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Part 4: Ethical Challenges Linked to Involvement after the end of research

2019: Overcoming ethical challenges affecting the involvement of people with dementia in research


The involvement of people with dementia in research is not only important during research but also after it ends. People with dementia who contribute towards research through PI or as research participants should not be simply dropped or disregarded even if researchers need to move on to other studies. People have often invested a great deal of time and effort in research projects and may be interested in knowing what changed as a result of their investment. Regardless of the nature or level of their involvement, out of a sense of respect, gratitude and reciprocity, and in keeping with the relationship of trust hopefully already established, researchers should carefully plan how the involvement of people with dementia in a particular study ends. The aim should be to ensure that people with dementia feel appreciated, valued and hopefully motivated to repeat the experience.

Feeding back findings to relevant individuals and communities

In keeping with the principle of reciprocity, researchers have a moral duty to provide feedback to those who contributed to the research and to relevant lay communities (e.g. to the general public, minority communities for whom the topic was particularly relevant). As stated by Taylor (2019, p. 1),

“Research subjects contribute to the greater good and expose themselves to risk of harm. They have a right to know the outcome of the research. This is especially important for participants with a direct interest in the findings, for whom knowledge can be power.”

The ethical requirement to provide feedback is stated in the Declaration of Helsinki (World Medical Association 2013) but only in relation to medical research. In addition to reciprocity, which involves an element of gratitude and respect, involving people with dementia in the period following the end of the study also provides an opportunity to ensure that the findings are communicated in an accessible way to the people and communities for whom they are particularly relevant and who could benefit from them. Some findings could have a direct impact on people’s lives and some findings could be used to influence policy and service development.

“….social scientists do not have a mandate to guarantee justice, but we do have a responsibility to our research participants who have consented to let us into their worlds, to treat them with respect and understanding and to ensure that the results of our research are appropriately disseminated” (Shaw, Howe, Beazer and Carr 2019, p.14).

Through effective and meaningful feedback, this may also raise awareness about the importance of research and encourage people to get involved. Measures to inform people with dementia about the results and significance of the findings can be planned and costed in advance and form part of dissemination activities. The role of PI continues here for example in supporting the development of easyread or plain language findings that enable the sharing of findings and recommendations in an accessible manner. In large-scale research projects (e.g. European, cross-country studies), some members of the consortium may be allocated responsibility for this and have funds to accomplish this work. Such work may also be part of a broader initiative aimed at creating and maintaining interest in the research topic and work amongst the general public. In smaller scale research projects, principal investigators may need to do this themselves. Social media may support this process by increasing the impact and reach of work and positively influencing relevant communities. The obligation to provide feedback to participants should not be considered as being dependent on having dedicated or remaining funds.

„“We want researchers to come back and tell us the outcome of research that we have been involved in. Please be honest and don’t bury ‘bad’ findings”(Scottish Dementia Working Group 2014).

Structural barriers

There may often be challenges to fulfilling the duty to provide feedback which appear to be structural. For example, researchers may have to account for the hours they spend on particular projects. If after-study communication/feedback was not accounted for in the initial budget (which they might not necessarily have influenced), they may have difficulty dedicating the necessary time to this important task. In such cases, it would be necessary to use their own time to fulfil this duty, to challenge funding practices and

to ensure that future funding covers lay communication and feedback. There may be personal reasons and situations which make some researchers more successful than others in achieving this. However, the publication of the findings of research in scientific, peer-reviewed journals is not always covered by budgets (i.e. in terms of time and fees for open access journals) and yet researchers typically invest their time and energy in submitting articles for publication because it is in their interest to do so (e.g. for their academic careers).

Some researchers make a generalised and patronising assumption that participants would not be interested in the results, would not understand them or would misinterpret them (perhaps raising unrealistic hopes, or on the contrary shattering hope), whilst others raise concerns about the logistics of tracking people down and about data protection issues (Taylor 2019). For some, it may be a challenge to present the results in a clear and understandable way. However, even legitimate concerns about providing the right kind of feedback in the right way do not justify failure to respect this moral obligation. Structural barriers are created, maintained and perpetuated by individuals and therefore need to be challenged. Efforts to ensure that lay people also benefit from knowledge resulting from research have led to a few important changes. Some funders of research, for example, now require researchers to publish their findings in open access journals. This is a step in the right direction but as pointed out by Taylor (2019, p.1), “Results might be in the public domain but it doesn’t follow that people know about them, can find them, have access to them, or make sense of them”.

In the context of clinical trials, lay summaries of research findings have become obligatory under the Clinical Trials Directive, moving from a ‘nice to have’ to a ‘need to have’ status. Similarly, the British Medical Journal has recently introduced a requirement for researchers seeking to publish their papers to provide details of their plans for disseminating their findings to participants and other relevant communities, or to declare that they have no such plans. The British Journal of Learning Disabilities requires an accessible summary to be submitted with all article submissions for ease of all readers when scanning the content and with the explicit aim of making research findings more accessible to people with learning disabilities.

Post-trial access

Informing people with dementia who contributed to research about the findings is not the only way to show respect and appreciation for their time and efforts. In the context of biomedical research, post-trial access arrangements are becoming more important. Based on a justice argument, people who had the risk, burden and benefit of participation, shouldn’t be worse off after participation.

Therefore, since 2013 the Declaration of Helsinki sees it as a moral obligation towards research participants to make post trial arrangements.

 “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process” (Declarations of Helsinki 2013, article 34).

In practice, this entails, giving participants the opportunity to continue taking the experimental drug before it obtains marketing approval. One possible way to do this is through open label extension studies which seem quite fair as they give each participant the opportunity to freely consent to continue with the study in the full knowledge that s/he will receive the experimental drug.

Open label extension studies are often carried out immediately after a double blind randomised clinical trial of an unlicensed drug. The aim of the extended study is to determine the safety and tolerability of the experimental drug over a longer period of time, which is generally longer than the initial trial and may extend up until the drug is licensed. Participants all receive the experimental drug irrespective of which arm of the previous trial they were in. Consequently, the study is no longer blind in that everybody knows that each participant is receiving the experimental drug but the participants and researchers still do not know which group participants were in during the initial trial.

There are a few relevant ethical issues related to this practice. For example, people may base their decision on continued participation on whether they had a positive or negative experience of the trial. However, they would not know whether their experience was linked to having taken the experimental drug, another drug or having received a placebo. For those who were not taking the experimental drug, their experience in the follow-up trial may turn out to be very different (Taylor and Wainwright 2005).

Also, if they are told about the possibility of the open label extension trial when deciding whether or not to take part in the initial trial (i.e. with the implication that whatever group they are ascribed to, in the follow-up study they will be guaranteed the experimental drug), this may induce some people to consent to the initial study. Taylor and Wainwright (2005) suggest that this might even amount to a form of coercion. However, by the time they reach the end of the study, of those who did not initially receive the experimental drug, some may no longer meet the inclusion criteria, may no longer be in a position to benefit from it (assuming that it is effective) or the drug might be counter-indicated for them for reasons not known at the outset of the study. The extension study,although planned, may not even be carried out if the data from the main study are not such as to justify the extension. Consequently, researchers should be very clear about the prospect of the open label extension trial and avoid it becoming a potentially misleading incentive to participation.

Taylor and Wainwright (2005) suggest that the open label trials may serve the purpose of prescribing an unlicensed drug on compassionate grounds, which whilst laudable, should not be camouflaged as scientific research. Rather governments should take responsibility and set up the appropriate legal mechanisms to make it possible for participants whose medical condition merits prolonged treatment with the experimental drug to have access to it. It would also be important to ensure that any claims made at the recruitment stage of the trial are clear and enable potential participants to make a fully informed decision. For the re-consent linked to continuing (or in some cases starting) to take the experimental drug, it should be emphasised that it has not yet received marketing authorisation and that the long-term benefits which might arise from the taking it, as well as the potential risks, are not yet known.

Recommendations for researchers
  • —Plan, budget for and write plain language summaries (for guidelines on writing plain English summaries for people having participated in a particular study and for relevant lay communities, see:
  • —Engage with people from the communities (including gatekeepers) about how and what to give back and in what format, recognising that this may not always be written.
  • —Include costs for dissemination, including accessible dissemination, in funding proposals and bids.
  • —Be sensitive to how the findings or any feedback are communicated (e.g. issues related to terminology, tone and how members of different communities are portrayed). Please see guidelines developed in collaboration with the members of the EWGPWD in 2013 on the portrayal of dementia and of people with dementia ethical-issues-linked-to-the-perceptions-and-portrayal-of-dementia-and-people-with-dementia/ Guidelines
  • —Carefully plan how to bring the involvement of people with dementia in a particular study to an end so that people feel appreciated and valued rather than used and cast aside when no longer needed.
  • —Communicate findings to research participants and relevant lay communities using appropriate means of communication and dissemination (e.g. talks, pamphlets, reports on Internet, podcasts, web pages, newspapers, pictorial guides, graphic facilitation, professional/non-academic journals, social media etc.).
  • —Involve a broad range of people with dementia, people from relevant sub-groups and gatekeepers so as to ensure the best way to do this.
  • —Avoid sensationalistic reporting and unnecessarily complex explanations, without nevertheless this resulting in over-simplification and failure to communicate sufficient details for people to be able to understand the possible significance of the findings and to be able to use them to lobby for change.
  • —Explain how the findings fit into the ‘big picture’ (i.e. what is the next step, what now needs to be explored, what kind of changes will result from the findings?).
  • —If possible, discuss the results with people with dementia (i.e. those who were not involved in the study).


Recommendations for research ethics committees
  • Check whether lay reporting has been envisaged and the appropriateness of plans for the dissemination and communication.
  • —At the end of the study, ask for information on how research results have been disseminated and communicated to the participants and communities.
  • —Review policies on the return of results and make sure they are described in the protocol and information materials.
  • —Review post-trial arrangements in the protocol and make sure they are ethically acceptable.
Recommendations for funders
  • —Clarify study dissemination plans and routes to impact with a range of audiences (e.g. to individuals, communities and policy makers etc.).
  • —Provide a dedicated budget for lay reporting (i.e. reporting of the findings to the general public in a form and in places which are accessible to them).
  • —Include costs for open access publications within funding call.



Last Updated: Friday 13 November 2020