Navigating the Society-driven Research: PPI and the Quest for Research Integrity Associate Professor, Graduate School of Global and Transdisciplinary, Chiba University Jin HIGASHIJIMA

No matter how noble the purpose of a research project, it does not always have a positive social impact. If issues stemming from research and development are left unaddressed, they could lead to uncomfortable social consequences. So, what is needed to ensure that research and society work together to create a better future? We spoke with Associate Professor Jin Higashijima of the Graduate School of Global Transdisciplinary Studies, who has been exploring this question from two key perspectives: Patient and Public Involvement/Engagement in Research (PPI/E) and Research Integrity.

What is PPI/E?

Please tell us about your research

In short, I engage in research on what constitutes ‘good research.’ There are various approaches to the question. For example, some may explore it philosophically, asking questions like, “What is ‘good’?” or “What is the ideal form of research?” My focus is on What is good research for both society and science and How can develop ecosystems in Japan that foster such research.

For example, in medical research, ‘good research’ might be defined as research that minimizes societal harm while delivering significant benefits. However, I am not trying to define ‘good research for society.’ Instead, I aim to develop opportunities and systems for everyone in society to engage in that conversation.

What does your research focus on?

I have two main areas of focus. One is PPI/E in biomedical research and development, and the other is research on ‘Research Integrity and Research Ethics,’ which applies across all fields of study.

‘PPI/E’ is an unfamiliar term…

In the past, the mainstream view was that medical research was a domain where researchers and medical professionals acted as decision-makers, determining the best course of action. However, with changes in thinking in Europe, the United Kingdom, the United States, and elsewhere, people began to consider that the quality of research could be improved by incorporating the perspectives and values of non-specialists, including patients.
The concept of the term PPI/E emerged from these trends. PPI/E goes beyond involving patients and/or the general public as research subjects or promoting conversations between healthcare professionals and patients. It emphasizes actively incorporating their perspectives and values into the research and development process. Perhaps the term “co-creation”, which has a similar meaning, is more well-known.

In Japan, the Japan Agency for Medical Research and Development (AMED), which provides grants for medical research and development, launched a National and International PPI/E Trends Research Committee in 2017. As a member of the committee, I worked with other members to investigate the situation of PPI/E in Japan and overseas and contributed to the official definition of AMED’s PPI and PPI guidebook.

As the AMED’s PPI Guidebook was published only five years ago, in 2019 (English version in 2022), the concept of the PPI/E remains relatively new in Japan. Consequently, many people in Japan may still be unfamiliar with PPI/E at the moment. However, some people had been putting the concept of PPI/E into practice in Japan even before AMED officially defined the term. These individuals, including researchers, medical professionals, and advocates, have long been working to incorporate patient and public involvement in their fields.

Engaging in discussions with people from diverse backgrounds, while keeping both the present and future in mind

Do you mean that researchers and healthcare professionals have traditionally determined what qualifies as good research, but now they are beginning to consider what constitutes good research from patients’ perspectives?

Yes, but it is not as straightforward as just saying, ‘research and development for patients.’ We are all different, and we all perceive things differently. For example, while some people place particular importance on the development of gene-editing technology that can eliminate a specific disorder in children, others may value different types of technology development. Furthermore, some people with such conditions may feel as if their existence is being invalidated by this development.

While certain therapies and/or treatments may be significantly beneficial for patients, their high costs can raise questions about societal responsibility and the extent to which can be covered by health insurance. Thus, we must also consider not only the current needs of patients and society, but also the long-term impacts of these science and technology.

What is important is ensuring that people from diverse backgrounds and perspectives participate in discussions about how research and development could be taken forward, how the public might respond to the results, what kind of future would be good for us, and what steps are needed to make the future a reality. I regard PPI/E as a ‘tool’ for minimizing Ethical, Legal, and Social Issues (ELSIs) that may arise from health research, and for addressing them quickly when they occur. As a PPI/E researcher, I am currently collaborating with researchers, practitioners, patients, and members of the public to create a variety of PPI/E opportunities to establish an effective PPI/E ecosystem in Japan.

Plagiarism, fabrication, and data falsification undermine the credibility of science

Please tell us about another research topic: research integrity

When plagiarism, fabrication, or data falsification occurs, the research can no longer be considered ‘good research.’ Not only will the results be unreliable, but they will also disrespect the feelings and efforts of those who contributed to the research, and the funds used will be wasted. Furthermore, such misconduct can undermine society’s trust in the research community as a whole, preventing the research findings from being applied to practical use. Once trust in research results, the research community, and the research process itself is lost, it can have serious negative consequences. This is why I am focusing on strategies to mitigate these problems and ensure that research is conducted in a responsible manner.

My original specialty was experimental psychology, a field that aims to understand human and animal behavior, as well as brain functions, through experiments. Psychology is known for having many studies with ‘low reproducibility’―meaning that even when experiments are conducted in the way described in a paper, the results may not match the original findings.

Part of the reason behind this is the so-called ‘post-hoc hypothesis,’ which is common in some fields of psychology. Suppose an experiment is conducted to test hypothesis A. If hypothesis A is not supported by the result, the researcher might then create hypothesis B, which aligns with the experimental data, and write the paper as though the experiment had been designed to test hypothesis B from the beginning.

The prevalence of post-hoc hypotheses leads to a large number of papers supporting hypotheses that have not been tested, and this reduces the credibility of the field as a whole. However, because it is easier to publish papers if you post-hoc a hypothesis in many cases, we cannot expect the number of researchers using this inappropriate method to naturally decrease.

Creating a scheme to evaluate ‘good research’

It seems impossible to identify whether a hypothesis is post-hoc simply by examining the published paper. Is there a way to reduce inappropriate behavior that is not being visualized?

The first step is to educate researchers about ‘good (or bad) research practices’ at an early stage in their careers, for example, during graduate school. In addition, faculty members responsible for teaching must regularly update their awareness. Before that, it is necessary to organize and visualize the fundamental research practices that are common to or specific to each field and method. There are considerable differences in awareness and practices among researchers.

The other thing is to change the dynamics within research communities. From the perspective of verifying reproducibility, it would be better if more academic journals encouraged the publication of papers that “report findings that cannot be reproduced using the same methods.” Of course, it is not desirable to publish all research without any screening, and careful discussion is necessary.

Systems for registering hypotheses before conducting research are also becoming more widespread in some fields of research. This is a system that allows you to see whether registered hypotheses have been verified or not.

It would be even more effective to include pre-registration in the guidelines for submitting papers.

While the number of academic journals supporting this practice is increasing, it remains challenging to determine what constitutes good research practices versus inappropriate ones. To address this issue, we are currently engaged in research to clarify what constitutes multiple submissions and plagiarism for example, by conducting a large-scale survey of the submission and author guidelines for academic papers in Japan.

Please tell us about your prospects.

Many people are still unfamiliar with practices like PPI/E or research integrity, and some do not see these as pressing issues. A significant challenge lies in how to raise awareness about these topics specifically in encouraging the public to participate in PPI/E activities, rather than merely addressing what actions to take. I hope that by having conversations and giving lectures to students at Chiba University, I can contribute to making progress in this area.