew B Wallenstein Correspondence to Dr Matthew B Wallenstein, Department of Pediatrics, Stanford University School of Medicine, 725 Welch Road, Palo Alto, CA 94304, USA; [email protected] Competing interests None. Provenance and peer review Not commissioned; internally peer reviewed. To cite Wallenstein MB. Arch Dis Child Fetal Neonatal Ed 2014;99:F251. Accepted 30 November 2013 Published Online First 19 December 2013 Arch Dis Child Fetal Neonatal Ed 2014;99:F251. doi:10.1136/archdischild-2013-305621 Arch Dis Child Fetal Neonatal Ed May 2014 Vol 99 No 3
F251
Downloaded from http://fn.bmj.com/ on June 6, 2015 - Published by group.bmj.com
The trouble with informed consent Matthew B Wallenstein Arch Dis Child Fetal Neonatal Ed 2014 99: F251 originally published online December 19, 2013
doi: 10.1136/archdischild-2013-305621 Updated information and services can be found at: http://fn.bmj.com/content/99/3/F251.1
These include:
References Email alerting service
This article cites 3 articles, 0 of which you can access for free at: http://fn.bmj.com/content/99/3/F251.1#BIBL Receive free email alerts when new articles cite this article. Sign up in the box at the top right corner of the online article.
Notes
To request permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://group.bmj.com/subscribe/
