More questions than answers in research ethics debates
- Wits University
Medical ethics expert lectures on safeguarding research participants in line with Council of International Organizations of Medical Sciences (CIOMS) guidelines.
Professor Hans van Delden, former President of CIOMS and Chair of the workgroup for the revision of the CIOMS ethical guidelines for biomedical research, addressed some 500 delegates in Johannesburg on 20 February 2024.
As Professor of Medical Ethics at the University Medical Centre (UMC) Utrecht University, the Netherlands, Van Delden leads the project on patient and public participation.
His research team has a strong track record in the ethics of end-of-life decisions, research ethics, and ethics of biomedical innovation.
Wits University’s Research Office and the Academy of Science South Africa (ASSAf) hosted the landmark conference that for the first time brought together research integrity offices, integrity officers and managers; research ethics committee (REC) professionals, Chairs and members; research management professionals and administrators; research compliance managers and advisers, and researchers and research directors in Southern Africa and beyond.
Van Delden’s lecture was titled Explore the Frontiers of Safeguarding Research Participants. [WATCH].
From conducting experiments without robust clinical data, violating informed consent, and protecting people’s privacy, the safety of the people who participate in research is as vital as the science that pilots the clinical trials. Indeed, the concept of research ethics and integrity grew out of scandal.
“Research ethics asks us to question how we do research. It’s not just about involving the community and ensuring we meet certain requirements. Research ethics shows the way research should be conducted. We’ve followed a publish-or-perish culture. We need a change in the academy rather to foster creativity in a safe research environment,” said van Delden.
His starting point is that research should have intrinsic social value. “Research should protect the status of its stakeholders as free and equal.” But it shouldn’t only be something to be protected from. The degree and ways in which participants are protected must be balanced with the advancement of medical science and medical research.
He acknowledged the significant research challenges faced by practitioners. This includes bridging the so-called ‘valley of death’ where research doesn’t readily translate into practical applications that benefit patients and society.
“We ask the questions at the beginning: does this promote research and social value? Does it have sufficient moral weight? Of course, we know that research participants are not always free and equal. We need to understand the risks and burdens of promoting this research, and to protect those who are vulnerable,” he said.
In his address, Van Delden clarified the 2016 CIOMS Ethical Guidelines for Biomedical Research and how to apply them. CIOMS guidelines have been widely used in low- and middle-income countries. The last update was released in 2023.
He noted that not only is social value central in the guidelines, but that further specifications for research in poorer settings should include ancillary care (medical care beyond the parameters of what is being studied), and that in addition to broad informed consent for data-banking and biobanking, long-term governance of such data should be mandatory.
How do we determine vulnerability in research?
The traditional approach to determining vulnerability was to identify whole ‘groups’ as such and thus exclude them from research. The CIOMS guidelines reveal that this is no longer necessary. “When is someone vulnerable? This is relative and could include absolute impairments in decision-making capacity, education and resources necessary to protect their own interests. We look for several layers of vulnerability. A poor single mother taking part in research could be classified as such because her participation has greater implications,” says van Delden.
However, the CIOMS guidelines provide mechanisms for protection in various contexts and are encompassed in a ‘vulnerability toolkit’. One of the main mechanisms is using the subsidiarity principle. “If we look at research studies in children, we know from the outset that they are a vulnerable group and that we should be risk averse. We also know that we desperately need data on children because there is so little of it. But we ask ourselves whether this research could indeed be done in other non-vulnerable groups, like adults, which then has time and cost implications. Indeed, done this way, the intervention given to children based on the research is delivered three or four years later,” he says.
Of course, all vulnerable groups and individuals should receive considered protection. “In the Declaration of Helsinki, medical research with a vulnerable group is only justified if the research is responsive to this group's health needs or priorities and the research cannot be carried out in non-vulnerable groups. Most importantly, the group should stand to benefit from the knowledge, practices and interventions that result from the research.”
Community involvement protects the vulnerable
Community participation is vital to determine the level of vulnerability and the degree to which the research risks and burdens outweigh the benefits. Communities can provide accurate contextual information as to what might make people more vulnerable than others. Measures to prevent vulnerability can be better informed by community participation, too.
“Sometimes excluding vulnerable people from research can lead to increased vulnerability and compromise the science and the speed at which interventions are developed. It’s an important question: How do we balance protection with access?” asked van Delden.
Different committees may come up with different answers. “This principle is not easy to apply. We all have different ways of interpreting guidelines and then reasoning with how to use them in complex situations.”
Notably, it’s not just research and ethics committees that should decide the frontiers of research. An entire ecosystem, including the community, should be involved.
“Community engagement is a way to protect the vulnerable. But it also has many other functions. It is a means to prevent research waste and to promote science’s social value. It’s good to think of community engagement as a protective mechanism and important for co-creation,” said van Delden.
In addition to van Delden’s keynote lecture, various professionals delivered ethics-related presentations. The event addressed topics such as safeguarding indigenous knowledge, industry perspectives on clinical trial participant concept, the role of research integrity in participant protection, and the concept that ethics is multifacted and encompasses more than compliance with regulations.
Closing the event, Emeritus Professor Paul Ruff, the Wits Human Research Ethics Committee Chairperson, noted that capacity-building in ethics is essential in South Africa because many ethics committee members are volunteers. In addition, most of the work is located only in Gauteng and the Western Cape.
“Today’s proceedings reveal that research and ethics debates often raise more questions than answers. But this is the nature of the work we do,” said Ruff.