Designing a research study
When designing a research study, it should be carefully considered whether there is a risk that participants can come to any harm. Harm could include (1) physical harm, such as older adults in a dance class getting injured; (2) psychological harm, such as participants becoming distressed by sensitive questions in an interview; (3) social harm, for example HIV patients’ diagnosis becoming public knowledge through participation in a project; (4) economic harm, such as participants having to spend excess money travelling or paying for carers while involved in the project; or (5) legal harm, such as participation in the study leading to complications with rights to healthcare insurance. Harm can also extend to researchers, healthcare professionals, and artists involved in a project. Consequently, care should be taken at the design stage to consider how and when harm might occur and what steps can be taken to mitigate this. Safeguarding procedures such as risk assessments and confirmation of insurance and indemnity for the host organization should be undertaken prior to any study activity taking place (see Chapter 8).
It is also important that there is a careful consideration of how to ensure participant confidentiality. This extends to how and when participants are given anonymized participant codes, where any databases linking identifiable information with participant data are kept and who will have access to them, and under what circumstances the codes will be ‘broken’ (meaning data are linked back to the individuals who provided them). For example, if a psychological questionnaire reveals that a participant is contemplating self-harm, there may need to be a system in place to allow the data to be de-anonymized and the healthcare professional responsible for that participant to be notified so that they can be provided with support. Details such as how data will be kept anonymous and when codes will be broken need to be planned in advance and communicated to potential participants to ensure they are happy with how their data will be handled (see Chapter 8 for more on confidentiality).
The British Medical Association has developed a toolkit entitled ‘Confidentiality and the Disclosure of Health Information’ available as part of its ‘Ethics: A to Z’ on its website www.bma.org.uk.
Care also should be taken to make sure data collection measures are appropriate to the participant group. Here, patient and public involvement (PPI), which was discussed in Chapter 10, is especially important, as people from the target participant group can be asked in advance to check through questionnaires or interview schedules to confirm that questions are appropriate and not likely to cause undue distress. Where participants are to be drawn from a vulnerable group, the support of parents or carers may be crucial to the project being ethical, so their role and how they will be involved needs to be identified early on.
There are also ethical issues in recruitment. Some eligible participants may be easy to reach, such as through newspaper advertisements and online public advertisements. However, other participants may be harder to reach who do not access these channels. It is important to ensure that a wide range of people who are eligible are given the chance to participate to ensure that opportunities are not biased towards subsets of participant populations. Recruitment strategies, and in particular who will make the first approach to potential participants, should be mapped out in advance.