Return of Genetic Research Results: The Japanese Experience and its Implications for the International Debate

Abstract

In conducting medical and genetic research an ethical dilemma is faced as to whether individual genetic research results should be disclosed where such results may be relevant to the consideration of an individual’s health and medical care. Japan’s participation in this debate has yielded no consensus on policy as yet but has influenced the establishment of certain national guidelines. Japan established principles in 2000 that emphasized participants’ rights to know their genetic research results, and incorporated this policy into governmental guidelines for genetic/genomic research in 2001, as the stance of in principle. The newly-revised guidelines in 2013 retained the in principle, and added stipulations regarding disclosure giving a greater role to researchers in creating disclosure policies of genetic research results. The process of their revisions was strongly influenced by the Act on the Protection of Personal Information 2003. This article considers the management of clinically significant findings in the context of the revision of the genetic/genomic research guidelines. We argue that the governmental guidelines based on the Act have the potential to give rise to practical and ethical challenges, which suggest the clear need for additional mechanisms for governing disclosure decisions. This method includes that the revised Guidelines can be interpreted to permit genomics researchers to adopt more active research disclosure policies with more participant-focused ethical consideration. This is consistent with researchers’ ethical responsibilities to carefully consider the rights and interests of research participants to ensure the public’s trust and confidence in research is maintained. The Japanese experience has implications for the international debate, as there is, as yet no clear and agreed guidance for researchers determining policies on the return of research results in other countries.