Clinical Trial Ethics: When Scientists from Europe and China Join Forces . . .

Over the past several years, biomedical researchers and scientists from Europe and China have been holding workshops and collaborating on a project to establish an ethical framework for clinical trials and biomedical research conducted across cultures—namely, as a result of partnerships between European and Chinese life science companies. The fruits of the BIONET project are being realized this year, and the project’s final report has recently been released. (Click here to view.)

The premise of the project can be summarized by these words from the report: “When scientists from Europe and China join forces, they are not only bringing together scientific expertise, they are also bringing together distinct forms of ethical deliberation and communication, different systems of ethical regulation, varied procedures for ethical review as well as different traditions of recruitment and interaction between researchers and research subjects. Moreover, the increasing commercialisation of science on a global scale further complicates attempts to ethically supervise international collaborations.”

The medical researchers involved in BIONET should be commended for communicating the sheer complexity of cross-cultural research and the ethical challenges involved, without leaning towards either a cultural relativism—everything’s okay because it’s the way we do it in our part of the world—nor an absolutism—there’s only one true ethics.

The report also emphasizes that when clinical trial subjects are victim to unethical treatment, it’s more often a matter of neglect than of conscious wrongdoing: “In by far most cases, ethical oversight of scientific research ends once a research proposal has been ethically reviewed and approved. There is little follow up or quality control of informed consent processes, not least because of a lack of resources. Yet it is exactly at this stage that research integrity is most under pressure from multiple directions. A university might be pressuring senior researchers who in turn might be putting pressure on junior researchers to ‘get some results’, conflicts of interest can arise if researchers have financial interests in the research at hand, community research projects can have unintended consequences on community cohesion if certain members of the community are excluded while others are included in research projects, patients may feel that saying no to participation will affect their access to medical treatment, etc. Moreover, the pressures of limited resources and time mean that informed consent processes can quickly become routinised and bureaucratic, a matter of signing a form with minimal interaction around and explanation of intended research.”

Perhaps the lasting message of the project is that ethics matter, no matter the country, and that deliberation and debate over research ethics is something that all nations vigorously engage in. “Western” notions of autonomy and individuality and “Eastern” notions of harmony and collectivity can be overemphasized, the report notes, and both regions appear to share the same “ethical intuitions” regarding fair treatment of clinical trial subjects.

--PWT