Research Involving Minorities & Non-English Speaking Subjects
MinoritiesThe inclusion of minorities in research is important, both to ensure that they receive an equal share of the benefits of research and to ensure that they do not bear a disproportionate burden.
In addition to ensuring adequate appropriate representation of minorities in study populations (and guarding against inappropriate overburdening of minorities), IRBs must ensure that any special vulnerabilities of subjects are accounted for and handled appropriately. To the extent that prospective minority study populations are also economically or educationally disadvantaged, IRBs should safeguard their rights and welfare by making sure that any possible coercion or undue influence is eliminated (e.g., compensation that is not commensurate with the risk, discomfort, or inconvenience involved, or recruiting in institutional settings where voluntary participation might be compromised).
IRBs must safeguard the consent process (and, indeed, the entire research relationship) to ensure open and free communication between the researcher and the prospective subject. Consent documents must be written in language easily understandable to subjects; the possibility of illiteracy should be accounted for, as should the need for communicating in foreign languages. The informed consent documents should be available in English and other languages as appropriate to the subject population(s). Foreign language consent documents should be developed using quality control procedures such as translation from English to the other language and then back to English, to ensure that the information is correctly conveyed. The role of cultural norms of subjects should also be addressed.
Non-English Speaking Subjects
The consent form must be in a language understandable to the subject. Researchers should prepare both English-language and translated consent forms for proposals involving non-English-speaking subjects. An explanation of the translations and the expertise of the translator should be provided for IRB review. The IRB may consult with language experts or require a “back-translation” into English.
A witness, fluent in both English and the language of the subject, must be present during the consent process and must sign the consent document. The witness is verifying that the subject was fully informed and that the subject voluntarily agreed to participate.
Sometimes a subject understands English but does not read or write English. Again, an impartial witness should document that the subject understands the study and the consent process and consented to participate.