Caregivers

In some experiments, caregivers are involved to support the participants of the experiment. For example, parents supporting young research participants or relatives of seriously ill people who need support during the experiment. Such arrangements raise a number of different issues, which you can read more about in the following.

Participants, research personnel, or something entirely different?

When caregivers are involved in an experiment, it's not always clear whether these individuals should be considered as participants in the experiment, part of the research personnel, or something entirely different. This distinction has significant implications for the rules applicable to their involvement in the experiment. If they are considered participants, they must give their consent to participate just like all other research participants. This means they must receive participant information, oral information, a consent form, etc. In this case, they would also be subject to the specific rules for compensation that apply to research participants, and this condition could have implications for their insurance coverage during the experiment. If, on the other hand, they are considered part of the research personnel, specific employment conditions apply, which fall outside the committee system's scope. When assessing whether caregivers should be considered participants in a specific experiment, it is crucial whether data from the caregivers are included in the measurement of the study's endpoints. For example, data from questionnaires about the caregivers' experiences during the experiment. If their data are included in the measurement of endpoints, they should generally be considered as research participants. This ensures that they have the same protection as other research participants, especially regarding the use of their data.

What should be disclosed?

Regardless of whether caregivers in an experiment are considered participants or not, it's always a good idea that they are informed about any burdens or stresses associated with being a caregiver in the experiment. This is especially important if 1) the experiment involves many physical or virtual visits to a research site, 2) caregivers are to participate in research procedures such as filling out questionnaires, or 3) the intervention in the experiment is particularly demanding for the caregiver in terms of frequency, complexity, or duration. If special training is required to participate as a caregiver in an experiment, potential caregivers must also be informed about what this training consists of and how extensive it will be. They should also be informed whether caregivers are covered by insurance in connection with handling medical devices or drugs in an experiment, and what opportunities they might have to seek compensation for expenses incurred in connection with the experiment. Finally, it might be a good idea to inform that answering questions about their relatives could be emotionally taxing for caregivers. This can be especially taxing if it's difficult to determine how to respond to the various questions due to their relatively subjective nature. It can also be emotionally taxing for caregivers to answer questions about their relatives if the questions in one way or another clarify their relatives' illness or worsening over time. This consideration is especially relevant for experiments that have a long duration.

What else should be noted?

There are three additional things worth noting when caregivers are involved in an experiment. Firstly, it's significant if questionnaires are filled out in connection with the experiment, whether it has been established who fills out the forms. Is it the participants themselves, or their caregivers? And in the latter case, are they professional caregivers or relatives filling out the forms? There can be differences in how various actors fill out such forms, and if it varies uncontrollably in the study who fills out the forms, it can introduce noise in the experiment's results. Secondly, it's worth noting that the support of caregivers for scientific experiments often means a lot, especially where placebo control is used, whether all participants have access to the experimental treatment. This could be through a trial design with the possibility of crossing over or by offering all participants access to the experimental treatment after the treatment period ends. This condition can thus have a significant impact on the practical implementation of the experiment. Thirdly, it's worth paying attention to whether the responsibilities and tasks of caregivers are clearly defined in the protocol or the clinical trial plan. If caregivers are supposed to encourage or motivate participants to complete the experimental treatment, it should be described what this precisely entails. This is especially important when dealing with incapacitated research participants, where caregivers may face conflicts between different considerations.