This article was downloaded by: [North Carolina State University] On: 09 March 2015, At: 21:27 Publisher: Routledge Informa Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House, 37-41 Mortimer Street, London W1T 3JH, UK
The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
The Ethical Imperative of Risk Disclosure in Research: The Answer Is Always Yes a
a
b
Gwendolyn P. Quinn , Eric B. Haura & Devin Murphy a
Moffitt Cancer Center and University of South Florida
b
Miller Children's Hospital Published online: 14 Apr 2014.
Click for updates To cite this article: Gwendolyn P. Quinn, Eric B. Haura & Devin Murphy (2014) The Ethical Imperative of Risk Disclosure in Research: The Answer Is Always Yes, The American Journal of Bioethics, 14:4, 18-19, DOI: 10.1080/15265161.2014.889242 To link to this article: http://dx.doi.org/10.1080/15265161.2014.889242
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
Downloaded by [North Carolina State University] at 21:27 09 March 2015
The American Journal of Bioethics
National Commission for the Protection of Human Subjects of Biomedical Behavioral Research. 1979. The Belmont Report. April 18. Available at: http://www.fda.gov/ohrms/dockets/ac/05/brie fing/2005-4178b 09 02 Belmont Report.pdf (accessed November 5, 2013).
http://www.immunize.org/concerns/vaticandocument.htm (accessed November 6, 2013).
Pontifical Council for Life. 2005. Moral reflections on vaccines prepared from cells derived from aborted human fetuses. Available at:
Wear, S. 2004. Informed consent. In Handbook of bioethics, ed. G. Khushf, 251–290. Dordrecht, The Netherlands: Kluwer Academic.
Strauss, R., et al. 2001. The role of community advisory boards: Involving communities in the informed consent process. American Journal of Public Health 91(12): 1938–1943.
The Ethical Imperative of Risk Disclosure in Research: The Answer Is Always Yes Gwendolyn P. Quinn, Moffitt Cancer Center and University of South Florida Eric B. Haura, Moffitt Cancer Center and University of South Florida Devin Murphy, Miller Children’s Hospital The ACCORD trial was designed to test whether intensive blood sugar control reduced cardiovascular events more than standard control. Prior to the initiation of the trial, the ACCORD investigators had access to data from three studies suggesting mortality was associated with intensive blood sugar control. ACCORD investigators believed the evidence from these prior studies was inconclusive and the associated deaths to subjects remained “unexplained.” As a result, the consent document contained no mention of the risk of death as a potential harm. ACCORD subjects in the experimental arm had greater mortality than controls. As a result, an independent Data Safety and Monitoring Board stopped the experimental arm of the study. De Marco and colleagues (2014) rightly suggest the ACCORD trial investigators were negligent in withholding information in the consent document about the risk, even if it was deemed controversial by the research team. The authors suggest adherence to best ethical practices constitutes developing consent documents with greater transparency about all suspected risks, and the use of clinical equipoise when informing prospective research subjects of such risks. DeMarco and colleagues focus on the documentation of such risk in the consent form using the ACCORD study example and the context of specific controversial risk associated with death. The expansion of the concept of clinical equipoise to controversial research risks (beyond the traditional application to the offer of research participation) is progress toward the path of improved transparency and full disclosure in clinical research. This call for improvement has been echoed by numerous U.S. and European publications and medi-
cal societies, most recently in the UK House of Commons (2013) report on clinical trials stating that “the lack of transparency . . . undermines public trust, breaks the ethical pact between scientists and those participating in trials and leads to clinical decisions being made on the basis of incomplete evidence” (House of Commons Science and Technology Committee 2013, 6). However, we suggest true clinical equipoise must uphold the principles of “do no harm” and “duty to disclose” through regular modifications to the consent form as new information is obtained and, more importantly, through the understanding that the opportunity for a potential participant to have a dialogue with the researcher may be more informative than a written consent form. The ethical principle of nonmaleficence (do no harm) offers that a moral obligation exists to disclose all risks associated with a treatment or experimental study, as well as potential benefits or lack of any known benefits. All known or suspected risks, even controversial risks and the nature of that controversy, must be shared with prospective research participants in order for them to make an informed choice. However, it has been argued that the ability to fully evaluate and weigh personal meaning of risk and benefits, especially in a very ill or medically complex patient, is questionable for two reasons. One, without specific guidance from a health care professional who is familiar with their medical history, subjects cannot interpret how the risks may apply to them. For example, offering an experimental treatment to a metastatic, chemotherapy-refractory cancer patient where the benefits include the potential for an additional 6 months of life but the potential risks include loss of sight or mobility
Address correspondence to Gwendolyn P. Quinn, PhD, 12902 Magnolia Drive, MRC CANCONT, Tampa, FL 33612, USA. E-mail: [email protected]
18 ajob
April, Volume 14, Number 4, 2014
Downloaded by [North Carolina State University] at 21:27 09 March 2015
Obligation to Disclose Controversial Risk
must be weighed on an individual basis. Two, the potential information overload from the consent document and the need to understand each nuance of the information is potentially burdensome for subjects/patients and they often rely on a health care professional to tell them what to do (Belcher, Fried, and Agostini 2006). The presence of this information in written form on a consent document may offer intricate details about potential benefits and harms, but these are risks written for the general pool of participants and not the individual. Additionally, when a potential research participant has not had experience with the potential risk, it is uncertain whether he or she will be able to make an informed choice. Several patient reports highlight the “wish I knew then what I know now” principle of decision making (Gaston and Mitchell 2005). An example is an 82-year-old patient who opts for a treatment where she believes she is making the trade of benefit for a potential 6 more months of life in exchange for potential harms of Grade 3 diarrhea. For a patient who has never experienced the intensity of this type of health outcome, it can be difficult to make a decision about whether it is preferable to have a shorter life without diarrhea or a few more months of life with incapacitating diarrhea that requires hospitalization. Thus, the true beneficence of disclosure may only be seen when the harms and benefits are described and discussed not only through dialogue, but also dialogue tailored to the physical and psychological situation of the patient (Thorton 2003). Discussing controversial harms and benefits with a potential research subject on an individualized level is only one half of the duty of the investigator. The legal system has continually upheld that physicians/researchers have a duty to disclose material information: “Material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient’s position when deciding to accept or reject the recommended medical procedure” (Truman v. Thomas. 1980). In the 1972 case of Canterbury v Spence (1972) a young man became a paraplegic and incontinent following spinal surgery and sought damages against the surgeon for failure to disclose that these health outcomes were a potential risk. The surgeon’s response was that he had “no duty to warn of such an unexpected complication.” The District of Columbia Court of Appeals ruled that the customary standard for assessing negligence (what would a reasonable practitioner have done?) was no longer valid and instead required a new patient-centered standard (what would a reasonable patient want to know?). In a recent review of Australian malpractice claims and health care complaints, Bismark and colleagues (2012) identified 481 disputes over informed consent, of which 9% were “disputed duty cases”—disagreements be-
April, Volume 14, Number 4, 2014
tween patients and doctors over whether a particular clinical risk should have been disclosed before treatment. The most common justification physicians offered for nondisclosure was that the risk was too rare to discuss (Bismarck et al. 2012). This suggests investigators are responsible for the additional step of identifying not only what would a reasonable patient/subject want to know, but what would this particular patient want to know. The purpose of clinical research trials is not to make the subject/patient better; it is to improve scientific knowledge, although change in the better or for the worse may occur in the patient. It has been suggested that subjects who enroll in a clinical trial solely because of hoped-for benefits represent a failure in the informed consent process (Raab 2004). DeMarco and colleagues make a well-justified and compelling case for a framework to evaluate the inclusion of important controversial risks in the consent document. We suggest this ethical obligation of risk disclosure must focus equally on the discussion, tailored to the individual circumstances of the subject patient who is considering participation. REFERENCES Belcher, V. N., T. R. Fried, and J. V. Agostini. 2006. Views of older adults on patient participation in medication-related decision making. Journal of General Internal Medicine 21(4): 298–303. Bismark, M., A. J. Gogos, R. B. Clark, R. L. Gruen, A. A. Gawande, and D. Studdert. 2012. Legal disputes over duties to disclose treatment risks to patients: A review of negligence claims and complaints in Australia. PLoS One. doi:10.1371/journal.pmed.1001283 Canterbury v. Spence. 1972. 464 F.2d 772 (D.C. Cir 1972). De Marco, J. P., P. J. Ford, D. J. Patton, and D. O. Stewart. 2014. Is there an ethical obligation to disclose controversial risk? A question from the ACCORD Trial. American Journal of Bioethics 14(4): 4–10. Gaston, C. M., and G. Mitchell. 2005. Information giving and decision-making in patients with advanced cancer: A systematic review. Social Science & Medicine 61(10): 2252–2264. House of Commons Science and Technology Committee. 2013. 17 September. Available at: http://www.publications.parliament.u k/pa/cm201314/cmselect/cmsctech/753/75302.htm (accessed 11 December 2013). Raab, E. L. 2004. The parameters of informed consent. Transactions of the American Ophthalmological Society 102: 225–232. PMCID: PMC1280103 Thorton, H. 2003. Enabling understanding must not lead to manipulation. British Medical Journal 327(7417): 693–694. doi:10.1136/ bmj.327.7417.693, PMCID:PMC200792. Truman v. Thomas. 1980. 27 Cal 3d, 611 P2d 902 (1980).
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The American Journal of Bioethics Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uajb20
The Ethical Imperative of Risk Disclosure in Research: The Answer Is Always Yes a
a
b
Gwendolyn P. Quinn , Eric B. Haura & Devin Murphy a
Moffitt Cancer Center and University of South Florida
b
Miller Children's Hospital Published online: 14 Apr 2014.
Click for updates To cite this article: Gwendolyn P. Quinn, Eric B. Haura & Devin Murphy (2014) The Ethical Imperative of Risk Disclosure in Research: The Answer Is Always Yes, The American Journal of Bioethics, 14:4, 18-19, DOI: 10.1080/15265161.2014.889242 To link to this article: http://dx.doi.org/10.1080/15265161.2014.889242
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions
Downloaded by [North Carolina State University] at 21:27 09 March 2015
The American Journal of Bioethics
National Commission for the Protection of Human Subjects of Biomedical Behavioral Research. 1979. The Belmont Report. April 18. Available at: http://www.fda.gov/ohrms/dockets/ac/05/brie fing/2005-4178b 09 02 Belmont Report.pdf (accessed November 5, 2013).
http://www.immunize.org/concerns/vaticandocument.htm (accessed November 6, 2013).
Pontifical Council for Life. 2005. Moral reflections on vaccines prepared from cells derived from aborted human fetuses. Available at:
Wear, S. 2004. Informed consent. In Handbook of bioethics, ed. G. Khushf, 251–290. Dordrecht, The Netherlands: Kluwer Academic.
Strauss, R., et al. 2001. The role of community advisory boards: Involving communities in the informed consent process. American Journal of Public Health 91(12): 1938–1943.
The Ethical Imperative of Risk Disclosure in Research: The Answer Is Always Yes Gwendolyn P. Quinn, Moffitt Cancer Center and University of South Florida Eric B. Haura, Moffitt Cancer Center and University of South Florida Devin Murphy, Miller Children’s Hospital The ACCORD trial was designed to test whether intensive blood sugar control reduced cardiovascular events more than standard control. Prior to the initiation of the trial, the ACCORD investigators had access to data from three studies suggesting mortality was associated with intensive blood sugar control. ACCORD investigators believed the evidence from these prior studies was inconclusive and the associated deaths to subjects remained “unexplained.” As a result, the consent document contained no mention of the risk of death as a potential harm. ACCORD subjects in the experimental arm had greater mortality than controls. As a result, an independent Data Safety and Monitoring Board stopped the experimental arm of the study. De Marco and colleagues (2014) rightly suggest the ACCORD trial investigators were negligent in withholding information in the consent document about the risk, even if it was deemed controversial by the research team. The authors suggest adherence to best ethical practices constitutes developing consent documents with greater transparency about all suspected risks, and the use of clinical equipoise when informing prospective research subjects of such risks. DeMarco and colleagues focus on the documentation of such risk in the consent form using the ACCORD study example and the context of specific controversial risk associated with death. The expansion of the concept of clinical equipoise to controversial research risks (beyond the traditional application to the offer of research participation) is progress toward the path of improved transparency and full disclosure in clinical research. This call for improvement has been echoed by numerous U.S. and European publications and medi-
cal societies, most recently in the UK House of Commons (2013) report on clinical trials stating that “the lack of transparency . . . undermines public trust, breaks the ethical pact between scientists and those participating in trials and leads to clinical decisions being made on the basis of incomplete evidence” (House of Commons Science and Technology Committee 2013, 6). However, we suggest true clinical equipoise must uphold the principles of “do no harm” and “duty to disclose” through regular modifications to the consent form as new information is obtained and, more importantly, through the understanding that the opportunity for a potential participant to have a dialogue with the researcher may be more informative than a written consent form. The ethical principle of nonmaleficence (do no harm) offers that a moral obligation exists to disclose all risks associated with a treatment or experimental study, as well as potential benefits or lack of any known benefits. All known or suspected risks, even controversial risks and the nature of that controversy, must be shared with prospective research participants in order for them to make an informed choice. However, it has been argued that the ability to fully evaluate and weigh personal meaning of risk and benefits, especially in a very ill or medically complex patient, is questionable for two reasons. One, without specific guidance from a health care professional who is familiar with their medical history, subjects cannot interpret how the risks may apply to them. For example, offering an experimental treatment to a metastatic, chemotherapy-refractory cancer patient where the benefits include the potential for an additional 6 months of life but the potential risks include loss of sight or mobility
Address correspondence to Gwendolyn P. Quinn, PhD, 12902 Magnolia Drive, MRC CANCONT, Tampa, FL 33612, USA. E-mail: [email protected]
18 ajob
April, Volume 14, Number 4, 2014
Downloaded by [North Carolina State University] at 21:27 09 March 2015
Obligation to Disclose Controversial Risk
must be weighed on an individual basis. Two, the potential information overload from the consent document and the need to understand each nuance of the information is potentially burdensome for subjects/patients and they often rely on a health care professional to tell them what to do (Belcher, Fried, and Agostini 2006). The presence of this information in written form on a consent document may offer intricate details about potential benefits and harms, but these are risks written for the general pool of participants and not the individual. Additionally, when a potential research participant has not had experience with the potential risk, it is uncertain whether he or she will be able to make an informed choice. Several patient reports highlight the “wish I knew then what I know now” principle of decision making (Gaston and Mitchell 2005). An example is an 82-year-old patient who opts for a treatment where she believes she is making the trade of benefit for a potential 6 more months of life in exchange for potential harms of Grade 3 diarrhea. For a patient who has never experienced the intensity of this type of health outcome, it can be difficult to make a decision about whether it is preferable to have a shorter life without diarrhea or a few more months of life with incapacitating diarrhea that requires hospitalization. Thus, the true beneficence of disclosure may only be seen when the harms and benefits are described and discussed not only through dialogue, but also dialogue tailored to the physical and psychological situation of the patient (Thorton 2003). Discussing controversial harms and benefits with a potential research subject on an individualized level is only one half of the duty of the investigator. The legal system has continually upheld that physicians/researchers have a duty to disclose material information: “Material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient’s position when deciding to accept or reject the recommended medical procedure” (Truman v. Thomas. 1980). In the 1972 case of Canterbury v Spence (1972) a young man became a paraplegic and incontinent following spinal surgery and sought damages against the surgeon for failure to disclose that these health outcomes were a potential risk. The surgeon’s response was that he had “no duty to warn of such an unexpected complication.” The District of Columbia Court of Appeals ruled that the customary standard for assessing negligence (what would a reasonable practitioner have done?) was no longer valid and instead required a new patient-centered standard (what would a reasonable patient want to know?). In a recent review of Australian malpractice claims and health care complaints, Bismark and colleagues (2012) identified 481 disputes over informed consent, of which 9% were “disputed duty cases”—disagreements be-
April, Volume 14, Number 4, 2014
tween patients and doctors over whether a particular clinical risk should have been disclosed before treatment. The most common justification physicians offered for nondisclosure was that the risk was too rare to discuss (Bismarck et al. 2012). This suggests investigators are responsible for the additional step of identifying not only what would a reasonable patient/subject want to know, but what would this particular patient want to know. The purpose of clinical research trials is not to make the subject/patient better; it is to improve scientific knowledge, although change in the better or for the worse may occur in the patient. It has been suggested that subjects who enroll in a clinical trial solely because of hoped-for benefits represent a failure in the informed consent process (Raab 2004). DeMarco and colleagues make a well-justified and compelling case for a framework to evaluate the inclusion of important controversial risks in the consent document. We suggest this ethical obligation of risk disclosure must focus equally on the discussion, tailored to the individual circumstances of the subject patient who is considering participation. REFERENCES Belcher, V. N., T. R. Fried, and J. V. Agostini. 2006. Views of older adults on patient participation in medication-related decision making. Journal of General Internal Medicine 21(4): 298–303. Bismark, M., A. J. Gogos, R. B. Clark, R. L. Gruen, A. A. Gawande, and D. Studdert. 2012. Legal disputes over duties to disclose treatment risks to patients: A review of negligence claims and complaints in Australia. PLoS One. doi:10.1371/journal.pmed.1001283 Canterbury v. Spence. 1972. 464 F.2d 772 (D.C. Cir 1972). De Marco, J. P., P. J. Ford, D. J. Patton, and D. O. Stewart. 2014. Is there an ethical obligation to disclose controversial risk? A question from the ACCORD Trial. American Journal of Bioethics 14(4): 4–10. Gaston, C. M., and G. Mitchell. 2005. Information giving and decision-making in patients with advanced cancer: A systematic review. Social Science & Medicine 61(10): 2252–2264. House of Commons Science and Technology Committee. 2013. 17 September. Available at: http://www.publications.parliament.u k/pa/cm201314/cmselect/cmsctech/753/75302.htm (accessed 11 December 2013). Raab, E. L. 2004. The parameters of informed consent. Transactions of the American Ophthalmological Society 102: 225–232. PMCID: PMC1280103 Thorton, H. 2003. Enabling understanding must not lead to manipulation. British Medical Journal 327(7417): 693–694. doi:10.1136/ bmj.327.7417.693, PMCID:PMC200792. Truman v. Thomas. 1980. 27 Cal 3d, 611 P2d 902 (1980).
ajob 19
