Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.003.0002
- Subject:
- Philosophy, Moral Philosophy
This chapter sets out, in revised form, the author’s basic position on medical researchers’ ancillary-care obligations, first set out in a pair of articles with Leah Belsky in 2004: the ...
More
This chapter sets out, in revised form, the author’s basic position on medical researchers’ ancillary-care obligations, first set out in a pair of articles with Leah Belsky in 2004: the partial-entrustment model. This model avoids assimilating medical researchers to clinicians or bench scientists and indicates that their special ancillary-care obligation is limited in two ways. First, it is limited in scope, for it applies only to needs that are uncovered by exercising the special permissions obtained from research subjects during the informed-consent process. Second, it is limited in strength on the basis of various contextual factors. Dickert & Wendler’s case-based criticism of the scope limitation (JAMA, 2009) is rebutted; their call for grounding ancillary-care obligations in the “relationship” between researchers and subjects is too vague as it stands, but motivates us to look more deeply into this relationship.Less
This chapter sets out, in revised form, the author’s basic position on medical researchers’ ancillary-care obligations, first set out in a pair of articles with Leah Belsky in 2004: the partial-entrustment model. This model avoids assimilating medical researchers to clinicians or bench scientists and indicates that their special ancillary-care obligation is limited in two ways. First, it is limited in scope, for it applies only to needs that are uncovered by exercising the special permissions obtained from research subjects during the informed-consent process. Second, it is limited in strength on the basis of various contextual factors. Dickert & Wendler’s case-based criticism of the scope limitation (JAMA, 2009) is rebutted; their call for grounding ancillary-care obligations in the “relationship” between researchers and subjects is too vague as it stands, but motivates us to look more deeply into this relationship.
Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.003.0008
- Subject:
- Philosophy, Moral Philosophy
Summing up the book, this chapter reviews the argument, notes the novelty of the partial-entrustment model and, looking forward, sets out practical steps that can be recommended even without ...
More
Summing up the book, this chapter reviews the argument, notes the novelty of the partial-entrustment model and, looking forward, sets out practical steps that can be recommended even without committing to that approach. The partial-entrustment approach is shown to be an important addition to the bioethical principles set out by Beauchamp & Childress (2009) and Emanuel et al. (2004) and to evade worries about paternalism raised by Wertheimer & Miller (2007). Further, the idea of moral entanglements on which it rests is of interest, more broadly, to moral philosophers. Regarding practical steps that need to be taken, the “four Ps” of a 2008 consensus paper by participants in a Georgetown ancillary-care workshop are reiterated and reinforced, along with their framework of three key questions for Institutional Review Boards and Research Ethics Committees.Less
Summing up the book, this chapter reviews the argument, notes the novelty of the partial-entrustment model and, looking forward, sets out practical steps that can be recommended even without committing to that approach. The partial-entrustment approach is shown to be an important addition to the bioethical principles set out by Beauchamp & Childress (2009) and Emanuel et al. (2004) and to evade worries about paternalism raised by Wertheimer & Miller (2007). Further, the idea of moral entanglements on which it rests is of interest, more broadly, to moral philosophers. Regarding practical steps that need to be taken, the “four Ps” of a 2008 consensus paper by participants in a Georgetown ancillary-care workshop are reiterated and reinforced, along with their framework of three key questions for Institutional Review Boards and Research Ethics Committees.
Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.003.0001
- Subject:
- Philosophy, Moral Philosophy
This chapter introduces the neglected issue of medical researchers’ ancillary-care obligations—their obligations to provide medical care that their research subjects need, but that is not required in ...
More
This chapter introduces the neglected issue of medical researchers’ ancillary-care obligations—their obligations to provide medical care that their research subjects need, but that is not required in order to carry out the study soundly and safely—via a series of examples. The issue, which first came to prominence in the context of HIV vaccine trials in developing countries, puts our understandings of the role obligations of medical researchers under pressure, revealing difficulties with assimilating them either to clinicians or to bench scientists. While the grounds for providing ancillary care include general duties incumbent on all people, such as the duty of rescue, crucial to any account of medical researchers’ ancillary-care obligations is a good understanding of why they owe special ancillary-care obligations to participants in their studies. This special ancillary-care obligation goes beyond what rescue requires.Less
This chapter introduces the neglected issue of medical researchers’ ancillary-care obligations—their obligations to provide medical care that their research subjects need, but that is not required in order to carry out the study soundly and safely—via a series of examples. The issue, which first came to prominence in the context of HIV vaccine trials in developing countries, puts our understandings of the role obligations of medical researchers under pressure, revealing difficulties with assimilating them either to clinicians or to bench scientists. While the grounds for providing ancillary care include general duties incumbent on all people, such as the duty of rescue, crucial to any account of medical researchers’ ancillary-care obligations is a good understanding of why they owe special ancillary-care obligations to participants in their studies. This special ancillary-care obligation goes beyond what rescue requires.
Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.003.0004
- Subject:
- Philosophy, Moral Philosophy
In our highly imperfect world, many of the most compelling claims for ancillary care arise in contexts of deep injustice. One might think, then, that the idea of justice could ground medical ...
More
In our highly imperfect world, many of the most compelling claims for ancillary care arise in contexts of deep injustice. One might think, then, that the idea of justice could ground medical researchers’ special ancillary-care obligations; however, because of the kind of generality that is essential to justice, this chapter argues, it cannot ground these special obligations. Still, it is important that the partial-entrustment model not conflict with justice. Some argue that offering ancillary care will serve in many instances unduly to induce study participation; but those worries about exploitation are better addressed by adequate review of study risks. Special ancillary-care obligations such as those posited by the partial-entrustment model do call for departures from impartialist accounts of distributive justice: this is only appropriate. Further, these departures will not be radical, as the model’s strength factors will tend to favor those who are victims of the severest distributive injustice.Less
In our highly imperfect world, many of the most compelling claims for ancillary care arise in contexts of deep injustice. One might think, then, that the idea of justice could ground medical researchers’ special ancillary-care obligations; however, because of the kind of generality that is essential to justice, this chapter argues, it cannot ground these special obligations. Still, it is important that the partial-entrustment model not conflict with justice. Some argue that offering ancillary care will serve in many instances unduly to induce study participation; but those worries about exploitation are better addressed by adequate review of study risks. Special ancillary-care obligations such as those posited by the partial-entrustment model do call for departures from impartialist accounts of distributive justice: this is only appropriate. Further, these departures will not be radical, as the model’s strength factors will tend to favor those who are victims of the severest distributive injustice.
Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.003.0005
- Subject:
- Philosophy, Moral Philosophy
If it were permissible for researchers to ask potential participants to waive their ancillary-care claims up front, no account of these claims and their correlative obligations would have much ...
More
If it were permissible for researchers to ask potential participants to waive their ancillary-care claims up front, no account of these claims and their correlative obligations would have much practical import. Conceding that it is possible for participants to waive these claims, this chapter notes two kinds of moral obstacles to soliciting such waivers. The first is that (as argued in Chapter 3) researchers’ special ancillary-care obligations are ultimately grounded in a special responsibility towards their participants. Accordingly, even if the participants then turned around and also waived their ancillary-care claims, then, while that might extinguish researchers’ special obligations, narrowly understood, it would not extinguish their special responsibilities towards these participants. Secondly, because of asymmetries in medical knowledge between researchers and participants, important moral considerations call on medical researchers to exercise restraint in soliciting waivers of ancillary-care claims.Less
If it were permissible for researchers to ask potential participants to waive their ancillary-care claims up front, no account of these claims and their correlative obligations would have much practical import. Conceding that it is possible for participants to waive these claims, this chapter notes two kinds of moral obstacles to soliciting such waivers. The first is that (as argued in Chapter 3) researchers’ special ancillary-care obligations are ultimately grounded in a special responsibility towards their participants. Accordingly, even if the participants then turned around and also waived their ancillary-care claims, then, while that might extinguish researchers’ special obligations, narrowly understood, it would not extinguish their special responsibilities towards these participants. Secondly, because of asymmetries in medical knowledge between researchers and participants, important moral considerations call on medical researchers to exercise restraint in soliciting waivers of ancillary-care claims.
Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.003.0007
- Subject:
- Philosophy, Moral Philosophy
Although attention to medical researchers’ ancillary-care obligations is increasing, the discussion of these issues is still in its early phases. This chapter outlines some of the crucial empirical ...
More
Although attention to medical researchers’ ancillary-care obligations is increasing, the discussion of these issues is still in its early phases. This chapter outlines some of the crucial empirical and conceptual points on which further work is needed. Conceptual and normative work is needed on how context affects what it means to provide ancillary care, on getting beyond the ideal type of the “researcher” in order to look at the complex collaborations among teams of investigators and staff with local hosts and perhaps more distant sponsors, on borderline cases of “participants” such as family members and those screened out of studies, on the boundaries of the concept of medical research, and on what to do when non-medical needs are uncovered by carrying out study procedures, as when surveys in HIV-transmission studies reveal spousal abuse. Empirical information about attitudes, practices, and ancillary-care needs is desperately needed across the board.Less
Although attention to medical researchers’ ancillary-care obligations is increasing, the discussion of these issues is still in its early phases. This chapter outlines some of the crucial empirical and conceptual points on which further work is needed. Conceptual and normative work is needed on how context affects what it means to provide ancillary care, on getting beyond the ideal type of the “researcher” in order to look at the complex collaborations among teams of investigators and staff with local hosts and perhaps more distant sponsors, on borderline cases of “participants” such as family members and those screened out of studies, on the boundaries of the concept of medical research, and on what to do when non-medical needs are uncovered by carrying out study procedures, as when surveys in HIV-transmission studies reveal spousal abuse. Empirical information about attitudes, practices, and ancillary-care needs is desperately needed across the board.
Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- book
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.001.0001
- Subject:
- Philosophy, Moral Philosophy
Interacting innocently with others, we can become morally entangled with their affairs, despite neither party having intended this. This route to obligation—underexplored by moral philosophers—is of ...
More
Interacting innocently with others, we can become morally entangled with their affairs, despite neither party having intended this. This route to obligation—underexplored by moral philosophers—is of great practical importance to those engaged in medical research on human subjects. Medical researchers encounter all sorts of medical needs in their human subjects. Malaria researchers working in rural Africa may encounter malaria, schistosomiasis, HIV, and other diseases. Brain-scan studies in high-tech research hospitals may reveal suspicious anomalies in the brains of normal volunteers. These subjects may need ancillary care from the researchers: medical care not required to carry out the study safely and soundly. Currently, no authoritative ethical guidance covers such situations. This book’s author’s partial-entrustment model has been the leading principled account of medical researchers’ ancillary-care obligations. Here, this book buttresses and extends this model, newly explaining how these obligations arise as moral entanglements to which researchers open themselves by accepting special permissions to examine study participants’ bodies, collect their bodily fluids and tissues, and probe their medical histories. In addition to providing a full-dress philosophical defense for the partial-entrustment model, this book addresses the most important concrete and practical issues that arise regarding ancillary care, including justice, exploitation, waivability, and prioritization. The book closes by noting issues needing further exploration, broader philosophical implications, and practical steps we can take now.Less
Interacting innocently with others, we can become morally entangled with their affairs, despite neither party having intended this. This route to obligation—underexplored by moral philosophers—is of great practical importance to those engaged in medical research on human subjects. Medical researchers encounter all sorts of medical needs in their human subjects. Malaria researchers working in rural Africa may encounter malaria, schistosomiasis, HIV, and other diseases. Brain-scan studies in high-tech research hospitals may reveal suspicious anomalies in the brains of normal volunteers. These subjects may need ancillary care from the researchers: medical care not required to carry out the study safely and soundly. Currently, no authoritative ethical guidance covers such situations. This book’s author’s partial-entrustment model has been the leading principled account of medical researchers’ ancillary-care obligations. Here, this book buttresses and extends this model, newly explaining how these obligations arise as moral entanglements to which researchers open themselves by accepting special permissions to examine study participants’ bodies, collect their bodily fluids and tissues, and probe their medical histories. In addition to providing a full-dress philosophical defense for the partial-entrustment model, this book addresses the most important concrete and practical issues that arise regarding ancillary care, including justice, exploitation, waivability, and prioritization. The book closes by noting issues needing further exploration, broader philosophical implications, and practical steps we can take now.
Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.003.0003
- Subject:
- Philosophy, Moral Philosophy
The partial-entrustment model sets out a position on medical researchers’ ancillary-care obligations that many have found attractive; but why should we believe it? What grounds the special ...
More
The partial-entrustment model sets out a position on medical researchers’ ancillary-care obligations that many have found attractive; but why should we believe it? What grounds the special obligations that it attributes to medical researchers? This chapter explains that they are grounded as a special case of moral entanglements: obligations that unintendedly arise as by-products of innocent transactions. Researchers’ ancillary-care obligations, more particularly, arise from their having accepted participants’ waivers of privacy rights (rights shielding their bodies, bodily samples, and medical histories) during the informed-consent process. In so doing, researchers have—perhaps unwittingly—taken on special responsibilities that are associated with those rights. These special responsibilities create a morally significant relationship between researchers and subjects and thus ground the special ancillary-care obligation. Rival impartialist accounts, such as Robert Goodin’s vulnerability-based account and Leif Wenar’s least-cost-threat-avoider account, cannot explain our intuitions about this kind of privacy-based moral entanglement.Less
The partial-entrustment model sets out a position on medical researchers’ ancillary-care obligations that many have found attractive; but why should we believe it? What grounds the special obligations that it attributes to medical researchers? This chapter explains that they are grounded as a special case of moral entanglements: obligations that unintendedly arise as by-products of innocent transactions. Researchers’ ancillary-care obligations, more particularly, arise from their having accepted participants’ waivers of privacy rights (rights shielding their bodies, bodily samples, and medical histories) during the informed-consent process. In so doing, researchers have—perhaps unwittingly—taken on special responsibilities that are associated with those rights. These special responsibilities create a morally significant relationship between researchers and subjects and thus ground the special ancillary-care obligation. Rival impartialist accounts, such as Robert Goodin’s vulnerability-based account and Leif Wenar’s least-cost-threat-avoider account, cannot explain our intuitions about this kind of privacy-based moral entanglement.
Henry S. Richardson
- Published in print:
- 2012
- Published Online:
- January 2013
- ISBN:
- 9780195388930
- eISBN:
- 9780199979196
- Item type:
- chapter
- Publisher:
- Oxford University Press
- DOI:
- 10.1093/acprof:oso/9780195388930.003.0006
- Subject:
- Philosophy, Moral Philosophy
To illustrate in some detail how the partial-entrustment model can concretely guide the determinations of Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) as they review ...
More
To illustrate in some detail how the partial-entrustment model can concretely guide the determinations of Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) as they review proposed studies’ ancillary-care provisions, this chapter shows how it can discriminate among different developing-country studies in which the ancillary care that predictably will be needed is HIV/AIDS care. Three factors highlighted by the model affect the stringency of medical researchers’ obligation to provide antiretroviral treatment to research participants in non-HIV-AIDS studies: (1) the centrality of HIV-AIDS to the study design, (2) the intensity or length of the researcher-participant interaction, and (3) the cost relative to the study budget. Analyzing the examples with these factors in mind reveals a gradation in the stringency of the obligation to provide this type of ancillary care, a gradation useful to IRBs and RECs.Less
To illustrate in some detail how the partial-entrustment model can concretely guide the determinations of Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) as they review proposed studies’ ancillary-care provisions, this chapter shows how it can discriminate among different developing-country studies in which the ancillary care that predictably will be needed is HIV/AIDS care. Three factors highlighted by the model affect the stringency of medical researchers’ obligation to provide antiretroviral treatment to research participants in non-HIV-AIDS studies: (1) the centrality of HIV-AIDS to the study design, (2) the intensity or length of the researcher-participant interaction, and (3) the cost relative to the study budget. Analyzing the examples with these factors in mind reveals a gradation in the stringency of the obligation to provide this type of ancillary care, a gradation useful to IRBs and RECs.
