The present paper constitutes the input of Alzheimer Europe and its member organisations to the ongoing discussions about the participation of people with dementia in research and in particular the Council of Europe Convention on Biomedicine and Human Rights and the Draft Additional Protocol to the Convention on Biomedical Research.
For the participation of people with dementia in clinical trials, the organisation refers to the specific position paper it has adopted with regard to this question.
Alzheimer Europe would like to recall a few general principles which guide this present response:
- A diagnosis of dementia does not in itself constitute a lack of legal capacity.
- Capacity is not an all or nothing affair. People with dementia should therefore be involved in decisions concerning research even if they are considered unable to consent.
- People with dementia have a right to participate in research, should they so desire.
- People with dementia should be encouraged to write advance directives covering the issue of participation in research.
- Subject to the fulfilment of certain conditions, a legal representative should be allowed to consent to participate in research on behalf of a person with dementia who is no longer able to consent him/herself (provided that they take into account his/her past and present wishes).
On the basis of these principles, Alzheimer Europe has developed the following position with regard to the participation of people with dementia in research:
- In the early stages of the disease, people with dementia can themselves consent to research or declare their willingness to participate in research in an advance directive irrespective of whether such research is likely to entail a direct personal benefit.
- A doctor with the relevant expertise and who is not linked to the research should assess the level of capacity of the person with dementia in order to ensure that s/he has sufficient mental capacity to take such a decision and is fully aware of the consequences.
- Legal representatives should be able to consent on behalf of people with dementia to participate in research, if the following main conditions are met:
- the potential benefit for the person's health is clearly greater than the possible risks;
- the risk of causing discomfort or distress is minimal; the research has been approved by an independent ethics committee;
- the same results could not be obtained with other subjects;
- the legal representative does not benefit financially from the decision;
- s/he has been specifically authorised to give consent by a court or the person with dementia;
- the necessary safeguards have been taken to protect the privacy of the person with dementia and to respect his/her dignity.
- In all cases, an independent adviser should be appointed with responsibility for the safety and welfare of the participants.
Based on its current information, Alzheimer Europe does not endorse the participation of people with dementia in research WITHOUT a potential benefit for the participants unless the person with dementia decided to participate him/herself and had sufficient capacity to make such a decision. Such decision could have been stated in an advance directive.
The full position can be downloaded below.