Research Participants who have Low Literacy or Limited English Language Skills
Researchers should carefully consider the inclusion or the exclusion of potential participants who have limited literacy and/or English language skills. The ability to understand information about the research and provide voluntary consent is key to the autonomy of and respect for research subjects. The IRB is tasked with ensuring that the proposed research includes a consent process in the language most appropriate for the subjects.
If your potential participants speak English, but are unable to adequately read a consent document, a verbal consent process may be more appropriate. A verbal consent script (i.e. what information will be read to and discussed with the participant) should be submitted for IRB review. In addition, you may want to request a waiver of documentation of consent - that is, a consent process is occurring, but participants will give the researcher verbal consent, rather than signing a form. Alternatively, in some studies, a witness and a short form consent may be required to support this process (see below).
For participants whose native language is not English, the researcher must carefully consider how these individuals would be consented into the study. If the study targets non-English speakers or if the majority of the participants are expected to be non-English speakers, then the consent process should be conducted in the language appropriate to those participants. An English version and a fully translated version of the consent form should be submitted for IRB review. The IRB would also expect that the study instruments (e.g. survey questions, interview questions, etc.) would also be translated into the appropriate language. The IRB should be informed of the researchers ability and qualifications to conduct the consent and the research in a language other than English.
For research where only some or a few of the participants are non-English speakers, the researchers may consider using a translator and a short form consent process. The translator can act as an impartial witness to help ensure that participant understands the information about the research and is giving voluntary informed consent. A short form consent (HRP-507 TEMPLATE CONSENT DOCUMENT: Short Form ) is a translated form which identifies the information that should be provided in the consent process and is conveyed in the written English consent document or summary. Please consult the Researcher Materials for a template of a short form consent.
For answers to questions and for guidance on the IRB review of research involving participants with limited English language skills, please contact the HSPP.