2005 Fiscal Year Final Research Report Summary
Comparative Pragmatic Study on Ethical and Legal Problems regarding Medical Use of Human Bodies
| Project/Area Number |
15530078
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
New fields of law
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| Research Institution | Kobe University |
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Principal Investigator |
MARUYAMA Eiji Kobe University, Graduate School of Law, Professor, 大学院・法学研究科, 教授 (10030636)
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| Project Period (FY) |
2003 – 2005
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| Keywords | informed consent / research ethics committee / biobank / personal information protection |
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| Research Abstract |
1.In this research, I studied ethical and legal problems of the use and utilization of human bodies in terms of (1)informed consent, (2)research ethics committees, (3)research resource banks and biobanks, (4)protection of personal information, (5)property rights and intellectual property rights in human cells and tissues, (6)consent requirements for organ donation for transplantation, based upon the investigation of developments in the United States and Japan.
2.My research concerning the topics (1)through (5)was largely based upon my involvement in biobank and cohort research projects or a research resource bank program as an ELSI/ethics committee member or an ethical/legal advisor. Major problems and observations that attracted my attention include : (a)the subjects' ability to understand the genomic research and biobank, i.e. that some, or perhaps, most prospective participants might not really understand the full significance of the subject to which their consent is requested ; (b)that researchers might not be able to project the every detail of their study plan that is necessary for them to provide the specific image of the research to prospective subjects ; (c)the difficulty of striking an ideal balance between ensuring the voluntariness of subjects and efficient implementation of the research. These problems are theoretically difficult and I will endeavor to find systematically consistent explanations. However, I think that they will be solved rather easily in practice if researchers can win the trust of people. If people trust researchers, the research projects (including biobanks) release freely the information on the developments of their program and the subject are assured of their right to retract their consent any time, I am rather confident that they will rarely exercise their right to retraction.
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