Part III Current Status of Dementia and Ethics in Research Involving Patients with It
4. Importance of ethical review for dementia research
Ethical review is important for dementia research, as patients with dementia are socially vulnerable, and it is difficult for them to make appropriate judgments independently, as previously mentioned. If they are forced to cooperate with studies, they may develop distrust. At the same time, they may be easily led to do so if they are asked very persuasively.
Actually, I myself sometimes become anxious, doubting if they have participated with a sufficient understanding of the study significance and objective, or they have consequently been led to do so without agreement.
To prevent these ethical problems in the consent process, the presence of a third person may also be helpful. If you can explain research details in the presence of a guardian or a similar person with a certain degree of knowledge of dementia, and obtain a patient’s consent after such an explanation, you will also feel secure about your study.
There have not yet been similar cases, but hopefully, measures like this will be systematized in the future.
As dementia research also seeks cooperation from caregivers without experience of research participation, applicable study methods are limited. In such a situation, it is burdensome for dementia researchers to fulfill requirements related to the strictness of the study design, such as subjects, intervention, assessment, and measurement methods, and assessment period, in ethical review.
Applicable assessment indices are also limited. In dementia research, patients’ QOL, represented by their improved or stable levels of satisfaction and conditions, is an important index, but such improvements or stability cannot be easily visualized. Not many patients with dementia could appropriately answer questions like “Are you happy?”.
In short, characterized by the difficulty of determining the appropriate assessment method and outcomes, dementia research differs from, for example, studies on iPS cells that are easily designed and evaluated based on the development of new treatment methods and drugs as visible outcomes. It would be helpful if ethics committee members would understand this point.
5. Expectations for corporate participation in dementia research
It is a pity that many companies withdraw from drug discovery projects, in which favorable outcomes are hardly achieved.
For companies, devices may be a less difficult area to address.
For example, there are electric hot pots with sensors. Whenever the solitary elderly use these pots, the sensors transmit signals, confirming that they are alive and safe. Products like these are not medical devices. Therefore, they are more easily ethically approved and put on the market. Network systems to observe wandering patients may also provide good business opportunities for those involved in the telecommunications industry.
It is expected that many companies will actively participate in these business activities that consequently benefit patients and their families.
We recognize dementia as a disease to be addressed by integrating medical, care, and nursing approaches.
Dementia research is often conducted beyond the boundary of each area. However, grants for scientific research from ministries and government offices tend to force vertical approaches. They push researchers, stating: “Please study long-term care payment with our grants”, “Our grants only target studies on medical services”, but this is in discord with actual needs in clinical environments.
Similarly, with regards to ethical review, it would be more constructive if they leave this area to our discretion, rather than enacting too detailed regulations on it.
There are already movements toward the establishment of such a system, but ethics committee members’ deeper insight will also make it easier for us to study, and consequently benefit patients and their families.