By Professor Margaret Sleeboom-Faulkner
The project aims to reveal how international cooperation in the life sciences deals with ‘differences’ between research and medical institutions in countries with different levels of income and different concepts of research and ethical governance.
The project examines:
- first, the nature of patient recruitment strategies and practices, shedding light on the increasingly important role of networking in the marketing of unproven stem cell therapies and in the exchange of biomaterials
- second, it investigates existing differences in biobanking practices on data collection, processing and storage, and the different legal, regulatory and bioethical frameworks, especially as problems have arisen around the acquisition, quality and trade of biomaterials
- third, it draws attention to actual patient needs, rather than those defined by stakeholders in research or therapy provision, by stimulating debate among regulators, scientists and patients through deliberative workshops held in India, China, South Korea, Japan and the UK
Due to the socio-economic and political sensitivity of the project, we have frequently encountered issues in relation to ethics review. Since the start of the project, late 2011, we have encountered many ethical issues, which I summarise as three challenging problem clusters:
When interviewing scientists, medical professionals and managers involved in the recruitment of patients in Asian countries, it proved very difficult to acquire written informed consent, as such formal approaches invited mistrust and sometimes caused offence. In most cases we had to revert to providing information sheets and requesting oral consent. In all cases, we guaranteed anonymisation of the person interviewed, and also of their affiliated institution, if so desired. In some cases, this was not appreciated, especially when interviewees wanted their voices heard.
When conducting ethnographic fieldwork at scientific or medical laboratories we always start by asking for permission to conduct the research from the institution concerned. In some cases, such as the research at a biobank and a hospital in China, this led to the signing of agreements that allowed research conditional upon not publishing certain data, effectively leading to censorship by these institutions.
We have also encountered issues when inviting patients, medical professionals and scientists to our deliberative workshops when hoping to video record discussions. Due to the sensitivity of the material, and fears of being misunderstood or misrepresented by the public or by the press in the UK and elsewhere, we refrained from publishing some of the debates on the internet.
Our experience in dealing with ethical review has taught us that it has come to function as a politicised tool. When topics are ethically sensitive, such as the provision of illegitimate stem cell therapies, it is rare that therapists are willing to sign an informed consent form, though the person in that case would not want to be interviewed either.
More seriously, more vulnerable people, such as patients or other members of the public are scared off by informed consent forms, even when they actually want their story to be heard. Paradoxically, this in our view runs against the ethicality of our research aim of exploring patient needs and perspectives.
Another lesson that we have learned has arisen as a result of being involved in research collaboration ourselves. We have found that it can be uncomfortable to require our partners from Asia to discuss the ethicality of their research practice to adopt Eurocentric approaches. On more than one occasion, discussions became painful when the friction between project requirements of informed consent and the etiquette of local relations were discussed.
Last updated: 21 February 2023