Obtaining and Documenting Informed Consent for Non-English Speaking Subjects

1. Obtaining and Documenting Informed Consent of Subjects Who Do Not speak EnglishUse of the Short Form Lifespan

2. Outline • Background • Purpose of the Short Form • Elements of Consent to be Included • Procedure for Using the Short Form • Sample Forms Lifespan

3. Background • Federal regulations require that informed consent information be presented “in language understandable to the subject” • Informed consent must be documented in writing unless the IRB grants a waiver or alteration of consent Lifespan

4. Background • For research subjects who do not speak/read English, consent forms must be translated into the subject’s native language whenever possible Lifespan

5. Background • If it is not feasible to translate the consent form into the subject’s language, then informed consent may be obtained through an oral translation of the English version along with a short form written in the subject’s language which includes the elements of consent Lifespan

6. Background • The short form does not take the place of the English language informed consent document • The translator used to facilitate the informed consent process must be fluent in both English and the language of the subject Lifespan

7. Purpose of the Short Form To provide the non-English speaking participant with a document which: • Explains that they are being asked to enroll in a RESEARCH study • Advises them to ask questions • Explains that they should understand what is being asked of them • Provides contact information of the PI in case of emergency or additional questions Lifespan

8. Elements of the Short Form 1. A statement that the subject is being asked to enroll in research 2. A statement that the researcher will explain the study including: • the nature and purpose, procedures, risks, discomforts, benefits, alternatives, and provisions for confidentiality. • the possibility of unforeseen risks, compensation in case of injury, • added costs, withdrawal, new findings, etc. Lifespan

9. Elements of the Short Form 3. A statement that participation is voluntary 4. A statement that the study has been explained orally and that the subject agrees to participate 5. Contact information for the PI and Office of Research Administration 6. Signature of the subject and witness to the consent process Lifespan

10. Process for Using the Short Form 1. Provide a copy of the short form in the subject’s native language 2. Verbally translate the full version of the English language consent form(s) into the subject’s language. If the researcher will conduct the translation, then a witness to the consent process is also required. Lifespan

11. Using the short form- continued 3. Researchers ask if the subject has any questions and ask if the subject is willing to participate 4. The subject signs the short form consent document 5. The researcher signs the English language consent form Lifespan

12. Using the short form- continued 6. The translator or witness signs the short form and the English language consent form 7. Provide a copy of the short form and English language consent form to the research subject 8. Document that copies of the translated short form and the full version English language consent form were provided to the research subject Lifespan

13. Using the short form- continued • The IRB must approve all foreign language versions of the short form consent document. • Short form consents are currently available in the 12 languages most commonly encountered in our community • Requests for translation into additional languages must be submitted in writing to the IRB Lifespan

14. Sample Short Form Written Consent document for Subjects Who Do Not Speak English THIS DOCUMENT MUST BE WRITTEN IN A LANGUAGE UNDERSTANDABLE TO THE SUBJECT IRB Committee Number: ______________________ Principal Investigator: ______________________ Consent to Participate in Research ___________________________ (Project Title)  You are being asked to participate in a research study. Before you agree, the investigator must tell you about (i) the purposes, procedures, and duration of the research; (ii) any procedures which are experimental; (iii) any reasonably foreseeable risks, discomforts, and benefits of the research; (iv) any potentially beneficial alternative procedures or treatments; and (v) how confidentiality will be maintained. Where applicable, the investigator must also tell you about (i) any available compensation or medical treatment if injury occurs; (ii) the possibility of unforeseeable risks; (iii) circumstances when the investigator may halt your participation; (iv) any added costs to you; (v) what happens if you decide to stop participating; (vi) when you will be told about new findings which may affect your willingness to participate; and (vii) how many people will be in the study. If you agree to participate, you must be given a signed copy of this document and a written summary of the research. You may contact ____name____ at ___phone number__ any time you have questions about the research. You may contact ____name____ at ___phone number__ if you have questions about your rights as a research subject or what to do if you are injured. Your participation in this research is voluntary, and you will not be penalized or lose benefits if you refuse to participate or decide to stop. Signing this document means that the research study, including the above information, has been described to you orally, and that you voluntarily agree to participate. _______________________________________ signature of participant date _______________________________________ signature of witness date Lifespan

15. Sample Short Form Written Consent document for Subjects Who Do Not Speak English- Spanish version • Affiliate: □ Rhode Island Hospital □ The Miriam □ Bradley Hospital □ Newport Hospital • IRB Committee Number: ______________________ • Principal Investigator: ______________________ • CONSENT TO PARTICIPATE IN A RESEARCH STUDY • CONSENTIMIENTO PARA PARTICIPAR EN UN ESTUDIO DE INVESTIGACIÓN • ___________________________ • (Title) • Le están pidiendo participar en un estudio de investigación. Los estudios de investigación incluyen solamente a gente que elige ser parte del estudio. Dese tiempo para considerar si desea participar. • Antes de que acuerde participar el investigador debe informarlo a usted sobre: • El porqué se lleva a cabo el estudio; • Cuánta gente habrá en el estudio; • Qué hay implicado en el estudio y qué procedimientos son investigativos; • Por cuánto tiempo estará usted en el estudio; • Cuáles son los riesgos y malestares; • Cuáles son las ventajas del estudio; • Cuáles son sus otras opciones o alternativas de estar en el estudio; • Cómo se manejará la confidencialidad de su información; • Cuáles serán sus costos de su participación en el estudio; • Si habrá alguna remuneración para usted de ocurrir una lesión; • Cuáles son sus derechos como participante en el estudio; • Con quien puede usted ponerse en contacto si tiene preguntas o inquietudes sobre el estudio o sus derechos; • Lo qué sucede si usted decide dejar de participar en el estudio; y • Cuándo lo informarán de cualquier nuevo resultado que pueda afectar su buena voluntad de continuar participando en el estudio. • Si usted acuerda participar, le darán una copia firmada de este documento y una copia del consentimiento del estudio en inglés. • Puede ponerse en contacto con _____________________ llamando al _____________ en cualquier momento que tenga alguna pregunta sobre este estudio de investigación. Si tiene cualquier pregunta sobre sus derechos como sujeto de una investigación, puede ponerse en contacto con Patricia E. Houser llamando al (401) 444-2099. • Su participación en este estudio de investigación es voluntaria y su atención médica actual o futura no se verá afectada. Usted no perderá ningún beneficio si decide no participar o dejar de participar en el estudio de investigación. • La firma en este documento significa que a usted se le explicó oralmente el estudio de investigación y toda la información arriba descrita y que usted acuerda voluntariamente en participar. • ________________________________________ __________________ • Signature of Research Participant Date • ________________________________________ __________________ • Signature of Witness Date Lifespan

16. Contacts for IRB Questions If you have any questions you can contact: • Patricia Houser, Manager Research Review Committees and Communication at phouser@lifespan.org 444-2099 • Jacqui Poore, Coordinator Review Committees and Compliance at jpoore@lifespan.org 444-2093 • Deb Temple, Manager Compliance and Training, dtemple@lifespan.org 444-5843 Lifespan