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

Abstract

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.

Equitable Participation in Biobanks: The Risks and Benefits of a “Dynamic Consent” Approach

“…Some groups have different views as to who can appropriately provide consent, which may diverge from the Western individualist notion of autonomous decision-making. Collective (family or community) engagement, recruitment, and consent has been utilized in settings including some indigenous communities [e.g., Australia, New Zealand, and Alaska ( 29 )], southern Africa ( 28 ), and East Asia ( 31 – 33 ). Where research focuses on a specific community, the International Society for Biological and Environmental Repositories endorses community participation in planning for the study and consent processes, specimen use and dissemination of research findings ( 34 ).…”

Meaning of Ambiguity: A Japanese Survey on Synthetic Biology and Genome Editing

“…However, as emerging biotechnologies have a broad influence on many facets of society, it has become more important to assess the social implications by conducting research to identify public attitudes regarding the early phase technology development (Guston and Sarewitz, 2002). Despite the current established regulations and agreements, certain ethical, legal, and social issues need to be addressed to reflect regional, national, and global contexts (Yoshizawa et al, 2014(Yoshizawa et al, , 2017Minari et al, 2018). Particularly, it is controversial how to practically apply germline genome editing for humans and the natural environment.…”

Globalisation and the Ethics of Transnational Biobank Networks

“…Issues surrounding consent in the context of the globalisation of biobanks are made more complex by differences in values across different cultures. For example, an analysis of consent forms in East Asia found that they performed a broader social and communicative function than comparable documents from genomic research projects in Europe, the UK and Africa (Yoshizawa et al 2017). This reflects earlier findings that in East Asian countries, informed consent is more of a collective process than an individual one (Yoshizawa et al 2014), with significant involvement of participants' family and community members in the decision making process.…”

“…Another consideration is that the imposition of UK standards for safeguarding patient data leads to a more individualistic emphasis on participant rights. This does not necessarily align with the tendency of East Asian countries to emphasise the broader societal benefits of participating in genomic research (Yoshizawa et al 2017).…”

“…They were also motivated by an interest in contributing to scientific research, which reflects a general trend observed in East Asian countries, where researchers have been observed to have a tendency to emphasise the virtue of participating in medical research for the purpose of advancing medical and scientific knowledge (Yoshizawa et al 2017). The ethical issue here is how the transnational activities of biobanks such as the CKB flow to the subnational realm.…”