Issues Concerning Clinical Research Using Human Pathologic Bioresources in the Biobank Era

Inoue, Hikari; Tsuruyama, Tatsuaki

doi:10.19070/2332-287x-1500043

Cited by 2 publications

(2 citation statements)

References 13 publications

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“…Because this template is designed for the government-funded MGSP and the government has been developing national genome databases and biobanks, the value of the registration of data and samples to public databases and biobanks is emphasized in two sections of the information sheet. The term ‘disclosure of the results of genetic analysis’ refers to terminology used in the revised Genome Guidelines 2013, which follows the Protection of Personal Information Act 2003 ( Inoue and Tsuruyama, 2015 ). In legal terms, researchers should disclose the results of genetic analysis at request of the research participant, regardless of whether the participant can fully understand the meaning of the results.…”

Section: Japanmentioning

confidence: 99%

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

Yoshizawa

Sasongko

et al. 2017

Front. Genet.

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The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases.

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Section: Japanmentioning

confidence: 99%

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

Yoshizawa

Sasongko

et al. 2017

Front. Genet.

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show abstract

“…The current authors previously reported on ethical guidelines in Japan for the use of human samples for research purposes [1,2]. In Japan, Ethical Guidelines for Medical and Health Research Involving Human Subjects (EGM) have been established primarily by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labour and Welfare, and applied research in which human samples are used [3].…”

Section: Background Informed Consent In Forensic Autopsiesmentioning

confidence: 99%