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The development of new treatments and vaccines for disease can take years, or even decades to come to fruition, due partly to the difficulties of testing the reliability of such treatments in real-life infection scenarios. One innovative method seeking to speed up this process is known as Human Infection Studies. In a Human Infection Study for a vaccine, for example, participants would be given a dose of the vaccine being tested, before being given a dose of the disease the vaccine aims to protect against, in strictly controlled conditions. If they don’t develop the disease, then it looks like the vaccine is effective. Watch the video below to find out more.
There are strict guidelines surrounding Human Infection Studies; for example, they can only involve diseases with effective cures, such as malaria, and not chronic or otherwise difficult to cure illnesses such as HIV. Most of these studies have been conducted in high-income settings such as the UK and the US, but recently there have been increased interests to carry out these studies in low- and middle-income countries (LMICs) where the diseases are endemic, such that the vaccines are developed in a way most relevant to the people at risk. Human infection studies however can be ethically sensitive, and some of the issues may be particularly pertinent to studies in LMICs. For example, questions arise such as how to compensate people taking part – if the financial incentive is too large, does it become unethical? How do you ensure fully informed consent in communities where scientific literature levels might be lower? And how do you account for what these studies may represent in different cultural contexts?
Community and public engagement (CPE) is therefore a vital part of planning and rolling these studies out further. Funders such as Wellcome have been working to develop CPE strategies and guidelines for engagement with Human Infection Studies. A number of representatives working on this took part in a panel discussion on the topic at the 2018 Wellcome International Engagement Workshop. The discussion was chaired by Cecilia Chui, Project Officer on Vaccines at Wellcome.
Image: The panel speakers at the workshop | Minh Tan
Engagement and Human Infection Studies in Kenya
Noni Mumba, Head of Community Engagement at the KEMRI Wellcome Trust research program in Kenya, described their experience on developing engagement strategies for Human Infection Studies in their community. At first, Noni and her team struggled to get buy-in from policymakers and the ministry of health, but they were eventually able to begin studies using university students as participants. Engagement around these studies was fairly straightforward, involving just university administration and lectures for students. However, they later began a pilot study in the wider community in Kilifi, a coastal town in Kenya. This was the first Human Infection Study in Kenya outside of a university setting and aimed to test acceptability of a Human Infection Study amongst the community, while also developing protocols on who to engage with, how to best go about it, how to establish an effective feedback mechanism, what the community members would need in order to engage meaningfully with the process and more.
While there were no direct health benefits from this study, since it was only a pilot, Noni highlighted that for participants, the regular medical check-ups they were given as part of the process sometimes found other illnesses or health problems they were unaware of before. This medical attention could be one of the incentives for citizens of LMICs to take part in Human Infection Studies. Noni highlighted however that if another illness is found, treatment can’t be offered as part of the study, but they can be referred elsewhere.
Noni and her team developed a strong feedback mechanism that can be replicated in future Human Infection Studies. The Community engagement Advice for Studies (CAST) committee was established for the research team with the aim of supporting implementation of engagement and ensuring constant feedback to the study team from community and study participants. The engagement team would then meet with the community and participants in the patient facilities to explain the institution and the process of the study. Participants would also be given a tour of the labs to get a better sense of how the research institution worked. Any feedback the community provided was passed to the research team via the committee. And finally a helpline, which was originally established for community members to call or text for help or information about any study being done at KEMRI-Wellcome Trust, also grew to offer advice on Human Infection Studies. This helpline also provides support for participants once the trial is over.
One of the difficulties of Human Infection Studies is dealing with media attention. It is easy to pick up on potential dangers of Human Infection Studies and sensationalise them, and so it is important to provide accurate and reasonable information to media outlets. Noni recommended tailoring your information to the type of outlet you’re dealing with to avoid having things blown out of proportion, although she said that at the end of their study, after media attention, they actually had more people wanting to sign up rather than negative responses. By working with social scientists the group were able to present the information in a way that was, and is, acceptable to the communities they were working in.
Human Infection Studies and Engagement in Vietnam
Mary Chambers, Head of Public Engagement at the Oxford University Clinical Research Unit (OUCRU) in Vietnam, told attendees about proposed Human Infection Study researching Shigella, a bacteria that can cause severe diarrhoea and fever in affected individuals, especially children, and dengue, a viral infection transmitted by mosquitoes. There are no legal or ethical frameworks in Vietnam for studies involving intentional infection of human subjects, so the team are starting a three-year project to engage government bodies to develop regulatory frameworks that would enable Human Infection Studies, and explore the public perceptions of these studies.
An initial stakeholder consultation was held in March 2018, bringing together 50 stakeholders, including researchers involved in Human Infection Stidies, representatives from the Ministry of Health, doctors, university leaders and more. Key themes emerging from this consultation include:
- Benefit vs risk to the community
- What is the economic benefit to the community? Any longer-term impacts must be felt in the community, for example by making sure the vaccine is affordable. How much power do the researchers really have to do this?
- What are the risks to the community? These could be serious, for example the risk of transmission of the studied disease into the wider community; in the case of Shigella this is especially pertinent as it is spread in water, so any waste water from the research facility would need to be specially treated.
- Benefit vs risk to the individual
- Benefits to the individuals involved in a Human Infection Study include free healthcare and regular, in-depth health check-ups, as well as a financial incentive;
- Risks from subsequent dengue infections;
- Risks to the individual could come from certain cultural pressures in Vietnam. Young people are likely to need parental consent to be involved in this type of study, and from the parents’ perspective, they may not want to put their child – who they have invested heavily in, as they are at university – in harm’s way. Also, researchers had to think of their responsibilities to any participants who were severely affected by the illness.
Like Noni, Mary also was wary of public and media perceptions, and struggled with a lack of legal framework to support the study development.
Human Infection Studies and Engagement in India
Amrita Sekhar, from the Translational Health Science and Technology Institute based in India, described a study on engagement with Human Infection Studies in progress at the time of the workshop. India currently has no policy, regulatory or ethical guidance for Human Infection Studies, so the researchers had to start from scratch. They worked with a range of stakeholders, and communities in both urban and rural settings. Specifically, they spoke to groups from the student community and housewives. The latter threw up interesting points around the cultural complexities of carrying out this kind of research; it was found that wives needed consent from their husbands to take part in studies, but men didn’t need any consent beyond their own. Ethicists and lawyers pointed out that in Indian law, it was not possible to legally consent to have harm done to you intentionally. A legal change was therefore required before Human Infection Studies could occur. However, this looks to be tricky; there is a lack of trust in the Indian media about clinical trials, so messaging will need to be improved to gain the necessary media support.
The biggest question Amrita and her team struggled with was how to ensure participants could give truly informed consent, especially non-scientifically literate communities. How could they make sure participants truly understood the risks they were signing up for?
This discussion highlighted many of the key challenges related to Human Infection Studies and engagement around them. However, the research shows these studies can be highly effective and can make the process of drug and vaccine development significantly faster, so the need for these studies to involve good and ethical engagement is greater than ever.
The content on this page forms part of the online report for the 2018 International Engagement Workshop “Taking it to the Next Level: How can we generate leadership and develop practice in engagement?". To learn more about the workshop, access the rest of the report and browse the video presentations, discussion summaries, and tools, visit the workshop page.