Bassan Sharon, Harel Ofer
Princeton University.
University of Connecticut.
J Law Health. 2018;31(1):87-117.
An ethical advancement of scientific knowledge demands a delicate equilibrium between benefits and harms, in particular in health-related research. When applying and advancing scientific knowledge or technologies, Article 4 of UNESCO's Universal Declaration on Bioethics and Human Rights, ethically justifiable research requires maximizing direct and indirect benefits and minimizing possible harms. The National Institution of Health [NIH] Data Sharing Policy and Implementation Guidance similarly states that data necessary for drawing valid conclusions and advancing medical research should be made as widely and freely available as possible (in order to share the benefits) while safeguarding the privacy of participants from potentially harmful disclosure of sensitive information. This paper discusses the challenges in the maximization of research benefit and the minimization of potential harms in the unique context of health-related research in Big Data from multiple sources, which are differently protected by the law. Part I frames the ethical dilemma by discussing potential benefits and harms, showing the constant misalignment in health-related research in Big Data from multiple sources, between the benefits in the use of confidential information for scientific purposes and the value in keeping confidentiality. Part II addresses existing regulations, including their nature and legal coverage. It highlights the prevailing challenges when combining data from multiple sources that are differently protected by the law. Part III compares different requirements for consent or authorization to use persons' health information for research. It focuses on the difficulty of existing regulation to ensure those requirements when using multiple sources of data. Part IV investigates whether exemptions from the authorization requirement could prevail in the context of information that exceeds the protection of HIPAA and the Protection of Human Subjects Regulations. In Part V the paper proposes a solution of a statistical nature, using the method of synthetic data to balance conflicting considerations. Part VI shows how the use of synthetic data can overcome some of the ethical challenges.
科学知识的伦理进步要求在利益与危害之间达成微妙的平衡，尤其是在与健康相关的研究中。在应用和推进科学知识或技术时，联合国教科文组织《生物伦理与人权世界宣言》第4条规定，符合伦理的可辩护研究要求使直接和间接利益最大化，并将可能的危害最小化。美国国立卫生研究院（NIH）的数据共享政策与实施指南也同样指出，为得出有效结论和推进医学研究所需的数据应尽可能广泛且免费地提供（以便共享利益），同时保护参与者的隐私，防止敏感信息被潜在地有害披露。本文讨论了在多源大数据这一独特背景下，与健康相关的研究在实现研究利益最大化和潜在危害最小化方面所面临的挑战，这些数据受到不同法律的保护。第一部分通过讨论潜在利益和危害来构建伦理困境，展示了多源大数据中与健康相关的研究在将机密信息用于科学目的的利益与保密价值之间持续存在的不一致。第二部分阐述现有法规，包括其性质和法律涵盖范围。它突出了在合并受不同法律保护的多源数据时普遍存在的挑战。第三部分比较了使用个人健康信息进行研究时不同的同意或授权要求。它着重于现有法规在使用多源数据时确保这些要求的困难。第四部分调查在信息超出《健康保险流通与责任法案》（HIPAA）和《保护人类受试者条例》保护范围的情况下，授权要求的豁免是否可行。在第五部分，本文提出一种统计性质的解决方案，即使用合成数据方法来平衡相互冲突的考量。第六部分展示了合成数据的使用如何能够克服一些伦理挑战。
