the authors reply t We appreciate Felicitas Holzer and Ignacio Mastroleo’s comments. As they note, we described four models of informed consent for decisions regarding the return of incidental findings, drawn from our surveys and interviews with investigators and research participants. However, they criticize what they consider our inadequate focus, as we discuss the advantages and disadvantages of each model, “on the importance of the ethical requirement of voluntary and autonomous choice and its precondition: full comprehension of the facts and circumstances prior to consenting.” And they express a strong preference for the traditional model of consent, which would provide participants with an “extensive information process prior to consenting.” This focus on “full information,” though, elides the difficulties with traditional approaches to consent. At the time of recruitment, potential participants must already absorb substantial amounts of information about the study in which they are considering enrollment. To insist that a comprehensive discussion of possible incidental findings and their implications take place at that point risks overwhelming participants’ capacities to attend to and process information. Although participants exposed to such disclosure may nominally be “fully informed,” the result may be worse—not better or even adequate—decision-making. Hence, the possibility that alternative models of consent might lead to improved understanding and more thoughtful decisions needs to be given serious consideration. In particular, staged consent can provide general information about the possibility of return of incidental findings at the time of initial consent and further detailed information about incidental findings only when and if they occur, and this Contributions to Exchange may be submitted to editorial@thehastingscenter. org. They should be no more than eight hundred words and without endnotes. They may be edited for style and length. 4 HASTIN G S C E N T E R R E P ORT
model may represent a better way of allocating the attentional and cognitive resources of both investigators and participants. We noted in our article the need for an effective mechanism for ongoing communication with participants if consent is to be staged, a need highlighted by Holzer and Mastroleo. Indeed, in a follow-up survey with investigators, we have found that the presence of such infrastructure would substantially increase their support for a staged consent model (to a level equivalent to traditional consent). “Full comprehension” has proven to be a remarkably elusive endpoint in informed consent to research. Nor is it clear what that desideratum would actually require participants to understand. The quest for this unicorn has led to participants’ exposure to everincreasing amounts of information at the time of recruitment, with little apparent benefit. No one believes that research participants can absorb (and many do not even read) the information contained in the standard twenty-page, single-spaced consent form. Recognizing the complexity of decisions about return of incidental findings may help free us from the illusion that more information is always better or that everything that might be relevant to participation in a study must be disclosed to research subjects at the time of enrollment. Unfortunately, that reality is much more complex than Holzer and Mastroleo’s comments would suggest. • Paul S. Appelbaum, Wendy Chung, Abby J. Fyer, Robert L. Klitzman, and Josue Martinez Columbia University • Erik Parens The Hastings Center • W. Nicholson Price University of New Hampshire • Cameron Waldman Albany Medical Center DOI: 10.1002/hast.408
ON THE WEB n Bioethics Forum http://www.bioethicsforum.org How Brittany Maynard Changed the Conversation about Aid in Dying By Dena S. Davis For a few weeks before and after her death, her name and face were everywhere. She and her husband posted videos on the Internet explaining her decision, and inviting viewers into their lives. . . . [M]y students were simply mesmerized. What had been a policy they thought was just relevant to old people, was suddenly captured in this fresh-faced woman . . . Trapper’s Care in the Animal ER and Frank Talk about Costs By Chelsea A. Jack Because medical doctors are often reluctant to talk about end-of-life care with their patients, conversations about the financial costs of such care do not occur either. This is not necessarily the case with veterinary care, where, if anything, vets go out of the way to prepare families for the likelihood of death—and its costs. Responding to Ebola: Health Care Professionals’ Obligations to Provide Care By Joel Frader and Lainie Friedman Ross Professionals acquire specialized knowledge and skills that others do not and cannot have. Having these skills creates a presumptive obligation to use them. However, such an obligation is tempered by the likelihood that intervention will actually benefit patients by either curing them or relieving pain and suffering. The extent of professionals’ duty to assume risk must take into account the rights of the providers to receive appropriate training and resources to protect themselves. Also, in the Hastings Center’s other blog, Over 65, Muriel Gillick recommends an expanded understanding of who can benefit from palliative care and of over how long a time.
January-February 2015
model may represent a better way of allocating the attentional and cognitive resources of both investigators and participants. We noted in our article the need for an effective mechanism for ongoing communication with participants if consent is to be staged, a need highlighted by Holzer and Mastroleo. Indeed, in a follow-up survey with investigators, we have found that the presence of such infrastructure would substantially increase their support for a staged consent model (to a level equivalent to traditional consent). “Full comprehension” has proven to be a remarkably elusive endpoint in informed consent to research. Nor is it clear what that desideratum would actually require participants to understand. The quest for this unicorn has led to participants’ exposure to everincreasing amounts of information at the time of recruitment, with little apparent benefit. No one believes that research participants can absorb (and many do not even read) the information contained in the standard twenty-page, single-spaced consent form. Recognizing the complexity of decisions about return of incidental findings may help free us from the illusion that more information is always better or that everything that might be relevant to participation in a study must be disclosed to research subjects at the time of enrollment. Unfortunately, that reality is much more complex than Holzer and Mastroleo’s comments would suggest. • Paul S. Appelbaum, Wendy Chung, Abby J. Fyer, Robert L. Klitzman, and Josue Martinez Columbia University • Erik Parens The Hastings Center • W. Nicholson Price University of New Hampshire • Cameron Waldman Albany Medical Center DOI: 10.1002/hast.408
ON THE WEB n Bioethics Forum http://www.bioethicsforum.org How Brittany Maynard Changed the Conversation about Aid in Dying By Dena S. Davis For a few weeks before and after her death, her name and face were everywhere. She and her husband posted videos on the Internet explaining her decision, and inviting viewers into their lives. . . . [M]y students were simply mesmerized. What had been a policy they thought was just relevant to old people, was suddenly captured in this fresh-faced woman . . . Trapper’s Care in the Animal ER and Frank Talk about Costs By Chelsea A. Jack Because medical doctors are often reluctant to talk about end-of-life care with their patients, conversations about the financial costs of such care do not occur either. This is not necessarily the case with veterinary care, where, if anything, vets go out of the way to prepare families for the likelihood of death—and its costs. Responding to Ebola: Health Care Professionals’ Obligations to Provide Care By Joel Frader and Lainie Friedman Ross Professionals acquire specialized knowledge and skills that others do not and cannot have. Having these skills creates a presumptive obligation to use them. However, such an obligation is tempered by the likelihood that intervention will actually benefit patients by either curing them or relieving pain and suffering. The extent of professionals’ duty to assume risk must take into account the rights of the providers to receive appropriate training and resources to protect themselves. Also, in the Hastings Center’s other blog, Over 65, Muriel Gillick recommends an expanded understanding of who can benefit from palliative care and of over how long a time.
January-February 2015
