Federal regulations require that every consent document utilized in a bilingual consent process bear the signature of a witness unaffiliated with the study team. The witness’s signature indicates that they observed an oral informed consent process based on the information within an IRB-approved informed consent document (either in the potential participant’s own language or, in a short form consent procedure, in English) and facilitated by an interpreter. The informed consent process involves both conveyance of the information within the consent document and, in most cases, discussion and question and answer between potential participant and researcher.
The signature of the witness does not attest to any of the following, all of which are responsibilities of the researcher:
- The accuracy and/or completeness of the researcher’s descriptions and explanations, either within the consent document or during the consent discussion
- The researcher’s compliance with federal regulations, institutional policies, and/or other requirements
- The accuracy and/or completeness of the potential participant’s understanding of the information presented to them, both within the consent document and during the consent discussion
- The potential participant’s decision whether to take part in the research, free of undue influence or coercion by the researcher or other parties.
In sum, the role of the witness is to observe and formally acknowledge that an oral informed consent process took place, not to attest to its regulatory, legal, or ethical quality. In a bilingual consent process, this role necessitates fluency in both languages. For this reason, the interpreter tasked with facilitating the bilingual consent process is most often asked to sign the consent materials in the role of witness.
Signature: As indicated above in this guidance, Michigan Medicine Interpreter Services (or the non-UM vendors they contract with) provides interpretation services to all clinics at Michigan Medicine for both in-person and remote (e.g., over-the-phone) interpretation. When this service is provided in person, the interpreters (when acting as a witness) will sign the informed consent documents as indicated above in the table. When this service is provided remotely, signature can be obtained via accepted electronic platforms (SignNow, etc.). However, when it is not possible to obtain electronic signature of the interpreter who is acting in the role of a witness, IRBMED accepts the following method in lieu of the traditional (wet or electronic) signature:
- In Section 12 of the informed consent template, on the witness line, the researcher indicates on the first name (if the full legal name will not be provided) and employee ID of the interpreter and the vendor services (internal or external[name of the vendor]).