ࡱ>  T>bjbj  }c}c65B---AAA8yDA)ABIT)h)$)@@@@@@@$kC!F\@-))@T)))@! @+++)^8-@+)@++>=.?pR*=@@0)A=6}F*}F,.?.?&}F-T?@))+)))))@@+))))A))))}F))))))))) :  Institutional Review Board (IRB) GUIDELINES FOR RESEARCH INVOLVING NON-ENGLISH SPEAKING SUBJECTS 1. Introduction Research involving potentially vulnerable populations must include additional protections to minimize the possibility of coercion or undue influence. Federal regulations provide specific protections for pregnant women and fetuses, prisoners, and children; however, consideration may also be necessary for other groups, including participants who do not speak or understand English. The purpose of these guidelines is to outline special considerations for research involving non-English speaking participants, including methods for obtaining the informed consent of human subjects who are unable to speak or understand English. 2. Submission to the IRB When enrolling non-English speaking research subjects, investigators must have a plan to manage communications with the participant duringall phasesof study participation. This extends beyond recruitment, the consent process and initial enrollment, to include study visits as well as possible unexpected phone calls or follow-up questions. It is the investigators responsibility to be fully prepared to communicate with all participants during any phase of the study. Submitting Translated Materials When investigators enroll non-English speaking subjects or subjects with limited English proficiency and materials distributed to those subjects in their native language (non-English), the IRB requires that both an English version and the non-English versions of materials be submitted to the IRB for review. Materials may include, but are not limited to: Questionnaires Recruitment Materials (Flyers, Newspaper Ads, Brochures, etc.) Consent Documents & HIPAA Authorization Form In most cases, it is in the best interest of the investigator to submit translated versions of materials after the English versions receive IRB approval (in case modifications are required by the IRB). If waiting to submit translations, at initial submission the protocol should note that translated versions will be submitted once English versions are approved. Translated versions can be submitted before the IRB issues full approval or via an Amendment form after the IRB issues full approval. The translated documents must be approved by the IRB before they are used in the study. The submission to the IRB should specify who will be serving as an interpreter to the non-English speaking subjects at the time of consent to participate in the study and any study visits. For further explanation see the section, Obtaining and Documenting Informed Consent below. Obtaining Approval of Translated Consent Forms and Study Materials Study materials distributed to subjects must be translated into the non-English language(s) of the subject population. The materials must be translated by a paid transcription service or qualified translator, such as a person native to the language of the subject or one who is fluent in the English and non-English language. The qualifications and contact information of the translator should be provided to the IRB (i.e., in the IRB Application or by attaching Appendix 1 to the IRB Application). If a professional (paid service) is used, attach a copy of the documentation from the paid service to confirm the translation. For all other studies, the non-English study materials must be reviewed and verified by a second person (the verifier) prior to IRB submission. The verifier cannot be the same person who provided original translation. The verifier should check for consistency between both non-English and English versions of study materials. The verifier does not have to do a word for word back translation. The verifier should complete and sign the  HYPERLINK \l "verificationform" verification form (see sample in Appendix 1) or investigators provide comparable documentation in the IRB Application. NOTE: If the research team cannot identify a verifier, the IRB may be able to identify a service or individual who may provide this service. See Local Resources below. Modifying Study Materials after Initial Approval If modifications are needed to study materials being distributed to non-English speaking subjects, an Amendment must be submitted to the IRB along with the revised copy of both English and Non-English versions of the document. Only the changes to the materials need to be verified by a translator. All changes should be tracked, shaded, or highlighted in yellow. 3. Obtaining and Documenting Informed Consent Interpreter Requirements The IRB requires that an individual fluent in the subjects non-English language be available to verbally translate during the consent process. A qualified healthcare interpreter with specific training in medical interpretation should be used whenever practicable in research involving complex diagnostic or medical procedures. For other research, family members or other qualified persons may serve as interpreter. This individual may be a part of the research team. A detailed explanation of who will serve as interpreter should be provided in the consent section of the IRB Application. Informed Consent Document When obtaining informed consent from a non-English speaking subject, there are two options for documenting the informed consent. IRB Approved Translated Consent Form If non-English speaking subjects are expected to be involved in research activities, then a full translated consent form and HIPAA Authorization should be used. The process for IRB approval of translated study materials is explained above. 2. Short Form with a Written Summary Short Form: A written document stating that the elements of informed consent required by regulation have been presented orally to the subject or the subject's legally authorized representative (LAR). The short form consent document must be written in a language understandable to the subject or the subject's LAR. Written Summary: A written version of the full information presented to a subject or the subject's LAR during the informed consent process, used in conjunction with a short form consent document. The IRB-approved English language consent form and HIPAA Authorization (if applicable) may serve as the summary when an appropriately translated document is not available. The short form consent document may be used only in the following circumstances: The participant or LAR does not speak/understand English, The participant or LAR speaks only a language(s) that was not anticipated in the study population or location (i.e., unexpectedly encountered), An appropriately translated consent form in the participants language has not been approved by the IRB, and There is not adequate time for preparation and IRB review and approval of a translated consent form. When the study population or location includes people who speak a language other than English, or where the circumstances of subject enrollment provide sufficient time for preparation and IRB review of translated documents, the short form should not be used. When informed consent is obtained using the short form, an oral translation of an IRB approved summary (typically the approved English language consent form and HIPAA Authorization, if applicable) is presented. Participants must receive both: The written short form consent document translated into the appropriate language, and A copy of the IRB-approved written summary of the research (e.g., English language consent form and HIPAA Authorization, if applicable). A witness to the oral presentation of the informed consent information is required as described below. Witness Requirements An adult who is fluent in both English and the language understandable to the prospective participant must witness the entire consent process. The witness is required to verify the adequacy of the informed consent process and the participants voluntary consent. An individual who assists as an interpreter may also serve as the witness. The individual obtaining consent or other research team member may not serve as a witness to the process. Signature Requirements If using the IRB approved translated consent form and HIPAA Authorization, the consent and HIPAA Authorization should be signed as it normally would. In the short form consent scenario, the subject or the subjects LAR and the witness must sign and date the short form consent document and HIPAA Authorization, if applicable. The witness must sign and date a copy of the short form and written summary (i.e., IRB-approved English language consent form). The person obtaining consent should sign all documents. Copies In accordance with IRB policy, a copy should be made of the signed and dated consent form and HIPAA Authorization and provided to the research participant or their LAR (with original copy kept in the SLU research records). If using a short form consent process, a copy of all documents will need to be provided to the participant or LAR and kept in the research record. Short Form Translation Requirements Translations of the short form consent document must receive IRB approval before use. The IRB-approved English language short form template and approved translations are available on the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb-process/submit-irb-application.php"Submitting the IRB Application website. Investigators who require a short form consent document in a language not previously approved may contact the IRB for assistance. New translations of the approved English language short form may receive expedited IRB review. As additional versions of the short form are approved, they will be made available for general use. Follow-up Translation Requirements for Short Form Consent Process As practicable, if a participant was enrolled via a short form consent process, the full IRB-approved English language consent form and HIPAA Authorization should be translated into a written document in the language of the subject or the subjects LAR and provided within a reasonable time (e.g., 90 days). New signatures should be obtained on these documents, and a corresponding consent process note written in the research record. Subsequent participants speaking the same language who enroll in the research must be presented with the translated written consent document. 4. Local Resources Below is a list of local paid translation services located in the St. Louis area. This is not an exhaustive list of all services located in the St. Louis area, but rather, is a list provided as a courtesy to investigators who may need a starting point in locating translation services. The IRB is not responsible for the quality of these services. For complete listings of professional translation services, see the local yellow pages. If you are unsuccessful locating a translation service, the IRB may be able to assist you with locating a translator. Some SLU affiliates may be able to do translation verifications. Please contact the IRB if you need a referral. The IRB cannot guarantee that these individuals will be available. Preferred Vendors  HYPERLINK "http://www.slu.edu/slucare-home/patient-information/notice-of-nondiscrimination?site=mobile" SLUCare Services 314-977-6007 International Language Center 314-647-8888  HYPERLINK "http://www.ilcworldwide.com/" http://www.ilcworldwide.com/ The Language Access Metro Project (LAMP) 314-961-8500  HYPERLINK "http://www.lampagency.com/services.html" http://www.lampagency.com/services.html Other local vendors Language Solutions Inc 699 West Woodbine Ave. St. Louis, MO 63122  HYPERLINK "http://www.languagesolutions.net" http://www.languagesolutions.net International Institute St. Louis  HYPERLINK "http://www.iistl.org/trans_interpretations.html" http://www.iistl.org/trans_interpretations.html 5. References 21 CFR 50.27(b)(2) 45 CFR 46.117(b)(2) OHRP Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English FDA Information Sheets A Guide to Informed Consent AAHRPP, Inc. Elements II.3.F, II.4.A APPENDIX 1 Verification Form- This form should be completed by the verifier and attached with submission to the IRB. VERIFICATION OF TRANSLATED MATERIALS Dear Verifier: Enclosed are copies of materials in both English and [name language]. The Saint Louis University Institutional Review Board (IRB), the Board that is responsible for protecting the welfare of human subjects recruited to participate in research, requires review of these materials to verify that the foreign language corresponds with the English wording. If you have comments or suggestions for changes to the translated materials, please note them on the attached materials. If you have any questions, please contact the Principal Investigator of this study at [enter PIs phone number and email] If you have any questions for the IRB, please call the IRB office at 314-977-7744 or email  HYPERLINK "mailto:IRB@slu.edu" IRB@slu.edu. Thank you for your assistance! I have reviewed the enclosed materials and (please check one of the following): ______ I believe the materials presented in the foreign language correspond with the English version. ______ I have comments or suggestions for changes to the translated materials. 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