Consent with Subjects Who Do Not Speak English CITI Program

In certain circumstances, the federal regulations permit researchers to enroll subjects without a written translation by using a "short form" written consent document, in a language the subject understands. Researchers should know that the use of a short form is conditioned upon:

IRB approval of a written summary of information to be presented 21 CFR 50.27(b)(2) (Protection of Human Subjects 2015) and 45 CFR 46.117(b)(2) (Protection of Human Subjects 2017) state that "the consent form may be...: A short form written consent document stating that the elements of informed consent ... have been presented orally to the subject or the subject's legally authorized representative." When this method is used, there shall be a witness to the oral presentation. In addition, the IRB shall approve a written summary of what is to be said to the subject or the representative. An information sheet may be close to what the regulations require, but there is no requirement for a specific reading level. While a witness is required when using a short form, a LAR is not. There is no requirement for researcher fluency.

The most concerning issue with using a family member to interpret in the consent process is that the family member may not:

Interpret accurately due to language issues, cultural standards, or embarrassment A concern with this method is that the family member may not interpret accurately due to language issues, cultural standards, or embarrassment. Any interpreter, whether family member or professional, should not insert their own responses in lieu of the subject's response. Legal standing is an issue with legally authorized representatives (LARs), but not interpreters or witnesses.

Researchers should engage certified interpreters to ensure the subject's comprehension. Even so, communication and comprehension may be difficult. The best strategy for the researcher is to:

Meet with the interpreter prior to meeting with the subject to ensure the interpreter understands the terms and concepts. It is essential to meet with the interpreter before meeting with the subject to ensure that the interpreter is familiar with the specific terminology related to the research plan as well as any new concepts that may be unfamiliar. Understanding the study in advance helps ensure accurate and complete interpretation. In addition, the interpreter can discuss any cultural concerns that may arise based on the type of study. Surveying family and friends could be intrusive, violate privacy, and undermine the subject's confidence. To be truly informed, the consent process must be responsive to an individual's needs.

When developing a research project that will enroll non-English speakers, researchers should:

Prepare consent documents at an eighth-grade reading level or lower and budget for the cost of translation. Challenges of research are magnified when obtaining consent from subjects with low literacy levels and who speak languages other than English. It is best to create consent forms at an eighth grade reading level or lower to ensure readability and comprehension. In addition, translation of documents is a costly endeavor depending on the language and the number of documents or languages required to translate for study purposes.

When a researcher is conducting an interpreter-mediated consent discussion with subjects, which of the following is an appropriate action for the interpreter?

The interpreter may explain research-related terms to the subject using culturally relevant examples. The interpreter may explain research-related terms to the subject using culturally relevant examples; for example, explaining randomization as the tossing of prayer stones rather than pulling numbers from a hat. An interpreter is not allowed to share his or her opinion with the subject regarding concerns they may have related to the researcher's study plan according to the National Standards of Practice. The interpreter must remain transparent at all times, only interpreting what has been said by researcher and subject.