E THICAL CONSIDERATIONS

The project was conducted in accordance with the Declaration of Helsinki, which emphasizes that it is a duty to protect the life, health, privacy, and dignity of the human subject when doing research (World Medical Association, 2013). The Regional Committee for Medical Research Ethics approved the project.

Since the randomization was done on an institutional level, the participants were aware of the conditions under which they would participate when they were recruited. This made participation in the project predictable, and eliminated the risk of disappointment due to being randomized to a condition they were not motivated for. Participants’ ability to consent was evaluated by health care workers close to the participant in close relationship with the participant’s relative. A procedure was developed for evaluating the participants’ capacity to give informed written consent. This was done according to the Norwegian law of patients right § 4 (Norwegian Ministry of Health and Care Services, 2015c). Written and verbal information about the study was given to potential participants and their relatives by their primary caregivers. The information contained necessary information according the Helsinki declaration, and was customized for persons with dementia. This means that the information was precise, presented clearly, and illustrated with photos. Even if the participant expressed willingness to participate,

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the information was repeated the next day to make sure that the participant truly had understood what participation would implicate. If the participant remembered the information that was given the previous day and seemed to understand it, they were asked to give their written consent to participate in the study. In cases where the participant did not seem to fully understand what it would mean to participate, either their health care workers and/or their next-of-kin took the decision as to whether to give written consent on their behalf. Participants were informed that they could withdraw from the study at any time. Associated health staff allocated eligible participants, provided information about the study, and gathered the written consent.

One of the inclusion criteria was a wash-out period without any organized dog activity for both the intervention group, as well as the control group. As some of the institutions already had more or less organized dog visits from time to time, this could actually deprive some of the participants from this kind of activity. Another ethical dilemma is to introduce an intervention that has a positive influence on the participants and then end the intervention after 12 weeks. Proper and adapted information was given before inclusion to ease possible disappointment among the participants. In addition, the dog handler prepared the participants in the intervention group the last sessions about the fact that the intervention was about to be finished, and the participants were told that they could resume regular, organized contact with a dog after the 3 month follow-up period. All institutions in the control grofollow-up were offered animal-assisted activity with a dog after end of the assessment period.

Doing research involving vulnerable participants is an ethical issue. Often, persons with dementia are aware of the disease and one’s own situation, but the complexity of the disease also leads to lack of insight. This makes self-evaluation difficult, and will also raise issues regarding informed consent and the potential risk of psychological strains through research participation (von Kutzleben et al., 2012). To ease the burden on the participants, proxy measures were deliberately used where appropriate, although research has shown that especially persons with dementia with mild or moderate dementia are capable of completing self-reports (Logsdon et al., 2002).

Some of the assessments, such as Mini-Mental State Examination and Berg Balance Scale (BBS) could be a stress for the participants. It takes approximately 10-15 minutes to perform each test.

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Participants at day-care centres had to perform the BBS several times, which could cause an extra burden. On the other hand, participants expressed positive feedback during assessment of the BBS, as they were able to challenge them self at some point, and it gave them the opportunity to be in focus of the health care worker for some ‘alone-time’.

Video recordings constitute another ethical issue. The videos were recorded by members of the project group, and were not to be watched by others. The participants were informed about the video recordings in the informed consent letter, and were told the day in advance as well as the same day of the recording, that a member of the project group would do the video recording during that day’s session with animal-assisted activity. They were told that they were free to withdraw from that session, but could continue to be part of the project if they were uncomfortable with the video recording. The videotapes were kept in a locked file cabinet.

The use of actigraphy could be seen as an ethical consideration. An actigraph does not gather sensitive information, and is considered not to be invasive. However, for persons with dementia, carrying the device for a whole week several times might be a burden, since they might forget why they had to wear it, and also that it did not collect sensitive information. The shape of the device is like a watch, and easy to remove. The participants were free to remove the device at any time. Both relatives and health care workers were given information about the device, and could answer questions if the participant seemed insecure or frustrated regarding what this was and why he/her had to wear it.

Even though there are several ethical issues when including persons with dementia in research, such as protecting vulnerable individuals and maintaining an individual's right to take part in research, it is important to include persons with dementia in research to gain more knowledge about this particular group. By considering the ethical issues well, the burden on recruited participants hopefully was not too heavy. A lot of effort was put into giving proper information both before inclusion, as well as during the study period in order to prevent participants of being disappointed for any reason. To prevent possible injuries or adverse events, the participants were followed closely during the assessments. They were asked if they needed breaks, and they were

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also instructed that they had the ability to withdraw from further testing and from the entire study at any time. No adverse events were recorded.

2.4.1. Animal welfare

Another ethical consideration is the use of dogs in animal-assisted interventions. All dogs had to pass a screening test in addition to an exam to see that they were suited for this kind of work (see Section 2.3.3). We also made sure that they would not be exposed to negative experiences by doing the intervention, by modelling the sessions, and by having a health care worker present to observe unwanted behaviour from the participants. The dogs’ welfare was considered continually, both from their handlers’ view, but also by the Norwegian Centre of Anthrozoology.

The dogs’ behaviour was registered in a log after each session (see Appendix 2). A master thesis to examine the animal welfare was conducted alongside this study. The master thesis was supervised by two ethologists. This thesis concluded that animal welfare of the dogs working in the project was not compromised (Barstad, 2014). This is an important aspect of studies of animal-assisted interventions, and demonstrates that the project have stressed to consider all aspects of the intervention.

2.4.2. Potential risk factors of animal-assisted interventions with dogs

Zoonosis are diseases and infections that are naturally transmitted between vertebrate animals and humans (Pan American Health Organization, 2003). Zoonosis are a relatively small problem in the interaction between humans and dogs, and especially in Norway and Scandinavian countries. Transmission of most zoonosis can easily be avoided by thorough hand wash and normal hygiene. By keeping the dog clean, treat it against parasites, take hygienically precautions and avoid contact with urine and faces the contamination risk will be kept at a bare minimum. A health certificate conscribed by a veterinarian should be required.

Allergic reactions can occur in people through spit, hair, urine and other secretes from animals.

Symptoms may be asthma, cough and itch in nose and eyes. To prevent allergies, the dog’s access to the institution should be restricted to certain rooms, preferably close to an exit to minimize

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the spreading of dirt and allergens. This will help the people living there, staff, relatives and other people not participating in the intervention from being affected by the dog visiting the institution.

To avoid dog hair and drool on clothes and furniture, a blanket or a towel can be used when in contact with the dog. A clothing roll can be used to remove hair from clothes and furniture. When in physical contact with the dog, the client’s hands should be washed afterwards. After a visit from the dog, floors should be cleaned to reduce dirt and dust. The dog should be bathed regularly, and groomed so that excess hair is removed before visits. Washing the dog twice a week is found to reduce dog allergen levels (Hodson et al., 1999).

Some people are scared or dislike animals. There may be different reasons and experiences that may cause this, and it is important to take this into consideration when implementing animal-assisted interventions. People who are scared or dislike animals will most likely not have anything to gain through contact with animals, and it may be extra burdensome for him or her. Fear of dogs was an exclusion criterion.

Harm caused by the dog, such as bites, or claw marks from dogs may cause rifts, wounds and bruising. Bites, and in some rare cases claw marks, can cause infections in humans. Special consideration should be given to this when dealing with people who have lowered immune resistance. By screening dogs that are to work in animal-assisted interventions and only select dogs proper to do this kind of intervention, accidents are not likely to occur. However, a procedure in case of accidents was developed. Manager of the institution should be notified, and a protocol should be filled out.