I’m just starting to write this on the train as I form the thoughts in my head, so this blog piece may turn out to be rambly nonsense. Today, I was at Bristol University’s Establishment Licence Holder Annual Meeting – we were asked to present our ‘Replacement Checklist’ to Bristol’s animal-using community. Our lovely Policy Officer, Jessie. is also based in the Bristol area, so we met up and had a wander round the campus together.

We headed off to find the University’s statue of Henrietta Lacks on campus, and the garden they dedicated to her, planted with the flowers that she loved.

The issue of consent

You may have heard of Henrietta. In the United States in 1951, the year of her death, she was the unwitting source of the HeLa cell line – a cancer cell line that is still widely used across the world in research labs today. Even though parts of the research community were aware of the origins of the HeLa immortalised cell lines by 1970, the Lacks family was not told about it until 1975.

When the HeLa’s cell line provenance became public knowledge, its use for medical research, and commercial purposes, raised obvious concerns about privacy and patients’ rights, and still does to this day.

Henrietta’s story also demonstrates the racial inequities that were, and still are, rooted in research and health-care systems, and not just in the US. Henrietta was an African American, a Black woman. The hospital where her cells were collected was one of only a few that provided medical care to Black people, and both her name and medical history were given freely, including to the press, with no consent sought or given from her family.

In the years that followed, Henrietta’s family have been involved in legal cases related to the use of their genetic material, taking various science and biotech companies to Court for profits generated from using the HeLa cell line without their consent or proper compensation. The ethical and legal questions about ownership of genetic material and the rights of individuals whose cells are used in research and commercial applications continue to be contentious and are rarely straightforward.

Medical Research Ethics for human participants today

Here in the UK, the Health Research Authority and the Devolved Administrations provide a Research Ethics Service, and research proposing to use human patient participants is reviewed by Research Ethics Committees (RECs). Protecting the rights, safety, dignity and well-being of research participants is the main function of these processes, and any proposed research involving the NHS, social care, or the criminal justice system must undergo some degree of review.

NHS RECs are independent of the organisation proposing the research

NHS research ethics committees (RECs) are designed to be independent from researchers, funding bodies, and the organisations where the research is conducted. This independence ensures that the ethics review process is unbiased and focused on protecting the rights, safety, and well-being of research participants.

There are more than 80 RECs across the UK, and they consist of up to 15 members, a third of whom are ‘lay’ – their main professional interest is not in a research area, nor are they a registered healthcare professional.

RECs review research proposals and give an opinion about whether the research is ethical. As the committees are entirely independent of research sponsors (the organisations responsible for the management and conduct of the research), funders and the researchers themselves, they can put participants at the centre of their review, asking questions such as whether participants are fully informed before they consent, can they withdraw consent if they change their mind, and whether the burden of being a participant in a particular study may be too much for them, given the expected benefit of the outcome.

Animal Research Ethics Review is not so independent

Animal research is very different. There is no consent process. Animals cannot volunteer to be in a study or be informed about what is happening to them and why. Humans make all the decisions for them. They are not able to make choices about it themselves.

The Animals in (Scientific Procedures) Act 1986 requires each breeding, supplying, and user establishment to set up its own Animal Welfare and Ethical Review Body.

The ethics review for proposed animal research is therefore not independent of the organisation running and managing the research in the way that RECs are. 

Animal Welfare and Ethical Review Bodies, or AWERB

In the UK, an AWERB, is tasked with

• promoting awareness of animal welfare and the 3Rs

• providing a forum for discussion and development of ethical advice to the establishment licence holder on all matters related to animal welfare, care and use at their establishment

• supporting ‘named persons’ and other staff dealing with animals, on animal welfare, ethical issues and provision of appropriate training

• helping to promote a ‘culture of care’ within the establishment and, as appropriate, in the wider community.

The core membership of an AWERB must include at least one of the establishment’s

• Named Animal Care and Welfare Officer(s) (NACWO)

• Named Veterinary Surgeon(s) (NVS) plus
• A scientific member (if the establishment is a user establishment).

This is the minimum necessary. 

However, the UK Home Office recognises the need for wider involvement and expects ‘Active engagement’ from the Named Information Officer and the Named Training and Competence Officer as well. Establishments are also encouraged to involve “people who do not have any responsibilities under [the legislation] as well as one or more persons who are independent of the establishment”.

Why does this matter?

From a personal perspective, I have been an active, external, independent AWERB member at a University for about 8 years. I am not ‘lay’, and I represent myself rather than my employer. I have no other connection with the University, and therefore I experience no conflict when I need to be critical of proposed, or current, research, policy and processes within the University. But I am only one voice on that committee. There are many others, and most of them are employees or retired employees of the establishment.

Committees have to function and make decisions, so it can often be the case that my opinion is listened to, but decisions are subsequently made that I may disagree with – something that many ethics committee members will also experience.

But I often question whether an AWERB really can make unbiased decisions that are truly independent of an establishment’s own interests. If the law were written very differently, and proposed research involving animals had to be reviewed by an external committee in a similar way to an NHS REC, would research involving animal procedures be more effectively challenged? Would the whole sector be in a different position with respect to the continued use of animals in science? Would replacement approaches be used more widely?

Obviously, these thoughts continued after I got off the train, and they will continue to rumble around in my brain. But what do you think?