Abstract
As evidenced by high-throughput sequencers, genomic technologies have recently undergone radical advances. These technologies enable comprehensive sequencing of personal genomes considerably more efficiently and less expensively than heretofore. These developments present a challenge to the conventional framework of biomedical ethics; under these changing circumstances, each research project has to develop a pragmatic research policy. Based on the experience with a new large-scale project—the Genome Science Project—this article presents a novel approach to conducting a specific policy for personal genome research in the Japanese context. In creating an original informed-consent form template for the project, we present a two-tiered process: making the draft of the template following an analysis of national and international policies; refining the draft template in conjunction with genome project researchers for practical application. Through practical use of the template, we have gained valuable experience in addressing challenges in the ethical review process, such as the importance of sharing details of the latest developments in genomics with members of research ethics committees. We discuss certain limitations of the conventional concept of informed consent and its governance system and suggest the potential of an alternative process using information technology.
Highlights
The completion of the Human Genome Project (HGP) has brought about a dramatic advance in the life sciences, especially genomics (International Human Genome Sequencing Consortium 2004; Green et al 2011)
Based on a consideration of the Japanese context, we describe in this article the approach and experience in formulating the research policy of the Genome Science Project (GSP)—especially with regard to a suitable informed consent form (ICF) for personal genome research
We found that several investigators supported by the Medical Genome Science Program (MGSP) did encounter some difficulties in obtaining research ethics committee (REC) approval
Summary
The completion of the Human Genome Project (HGP) has brought about a dramatic advance in the life sciences, especially genomics (International Human Genome Sequencing Consortium 2004; Green et al 2011). Combining the advantages of these domestic documents and foreign documents and policies that incorporated personal genome research, we came up with a draft of a model ICF template for the MGSP that was in accordance with both Japanese government guidelines and international norms and guidelines We believed that this approach would be beneficial in formulating a national standard that adhered to international standards. The email-based forum played a role in concrete considerations related to the ICF template and involved detailed, specific modifications to the document This system worked effectively toward rapidly reaching a consensus on research policy within the MGSP: the leaders of the MGSP and GSP actively took part in the process and increasingly recognized the importance of ethical aspects in personal genome research. The consensus regarding the research policy of the ICF template for MGSP applicants consisted of the following five key issues (Table 1): research purpose; collaboration with external institutes; data sharing; withdrawal of consent; and risk assessment and management. With regard to data sharing, there were notable difficulties in effecting an appropriate system since this was the first attempt to introduce two access levels (open-access and controlled-access levels) into informed-
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