Ethical Issues in Research with Persons with Dementia: Potential and Restrictions

When selecting a capacity assessment instrument for research on a particular population, researchers should choose an instrument developed for use with that population, where possible. Of the instruments listed in Table 24-1, for dementia participants, the CCTI could be a useful supplement to clinical judgment, and the HCAI for more impaired participants in residential care settings. Participants with moderate to severe dementia are most likely to have problems understanding diagnostic or treatment information, but research indicates that diagnosis alone does not predict capacity impairment completely [34].

Whether using an instrument or clinical judgment or both, information needs to be presented in a way that is appropriate to the participant’s education level, and is as simple and organized as possible using visual cues.

DESIGNING APPROPRIATE PAIN RESEARCH TRIALS FOR PEOPLE LIVING WITH DEMENTIA

It is unethical to exclude people living with dementia from taking part in pain research. Furthermore, there is a need for pain research in people living with dementia, as pain is a common phenomenon among people living with dementia [21, 22]. However, people with advanced dementia receive less pain treatment than people who are more cognitively intact [27]. Exactly why this occurs is unknown: does dementia change the brain such that people in the advanced stages are no longer as sensitive to pain, or is pain underrecognized and undertreated in this vulnerable population, and how effective are analgesics in someone with dementia given placebo efficiency reductions? Research has shown that people with mild to moderate AD are at least as sensitive to pain as aged-matched controls [11]. Presently, due to a lack of research in this area vulnerable people living with dementia may be suffering.

Ethical Guidelines

Many guidelines for conducting research on people who cannot consent require the risks of participating in the study to be minimal. Minimal risk is usually defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” [43, Section 46.102]. Further it has been argued that “minor increase over minimal risk” and even “greater than a minor increase over minimal” risk (p. 1285) may be permissible with appropriate safeguards, if the potential benefits of such research exceed the risk of harm [33].

The International Association of the Study of Pain has set out ethical guidelines for pain research in humans [28]. Pain researchers must adhere to all of the guidelines, some of which are especially relevant to research design for people living with dementia:

• People who are unable to consent should not be used for research unless they are essential for the goals of the proposed research. The inclusion of people living with dementia in pain research is essential if the goal of the research is to improve pain understanding, recognition, or treatment in people living with dementia. In such cases, consent must be obtained from proxies.

• The pain stimuli should never exceed the participant’s tolerance limit. Pain to tolerance trials are not permitted in some jurisdictions with participants who cannot themselves provide informed consent.

• The participant should be able to escape or terminate a painful stimulus at will. In the advanced stages of dementia this requirement will be challenging to meet and careful study design will be required.

• The minimum intensity of noxious stimulus necessary to achieve the goals of the research should be established, and not exceeded.

• In all circumstances, including placebo-controlled trials, an effective, accepted method of pain relief must be provided on request. The availability of alternative pain relief and options other than participating in the research should be made clear in the information disclosed before gaining consent and beginning the study [28]. In people living with dementia who cannot request pain relief, the study design must include safeguards to ensure participants receive pain relief if required, which is an ethical conundrum addressed in this chapter.

The standard of care needs to be very high and multiple safeguards must be in place for pain research in dementia to be ethical. Standard practices and safeguards include the following:

• Full disclosure of associated risks and benefits and study procedures—full disclosure is mandatory.

• Approval from an ethics review board which adheres to the Declaration of Helsinki for Ethical Principles of Medical Research Involving Human Subjects is necessary [45].

• Additional codes and statements of ethical conduct enacted and enforced by local jurisdictions must also be respected.

• Involvement of a medical doctor in the design and oversight of the research.

• Encouragement of proxies to consult with the participant’s own medical doctor should they have any concerns.

• Research participation and any findings for individual participants should be reported to their medical doctor where possible and appropriate.

• Inclusion of proxies and any organizations which oversee the rights of disabled people in the research process. This may require having the proxies, a member of an ethics review board, and a person who safeguards the right of disabled people undergo the research procedures before proceeding [33].

• Inclusion of proxies and medical assessment during procedures to confirm participants with dementia are coping with the demands of the research.

• Usual care for comorbid medical conditions should continue during the person’s research participation.

Types of Pain Trials

For ethical considerations in designing appropriate pain research trials that include people living with dementia, it is helpful to distinguish between pain treatment research and experiential pain research trials. As proxies generally consider the possible benefits to the person with dementia before enrolling them in research, it is likely research for pain treatment in people living with dementia would be more widely consented to by proxies than experiential research designed only to develop understanding of the pain experiences of people living with dementia. This makes the design of and recruitment for experiential pain trials with people with dementia more complicated.

Experiential Pain Research Trials

Prima facie, the idea of purposely inflicting pain on someone with dementia, who cannot consent, for the purpose of studying the experience sounds like gross ethical misconduct of the highest level. Designed without proper care, oversight and concern for the interests of the participants, research of this nature is unethical, but that does not mean all experiential pain research is unethical, even in people who cannot consent. This is why study design is important.

Pain attracts attention, and it is a normal response to avoid pain. When people living with dementia do not understand or remember they are participating in a research trial they may try to avoid noxious stimuli. Dissent may therefore be a normal reaction to experiential pain research. Dissent from people living with dementia should be respected. Use of normal procedural states may therefore be necessary when designing ethical experiential pain research trials in people living with dementia. Pain is an everyday experience. Pain of varying degrees is also associated with many routine physical tests, and is a known side effect of many necessary medical interventions in older people. For example, annual flu vaccinations, surgery after a fracture and assisting someone with osteoarthritis out of bed in the morning are known to produce pain, but are all considered usual and ethical care. Potential exists for the use of these experiences and other usual care experiences in designing ethical experiential pain research trials. By using pain that exists in everyday life, pain research can be ethically designed even with people who cannot themselves consent.

Case Study Summarizing Ethical Issues and How They Were Addressed in a Pain Treatment, Randomized Placebo-Controlled Trial in People Living with Dementia

A trial of analgesic interventions in people with dementia living in residential care facilities, to monitor the effects on pain and consequent changes in the frequency of behavioral and psychological symptoms of dementia (BPSD), demonstrates how an ethical randomized placebo-controlled pain treatment trial can be designed.

Study Design

Participants with dementia living in residential care facilities, who were not taking regular analgesics, had BPSD and were assessed by the researchers as also having pain, were randomized to one of three treatments: paracetamol or paracetamol plus codeine or placebo. (Australian New Zealand Clinical Trials Registry number RN12611000062921; Alfred Hospital Ethics Approval Project Number 35/11)

Recruitment of Participants

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