国家治理视域下科技伦理审查的制度路径

为应对科学研究活动可能产生的伦理道德问题，我国建立起以伦理审查委员会为主体的伦理审查制度。由于制度安排及体制机制存在先天不足与运行梗阻，运行中针对审查权缺乏有效监管，伦理审查未能达到预期风险防范效果，反而屡屡曝出有违伦理道德的学术丑闻。分析科技伦理审查的价值以及伦理审查制度安排的不足，最后提出，基于伦理审查较强的公权属性与公益目标价值，应以确立“风险预防”为核心的更加审慎的审查原则，优化审查主体建制模式，强化对伦理审查的监督与制约，以及加快伦理审查统合性立法进程，作为伦理审查制度完善走向，为科技发展扎紧伦理“篱笆”，推动科学技术“向善”良性发展。

The Institutional Path of Ethical Review of Science and Technology from the Perspective of National Governance

Modern science and its development have an increasingly far-reaching impact on human society and the future. While releasing technological dividends, it also brings unprecedented challenges to ethical and moral risks as well as scientific and technological governance. In order to deal with the ethical and moral problems that may arise from scientific research activities, China has established an ethical review system with the ethical review committee as the main body. From the perspective of the deep-seated structure and function of review power, ethical review shows a strong attribute of public power regulation, adjusting and restricting the social public interests closely related to scientific researchers, scientific and technological community and the public. The ethical challenges brought by unregulated scientific research may pose a major threat to human society. Therefore, ethical review must act as a "gatekeeper". However, the traditional ethical review mode follows the principle of damage prevention, which is a minimum prevention strategy based on the relatively determined relationship between damage risk and benefit ratio. The reviewers only consider the deterministic damage consequences and even ignore the unknown and potential risks. At the same time, the ethical review ability of the review organization is objectively constrained by the institutional mode of the filing and registration system of "one court and one committee", coupled with the insufficient restriction and incentive of the review and supervision responsibility, as well as the lag of the ethical review legislation, so that the ethical review may fail to achieve the expected risk prevention effect, and there might be academic scandals against ethics. In order to improve the ethical review system, it is urgent to improve the ethical review system.#br#The most important point is to establish the review principle with risk prevention as the core. Ethical review should not stop on the premise of proving the causal relationship between scientific research behavior and damage consequences with conclusive evidence, and should not ignore the personal risks of the subjects in order to expect social benefits, as long as there is the possibility of causing serious or irreversible risks, or the risk-benefit ratio in the trial period is difficult to predict. The development of scientific research activities should be limited based on the concept of potential risk prevention. The second point is to establish some regional ethics review committees. It is essential to gradually replace the review mode of "one academy and one committee" through regional centralized review, optimize the review process, enhance the ability of scientific review and risk benefit evaluation of scientific research schemes, and ensure the independence, scientificity and impartiality of ethical review of research projects. The third point is to strengthen the supervision and restriction of ethical review. On the one hand, the legislation should clarify the independent legal status of the regional ethics review committee to ensure that the legal responsibility for violation review can be traced back to the regional ethics review committee and its members; on the other hand, it is necessary to refine the procedural design of defense and relief to prevent the arbitrary exercise of the review power from indirectly causing damage to the legitimate and private interests of other individuals. The fourth is to speed up the integrated legislative process of scientific research ethics review, introduce a more specialized and more effective "scientific research ethics law", and build a reasonable and broader scientific research supervision framework with more authoritative and integrated legislation. In addition, it is important to improve regulatory incentives is also an important measure. The establishment of a special government financial subsidy mechanism and evaluation and reward system will help to improve the enthusiasm and initiative of staff.#br#To sum up, it is vital to maintain a cautious attitude, actively respond to the ethical challenges brought by the development of emerging technologies, and avoid differences between the instrumental rationality of science and technology and the ethics of human society with good values, so as to ensure that scientific research activities abide by the bottom line of ethics and morality. Ethical review must act as the driving and escort duty of the "gatekeeper" of scientific and technological ethics, and turn the basic theoretical topics of bioethics and human rights protection to how to shape a more efficient ethical review system and operation mechanism, so as to strenghthen the ethical "fence" for scientific and technological development and promote the "good" and benign development of science and technology.#br#