The third in the series of forthcoming AJT papers about incentives/disincentives for donation discusses the basis for pilot studies (see earlier posts 1 and 2)
Between Scylla and Charybdis: Charting an Ethical Course for Research Into Financial Incentives for Living Kidney Donation
J. S. Fisher1, Z. Butt, J. Friedewald, S. Fry-Revere, J. Hanneman, M. L. Henderson, K. Ladin, H. Mysel, L. Preczewski, L. A. Sherman, C. Thiessen andE. J. Gordon*
Article first published online: 31 MAR 2015
DOI: 10.1111/ajt.13234
"The transplant community appears to be in a state of equipoise regarding the ethical soundness of empirically investigating a regulated system of financial incentives for living kidney donation. ...Proponents of financial incentives for nondirected living donors posit that incentives would increase the supply of high quality organs, prolong quantity, improve quality of life of recipients, and offset the societal cost by reducing the patient population receiving dialysis [10, 11]. Opponents argue that financial compensation beyond recovering expenses would: (1) cause undue pressure to donate, (2) exploit at-risk individuals (such as the poor), (3) commodify the human body, (4) exacerbate disparities in access to transplants between different socioeconomic strata, and (5) negatively impact public opinion and potentially lead to decreased organ donation rates [12, 13]. However, the debate over the intended and unintended effects of a federally regulated system of financial incentives in the United States remains unresolved partly due to a lack of empirical data.
Critics commonly turn to national programs outside the United States (e.g. India, China, Philippines, Eastern Europe) where black market incentives are the rule to justify concerns that financial incentives are exploitative of living donors. We do not disagree that paying donors illegally is exploitive. Other countries like Israel, Saudi Arabia, Iran, Singapore, and Ireland, however, have implemented legal compensation policies that assist living kidney donors to varying degrees and with varying success. However, these programs developed organically without extensive transparency or oversight, rather than as part of a prospective study designed with embedded outcome measures. Thus, it is unclear whether the successes of such policies are translatable to the US context given the differences in our governmental, medical, and societal infrastructures. Until rigorous, relevant data are properly collected, there is no way to determine whether concerns are warranted about potentially adverse effects of financial incentives on patient safety, exploitation, autonomy, and public trust as part of a US federally regulated system.
Members from several academic and professional organizations have called for pilot studies to investigate the provision of financial incentives to eligible living kidney donors to increase donation rates [14-17]. Logistical parameters for such studies have been suggested [18, 19]. However, while proposals for pilot studies commonly advance arguments for financial incentives, they have not systematically addressed the ethical concerns raised by opponents of a pilot study. This paper provides an ethical justification for conducting a pilot trial to study the feasibility and impact of a federally regulated system utilizing financial incentives on living kidney donation rates.''
...
in conclusion...
"the first step to resolve equipoise will require one or more carefully designed pilot studies to assess individual perceptions to determine if a course can be charted between exploitation and undue influence. Only such pilot studies can inform the transplant community as to whether larger, randomized controlled trials may be ethically undertaken to determine if ultimately, a federally regulated financial incentives program could feasibly and effectively increase living kidney donation rates without living donors incurring perceptions of negative psychological experience or generating negative public reaction.
Between Scylla and Charybdis: Charting an Ethical Course for Research Into Financial Incentives for Living Kidney Donation
J. S. Fisher1, Z. Butt, J. Friedewald, S. Fry-Revere, J. Hanneman, M. L. Henderson, K. Ladin, H. Mysel, L. Preczewski, L. A. Sherman, C. Thiessen andE. J. Gordon*
Article first published online: 31 MAR 2015
DOI: 10.1111/ajt.13234
"The transplant community appears to be in a state of equipoise regarding the ethical soundness of empirically investigating a regulated system of financial incentives for living kidney donation. ...Proponents of financial incentives for nondirected living donors posit that incentives would increase the supply of high quality organs, prolong quantity, improve quality of life of recipients, and offset the societal cost by reducing the patient population receiving dialysis [10, 11]. Opponents argue that financial compensation beyond recovering expenses would: (1) cause undue pressure to donate, (2) exploit at-risk individuals (such as the poor), (3) commodify the human body, (4) exacerbate disparities in access to transplants between different socioeconomic strata, and (5) negatively impact public opinion and potentially lead to decreased organ donation rates [12, 13]. However, the debate over the intended and unintended effects of a federally regulated system of financial incentives in the United States remains unresolved partly due to a lack of empirical data.
Critics commonly turn to national programs outside the United States (e.g. India, China, Philippines, Eastern Europe) where black market incentives are the rule to justify concerns that financial incentives are exploitative of living donors. We do not disagree that paying donors illegally is exploitive. Other countries like Israel, Saudi Arabia, Iran, Singapore, and Ireland, however, have implemented legal compensation policies that assist living kidney donors to varying degrees and with varying success. However, these programs developed organically without extensive transparency or oversight, rather than as part of a prospective study designed with embedded outcome measures. Thus, it is unclear whether the successes of such policies are translatable to the US context given the differences in our governmental, medical, and societal infrastructures. Until rigorous, relevant data are properly collected, there is no way to determine whether concerns are warranted about potentially adverse effects of financial incentives on patient safety, exploitation, autonomy, and public trust as part of a US federally regulated system.
Members from several academic and professional organizations have called for pilot studies to investigate the provision of financial incentives to eligible living kidney donors to increase donation rates [14-17]. Logistical parameters for such studies have been suggested [18, 19]. However, while proposals for pilot studies commonly advance arguments for financial incentives, they have not systematically addressed the ethical concerns raised by opponents of a pilot study. This paper provides an ethical justification for conducting a pilot trial to study the feasibility and impact of a federally regulated system utilizing financial incentives on living kidney donation rates.''
...
in conclusion...
"the first step to resolve equipoise will require one or more carefully designed pilot studies to assess individual perceptions to determine if a course can be charted between exploitation and undue influence. Only such pilot studies can inform the transplant community as to whether larger, randomized controlled trials may be ethically undertaken to determine if ultimately, a federally regulated financial incentives program could feasibly and effectively increase living kidney donation rates without living donors incurring perceptions of negative psychological experience or generating negative public reaction.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.