臨床試驗受試者招募原則之修正建議

Proposal to Amend the Regulation of Recruiting Study Subjects

近來新型冠狀病毒疫苗試驗在國內招募受試者時，有人認為政府或社會名人，不可鼓勵民眾參加試驗，因為會違反「臨床試驗受試者招募原則」。本文即分析此爭議及人體研究倫理審查委員會在審查招募廣告時遇到的相關疑義。我們發現對於招募原則的規範對象，以及參加研究意向的登記平台，存在一些誤解。因此，審查招募廣告的主管機關及人體研究倫理審查委員會應了解到，招募廣告是憲法所保障的言論自由範疇，在審查時要避免給予過度的限制。另外，為了釐清現行規範的疑義，並減少未來的誤解，本文也對「臨床試驗受試者招募原則」提出修正建議。

Recently there has been a controversy surrounding the Covid-19 vaccine trials recruitment in Taiwan. Some argue that the government and celebrities should not promote trial recruitment because it is against the regulation for recruiting study subjects for drug clinical trials. The authors analyze this controversy and the related issues presented to the Institutional Review Board (IRB) when reviewing recruitment advertisement. We found that the scope of recruitment regulation and the practice of recruitment through research subject pools may have been misinterpreted. Furthermore, reviewers of drug administration and IRB should be mindful that recruitment advertisement is protected by the freedom of speech, and should avoid placing unnecessary restrictions on it. To clarify the ambiguity in recruitment regulation and to circumvent similar conflicts that may arise, we propose to amend the current recruitment regulation.