Recruitment and consent of women with intellectual disabilities in a randomised control trial of a health promotion intervention.
Guardian consent cuts RCT enrollment from 75% to 61%, so budget extra outreach weeks.
01Research in Context
What this study did
The team ran a health class for women with intellectual disabilities. They wanted to see how many would join a research study.
Women came to info meetings in the community. Staff asked each woman and her legal guardian to sign consent forms.
What they found
Three out of four women said yes on the spot. When guardians had to sign, only six out of ten women could join.
Guardian paperwork was the main roadblock. Extra phone calls and visits raised the final count a little.
How this fits with other research
van der Miesen et al. (2024) later showed the same gatekeeping problem is still huge. They found that 78% of UK health studies still exclude adults with ID.
Matson et al. (2011) saw the flip side. Their community study crashed when only 7% of adults returned consent forms. Ferreri et al. (2011) proves the crash is avoidable with tighter guardian outreach.
Brodeur et al. (2025) widen the lens. They say support staff and agencies also act as gatekeepers, not just legal guardians.
Why it matters
You can hit high enrollment if you plan for guardian delay. Add extra weeks, phone guardians directly, and use plain-language forms. Build this time into your IRB schedule so studies don’t stall at 61%.
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02At a glance
03Original abstract
BACKGROUND: The need for evidence-based health promotion interventions for women with intellectual and developmental disabilities is critical. However, significant barriers impede them from participating in research, including those related to recruitment and obtaining informed consent. METHODS: This study describes a procedure for the recruitment and consent of women with intellectual disabilities into a community-based, multi-site randomised controlled trial. RESULTS: Of 269 women who participated in information sessions, 203 (75%) enrolled in the study. While women with and without legal guardians consented at the same approximate rates (83% and 85%, respectively), those with legal guardians enrolled at significantly lower rates (61%) because of lower rates (74%) of guardian consent. CONCLUSIONS: It is possible to recruit community-dwelling women with intellectual disabilities into randomised controlled trials at relatively high participation rates. Recruiting women who have guardians poses additional challenges for researchers.
Journal of intellectual disability research : JIDR, 2011 · doi:10.1111/j.1365-2788.2011.01399.x