CARILION CLINIC INSTITUTIONAL REVIEW BOARD Standard Operating Guidelines Title: 5.5: Informed Consent Process: OBTAINING CONSENT FROM NON-ENGLISH SPEAKING SUBJECTS Original Date: April 2009 Date of Last Revision: Primary Sponsor: Department of Approved By: Director of Biomedical and Biomedical and Research Ethics Research Ethics Objective: To describe the process researchers and their staffs should use to obtain and document informed consent from subjects who are non-English speakers and require an interpreter and translated consent materials. General Description: The governing principles of human subject research -- respect for persons, beneficence, and justice -- require that researchers not exclude subjects based solely on their inability to read, speak or understand English. Investigators need either to communicate directly with subjects, or to provide a reliable alternative to ensure that: Study participation is voluntary , as indicated by free and truly informed consent (respect for persons); and Study schedules, procedures, and risks are accurately communicated , and subjects have ongoing opportunities to express concerns and ask questions, in order to minimize risks to subjects (beneficence); and There are fair procedures and outcomes in the selection of research subjects so that risks and benefits of research are shared in society (justice). Federal regulations enforced by the Office for Human Research Protections (45 CFR 46.116) and the Food and Drug Administration (21 CFR 50.20) state that informed consent "shall be in language understandable to the subject or the representative," and 45 CFR 46.117, along with 21 CFR 50.27, describe how the informed consent is to be documented. Procedure: There are two methods for obtaining and documenting informed consent for research subjects who do not read, speak, or understand English: 1. The preferred method is to provide consent forms written in the subject's language. 2. For the occasional and unanticipated non-English-speaking subject, an alternative "short form" method is allowed [21 CFR 50.27(b)(2) and 45 CFR 46.117(b)(2)]. 5.5: Page 1 of 3 Informed consent is an ongoing process throughout a study. For non-English speakers, the investigator should address the means for providing continued, qualified interpretive services. Use of Translated Consent Documents The IRB strongly encourages the use of a written consent document that has been translated into a language understandable to the subject and which contains all necessary elements for obtaining legally effective informed consent. In addition, other written materials used in the consent process should be translated into a language understandable to the subject. As part of the IRB application process, investigators should estimate the likely proportions of non-English-speaking-people who may be encountered as eligible subjects for a proposed study and make plans to have the consent form and other materials translated. The cost of translating written consents is the investigator's responsibility. These costs may be quite high, particularly for large studies where multiple translations are needed and/or studies with relatively complex consent information that may require additional time by a skilled professional. Investigators should include the costs of written translations as well as medical interpreter services on grants and contracts. Industry sponsors are often willing to pay the costs of translating consent forms. The IRB will accept documents translated by Manzana Publications and Program Services or the Roanoke Office of Refugee and Immigration Services. These groups are approved by the office of the Vice President of Administration/Regulatory. If languages cannot be translated by these groups, contact the office of the VP of Administration/Regulatory for further help. Use of “Short Forms” The IRB also permits oral presentation of informed consent information in conjunction with a short form written consent document and a written summary of what is to be presented orally. The short form notes that elements of informed consent have been presented orally. When the short form is used with subjects who do not speak English: The oral presentation and the short form written consent document should be in a language understandable to the subject; The IRB-approved English language informed consent document may serve as the summary; The witness should be fluent in both English and the language of the subject. At the time of the consent discussion: The short form document should be signed and dated by the subject (or, if the subject lacks decision making capacity, by the subject’s legally authorized representative); The summary (such as the English language informed consent document) should be signed and dated by the person obtaining consent as authorized in the protocol; The short form document and the summary (or English language informed consent document) should be signed and dated by a witness. When the person obtaining consent is assisted by a translator, the translator may serve as the witness. 5.5: Page 2 of 3 The IRB must approve the English version of the short form, the translated version of the short form and the summary of information that will be presented to the subject, including the English language informed consent document. Ethical and Legal Considerations As part of each consent discussion, investigators have an ethical and legal obligation to assess the subject's understanding of the consent information to ensure that the consent is truly "informed." When the investigator and subject do not share a language, the investigator must depend on the accuracy of the translated consent documents and the working relationship with the medical interpreter. The investigator's familiarity with the subject's culture ("cultural competency") or lack of familiarity affects the communication. Working Effectively With Medical Interpreters The medical and technical information discussed during the initial consent discussion, as well as ongoing, study-related information, can be very complex and should be communicated to nonEnglish speaking-subjects through an interpreter with training and understanding in medical terminology. In addition, an individual with a professional commitment to maintain strict confidentiality should handle the private medical issues discussed with subjects. The field of medical interpretation is evolving and although protocols are being developed, standardized practices do not exist. Investigators may want to discuss some or all of the following topics with the interpreter before participating in an interpreter-mediated consent discussion. If the English version of the consent form is orally interpreted for the alternative "short form" method, how will the interpreter incorporate cultural considerations into the consent information? How transparent will the interpreted conversation be? With three people communicating (subject, investigator and interpreter), will everything said by each person be translated? How will the investigator and interpreter determine whether the subject truly understands the consent information? Informed consent is an ongoing process. How will the investigator ensure that the subject will understand ongoing study-related communication? If the subject has questions about continuing in the study, how will that be communicated to the researchers? This SOG was adapted from material on the web site for the University of Virginia Health Sciences IRB. 5.5: Page 3 of 3