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 ...
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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/9780195388930.003.0004
- 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 ...
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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/9780195388930.003.0003
- 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 ...
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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.