Enrollment by Surrogate Authorization into Stroke Genetic Research
Enrollment by Surrogate Authorization into Stroke Genetic Research
European Neurological Review, 2009;4(1):64-7
US Neurology, 2009;5(1):41-4
Abstract
Continued clinical and translational research is necessary to address unmet clinical needs in stroke and cerebrovascular disease. Ethical and scientific challenges confront these research efforts. Genetic stroke research faces a number of specific challenges related to the legacy of genetic exceptionalism and the reality that stroke frequently impairs decision-making capacity. Maximizing scientific rigor and protecting human subjects have frequently and often erroneously been cast as opposing efforts. In this article, we review the challenges facing stroke genetic research and propose potential approaches given the current state of guidance and regulations. We consider the rationale behind including those with decisional impairment and several options to allow participation of these individuals. Appropriate infrastructure and processes should be established to ensure that genetic information poses minimal risk to individuals, just as has been done to minimize physical risk in non-therapeutic research.
Keywords
Research ethics, stroke genetic research, informed consent, decisional incapacity, surrogate consent
Disclosure: Donna T Chen, MD, MPH, receives support for her work in research ethics, in part funded by a grant from the National Institutes of Health (NIH) to the University of
Virginia General Clinical Research Center, M01-RR000847. James F Meschia, MD, has been the principal investigator on several National Institute of Neurological Disorders and Stroke (NINDS)/NIH-funded grants, including the currently funded Siblings With Ischemic Stroke Study: SWISS (R01 NS39987). Bradford B Worrall, MD, MSc, is funded in part by NINDS K08-NS045802. None of the authors has any commercial conflicts of interest to declare.
Acknowledgements: The authors would like to thank Margaret Foster Riley, JD, for critical review of an earlier draft of this manuscript. The opinions expressed are the authors’ own. They do not reflect any position or policy of the University of Virginia, Mayo Clinic, or the NIH.
Received:February 17, 2009 Accepted: May 6, 2009
Correspondence: Bradford B Worrall, MD, MSc, University of Virginia Health System #800394, Department of Neurology, Charlottesville, VA 22908. E: bbw9r@virginia.edu
Stroke is a major public health burden worldwide that demands continued research to improve treatment and prevention. However, stroke presents a number of practical and ethical challenges to research due to its unpredictability, apoplectic onset, and potential to render individuals incapable of providing informed consent. Disagreements regarding appropriate safeguards for subjects are as old as acute stroke research1–3 and continue to spark debate.4,5
Discussions of ethical issues in genetics research frequently treat gathering and using genetic information as exceptional.6 The view that genetic information must be handled differently and risks in genetic research are unique arose from a heritage of research into single-gene disorders—generally rare conditions where the relationship between genetic variation and disease is seen in deterministic terms.
Notions of genetic exceptionalism developed from concerns about what happens with information that someone ‘has the gene,’ including concerns about the potential for personal and familial distress were the information to be discovered inadvertently or without sufficient counseling, and about the potential for stigmatization or discrimination if that information were to get into the wrong hands. Concerns that individuals must be in a position to protect themselves against such risks reinforced the more general sense of importance placed on individual control over genetic information.
However, in the genomic era, understanding of the role that genes play in disease and circumstances surrounding the discovery of genetic contributions to risk of developing a disease has changed dramatically. The majority of genetic studies focus on complex disorders in which a specific genetic variant alters the probability of getting a disease, but does so in the context of many other risk factors. In this situation, any piece of genetic information is ultimately less informative, and thus the risk of psychological distress, stigmatisation or discrimination resulting from discovery of genetic information decreases. The ethics and policy communities remain divided as to how to treat this new form of genetic information,7,8 and by extension how to assess the level of risk in genetic studies.
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