Potential Barriers and Challenges

Ethics & Consent

• People with intellectual disabilities will often have difficulties processing information and may have difficulties with communication of complex ideas.
• Because of these difficulties, assessing and obtaining informed consent can be challenging, especially for participants who are more disabled.  It is important that participants understand the purpose of the study, what they are consenting to, and that they can withdraw their consent at any pstage in the research project.
• There can be a large variability across ethics committees, in terms of their understanding of the issues inherent in conducting ID RCTS, as well as the requirements that they ask from researchers.
• It is widely assumed that people with ID can not provide consent.  Legislation such as the Mental Capacity Act in the UK states that it should be assumed that a person with a disability can make decisions for themselves unless it is found that they lack capacity.  In practice, it would appear that this assumption is not being made when it comes to people with ID.
• Because of information processing and communication difficulties, some people with ID may not be able to provide consent for themselves.  In these cases a researcher would have to engage the support of an additional person who has authority to make decisions for the participant.  
• Most studies are not allowed to recruit directly to the person with a disability, and must recruit through a series of 'gatekeepers'.  As such, you will need to engage with multiple parties (agencies, managers, staff and carers) to agree to provide consent for a person to participate in a study.
• Consent may be fluid in an ID trial. People with ID may consent one day, and then for a number of reasons withdraw their consent and then re-consent at various time points throughout a study.
• Ethics Committees do not always understand the abilities or needs of people with ID, nor the complexities of conducting ID-RCTs.
• Ethics committees set high standards of protection for participants with ID in clinical trials.  While it is acknowledged that there is a need to ensure best practice, many researchers find the ethical requirements are set unnecessarily high, compared to non-disabled trials.  
   

helpful ideas and suggestions

• 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.