On Digital Ethics. Interview with Jean Enno Charton.
“Digital ethics must be context specific. To bridge the operationalization gap, we must consider that digital ethics cannot be a one-size fits-all approach.“
Q1. What is your responsibility and your current projects as Director Bioethics & Digital Ethics at Merck KGaA?
Jean Enno Charton: As the Director of Bioethics and Digital Ethics at Merck KGaA, I’m responsible for addressing ethical considerations and questions that arise from rapid advancements in science and technology especially in areas of legal ambiguity and moral complexity. Merck as a leading science and technology company is perpetually at the forefront of pioneering new projects that redefine our offerings and customer interactions. Consequently, my responsibilities and projects are dynamic, evolving in line with Merck’s growth and the ever-changing scientific landscape. Over the recent years I have built up a team as specialists that works as sort of ‘in-house consultancy for ethics.
For example, we have to carefully evaluate which organizations we supply with our life science products, such as genome editing tools, to prevent potential misuse or abuse for unethical purposes. Other recent projects that I am involved in are related to stem cell research, human embryo models, fertility technologies, clinical research, donation programs, and others. My work also includes ensuring data and algorithms at Merck are used in ethically favourable ways that align with our values and principles. Here, we are frequently delving into ethical considerations surrounding AI deployment and data utilization in research and development, data analytics, human resource management and other areas.
In addition, we coordinate with two advisory panels that provide independent external guidance on how to use the scientific and digital innovations developed by Merck KGaA in a responsible manner. These are the Merck Ethics Advisory Panel for Science and Technology (MEAP) and the Digital Ethics Advisory Panel (DEAP). My team and I select the topics and experts for these panels and disseminate their recommendations.
Q2. Recent attempts to develop and apply digital ethics principles to address the challenges of the digital transformation leave organizations with an operationalisation gap. Why?
Jean Enno Charton: The operationalisation gap in digital ethics arises mainly due to the necessarily high level of abstraction of ethical principle frameworks vis-à-vis the granularity needed to answer day-to-day challenges that arise from data and AI use.
Ethical principles are typically formulated at a high level of abstraction. While these principles serve as essential compass points, they lack the specificity needed for practical application. Imagine a map with coordinates indicating the general direction but failing to provide street-level details. Similarly, high level ethical principles guide organizations but fall short when it comes to navigating the intricacies of real-world scenarios.
Moreover, digital ethics must be context specific. To bridge the operationalization gap, we must consider that digital ethics cannot be a one-size fits-all approach. Each organization context – whether it’s healthcare, finance, or human resources – presents unique challenges. In some instances, you may need geopolitical maps and in others you may want geographical maps.
Q3. What are the main challenges in translating high-level ethics frameworks into practical methods and tools that match the organization specific workflows and needs?
Jean Enno Charton: The primary challenge lies in the intellectual capacity required for such translation. In the realm of bioethics and digital health, ethical considerations are intricate and multifaceted, demanding a nuanced approach to each unique scenario.
Organizations must have the capability to create tools and methodologies that are fit for their specific operational needs. Careful planning is essential, entailing a strategic plan of integrating these tools into current systems with minimal interruption and optimal productivity. Furthermore, fostering inter departmental cooperation is crucial to overcome the common challenge of compartmentalization within organizations. Often, the resources necessary for such endeavors are scarce or inadequately allocated.
Additionally, digital ethics presents unique challenges that necessitate a fundamental shift from the traditional model of one-time advisory consultations. The highly automated and dynamic nature of project oversight, coupled with the scale and velocity of data analytics projects, calls for ongoing ethical engagement and innovative approaches to responsibility assignment. In dispersed data analytics teams, attributing ethical accountability is particularly difficult because individual responsibilities can become unclear. Consequently, there is an imperative for developing new methodologies for ethical assessment. These methodologies must be adaptable to the changing landscape and sufficiently nuanced to reflect the complexities of data and AI utilization.
Q3. You helped develop a risk assessment tool called Principle-at-Risk Analysis (PaRA). What is it? And how does it work in practice at Merck KGaA?
Jean Enno Charton: The Principle-at-Risk Analysis (PaRA) is a standardized risk assessment tool developed to bridge high-level ethics frameworks with practical methods and tools that align with specific workflows and needs. At Merck KGaA, PaRA guides and harmonizes the work of the DEAP, ensuring alignment with the company’s Code of Digital Ethics (CoDE).
How does PaRA work?
- Identification: The first step is to identify potential scenarios or decisions in the project seeking guidance from the DEAP where ethical principles could be compromised. These principles include privacy, transparency, fairness, and accountability. At the end of the process, the panel receives a list of potential conflicts between Merck’s CoDE and the project being investigated, enabling a comprehensive review of all relevant ethical concerns.
- Assessment: Once potential risks are identified, they are assessed based on their potential impact on ethical principles. The assessment considers factors such as the severity of the potential harm, the likelihood of occurrence, and the company’s ability to mitigate the risk.
- Mitigation: After assessing the risks, measures are implemented to mitigate or manage them effectively. This may involve adjusting processes, implementing safeguards, or providing additional training and guidance to employees involved in decision-making.
- Monitoring and Review: The PaRA framework emphasizes ongoing monitoring and review of ethical risks to ensure that mitigation measures remain effective. This includes regular audits, feedback mechanisms, and adapting strategies as new risks emerge or circumstances change.
- Integration with Decision-Making: Importantly, the PaRA framework is integrated into the company’s decision-making processes. This ensures that ethical considerations are taken into account when making business decisions, from strategic planning to day-to-day operations.
In practice, we have applied PaRA in various contexts, such as ensuring the comprehensibility of consent forms in data-sharing scenarios at Syntropy, a collaborative technology platform for clinical research. The tool can also be applied across various departments and functions, such as research and development or marketing.
Q4. How can ethics panels make an effective contribution to implementing digital ethics in a commercial organization?
Jean Enno Charton: Ethics panels can play a crucial role in implementing digital ethics in commercial organization by providing expertise, guidance and oversight in navigating complex ethical quandaries associated with digital technologies.
In corporate context of companies like Merck, internal ethics teams may be limited in size, hindering their ability to handle diverse ethical issues effectively. This is where external advisory panels come in by contributing diverse knowledge from technical fields, ethics, sociology, anthropology, and law. This diverse expertise is essential for addressing complex ethical conundrums in areas such as stem cell, patient consent, and AI in HR.
Ethics panels also act impartially in balancing commercial interests and ethical considerations ensuring fair outcomes.
They contribute to developing robust ethical policies and frameworks, drawing from their experience in policy formation, public consultation, or regulatory roles. DEAP, for instance, assisted in developing CoDE, PaRA, among other recent methodological advancements at Merck.
Panels are also well equipped to conduct risk and opportunity assessments to identify potential ethical concerns and prioritize appropriate countermeasures. This approach promotes a more humane technological landscape that aligns opportunities with ethics for a conscientious contribution.
Q5. Merck created a digital ethics panel composed of external experts in digital ethics, law, big data, digital health, data governance and patient advocacy. How do you handle conflict of interests and ensure a neutral approach?
Jean Enno Charton: To address potential conflicts of interests and maintain neutrality, the panel members are required to disclose potential conflicts of interest, affiliations with other organizations, or any other factors that might affect their impartiality. This disclosure is part of an agreement that panel members make with Merck during the recruitment process, ensuring a commitment to good faith actions.
Additionally, Merck employs a transparent selection process for its panel members. Candidates are meticulously chosen through a comprehensive process that prioritizes independence, breadth of expertise that is pertinent to Merck’s diverse portfolio, academic merit, diversity of viewpoints, and the capacity to accurately reflect the views pertinent to specific geographic regions as well as the interests of minority groups that are often underrepresented in ethical assessments.
Furthermore, our Code of Ethics and PaRA standardizes the panel’s activities, providing structured support in the decision-making processes, thereby ensuring the utmost neutrality and integrity in the panel’s operations.
Q6. How do you avoid the risk that an ethics panel will form an isolated entity within the company?
Jean Enno Charton: Avoiding the risk of an ethics panel becoming an isolated entity within a company involves a delicate balance of independence and integration. It is crucial for such a panel to maintain a certain level of detachment to offer unbiased independent opinions. Yet, it’s equally important to prevent the panel from becoming isolated. At Merck, we achieve this balance by fostering a sense of inclusion within both the Merck and scientific communities.
Our panel members, while not Merck employees, often have a long-standing relationship with the company. We ensure they are well informed about Merck’s activities and specific use cases, enabling them to offer valuable insights without internal biases.
To promote transparency, we communicate the panel’s activities, decisions, and recommendations within the company through minutes or other appropriate communication methods. This open communication helps other stakeholders understand and value the panel’s role, mitigating the risk of isolation. It also nurtures a sense of belonging and contribution to the broader scientific endeavor at Merck.
Q7. Can you share some details of a best practice you have developed using the PaRA tool?
Jean Enno Charton: One of the best practices we have developed using PaRA tool involves integrating it with other ethical frameworks, such as CoDE, and collaborating with experts including DEAP and my own team to ensure a comprehensive approach to ethical considerations.
It’s important to note that the PaRA tool doesn’t encompass all ethical aspects. Therefore, revisiting and reassessing the tool’s output is sometimes necessary to identify any overlooked or missed elements. This practice has significantly enhanced our effective utilization.
Q8. What are the main lessons you have learned?
Jean Enno Charton: One of the main lessons I have learned is the importance of scientific rigor in developing and implementing a risk analysis tool like PaRA. While a principled framework provides a foundation, it must be supported by rigorous scientific and ethical analysis to ensure its effectiveness and meaningfulness. This involves conducting thorough research, gathering relevant data, and engaging with experts in various fields to inform the development of the tool.
Another key lesson is the necessity of garnering support from senior leadership for the success of the tool. Without the backing of senior leadership, it would have been challenging – if not impossible – to develop and implement PaRA effectively.
Further, I have learned the need for flexibility and sensitivity to the specific needs of individual departments within the organization. While overarching ethical principles guide the development of the tool, it’s essential to recognize that different departments may face unique challenges and priorities. As such, the tool must be adaptable enough to accommodate these varying needs while upholding ethical standards consistently across the organization. This flexibility ensures that the tool remains relevant and applicable across diverse departments and scenarios.
Q9. How do you make sure that the recommendations developed on the basis of the Principle-at-Risk Analysis are really enforced and not ignored in practice?
Jean Enno Charton: From a governance perspective Our role is advisory rather than decision or enforcement. We aim to convince our collaborators to adopt the recommendations from the panels and implement the principles laid out in the Merck’s Code of Digital Ethics.
Departments and individuals bear the primary responsibility for adhering to these principles. However, we support department leaders in creating mechanisms for effective enforcement.
For instance, we have created a handbook-style self-assessment tool for project managers working with generative AI to identify and mitigate ethical risks during project development. Additionally, we have embedded semi-automated ethics assessment processes into existing project management structures within data analytics.
We also actively engage with department leaders to encourage follow-up and implementation of recommendations to ensure accountability and transparency. When recommendations are not feasible due to various constraints, we communicate the constraints to the ethics panel, valuing their input while outlining implementation barriers.
Q10. What are the challenges and limitations of such an approach?
Jean Enno Charton: A significant challenge of this approach is the voluntary nature of compliance. Unlike traditional compliance departments that enforce rules and regulations, we rely on voluntary adherence to ethical principles. While the voluntary approach elevates ethics to a higher moral standard, it also means that there’s no direct mechanism for enforcement. This voluntary aspect can pose challenges in ensuring consistent adherence across all departments and levels of the organization. This has also to do with the culture and code of conduct we live at Merck – a still largely family-owned company with a long-term, generationally-thinking approach on doing responsible business.
Qx Anything else you wish to add?
Jean Enno Charton: (WHAT’S THE BIG TAKEAWAY)
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Dr. Jean Enno Charton, Director Bioethics & Digital Ethics , Merck KGaA
Dr. Jean Enno Charton is Director Digital Ethics & Bioethics at Merck. After a brief stint in the biotech industry, he has been with Merck since 2014 – first in the Research & Development department of the Healthcare division (Medical Affairs), later as Chief of Staff of the Chief Medical Officer Healthcare. Since 2019, he has built up the independent Digital Ethics & Bioethics department and is responsible for the topic across all divisions.
Jean Enno Charton studied biochemistry at the University of Tübingen and obtained his doctorate in cancer research at the University of Lausanne; his research experience includes stays at the Canadian Science Center for Human and Animal Health and Harvard Medical School.
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