Linking the Declarations of Helsinki and of Taipei: Critical Challenges of Future-Oriented Research Ethics

Abstract

Expansion of data-driven research in the 21st century has posed challenges in the evolution of the international agreed framework of research ethics. The World Medical Association (WMA)’s Declaration of Helsinki (DoH) has provided ethical principles for medical research involving humans since 1964, with the last update in 2013. To complement the DoH, WMA issued the Declaration of Taipei (DoT) in 2016 to provide additional principles for health databases and biobanks. However, the ethical principles for secondary use of data or material obtained in research remain unclear. With such a perspective, the Working Group on Ethics (WGE) of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) suggests a closer scientific linkage in the DoH to the (Declaration of Taipei) DoT focusing specifically on areas that will facilitate data-driven research, and to further strengthen the protection of research participants.

Influence of transurethral enucleation with bipolar of the prostate on erectile function: Prospective analysis of 51 patients at 12-month follow-up

“…were 3 (5.9%) capsular perforations, which was higher than that of the previous study [7]. Contrary to the previous study, the IIEF-5 scores in all of the present patients did not worsen in the comparison of preoperative, 3-, and 12-month follow-up data: (5,6,6), (11,7,14), and (10,15,16), respectively. Because the number of cases in the present study was small, it is difficult to evaluate the effect of capsular perforation on EF.…”

“…363). This study complied with the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks [ 16 ]. We obtained written informed consent from all patients who participated in this study.…”

“…We evaluated maximum urinary flow rate (Qmax), postvoid residual urine (PVR), International Prostate Symptom Score (IPSS), quality of life (QoL), and International Index of Erectile Function-5 (IIEF-5) preoperatively and at 3-and 12-month follow-up. We classified the patients according to their preoperative IIEF-5 score into group 1 (IIEF-5 �10; n = 24) and group 2 (IIEF-5 <10; n = 27), and for further evaluation of EF, into subgroups a: severe (IIEF-5 5-7), b: moderate (8)(9)(10)(11), c: mild to moderate (12)(13)(14)(15)(16), d: mild (17)(18)(19)(20)(21), and e: no erectile dysfunction (22)(23)(24)(25). Data are displayed as median or median (interquartile range).…”

Declaration of Helsinki: ethical norm in pursuit of common global goals

“…Meanwhile, the European Union’s General Data Protection Regulation ( 4 ) and the proposed regulations of the European Health Data Space ( 5 ) seek to increase the potential for secondary use of personal data within a strengthened governance framework whilst guaranteeing individuals’ rights to control their data and increasing data portability. In such an environment, clarification of the link between the DoH and the DoT is essential ( 6 , 7 ). The DoT is not limited to the protection of privacy and data security.…”

Medical staff's perception of factors contributing to accelerated rehabilitation in patients with cervical spinal cord injury: A qualitative research

“…The study was performed following the Helsinki principles of Ethics (Kurihara, et al, 2020 ). The study was approved by the Ethics Committee of Capital Medical University (batch number: Z2022SY032).…”