A screening and consent process for including people with intellectual disabilities in a randomized controlled trial of a health promotion intervention

Including people with intellectual disabilities in research requires specialized methods to ensure that consent is both informed and ethically obtained. This presentation will discuss a method used in the Healthy Lifestyles for People with Intellectual Disabilities (HLID) study, an ongoing randomized controlled trial of the efficacy of a health promotion program. All potential participants meeting study inclusion criteria were provided with an oral description of study activities, potential risks, confidentiality and data protection procedures, study group assignment, and participants' rights. Comprehension of the information was assessed via six screening questions. Both the study description and the screening questions were administered by study staff with extensive experience in communicating with people with intellectual disabilities. Potential participants who provided appropriate responses to the questions were considered capable of providing informed consent independently. Those who provided an appropriate response to only some screening questions were asked to select a family member or other person to serve as an authorized research representative (ARR). Individuals who were unable to provide an appropriate response to any of the questions were excluded from the study. Of 45 participants screened to date, 28 were able to provide consent independently, 15 required an ARR, and two were excluded from the study. Individuals requiring an ARR were enrolled with the participant's assent and the ARR's informed consent. Use of ARRs substantially reduced the proportion of potential participants excluded based on inability to provide informed consent but who were able to provide assent and be engaged intervention and study participants.