Inside CIOMS Interview

Since its creation in 1949 by WHO and UNESCO, CIOMS has evolved from a forum focused on a wide range of ethical topics and the upper- level foundations of biomedical research into a global body shaping guidance across research ethics, medicines safety and various aspects of medicinal product development.

In recent decades, CIOMS has also taken on board topics such as vaccines safety (e.g. CIOMS guidance on Active Vaccine Safety Surveillance, which had been issued before COVID-19), clinical research in resource-limited settings, patient involvement in medicines development and safe use, guidance on organ specific safety concerns (Drug Induced Liver Injury, 2020 and Severe Cutaneous Adverse Reactions, 2025) and pharmacoepidemiology in public health decision-making.

When CIOMS was founded, it focused on organizing various scientific meetings and publishing meeting reports and some substantial books. But over the years, CIOMS has broadened its membership and areas of activity. Its major activity today is its organization and management of its international expert Working Groups (WGs). These have served to strengthen its collaboration with stakeholders like academia, regulators and industry, and enabled the development of highly respected and internationally adopted guidelines.

Most CIOMS working groups (WGs) are typically composed of individual topic experts from academia, regulatory authorities, international organizations and pharmaceutical sector for profit companies. Because CIOMS itself is independent and non-regulatory, it can convene stakeholders who might not collaborate as easily elsewhere. Moreover, this stimulates solutions that are practical and balanced, rather than one-sided or purely academic.

CIOMS’ history informs its work today, by grounding it in consensus building, scientific rigor, and practical solutions that support regulators, industry, and public health systems worldwide.

Many WG participants have described their WG experiences in very positive terms, indicating a feeling of “achievement” and that they have made a “lasting impact”; that they have helped to “shape policy”. They value the high-level, open stimulating discussions” that typify WG meetings and the opportunity to build professional relationships that they can “carry back” to their organizations.

Most recently, organization of webinars has become an important element of CIOMS’ work programme. These introduce new WG reports or seek to raise awareness of an emerging public health issue.

CIOMS core mission today remains to advance public health through guidance on health research and policy including ethics, medical product development and safety. In the current global health landscape, CIOMS remains firmly committed to supporting ethical research and evidence-based health care.

CIOMS continuously analyses the evolving landscape of medical product development and regulatory science. In particular, it identifies areas where significant knowledge gaps exist, or for which clarity and consensus are lacking, and then works to develop guidance that addresses these gaps or that seeks to provide greater clarity and alignment.

Rapid change also means that we have to revisit our existing guidelines and, where necessary, update them. This was the case with our recent WG XII report on Benefit−Risk Balance for Medicinal Products (2025). The first CIOMS report on this topic was published by CIOMS WG IV in 1998. It was ahead of its time — guidance from other organizations started to emerge only several year later — but had become out of date by 2019 (although still interesting and valuable to read!) when the new WG XII started.

CIOMS operates with a small team and a highly streamlined governance structure. CIOMS’ Governing body, Executive Committee (EC) members, and its President and Vice-President, represent CIOMS member organizations. EC meets regularly (at least quarterly) to hear activity reports and help with strategic planning.

The Secretary General is responsible for exploring the feasibility of potential new working groups. The everyday work of running and setting up working groups is carried out by the secretariat, led by the Secretary General. During the past decade, CIOMS’ presidents have focused on supporting medicines research and development related work streams, whereas the focus of the vice-presidents has been on CIOMS’ ethics work stream. All mentioned above are accountable to the CIOMS General Assembly, consisting of representatives of CIOMS member organizations and meeting annually.

The starting point is the relevance of a potential topic. Preliminary ideas are worked through, both in terms of technical feasibility and the availability and of technical expert support from key stakeholders. If analysis by the secretariat is positive, a short concept paper is drafted. This is shared with the EC and, if approved, becomes the starting point for the secretariat to form a new CIOMS WG.

All CIOMS WG reports have impact, but perhaps the WG XII report on Benefit-Risk Balance for Medicinal Products and the WG XIV report on Artificial Intelligence in Pharmacovigilance will be the most influential. That said, the CIOMS International Ethical Guidelines for Health-Related Research Involving Humans was published in 2016 and continues to be used and cited very intensively. It is available in each of the 6 UN languages (English, French, Spanish, Arabic, Chinese and Russian, as well as Japanese, Polish, Portuguese and Ukrainian. Increasingly, new CIOMS new reports are translated upon publication into Chinese, and sometimes also into Japanese.

CIOMS ensures its guidance is adopted globally by developing it through broad, multi stakeholder working groups that include regulators, industry, academia, and public health experts from a wide range of countries. CIOMS also ensures that its reports are practical, implementable, and responsive to the real world needs of its major stakeholders. Since CIOMS guidance is consensus based, scientifically rigorous, and aligned with major regulatory authorities and WHO, it is readily adaptable to diverse systems.

CIOMS promotes uptake of its reports through active engagement with national regulators, regional and international regulatory networks, various international organizations of other stakeholders and its own global database of interested professionals (close to 40 thousand individuals today, and growing). courses. In addition to webinars introducing its WG reports, it develops e‑learning courses on selected topics

In more general terms we could say that looking ahead, CIOMS plans to address emerging ethical and regulatory challenges driven by scientific innovation and global health pressures. Key areas of involvement may include the responsible governance of advanced therapies and AI enabled health technologies, supporting ethical research related to medical product development, improving equity in global research, addressing organ-specific safety challenges, and enhancing pharmacovigilance for increasingly complex products.

CIOMS will continue to convene diverse stakeholders to develop practical, consensus based guidance that helps regulators and researchers navigate these evolving challenges. CIOMS has to consider taking on board regulatory science issues related to advanced therapy medicinal products (ATMPs), a category of cutting edge biomedical interventions that go beyond traditional small molecule drugs and biologics. Other potential topics include those involving therapeutic use of living cells, genetic modification, or engineered tissues designed to repair, replace, or modify biological functions. And finally, we may need to think how to address the issue of misinformation in science.