Declaration of Taipei

Research on Health Databases, Big Data and Biobanks

The 麻豆果冻传媒鈥檚 (麻豆果冻传媒) Declaration of Helsinki provides guidelines for medical research on human beings. It aims to promote the ethical conduct of research and to protect human subjects from associated risks. The Declaration of Helsinki was the first set of international research guidelines that required research participants to provide informed consent.

However, research has been evolving since the Declaration of Helsinki was adopted. Large collections of data and human specimens allow for the development of new research strategies and models, as well as new predictive types of research and analysis. The combination of large amounts of data, the possibility of combining large databases and the application of information technology is already changing all aspects of our lives. Research is no exception.

The potential of such databases is vast, but so are the dangers. While there is a strong possibility of finding solutions, cures and remedies for a multitude of medical problems, illnesses and suffering, the challenge lies in the considerable risk of abuse and misuse of health databases and biobanks. We are convinced that the answer to this dilemma is to be found in an ethically correct process which takes into account the willingness and trust of those donating and sharing their data (or specimens) while acknowledging the obligation to apply high standards of protection.

The Declaration of Taipei tries to achieve a balance between the rights of individuals giving their tissue or data for research and other purposes based on confidentiality and privacy rules while at the same time recognising that health data has become a very powerful tool for increasing knowledge.

In analysing the scenarios that already exist for the use (and misuse) of health data and biobanks, we came to the conclusion that the major risk scenarios may not result from science, but from the commercial, administrative or political use of such data. Limiting our guidelines to research only would have left us blind to the imminent risk of abuse from outside the field of medicine: commercialization, cost-cutting and potential political abuse.

Therefore, in contrast to the Declaration of Helsinki, this policy aims to address any use of health databases and biobanks excluding individual treatment and is not restricted to research. As physicians are the primary custodians of confidential health information, they feel an obligation towards their patients and other persons who entrust them with their data and specimens.