(Strengthening Research Integrity with an Emphasis on Conflicts of Interest - Summary of Previous Report)

The openness and internationalization of research is advancing worldwide, and it is widely recognized that being open both domestically and internationally is essential for a vibrant research system. At the same time, there is a growing shared awareness of the negative impact of improper use of open research systems on national security through the likes of technology leakage as well as of the damage to the soundness of research systems.

Over time, the research community (In this report, the term "research community" refers to researchers and research institutions and their networks.) has been proactively developing research integrity for the advancement of science based on research freedom and openness. Additionally, in recent years, the ideal nature of research integrity in response to factors such as the deepening relationship between research and society has been explored. Alongside this, the government and funding agencies have supported the efforts of the research community.

Reviewing the ideal nature of research integrity and strengthening it in light of changes in the environment, such as the emergence of values different from those previously shared in the field of research up to this point, the shaking of the current system, and requests to reaffirm and restructure norms and rules, is necessary to ensure the soundness and fairness of research systems. This also contributes to addressing issues that include national security concerns.

Based on this concept, in the report published in October 2020 (previous report), we viewed research integrity as the maintenance of research vitality by ensuring the soundness and fairness of research environments through responsible actions by the research community, and recommended the following:

• To ensure that the vitality of research systems is not undermined by overly strict regulations, a proactive and constructive response by the research community to risks is desirable.
• Since a commonality among many problem cases is that they are related to conflicts of interest, it is necessary to strengthen research integrity with an emphasis on conflicts of interest (including conflicts of responsibility when no particular standards are being emphasized).

In doing so, the management of conflicts of interest can be broadly divided into the following two phases:

• (i) Thoroughly disclosing of information from researchers to research institutions to increase transparency and help reduce risks that lead to misconduct, etc. (Phase 1).
• (ii) Assessing risks at research institutions based on disclosed information and taking action as necessary (Phase 2).

For Phase 1, the uniform process is relatively easy regardless of the circumstances of each research institute. If procedures are appropriately followed, it can be implemented promptly at many institutes, and certain effects can be expected in a relatively short period of time.

On the other hand, with regard to Phase 2, it is necessary to respond to each case on an individual basis, taking into account the circumstances of each institution. Continuous efforts to enhance experience and capacity at each institution are essential.

In Japan, because of the need for rapid response:

• First, efforts in Phase 1 (thorough information disclosure) should be pursued with priority. Efforts in Phase 2 (risk assessment and response) should be pursued steadily on an ongoing basis,
• We recommended that measures to ensure thorough information disclosure be taken through means such as reviewing government guidelines.

In addition, it is important to indicate the type, scope, and other elements of information regarding conflicts of interest that should be disclosed in order to alleviate researchers' concerns and reduce the burden on them as well. To be more specific, in conventional information disclosure procedures concerning conflicts of interests at research institutions, emphasis was frequently placed on monetary interests. However, it was established that in the future, past and present positions and roles at other institutions and the details of support obtained from external parties, not just that in the form of research funding, could conceivably be enumerated using specifics (The scope of information disclosure regarding conflicts of interest should be expanded from the existing scope, and information disclosure that concerns the ensuring of the transparency of research, including response to potential conflict of interest risks, should be thoroughly implemented.).

(Domestic and international trends since the release of the previous report)

In Japan, the government, in the response policy that it decided on in April 2021, established that it would address conflicts of interest in the form of appropriate information disclosure by researchers themselves, the strengthening of management by universities, research institutions, and other entities, and confirmation at the time of application by public funding agencies, among other forms. In December, the government's guidelines on competitive research funding were revised based on that response policy, indicating the government's policy of thorough information disclosure, etc., in line with the recommendations in the previous report.

Additionally, outside of Japan as well, the strengthening of research integrity is being studied internationally by the G7, OECD, and other organizations, and is also being studied and addressed by governments, funding agencies, and research communities in the United States, Australia, Canada, and the European Union (EU). In many of these efforts, the view has been expressed that strengthening research integrity with an emphasis on conflicts of interest will also contribute to strengthening research security (In this report, the term "research security" refers to response to the risk of improper use of open research systems, which could damage the integrity and fairness of research systems, adversely affecting national security through the likes of technology leakage as research becomes more open and internationalized.).

(Aim of this report)

Thus, strengthening research integrity is an important issue in research systems. Simultaneously, in response to government policies, etc., preparations are currently underway at Japanese universities, research institutions, and other entities to proceed to the implementation of specific measures such as the establishment of regulations and management systems related to conflicts of interest.

Overseas, in the eighteen months since the release of the previous report, there has been further progress in studies and efforts by governments, funding agencies, and the research community to strengthen research security and research integrity.

In Japan, with regard to strengthening research integrity with an emphasis on conflicts of interest, since reference cases are limited to examples of conflict of interest initiatives in industry-academia collaboration, and there is no accumulation in terms of strengthening research security, it is considered appropriate to refer to overseas cases as well.

Active discussions by the research community and others on how to proactively address research security from the research side, with a focus on strengthening research integrity, are desired. To contribute to these discussions, we decided to conduct further research on trends in overseas governments, funding agencies, and research communities toward strengthening research security and integrity.

In doing so, in promoting measures such as the establishment of regulations and management systems related to conflicts of interest at Japanese universities, research institutions, and other entities, research was conducted with a particular emphasis on regulations and management systems at overseas universities based on the following:

• Cases in which independent efforts are being proactively made based on the recommendations of governments, requests from funding agencies, recommendations from university associations and other organizations, etc., in each country are considered as references.
• Examples of universities where students (undergraduate and graduate) are enrolled and play a wide range of roles, including educational ones, in addition to research are considered to be of reference not only for universities but also for research institutions and other entities.
• The structure of university governance, consisting of the President, Vice President (or Provost), department heads, and so forth, is common in some countries. Due in part to this, the management structure is considered to be relatively easy to grasp.

(Structure of this report)

The structure of this report is as follows: Chapter 1 provides an overview of the previous report, followed by an overview of recent domestic and international trends (since the fall of 2020, when the previous report was published) regarding the strengthening of research integrity with an emphasis on conflicts of interest. Note that in addition to the United States, Australia, the United Kingdom, and the EU, which were covered in the previous report, Canada, which has been strengthening its efforts, was newly included in the survey as well.

In Chapter 2, efforts by overseas universities concerning seven items that are considered to be basic elements for Japanese universities and research institutions to establish regulations and management systems related to the management of conflicts of interest in order to strengthen research integrity (e.g., parties to disclose information, information to be disclosed, timing of disclosure, method of disclosure, review system for disclosed information, penalties for failure to properly disclose information, and support for ensuring appropriate disclosure) are summarized as reference examples alongside associated points to keep in mind (summarized in Table 2.1.1 and Table 2.1.2).

Reference 1 details risks associated with openness and internationalization and trends in research integrity in each country/region since the release of the previous report in the fall of 2020 for the United States, Australia, the United Kingdom, Canada, the EU, and Japan (For Canada, which was not included in the previous survey, trends prior to the fall of 2020 are also included). (For Canada, which was not included in the previous survey, trends prior to the fall of 2020 are also included.) Reference Material 2 includes examples of efforts by the overseas research community, etc. that are considered to serve as a reference, such as guidelines by university associations and other organizations, examples of efforts by universities to manage conflicts of interest, and examples of efforts by funding agencies and other entities in the United States to manage conflicts of interest.

(For the future)

There is a growing international consensus that strengthening research integrity with an emphasis on conflicts of interest is an effective means of enhancing research security. Standard rules are by and large in the process of being established with regard to areas such as to whom information on conflicts of interest should be disclosed and what the content of such disclosure is. In Japan, it is necessary to steadily promote measures in the research community while referring to overseas examples as well.

On the other hand, with regard to the evaluation of risks based on disclosed information, although perspectives of evaluation and examples of conditions and restrictions upon implementation have been clarified, it is thought that judgments on management methods for conflicts of interest, such as criteria for judging risks in individual cases, are made based on accumulated knowledge from the experience of each university, research institution, or other entity. Common criteria for judgment, etc., have not been clarified.

The research community in Japan has just started to take initiatives to strengthen research integrity from the perspective of strengthening research security, and as such has little experience in this area. For that reason, it is desirable to enhance management capabilities by accumulating knowledge through collaboration and cooperation, such as by sharing experience pertaining to conflicts of interest as a research community, including cases that have been pending in international research cooperation at various universities, research institutions, and other entities. Since there are only a limited number of examples in Japan, collaborating and cooperating with overseas research communities is also conceivable.

In addition, since examples of cooperation between government security agencies and universities, university organizations, and so forth are visible in other countries, it is desirable that the Japanese government, from the perspective of effective and efficient management of conflicts of interest in universities, research institutions, and other entities to actively share information on problematic cases in terms of research security with the research community.

It is also important for each university, research institution and other entity to also strengthen its risk management and management/administrative capabilities based on enhanced research integrity in order to enhance efforts to strengthen security, including compliance with regulations on the likes of security export controls, the management of intellectual property, cyber-security measures, data protection, the management of non-Japanese visitors, and access management for facilities and equipment.