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How can a profit organization manage its business ambitions and simultaneously safeguard research integrity? How to maintain the delicate balance of interests in an academic-business collaboration? What are the non-financial conflicts of interests we need to look out for?
With these questions in mind, On December 1st, the last Research Integrity Round of the year was held online. Around 300 people registered for the event, including 100 PhD students. Three panelists joined the audience to discuss the challenges of collaborating with profit and non-profit organizations.
Tanya Sluyter, a former immunology researcher, currently working at the pharma giant Novartis as the Head of Ethics, Risk and Compliance. Prof. Carel Hoyng is a professor at the Department of Ophthalmology at Radboudumc and an entrepreneur. He shared insights into how he combines his academic and business roles and how to detect and avoid complicated conflicts of interest. Prof. Lex Bouter is the former rector magnificus of Vrije Universiteit (VU) Amsterdam and current professor of Methodology and Integrity. He was among the writers of the Netherlands Code of Conduct for Research Integrity and is the chair of World Conferences on Research Integrity Foundation.
Ethics and risks in big pharma
After receiving her master's in biomedical sciences, Tanya Sluyter had the chance to work in various positions and learn from the challenges and conflicts unique to each position. She was once a lab researcher and battled with experiments she couldn’t reproduce—that sounded familiarly frustrating to most of us. Then, as a product specialist for cardiovascular products, she had to do much more communication, convincing, and marketing. Things that Ph.D. life does not prepare us for. Then the questions looked more like this: When marketing a product to doctors, should I always mention the side effects or only if the doctor asks? There is revenue on the line here, but also integrity.
Tanya also stepped into entrepreneurship with a startup biotech company on cystic fibrosis treatment. She later worked several years as a clinical research manager, monitoring the trials of new drug candidates. Since 2006, she has been in Novartis and since 2018, in her current role as the Head of Ethics, Risk and Compliance. But what does that title even mean? She describes it as “embedding ethical decision making into our DNA, increasing our risk awareness and engaging risks in the right way” that would ultimately translate to better patient and business outcomes.
Achieving this in a company like Novartis is tricky. The aim is to make sure the company always puts the patients first, engages appropriately, acts with clear intent, funds responsibly, and does research for the right reasons. High ethical standards and ambitious business objectives mean that Tanya and all her colleagues need to decide on ethical dilemmas daily.
The audience questioned how Novartis involves patients in decision-making. The answer is to include the patient groups as early as possible through patient advisory boards. The typical drug development process lasts more than a decade, and patient input is important at every step. Tanya thinks that this is the general trend across the industry nowadays.
However, an interesting point was made by fellow panelist Carel Hoyng: We need to be careful about involving patients too much. Don’t they have a conflict of interest?
Juggling business and academia
Apart from his role as professor, Carel has experience running both investigator-initiated and company-initiated trials through his business. Clinical trials, especially in later stages, can be pretty expensive to set up. Think of a multicenter trial focusing on a rare disease. This is highly unlikely with general funds. There, the industry can step in. However, this means new conflicts of interest. A neutral coordinating company/foundation is needed to prevent conflicts of interest (COIs).
Carel clarified that the industry collaborator should not be involved in the research process run by the neutral foundation. They can be involved by contributing opinions to a draft perhaps, but other than that, no influence, confirms Tanya.
COIs, however, are not always financial. How to handle non-financial COIs? Should we always be transparent about them? Carel’s answer was not clear-cut, as it is always with ethics. For instance, he is an advisor for some companies that invest in pharma. He doesn’t usually include this as a COI in his professor position, but he makes sure that Radboudumc is aware of everything. He adds, “Being transparent is not all of it. You should avoid creating certain COIs from the beginning.’’
His double role in academia and the profit world is delicate to balance. He advises the audience always to be critical but not too critical. Because companies need to work with university hospitals, that delicate balance is worth keeping. Carel remarks: “In research, we give the information we produce for free. The pressure of metrics like the impact factor is making publishing even hastier. We don’t market our intellectual property well. So, the industry and us academics can complement each other well.”
Is value-free science possible?
COIs are not only interesting for Carel Hoyng. Lex Bouter also has his focus on them. He shifted the gear away from the profit world and talked about the COIs that might occur with non-governmental organizations (NGOs) and governments. Collaboration with these organizations is usually manageable, but care is needed nonetheless.
In science, many things can distract from the actual goal of truth-finding: the interests of the funders (both profit and non-profit), research organizations, other parties such as journals and publishers, and of course, individual researchers. Being human comes with the threat of non-financial COIs. This type of COIs results from strong intellectual, political or religious convictions, and personal or institutional relationships.
“Research is not value-free,” as Lex pointed out. Everyone has different motives to be interested in something, and one might not even be aware of their non-financial COIs. If the COI is clear, managing it is still complex. For example, the declaration of some COIs might count as a breach of privacy. So, which COIs should be disclosed? Lex Bouter’s rule of thumb is “Mention everything that would embarrass you if it would become known later.”
Along with his rule of thumb, he also shared some useful measures against bias due to COIs. Operationalizing and enabling transparency, such as creating open payment databases for drugs and medical devices. Dutch Transparency Register is aiming to do just that. An international approach is another suggestion, for example, by linking everything to ORCID accounts. By including a link in papers, tying everything to registers, COIs can be made easily searchable and findable. Lastly, never accepting publication vetoes and always demanding open codes and open data, with a possible reasonable embargo period, is key to any collaboration with a funder.
Finally, he introduced the Mertonian norms, devised by sociologist Robert Merton. These principles are also reflected in the Netherlands Code of Conduct for Research Integrity. The norms state that scientific knowledge is not private property but belongs to the scientific community, and whether a knowledge is true or false should be judged by universal objective criteria. The intention of doing science must be discovering knowledge for its own sake, not for direct or indirect profit. And lastly, no knowledge should be regarded as sacred. Any idea should be open for criticism, questioning, and further investigation.
These ideas and more were discussed at the Q&A sessions. Different COIs come up with every position and every new collaborator, whether profit or non-profit. Science should ideally be value-free. But we are all human beings and not very good at staying disinterested.
Please check the website of the Research Integrity Rounds for the recording of the webinar and the slides.
To not miss out on the following Research Integrity Round, block March 9th, 2022 on your calendar!
