Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions.

IF 1.7 4区哲学 Q2 ETHICS

Journal of Empirical Research on Human Research Ethics Pub Date : 2022-07-01 Epub Date: 2022-02-10 DOI:10.1177/15562646221076764

Astrid Berner-Rodoreda, Shannon McMahon, Nir Eyal, Puspita Hossain, Atonu Rabbani, Mrittika Barua, Malabika Sarker, Emmy Metta, Elia Mmbaga, Melkizedeck Leshabari, Daniel Wikler, Till Bärnighausen

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引用次数: 0

Abstract

Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs. Health experts across all countries favored a strong evidence base, prior information to the affected populations, and individual consent for 'risky' HPEs. Differences pertained to individual risk perception, how and when consent by group representatives should be obtained and whether HPEs could be treated as health policies. The study adds to representative consent options for HPEs, yet shows that more research is needed in this field - particularly in the present Covid-19 pandemic which has highlighted the need for HPEs nationally and globally.

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检测健康政策的同意要求：专家意见的洲际比较

个人知情同意是人类受试者临床研究的核心要求，但同意要求是否以及如何适用于卫生政策实验仍不清楚。HPE在实施之前测试和评估公共卫生政策。我们采访了坦桑尼亚、孟加拉国和德国的58位卫生专家，了解HPE的知情同意要求。所有国家的卫生专家都支持建立强有力的证据基础，向受影响人群提供事先信息，并对“危险”的高氟氯烃给予个人同意。差异涉及个人风险认知、应如何以及何时获得团体代表的同意，以及是否可以将HPE视为健康政策。该研究增加了HPE的代表性同意选择，但表明该领域需要更多的研究，尤其是在当前新冠肺炎大流行中，这突出了全国和全球对HPE的需求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Empirical Research on Human Research Ethics 医学-医学：伦理

CiteScore

3.50

自引率

7.70%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.