• MATSUI Kenji
  Division Chair, Division of Bioethics and Healthcare Law, Institute for Cancer Control, National Cancer Center Japan

Patient and Public Involvement (PPI), which emerged from healthcare system reforms in the United Kingdom, initially addressed medical care situations such as hospital management policy decisions, the development of clinical practice guidelines, and drug pricing. By around 2006, however, its scope expanded to include research. Today, PPI is widely incorporated in clinical research policies and systems, playing a role in various stages including the formulation and evaluation of research policies, as well as the application for and review of public research grants. PPI policies in clinical research emphasize the approach of conducting clinical research “with” or “by” patients and members of the public, and establishing and promoting systems to support this approach.

The global trend of promoting PPI in clinical research, which originated in the United Kingdom, has also reached Japan and gradually taken hold in recent years. For instance, the Japan Agency for Medical Research and Development (AMED) states at the beginning of its ‘Calls for Proposals’ for different programs that: “It is essential to actively share with the society the significance and societal benefits of medical research and development, to ensure that research outcomes are aligned with societal needs by incorporating Patient and Public Involvement (PPI) from the planning stage of R&D, and expand collaboration between researchers, patients, and the public based on equal partnerships. (...) AMED programs promote PPI initiatives that enable researchers to integrate patient and public perspectives into their medical research and development processes.” Applications for R&D plans have a column to provide information on PPI. Also, this RInCA Program clearly emphasizes that “Proposals for this program should, (...) in principle, be tackled through concrete cooperation and collaboration with R&D sites, stakeholders and communities.” In fact, in our research project in the RInCA of the “ELSI on the clinical research for treating the fetal-maternal complex”, a program advisor has commented on the project during a site visit: “I hear that you are planning to develop some kind of guidelines or recommendations for fetal treatment research, but this would certainly require social acceptance from a political perspective, and some backlash can be expected. How do you plan to disseminate this idea to the general public?"

In general, it is true that research and innovation in many cases require discussion and dialogue for social acceptance and consensus building, involving the public as key stakeholders, because their social implementation can have far-reaching impact on the livelihoods and lives of the "general public”. Autonomous drone taxis are a case in point. However, in clinical research in the medical field, especially in clinical research that is not well known to the public and that deals with extremely sensitive issues, and when the technology developed is implemented in society, the stakeholders directly affected would be limited to patients and those close to them - such an example is the research on fetal treatment, where issues of the freedom of pregnant women who do not have access to research and the freedom to choose abortion are intricately intertwined - the voices and general views of third parties such as "ordinary citizens" and "society" can go beyond mere irresponsibility and sometimes assume an extremely violent nature for the stakeholders. In other words, an influx of heavy-handed “concerns” and “objections” from civil society can place additional strain on already limited research resources. Such reactions may also exert implicit pressure on ethics review committees, potentially leading to further delays in the research process.

In addition, in clinical research, it may also be important to draw attention to the ways in which referring to all individuals collectively as "patients" in discussions of patient involvement can take on a violent character. While patients are often seen as vulnerable, the term itself encompasses a wide range of realities. Some patients organize a patient organization, actively engage in policy-making and research planning to raise their voices (in a sense, the "empowered among the vulnerable"). Others, despite their willingness to do so, remain unable to voice their needs or even access opportunities for involvement, placing them among the "vulnerable of the vulnerable”. Furthermore, there are individuals - such as fetuses with medical conditions - who may be considered “the most vulnerable of the vulnerable” because they are not even recognized as members of society, let alone as stakeholders, although they are directly affected. In a social climate that celebrates and powerfully promotes PPI, these most vulnerable people risk being further marginalized, sometimes violently, with their existence and interests ignored.

Therefore, I do not believe that PPI, by its very nature, is something that should be promoted without reserves. However, within the fields of bioethics and ELSI, there appears to be a lack of sufficient reflection on the potential violent or morally problematic aspects inherent in the PPI itself. I have suspected if this oversight might somehow be related to the lack of deep insight into the "E" - the ethical dimension - in much of the recent discourse on ELSI. I wonder if it would be just me who feels this way, or is this just a needless worry?

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