Fair payment and just benefits to enhance diversity in clinical research.
Fair payment and just benefits to enhance diversity in clinical research.
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DOI：
10.1017/cts.2021.816
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发表时间：
2021
影响因子：
2.6
通讯作者：
Strauss DH
中科院分区：
文献类型：
--
作者：
Bierer BE;White SA;Gelinas L;Strauss DH
与参与临床研究相关的常规、非医疗和辅助医疗费用为经济弱势个体的入组设置了障碍。在某种程度上，种族，民族和性别与SES有关，这些障碍影响了临床研究招募多样化的努力。但是，支付政策和做法往往反映了一个长期存在的单一问题，即支付给参与者的费用将使决策产生偏见，并损害知情同意。我们认为，这种关注必须被视为在一个更大的伦理背景下，对个人参与者和更广泛的研究企业的不利后果是相当大的，当不充分或没有支付所产生的费用（“报销”）和时间承诺（“补偿”）。支付的公平性和防止支付对知情同意过程的不当影响是重要但不同的伦理考虑。从根本上说，由于参加研究而使参与者经济状况恶化的支付方法本质上是不公正的，因为它们对基于社会经济地位的招聘和保留产生了不同的影响。申办者、资助者、研究者和IRB必须认识到支付不足对临床试验纳入历史上研究不足的人群的影响。我们解决实际和公平的支付策略，以推进包容性，辅助医疗费用的额外障碍，以及支付的潜在意外后果。
Routine, nonmedical and ancillary medical costs associated with participation in clinical research create barriers to enrollment for economically disadvantaged individuals. To the extent that race, ethnicity, and gender are linked to SES, such barriers impact efforts to diversify clinical research enrollment. But payment policies and practices often reflect the longstanding and singular concern that payment to participants will bias decision-making and compromise informed consent. We argue that this concern must be viewed in a larger ethical context in which the untoward consequences for the individual participant and for the broader research enterprise are considerable when either inadequate or no payment is provided for expenses incurred (“reimbursement”) and time committed (“compensation”). Fairness in payment and protection from undue influence of payment on the informed consent process are important but distinct ethical considerations. Fundamentally, approaches to payment that leave participants financially worse off as a consequence of taking part in research are inherently unjust as they have a differential impact on recruitment and retention based on socioeconomic status. Sponsors, funders, investigators, and IRBs must be cognizant of the impact of inadequate payment on clinical trial inclusion of historically understudied groups. We address practical and fair payment strategies to advance inclusion, the additional barrier of ancillary medical costs, and potential unintended consequences of payment.
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DOI：
10.1177/17407745211011069
发表时间：
2021-08
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Fisher JA;McManus L;Kalbaugh JM;Walker RL
通讯作者：
Walker RL
DOI：
10.1177/1740774518792277
发表时间：
2018-10
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Cho HL;Danis M;Grady C
通讯作者：
Grady C
影响因子：
4.1
作者：
Wertheimer, A.;Miller, F. G.
通讯作者：
Miller, F. G.
影响因子：
2.7
作者：
Chingarande, George Rugare;Moodley, Keymanthri
通讯作者：
Moodley, Keymanthri
影响因子：
4.2
作者：
Clark, Luther T;Watkins, Laurence;Regnante, Jeanne M
通讯作者：
Regnante, Jeanne M