Ethical Foundations of Palliative Care for Alzheimer Disease

TWENTY: Conducting Research in the Alzheimer Disease Population: Balancing Individual, Group, Family, and Societal Interests

mc h a  t e r t w e n t y Conducting Research in the Alzheimer Disease Population Balancing Individual, Group, Family, and Societal Interests Søren Holm, M.D., Ph.D., Dr.Med.Sci. Research into the best ways of providing palliative care for persons with Alzheimer disease (AD) and other dementias is of paramount importance . The number of people with dementia is projected to rise rapidly in most countries (Fratiglioni, DeRonchi, & Aguero Torres, 2000). Although treatments are being developed and marketed, most of them are not targeting the underlying disease process and are able only to temporarily ameliorate the symptoms of the condition. Most patients with dementia will therefore progress to a state of moderate to severe dementia before they die, and many will need specialized palliative care. Such care should be evidence-based and not driven only by the different theoretical commitments of practitioners in the field. I address some of the major research challenges in regards to dementia.When I talk about dementia, it is always dementia caused by AD. I believe the general line of argument put forward is valid for a range of other dementias, but the specific symptoms of the different kinds of dementia vary and therefore the palliative approach may also vary according to specific circumstances. m The Traditional Problem: Research without Consent The traditional research ethics problem discussed in connection with dementia research is the problem of research involving persons who are incapable of giving valid informed consent. This problem has been extensively analyzed, and at the regulatory level of research ethics a close to complete consensus has developed on the requirements that have to be fulfilled for such research to be deemed ethically acceptable. These requirements are 1. Consent must be sought from the person’s representative (proxy) 2. If the person is able to assent or dissent, although unable to consent, the person’s assent must be obtained 3. The research must either be directly beneficial to the person or it must be beneficial to the patient group to which the person belongs, and it must be impossible to perform the research in a group of patients who can consent 4. The risk to the person must be minimal in those circumstances where there is no direct benefit This consensus is expressed in paragraphs 24–26 of the most recent revision of the Helsinki Declaration from the World Medical Association: 24. For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons. 25. When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. 26. Research on individuals from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a Conducting Research in Alzheimer Disease 321 condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate. (World Medical Association, 2000) Very similar provisions can be found in the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Article 17—Protection of persons not able to consent to research 1. Research on a person without the capacity to consent as stipulated in Article 5 may be undertaken only if all the following conditions are met: i. the conditions laid down in Article 16, sub-paragraphs i to iv, are fulfilled; ii. the results of the research have the potential to produce real and direct benefit to his or her health; iii...