When Community Engagement in Clinical Trials is Real

Many of the ethical principles so firmly defended today were missing just a couple of decades agoEvery time I talk about Community Engagement (CE), I like to emphasize how ethics is a heterogeneous field that evolves in different ways at different times. Many of the ethical principles so firmly defended today were missing just a couple of decades ago and still face some challenges–as we are seeing now with the use of placebo or control arms. And sometimes, we even face a backward step and have to work fiercely to defend them – e.g. the informed consent.

The real community engagement means that people understand, share and can give meaningful feedback on the trials taking place within their communitiesAnd so, when talking about CE we encounter a similar situation. Although CE can be considered an ethical high standard, it is not widely implemented or even well understood. Therefore, the participation of communities in clinical trials is interpreted differently from site to site, sponsor to sponsor or PI to PI. However, when talking with the communities, there seems to be a common denominator: the real community engagement means that people understand, share and can give meaningful feedback on the trials taking place within their communities.

How are we going to implement a successful CE plan if we are unaware of how to engage with communities?Of course, there are many and diverse ways of doing this. There is no just one way. Why? Well, because if the CE is real then the relationship is built in collaboration with all involved stakeholders. And, as we know, each relationship involving people is different. However, there are some universal principles that need to be considered: mutual respect, fairness, integrity, autonomy, transparency and accountability. This diversity of structures, mechanisms and situations may scare some people: how are we going to implement a successful CE plan if we are unaware of how to engage with communities?

CE helps the communities have a sense of ownership over the trials and encourages a support for scienceThere are as many answers as communities and trials. However, there are tools and guidelines that can help implementers create their own community engagement plan such as the Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials or the Good Participatory Practice Guidelines for TB Drugs Trials. Other guidelines for other type of biomedical research may come our way. But even though they are disease centred, these two documents help implementers understand the steps that need to be taken to have a successful and unique CE plan, to evaluate it and continuously improve it in order to respond to the needs of the communities they are working with –and independently even of the specific health area. 

Does CE benefit the trials? Yes! CE helps the communities have a sense of ownership over the trials and encourages a support for science; CE helps increase recruitment and retention rates; CE improves the clinical trials outcomes. However, is that the most important thing about CE? No. Given we don’t question the benefits of other ethical principles, we should not just focus on the benefits of CE to defend it. What do you think?

Community engagement is still quite new. We can see it in HIV/AIDS research, in cancer research and more recently in tuberculosis. In other health areas there are fewer examples and experiences. Hopefully, we will gradually see more communities really participating in the design and implementation of trials as well as in the dissemination of results, because CE is ethics in action.