Dementia and case law

The population in Sweden is rapidly growing, with an increasing proportion of elderly people. In the final stage of life, many of them suffer from dementia. The growing proportion of elderly people requires new drugs, which in turn require new research on dementia, among other things. What legal considerations are made with regard to these people, and how is the issue addressed by society?

Research on dementia, life support drugs and serious injuries requires testing on human subjects who are not always capable of making their own decisions.  It is of great importance to develop a legal practice for handling this, says Titti Mattsson, researcher at the Department of Law at Lund University.

“People who are not capable of making their own decisions are a vulnerable group. It is important to solve and deal with issues involving this lack of self-determination in the most practical and financially efficient way”, Titti Mattsson continues.

Despite improved legislation on ethical issues, regulations are never perfect, and different interpretations are inevitable. All research involving humans and animals must be tried by the Ethical Review Board. Titti Mattsson’s group of researchers have reviewed over 500 cases submitted to the board, of which approximately one third involved subjects without decision-making capacity. The purpose of the study was to attain a clearer understanding of how these types of cases are tried and interpreted.

“It is important to research and try to develop drugs for dementia patients.”

“With this study, we wanted to present and explain the considerations that are made in different cases involving ethical review. After all, it is about vulnerable individuals’ rights in society”, says Titti Mattsson.

“It turned out to be very difficult to draw any general conclusions – every case is unique, which was reflected in each assessment.”

In our conversation, Titti Mattsson often returns to the issue of the assessment made of the risk versus benefit of the research. If the study is considered to be of benefit from a research perspective, it may be approved even when it involves certain risks to some people.

The Swedish ethical review act states that research may be carried out on subjects incapable of making their own decisions without their consent if the results can be expected to be of direct benefit to the person in question. However, it is often difficult to determine whether something would be of benefit to you personally. Furthermore, the research must not involve more than an insignificant risk, or insignificant discomfort to the subject. This vague concept appears in the legal text without any clear definition.

“We can perhaps expect that the young people today will live to be up to 100 years old, and most of them will experience some form of dementia during the last 20 years of their lives. This makes it extremely important to research and try to develop drugs for dementia patients. It’s a societal issue that must be solved”, says Titti Mattsson.

Titti Mattsson and her research group have discovered that people in Sweden generally have a lot of faith in society and the government – perhaps even too much in some cases. We are convinced that all research conducted on us is good and properly managed. However, the Paolo Macchiarini scandal involving the artificial implanted tracheas has probably made many people reconsider their views.

“So much went so horribly wrong. Perhaps we need a new way of looking at issues concerning nursing and care, and different studies. Should there perhaps be a new understanding of law? Our faith in the perfect legal system should perhaps not be so strong and without any distrust”, says Titti Mattsson.

Another thing that Titti mentions is that in Sweden there is currently a lack of sufficient legal opportunities for people to make personal requests about their own private matters for the future. Unlike many other countries, Sweden for instance lacks legal procedures for informing others that you do not wish to receive any life support drugs, or that you might want your neighbour to look after your children if both parents were to die in an accident.

A new opportunity – and a somewhat extended version of a will – will be available this summer, 2017, and is called Framtidsfullmakt (Future power of attorney). This power of attorney means that, in addition to the slightly more common financial requests, it will also be possible to make a few more personal requests for the future. It is not entirely clear what will be included, however – this will be something for the courts to decide.

Text and photo: Peter Frodin

Facts

Beslutsoförmögna i forskning

Beslutsoförmögna i forskning – BIF (Research subjects without decision-making capabilities) – is an interdisciplinary research group at Lund University, which includes researchers from the Department of Law and the Department of Clinical Sciences, Division of Medical Ethics. Between 2012 and 2016 the group was funded by the Swedish Research Council to study the considerations that are – and should be – made in matters concerning the ethical review of research involving subjects with impaired decision-making ability. The project manager is Professor Titti Mattsson. Other researchers: Associate Professor Mats Johansson and PhD Linus Broström. Research assistant: Sofia Åkerman.