Frontiers in Public Health (Oct 2015)
Ethics and governance in digital mental health research – a joint academic and provider perspective
Abstract
Background Behaviour change techniques are often used in mental health interventions, and nowhere is that clearer than in the digital world. With the number of Digital Mental Health (DMH) services increasing more and more people are drawn to accessing them either alongside, or instead of, traditional services. They are an important field for research, particularly considering the unsuitable regulatory landscape, but there is little consensus about the research ethics of studies on DMH services and they are often an unfamiliar area for RECs (Research Ethics Committees). There are thousands of mental health-related apps and websites freely available to consumers, but there is often little incentive for their developers to invest in research – if indeed they have resources available. This presentation considers the ethics of DMH research from an academic and provider perspective and makes recommendations to maximise benefit for DMH users or potential users. It stems from the challenges faced by both a PhD researcher and an existing provider, hoping to clarify and combine their experiences to better understand the legal, ethical and moral issues surrounding research of existing DMH services. Although there are further perspectives that could contribute to a greater understanding, such as from users themselves, it is hoped that this stimulates further discussion and emboldens those in the field to work together to build evidence-based research guidance. Description – researcher perspective Is there a need to establish permission and consent from a DMH service if it has been gained from the user? Where does our responsibility lie? In a traditional service there are all sorts of ethical quandaries around researching without consent, but for a DMH service, where access is anonymous and/or in the public domain, many of those are slightly less clear. Researchers have been known to access Twitter and Facebook data, and blogs and forums, without consent from either the service or the participants. It could be argued that it is the responsibility of the RECs to make a call on whether there is a need for consent but it may be considered implicit due to the public availability or accessibility of data. As a researcher looking for ethical approval your first port of call is often the academic guidelines. Many of those based in Computer Sciences will find that these guidelines are sparse, if they exist at all, whilst even those of us in other areas like Health and Social Care often must find our own way. Considering the principles outlined in the Code for Human Research Ethics some questions are: 1. Respect for autonomy and dignity of persons: Who are researchers responsible to and for? 2. Scientific value: How do researchers find out what they need to know? 3. Social responsibility: How do researchers develop a culture of respect for people using DMHs who engage in research? 4. Maximising benefit and minimising harm: How do researchers better understand the potential risks and benefits, and how do they weigh them against each other? Description – provider perspective DMH services are often in a position to decide whether researchers can work with them. The author’s DMH service receives numerous requests for research involvement, ranging from undergraduate dissertations to proposals for large RCTs. This raises the question of how DMH service should decide who is able to access their members/users and their data. The British Psychological Society’s generally very helpful guidance on Internet Mediated Research says that DMH moderators may advise on research, but does not provide guidelines for the moderators or providers themselves. Many DMH services are fairly small and often run by informal volunteers. Some larger ones employ clinicians on their staff, but many do not. Unless based in a university they are unlikely to have significant research resources or expertise in ethical matters. Using the Code for Human Research Ethics as a guide, and in addition to the standard principles of good practice, DMHs may consider the following when they receive a research request: 1. Respect for autonomy and dignity of persons: Is the proposal congruent with the values of the community? For example, some DMH services adopt a recovery focused perspective which may clash with a more diagnosis/clinical research approach 2. Scientific value Researchers sometimes propose to study ‘internet’ interventions – a very heterogeneous group. If data from different services is to be grouped together, DMH services may question the value of theirs being included since it would be hard to draw specific conclusions 3. Social responsibility Too many requests to members create a danger of consultation fatigue and of pushing people away. This may be a particular risk for services with NHS contracts as this may mean some compulsory data is already required. 4. Maximising benefit and minimising harm DMH services need to weigh up staff or volunteer time spent on research with other activities which would also benefit users, as extra funding is rarely available. Where DMH services have taxpayer or charitable funding, they must consider whether it is acceptable to divert resources from this for research, however beneficial. Conclusions In DMH research the use of “ethics-as-process” can enable adaptation to the ‘unknown unknowns’ but there will be an increasing need for protocols to be established and maintained. Significant in these protocols will be guidance from DMH services as to how research can be encouraged as well as their position of responsibility. DMH services would benefit from a ‘toolkit’ to support their decision-making on which research to participate in, and how best to involve their users in this process.
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