Potential Barriers and Challenges

The panel of world-leading experts that contributed to the content of this Toolkit thought that these are some of the most important potential barriers or challenges relating to the unique nature of the participants, those upon whom they rely for their participation (families and staff - 'co-participants'), and the agencies within which the research will take place.

Population factors

• People with ID often have a range of co-morbidities, this can be a challenge during recruitment and can be a source of bias during data collection.
• Assessing ability based upon IQ alone can be a practical challenge, need to include functional assessment.
• Assessment tests will need to be of shorter duration, due to the ability levels of the participants – understanding, endurance and patience.
• Mainstream intervention programs may need to be adjusted to take account of the ability levels of the participants.
• There is a wide range of ability levels within ID populations.  Different versions of resources will be required which match the various ability levels of the participants.

co-participant factors

• People with ID often rely on a number of people for their participation in a trial, therefore burden on participants can have an exponential impact on a carers, staff or family.  Thus, participant burden needs to be reduced as much as possible.
• Retention and data collection can be a challenge if participant motivation is not maintained.  This can vary greatly with ID populations.
• Maintaining regular personal contact is essential to maintaining the motivation of the staff, carers and participants.
• Some services can be very protective of the data that they hold. This can slow the process of recruitment.
• People with ID often rely heavily upon others for transport to participate in research.  This can add logistical and financial complications to a study.
• ID trials are heavily dependent upon the cooperation of a range of ‘gatekeepers’ for recruitment, retention and data collection.
• At any stage of the research process (planning, funding, recruitment, intervention, data collection) gatekeepers can effectively hinder or halt a trial.
• Facilitating someone to participate in a study places additional burden on carers and families – this must be reduced as much as possible.

systems & agency factors

• Services can be multi-layered and each layer can either be a facilitator or a barrier to recruitment, retention and data collection.
• Engaging with services can be difficult without an ‘advocate’ within each service.
• Staff changes and staff turnover are common in ID services and pose a challenge to ID trials.
• As new staff are recruited they will have to be trained regarding the trial protocol and any interventions.
• Staff burden, apathy or stress, can have a major impact on recruitment, retention and data collection.
• Multi-site, multi-agency or multi-country trials may require multiple applications to ethics/governance committees, each with their own nuanced requirements.
• A trial may have to link with numerous health and care service providers who each have a responsibility for a given participant.
• Often these service providers are scattered, are inconsistent in their approach to research and are not adequately funded to allow staff to participate in research activities.
• There may be participants from both treatment and control arms of a study living in the same home or attending the same service, and this can lead to cross-contamination.
• Participant’s can move to new residential settings and clinical care staff may not inform research staff.