研究參與者動態同意的實務與法律

The Practical and Legal Aspects of Dynamic Consent in Study Participants

知情同意之倫理守則如何付諸實踐，實務上乃從自主決定權的觀點出發，依法課予告知義務並要未取得書面同意。基於資通科技發達改以電子文件方式存查，進一步發展成形之數位同意應值認同，將它導入線上介面化為溝通便捷之操作流程，有利於研究人員與參與者相互聯繫。數位同意與書面同意分屬不同型態的執行方法，動態同意則有別於概括同意及特定同意，視為法律針對法益侵害可能性之不同而異其規範密度，反映在同意權行使的光譜上，概括同意、特定同意及動態同意，是從最寬鬆排到最嚴格的授權規程。為求提升作業效能起見，採行數位同意之替代模式確有必要，但絕不容與動態同意混為一談，否則即會加諸學界過重之程序負擔，每每配合研究計畫之細部變更，而為反覆告知；參與者因受學識經驗所限，就比專業說明恐難完全理解，盲目回應反倒陷入無效同意之窘境，或者動輒以行使退出全(opt-out)收場。尤其，大數據分析正在生醫研究領域興起，健康數據納進次級資料庫以供應用，類屬對生命健康安全並無危害之虞者，置於利益權衡下宜予放寬限制，要不然法律之規範體系輕重倒置，勢必有礙醫藥研發而影響公共福祉。

The current practice of implementing the Code of Ethics for Informed Consent is founded on the concept of independent decision-making, with the requirement of notification and written consent. On the basis of the significant development of technology in electronic document production and inventory, digital consent should be further developed and included into the web platform as a convenient communication method, which shall benefit the interactions between researchers and participants. The execution mechanisms for digital consent and written consent are distinct. Dynamic consent, in contrast to general and specific consent, reflects that the normative density of the law fluctuates in relation to the probability of legal infringement, which is reflected in the spectrum of consent implementations, which includes general consent, specific consent, and specific dynamic consent, in the rank from easiest to most stringent. The alternative manner of digital consent must be implemented to enhance operational performance, but it must not be confused with dynamic consent. Otherwise, the academic community may be overburdened with procedures. Every revision to the study’s specifications may thus also be repeated. It may be difficult for participants to fully comprehend descriptions due to a lack of academic experience in this professional description, leading to responding blindly and to the dilemma of invalid consent or ending up exercising their right of exit (opt-out) when possible; consequently, the objective of enhancing autonomous control is failed. In particular, as big data analysis emerges in the field of biomedical research, health data is incorporated into secondary databases to be applied in further studies. However, those health data that do not endanger life or cause health hazards should be relaxed upon consideration of the balance of interests. Otherwise, the legal system will be misaligned, which will certainly hinder medical research and development and affect the health of all people.