Abstract
Governance defines all the political and administrative aspects of an authority that manage a country’s affairs, according to the Committee of Experts on Public Administration (2006). This includes the different institutions, processes and methods used by citizens and groups of individuals to formulate their interests, exercise their legal rights, meet their obligations, and arbitrate their disputes. Thus, science governance usually describes a global organization with a well-defined structure aiming to facilitate a desirable feature set. Many people would probably align on which are the functions that are desirable, and that structure somehow shapes the functions, meaning that this system can be dynamically driven (Lubell 2021).
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1 Historic and Definition of Terms
Governance defines all the political and administrative aspects of an authority that manage a country’s affairs, according to the Committee of Experts on Public Administration (2006). This includes the different institutions, processes and methods used by citizens and groups of individuals to formulate their interests, exercise their legal rights, meet their obligations, and arbitrate their disputes. Thus, science governance usually describes a global organization with a well-defined structure aiming to facilitate a desirable feature set. Many people would probably align on which are the functions that are desirable, and that structure somehow shapes the functions, meaning that this system can be dynamically driven (Lubell 2021).
Before the late 1960s, the regulations were performed case-by-case depending on the issues encountered at a specific time by the scientists and the general audience. Then a new the era of the prospective rule making was developed. At that period, regulatory agencies started to sharpen policy prescriptions that are called rules and that only differ from laws by the way they are developed. Laws and regulations appeared to be complementary: without a law, the rule would be illegal and not applicable in the courts, without a rule, a law would remain a meaningless declaration (Schmandt 1984). Some episodes in the last century led to precise the regulation concept such as the first In Vitro Fertilization (IVF) in 1978 which divided the thoughts of the public audience bringing morality and religious concerns into the debate. As an example, the first UK regulatory committee, composed of individuals from diverse horizons and not only from the scientific community, became responsible of choosing between prohibiting embryo research for moral reasons and allowing it to help science develops. One of the first rules was then to allow live embryo research but only during 14 days after fertilization, this rule also led to the implementation of the Human Fertilization and Embryology Authority (HFEA) that monitors research and clinical procedures. Beyond private morality, those decisions are a strong need for the public and could influence the whole society. From this, standards emerged, trying to balance potential harms and benefits for the community, while avoiding the risk of the individuals’ exploitation.
The lessons learned from IVF were applied later to other scientific areas such as embryonic stem-cell research, therapeutic cloning, mixed-species embryo construction, etc. (Warnock 2007).
2 Governance and Regulations in Science Today
Starting with the Nuremberg Code written beside the trials of Nazi “doctors” after the Second World War, and which described ethical principles on human experimentation such as obtaining the signed informed consent from the individuals or the fact that each human experimentation must be preceded by animal ones, international regulations have developed quite fast during the last century. Many noteworthy texts have been prepared like the Helsinki Declaration in 1964, the Animal Welfare Act of 1966 or the National Research Act of 1974, which made institutional reviews mandatory by asking the research centers to establish Institutional Review Boards (IRBs) for conducting research projects within an institution (Silberman and Kahn 2011).
IRBs are meant to review, approve, or disapprove research proposals based on the benefits and risks associated with the projects.
Very specific organizations emerged during these decades like for example the creation, in 1969, of the International Health Regulations aiming at coordinating and linking specific actions in different countries to fight infectious diseases. Those regulations were expanded and reviewed in 2005. IHR requires countries to implement core public health capacities such as legislation, policy and financing, risk communication, surveillance, laboratory, or human resources.
More largely, worldwide institutions such as the World Health Organization (WHO), the Food and Drug Administration (FDA) or the International Standards Organization (ISO) then dictated regulations or implemented standards through the years that are now being used in a large majority of countries and institutions in science and in medical areas.
3 A New Facet of Governance and Regulations: Digitalization in Science and Healthcare
Digital health technologies represent a unique opportunity to enlarge health coverage, strengthen patient care and develop research, using robust and efficient systems. This must be performed under the dome of legal and ethical regulations and policies to keep the healthcare systems and human research fair, trustworthy and accessible to everyone.
Digital innovations are part of the current healthcare system and our daily lives, this raises challenges on building robust frameworks for storing the different types of data (imaging, genetic reports, clinical information, etc.), accessing and sharing data involving many stakeholders, consenting patients, and protecting patients’ privacy. Datasets must also be linked together using a common language and an open communication between the different parties to build a trusty relationship and empower the users (Brall et al. 2019).
With the healthcare systems and human research’s digitalization, multiple risks exist regarding the patients’ privacy, including the access to their identities and medical information, that can jeopardize an individual’s accountability or employability. Some of the data can indeed be traded by data brokers to pharmaceutical companies or insurers, which can severely impact a person’s life based on algorithm predictions on their potential sickness or propensity scores to assess if the person will choose a medication or another.
Related to these threats, public organizations such as the Europe’s General Data Protection Regulation (GDPR) oversee the treatment of personal data (genetic information, biometric data, and health data) and are constantly establishing and reviewing specific consents for the use of personal data as well as anonymization or de-identification processes to keep the patients protected.
4 Near Future Improvements and Challenges
The governance and regulations landscape today, even if well implemented, accepted, and followed worldwide, remains disparate. Currently, some developing countries are still in need to develop basic health-system functions. Some examples have shown as well that the medical equipment is often worn out or not up to date which leads to data encryption or misconfiguration issues. Artificial intelligence can be used as a benefit but can also become a harm depending on its use and can threaten the digital health systems.
Cybersecurity must then be fully integrated into nowadays research and healthcare but also represents a non-negligible cost for the hospitals and research teams as well as for the governments.
The United Stated of America (as an example of well-developed countries) also faces some challenges like the broadening of regulations in private health care units which is still largely different from one to another. In Europe, research standards, protocols and guidelines are still missing in many places for example regarding reporting and disease notification (Suthar et al. 2018). Concrete examples such as eastern and southern African countries (Juma et al. 2021) have shown that some nations are still in the process of implementing health research legislation like in Botswana or Uganda.
Health research governance is essential to build a robust health research system. However, improving governance in science and health is relatively new compared to the strengthening of health science research capacities.
Some challenges that the countries are facing are usually the fact that only short-term improvements are made because of insufficient fundings for governance missions, discrepancies between research priorities and research fundings or a lack of coordination between the different stakeholders and the health research capacities. In some regions, developing new health research policies takes time and most of the current existing ones are outdated.
The creation or the strengthening of national research authorities is and will be essential in the future for the countries which still need them so far to enhance the sustainability of the operation of the governance system. Legal frameworks and effective resources are also one of the keystones to maintain research improvement.
Through the recent history, governance and regulations in science have shown their efficiency to keep experimentations safe and respectful of the society while helping to move forward the scientific findings. To help continuing this way, national and international authorities will have to keep up with according their rules to the constantly evolving environment and morality.
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Ferry, N., Hofman, P. (2024). Governance and Regulation Specifics. In: Kozlakidis, Z., Muradyan, A., Sargsyan, K. (eds) Digitalization of Medicine in Low- and Middle-Income Countries. Sustainable Development Goals Series. Springer, Cham. https://doi.org/10.1007/978-3-031-62332-5_22
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