Ethics In America Second Edition 2004 Tsunami
AbstractDisasters such as flash flooding, mass shootings, and train and airplane accidents involving large numbers of victims produce significant opportunity for research in the biosciences. This opportunity exists in the extreme tails of life events, however, during which decisions about life and death, valuing and foregoing, speed and patience, trust and distrust, are tested simultaneously and abundantly. The press and urgency of these scenarios may also challenge the ability of researchers to comprehensively deliver information about the purposes of a study, risks, benefits, and alternatives.
Under these circumstances, we argue that acquiring consent for the immediate use of data that are not time sensitive represents a gap in the protection of human study participants. In response, we offer a two-tiered model of consent that allows for data collected in real-time to be held in escrow until the acute post-disaster window has closed. Such a model not only respects the fundamental tenet of consent in research, but also enables such research to take place in an ethically defensible manner.
DISASTER RESEARCH: DEFINITIONS, AND ETHICAL AND REGULATORY CONSIDERATIONSA considerable number of natural and public disasters such as mass shootings, earthquakes, floods and hurricanes, and catastrophic accidents in the air and on the ground have occurred in recent years. Notwithstanding the deep tragedy of these events, they offer opportunities for important research in the biosciences to better understand, prevent, and respond to such disasters in the future in a manner that minimizes human suffering. However, research in this area is rife with inevitable ethical, legal, and policy challenges and implications.Fritz defines a disaster as ‘an event concentrated in time and space, in which a society or one of its subdivisions undergoes physical harm and social disruption, such that all or some essential functions of the society or subdivision are impaired’. As such, disasters provide real-world laboratories for the effects of harmful, irreversible loss, and damage requiring long-term recovery from their social, political, and economic repercussions., Agents of destruction vary, but in most traditional definitions of disaster research they fall into the category of natural forces. A basic framework categorizes disaster effects into three impact conditions: hazard exposure, physical vulnerability, and social vulnerability.
Research involving any of these conditions has, as at least one of its endpoints, the goal of reducing future risk.Disaster research began in the 1950s primarily in the USA, and has become increasingly international over time. Results have highlighted the importance of disaster research to society. Lindell's studies of the aftermath of 2005 Hurricane Katrina, for example, revealed invaluable knowledge about the impact of failed management and care of affected persons forced to disperse from the epicenter of an event, and remedies for future disaster planning.
Prior to Katrina, research on the 2004 tsunami in Asia demonstrated the value of effective organizational response. In Canada, the USA, and in other developed states, policies for protecting human subjects acknowledge that there are times when modification to standard research ethics board processes is justified, provided that ‘exceptions and the means to implement them are not unduly broad, overreaching, or unjustifiably invasive’. This guidance applies specifically to and enables research in the disaster setting.
These policies also widely acknowledge that research participants in the midst of a disaster or an emergency are vulnerable, and that pre-existing vulnerabilities are potentially exacerbated under these extreme circumstances. Gender, race, and class are all factors correlated with vulnerability during disaster events, including those such as Hurricane Katrina.,While traditional notions of informed consent make allowances for the exposure of research participants or groups through mechanisms such as assent for children or community consent in the case of indigenous peoples, a model that enables individuals to opt out of participating in a study to which they contributed data under acute circumstances has not been broached. In this way, consent in escrow builds on the two-stage model for retrospective clinical research proposed by Norris et al., that provides the opportunity for subsequent research and is sensitive to participant recovery with a lengthened timeline, but that is not a prerequisite to release of data for analysis and utilization. IMPLEMENTING CONSENT IN ESCROWUsing the consent in escrow approach, initial informed consent from participants for the collection of data is obtained in the acute setting, but the data are held unexamined in escrow by a data steward until contributors can be recontacted and the second tier of informed consent is obtained for data release (Figure ).
Respect for the autonomy of research participants is promoted through the opportunities afforded by the passage of time and the post-acute setting, and upheld by enabling them to re-evaluate their contribution. These benefits exceed the risk of potentially unwanted secondary contact. Multiple attempts for recontact are built into the protocol ex ante following other established ethics procedures where future attempts at recontact must be justified. Limits to repeated attempts must be factored into any protocol to preserve the benefit-risk balance with respect to autonomy and the right to refuse recontact. As with the model proposed by Norris et al., researchers using the consent in escrow model may invite participants to provide information for kin through whom recontact is pursued secondary to primary contact at the future timepoint. The significance and effectiveness of the kinship resource depends on the proximity of the kin to the affected person, the closeness of the tie, and the extent to which the kin is also affected. Nonetheless, it is common for study teams to collect information about relatives and friends of participants during the informed consent process for clinical trials when longer term follow-up is desired.
This option is explicitly stipulated and agreed upon during the initial consent process. Temporal dimensions of traditional models for informed consent and new model for consent in escrow.The timing of the second stage of consent for release of data held in escrow will vary by context, but we anchor it in the period of time when the lives of research participants can reasonably be expected or observed to have stabilized such as when social, economic, and political routines have been restored. New data may be collected under conventional procedures to compare or augment data collected at the acute timepoint, but originally collected data may not be modified post hoc. Should a recontacted participant desire the latter, the conditions for release of data under the consent in escrow model are not satisfied and the data are destroyed. The requirement to obtain community consent such as research with indigenous populations should not be circumvented in the first tier, and must be explicitly respected in the second.Under conditions when assenting youth attain age of majority during the data holding period, consent in the second tier is not required from the originally consenting surrogate. Under conditions in which competence of the participant is compromised over time after first-tier consent, proxy consent must be invoked at the second tier. In the case of participant's death, an advanced directive for research or the instructions of the executor of the estate to which data may become property prevail.
Alternatively, the data are destroyed.A limited version of this model is currently being applied successfully in a pediatric emergency research setting in British Columbia, Canada. Here, verbal consent for research is acquired at the time of tissue biopsy by a treating physician, and then confirmed at a later time when the research study can be explained in greater detail and at time of reduced stress by an arm's length researcher to avoid potential coercion. Situating consent in escrow in broader world events, the model would apply, for example, to a comparative study of emotional differences and long-term psychological changes between the families of those who vanished in flight MH370, which disappeared presumably off the western coast of Australia, and flight MH17, which was shot down over Ukraine. While the location of the former flight and, most significantly, the victims’ bodies remain a mystery, families associated with the latter tragedy have the opportunity for closure and healing.In what disaster or emergency research settings situations will consent in escrow not be suitable? For one, it cannot be applied to research with an immediate health intervention or short-term goal.
The current Ebola outbreak in West Africa is a prime example. It cannot be applied when real-time analysis is required. And, it cannot be applied to studies of war refugees, for example, where recontact would be too burdensome or simply a ludicrous requirement during times of political instability.Pre-reviewed, minimal risk research, as conceptualized and described above by Wendler and Jesus et al., can be excluded from two-tier consent.
Ethics In America Second Edition 2004 Tsunami Video
The collection of hair samples, for example, would qualify for such an exemption. Indeed, as with all research conducted in disaster and emergency settings, the consent in escrow model should be evaluated for its appropriateness to the specific research situation and for the associated risks and benefits it offers. Other complexities in applying the model will derive from heterogeneity in methods to determine return-to-life stability by research teams, and the inherent variability in progress along this continuum among people and populations. Recontact information may be unavailable at time of disaster or later invalidated due to a change in anticipated participant location.
Participants may also feel burdened by the two-stage model and not wish to be reminded of the traumatic event in question. Use of the model may compound or extend fear of retaliation experienced by disaster researchers who are confronted with pressures to reveal informants’ identities, such as those reported after the 1989 Exxon Valdez oil spill. Two-tiered consent imposes pressures on funding streams, on researchers who rely on sufficient data to be released from escrow to power their analyses, and is complicated by changes in research leadership and personnel that inevitably occur over time. Publication and dissemination of research findings may be delayed.
CONCLUSIONDecisional capacity and the ability to provide truly informed consent rely on durable and ongoing competence of research participants, and must neither be impulsive or be made under duress. These conditions are difficult to achieve in disaster and emergency situations, and increasingly so in this era of instant messaging and social media, in which the right to privacy has been all but lost. Still, human societies are remarkably resilient in the face of large-scale crises, and disaster victims do not become irrational, self-destructive, necessarily hopeless, or dependent. Disaster victims may well be able to provide consent for immediate or long-term data use, but our model alleviates the extra burden of decision-making and choice in situ, and privileges time for participant reflection. The model still needs to be tested, but we submit that when applied judiciously, consent in escrow will mitigate an extra strain that research brings to an already challenged setting, offer a welcome extra layer of protection to participants, and foster the completion of the research cycle for the advancement of the health and well-being of survivors.Generously enabled by the Canadian Institutes of Health Research, the Canada Research Chairs Program, and Vancouver Coastal Health Research Institute. The authors gratefully acknowledge Dr James Anderson for consultation on disaster research and reviewers for comments on the manuscript. Dr Holly Longstaff specializes in applied ethics and policy analysis from a social science perspective.
She is the ethicist for the UBC BC Cancer Agency Research Ethics Board and the communications officer for the national board of the Canadian Bioethics Society (CBS). She is also serving as the interim associate director for the Office of Research Ethics at Simon Fraser University. She is a former board member of both the BC and Manitoba Chapters of the Marketing Research and Intelligence Association (MRIA) and is a current member of the International Society for Environmental Information Sciences. She is also a partner of Engage Associates. Dr Alice Hawkins Virani is a clinical assistant professor in the Department of Medical Genetics at The University of British Columbia. She is a clinical and research ethicist who specializes in the social, ethical, and cultural implications of new genomic technologies; clinical, public health, and research ethics; the development, implementation and analysis of public and expert engagement events; and health care service delivery strategies. She has experience in clinical and research ethics and procedures, and has served on the Research Ethics Board (behavioral and clinical) at The University of British Columbia since 2008.
Dr Judy Illes is professor of neurology and Canada research chair in neuroethics at The University of British Columbia. She is the director of the National Core for Neuroethics at UBC and faculty in the Brain Research Centre and the Vancouver Coastal Health Research Institute. She is a co-founder and member of the Governing Board of the International Neuroethics Society. She has made ground-making contributions to ethical, social, and policy challenges at the intersection of biomedical ethics and neuroscience.
The Ethics in America Source Reader, 2/e, edited by Lisa H. Newton, is a valuable supplement to any course in ethics and philosophy as well as an essential reference book for the Ethics in America college credit course and television series. It contains a rich and varied selection of classical writings in philosophy and ethics spanning the history of philosophy through the ages.This new second edition has been expanded to include selections from Islamic, Buddhist, and Confucian thought, and includes new readings on topics such as existentialism, feminism, and environmentalism. A new selection on fiduciary duty has also been added as a complement to the selection from Josiah Royce.'
Synopsis' may belong to another edition of this title. © Reprinted by permission. All rights reserved.:The volume in your hands is greatly expanded from the first edition, published in 1989.
The expansion was undertaken on request by many who have used the book in their courses, and the reason was something of a surprise to me. It seems that this text is occasionally used, not just for a companion volume for the telecourse Ethics in America, but also on its own, as the text for an introductory level history of ethics course. But for that purpose, the selections were incomplete.In the first edition I included only those works which were appealed to, explicitly or implicitly, by the panelists on the various discussions, and that means only works in the Western tradition. Further, only those works were included that had suggestions to make about how to solve ethical problems, to help students follow the actual reasoning of the panelists. Where the panelists' reasoning appealed (usually silently) to an ethical tradition, that tradition was included in the selections and the selections referenced in the Study Guide, the other companion volume.
Only works so referenced were included in the Source Reader.Now, that is one very exclusive principle of selection. Omitted were all religious traditions but our own, all Eastern thought of any kind, the entire nineteenth- and twentieth-century literature of doubt and ethical restructuring, and the contemporary movements of feminism, environmentalism, and other forms of multiculturalism (all movements that change the center of ethical consideration). If the text is to be used for a complete course in ethics, surely some selections must at least entertain the possibility of taking these literatures into account.Accordingly, the second edition has expanded, to include selections from Islamic, Buddhist, and Confucian thought (attempts to put the Bhagavad Gita in some form that preserved the poetry were unsuccessful, so Hinduism is not included); also existentialism, feminism, and environmentalism. (A new selection on Fiduciary Duty, taken from the law, has also been added as a complement to the selection from Royce.) All the disclaimers that applied to the first edition still apply: you will get only a taste of these rich and fascinating authors, literature, and movements, the editor makes no claims to expertise on any of these authors in particular and certainly no claims to expertise on them all; you will be frustrated by the minimal selections provided; the only way you can relieve that frustration is by going in each case back to the original source. About this title' may belong to another edition of this title.