The Intersection of Consent to Participate in Research and Consent to Provide Personal Information in the Secondary Use of Medical Research Data: A Comparative Study Between Japan and Other Countries

Abstract

Secondary use of research data involves the issue of ensuring the trust of research participants in the use of their data. In Japan, informed consent, the primary mechanism for ensuring the trust of research participants, does not distinguish between consent to participate in medical research and consent to provide personal information to third parties. Not making a distinction between the two, which are historically different, raises the question of whether the research participantʼs consent for primary use can be considered consent for the provision of personal information to third parties.

In this paper, we examine whether consent to research participation and consent to the provision of personal information to third parties should be included in consent to research participation, based on the history of consent to research participation and consent to the provision of personal information to third parties, as well as the systems in each country. Then, with a case in mind in which a company receives health and medical data including sensitive personal information from a academic research institution or the equivalent and uses the data for the purpose of developing a product or service in a secondary way, we will discuss measures to be taken under the current Japanese laws and regulations from the perspective of balancing the protection of personal information and the use of research data, referring to the legal systems of other countries.