Researchers at Michigan Medicine should generally plan to include members of minority groups and disadvantaged groups in research, as compatible with the research design. Studies may not systematically exclude potential participants with limited English proficiency (LEP), low literacy, or vision/hearing impairments because of inconvenience in
- translating informed consent;
- securing an interpreter;
- converting study documents into an alternate format; or
- otherwise assuring a participant’s comprehension.
Exclusion of participants with communication limitations may be appropriate when
- the study uses instruments/surveys that have not been translated and validated in the alternate language or format; and/or
- the scientific aim or plan does not otherwise allow for adaptation into an alternate language or format;
It can be acceptable to exclude a single participant if it is unfeasible to adapt all subject-facing study documents, although making accommodations is more important when the study offers the prospect of direct benefit to the participant.
When the study team can anticipate multiple potential participants unable to use the usual informed consent process, they should plan for their inclusion. A new decision aid is available to help study teams and the IRB evaluate which studies require such a plan. The protocol should include a plan to manage communications with the participants during all phases of study participation, including in-person communications, telephone calls, or email/text. An overview of this comprehensive communication plan should be summarized in the IRBMED application. See also IRBMED SOPs Part 3.III.C.6.d.
Justification for exclusion(s) should be included in the protocol document and referenced in eResearch question 5.5.