Potential Barriers and Challenges
recruitment
The majority of ID-trials are not permitted to recruit directly to people with ID, and must go through a series of ‘gatekeepers’. This can add additional layers of complexity, management, and bias in a trial.
Identifying potential participants can be difficult as many countries do not maintain registers of people with ID.
You may find that recruitment is not as successful as planned. Many trials struggle to meet their recruitment targets on time. Some trials extend their timeframe, some seek out additional sites, and others have to sacrifice statistical power, and proceed with a reduced sample size.
It can be difficult explaining research methodologies to non-disabled people. Explaining a research project to people with ID can be additionally challenging due to their intellectual and communication difficulties.
Recruitment through gatekeepers can introduce selection bias into a trial. Gatekeepers may agree to provide their support for a trial, and facilitate participant, for a number of reasons. For example, clinical or care staff who are aware of a trial taking place will decide who they wish to introduce to the trial and who they do not. Thus, before the participants have a chance to decide for themselves, a process of discernment has already begun. Depending on the rational used by the gatekeeper, this can introduce a source of sampling bias into the study.
Different gatekeepers may require different, and multiple, ways to communicate – letters, emails, telephone calls and in-person meetings.
Due to difficulties with heterogeneity, it can be difficult to get adequately large sample sizes.
Recruitment for ID trials requires considerable additional resources.
Multi-site studies are often required in order to get larger samples – this can lead to complications with co-ordination, communication, costs and logistics.
Sometimes staff are reluctant to support a trial because they are weary of causing harm to the person with ID.
recruitment
The majority of ID-trials are not permitted to recruit directly to people with ID, and must go through a series of ‘gatekeepers’. This can add additional layers of complexity, management, and bias in a trial.