Conduct the participant's informed consent process with the appropriate study team member and a qualified interpreter fluent in English and the foreign language. Whenever feasible, consult with Interpreter Services and coordinate scheduling in advance to assure availability. If scheduling cannot be arranged in advance, availability of in-person interpretation may be limited and over-the-phone interpretation may be a suitable alternative.
Americans with Disabilities Act (ADA) defines a qualified interpreter as someone who is able to interpret effectively, accurately, and impartially, both receptively (i.e., understanding what the person with the disability is saying) and expressively (i.e., having the skill needed to convey information back to that person) using any necessary specialized vocabulary.
In nearly all instances, IRBMED expects researchers to utilize the services of impartial, professional interpreters to facilitate the bilingual consent discussion. However, in keeping with the Belmont Report’s emphasis on equitable subject selection, as well as in the spirit of other federal provisions, such as regulations governing federally-funded medical care (45 CFR 92), potential participants’ adult family members or friends may act as interpreters if the services of a professional cannot reasonably be obtained. In all instances, especially those involving nonprofessional interpreters, researchers should clearly explain to those serving as interpreters the importance of conveying all information as fully and accurately as possible.
If the participant agrees to enroll in the research study,
- Obtain signatures as follows:
- Appropriate study team member
|Foreign language document (short form or translated full ICD)
- A study team member may serve as verbal interpreter if qualified; however, in this case a separate witness fluent in both languages must sign both documents.
- When the foreign language interpreter is independent of the study team (e.g. Michigan Medicine Interpreter Services), the interpreter generally serves as the witness.
- The witness’s signature attests that the consent information was accurately explained, that the participant appears to have fully understood the information, and the participant’s informed consent was given freely.
- The participant is given a copy of BOTH the foreign language form and signed English informed consent document (even though the participant may not understand English).
- Maintain copies of BOTH signed documents in the study records.
- Important note for Michigan Medicine studies: A complete (every page) copy of both signed consent forms should be placed in the UM medical record of participants (level-2 login or VPN required), particularly when the research intervention may affect other treatment or care (in most cases this means scanning the document into MiChart (level-2 login or VPN required)). However, doing so may not be appropriate in all cases (for example if identification of the participant might put them at risk of criminal prosecution or harm to reputation).