The Caribbean Exploratory [NIMHD] Research Center of Excellence and Global Health Research Collaboration:

1. Caribbean Exploratory [NIMHD] Research Center of ExcellenceUniversity of the Virgin IslandsSchool of NursingGrant Support: National Institute on Minority Health and Health Disparities, NIH (# P20MD002286). The Caribbean Exploratory [NIMHD] Research Center of Excellence and Global Health Research Collaboration: Protecting Haitian Women and Children  Earthquake Survivors from Violence and Abuse

2. Sandra Millon-Underwood,PhD,RN, FAAN University Wisconsin-Milwaukee Doris W. Campbell, PhD., ARNP,FAAN, University Virgin IslandsPhyllis Sharps, PhD., RN,FAAN Johns Hopkins University Desiree Bertrand, MSN, RN & Lorna Sutton, MPA University Virgin Islands PARTICIPANT CONSENTING AND DOCUMENT TRANSLATION INTO THE NATIONAL LANGUAGE

4. CERC NBNA SYMPOSIUMJULY 13, 2011 • OBJECTIVES: • Describe general NIH and IRB requirements for conducting research involving human subjects in a foreign country. • Describe elements essential to the consenting process when conducting research involving human subjects in a foreign country. • Describe processes for assuring accurate translation of consent forms and data collection documents into the national language of the country where the research is being conducted.

5. Human Subjects Ethics Codes • The Nuremberg Code: 1947 • The Declaration of Helsinki:1964 • The Belmont Report: 1979 • Council for International Organizations of Medical Sciences (CIOMS): 2002

6. The Nuremberg Code, 1947 • The voluntary consent of the human subject is absolutely essential. • Criteria for research identified • Researcher must inform subjects. • Research for the good of society • Research based on animal experiments • Researcher must avoid injury to subjects • Researcher must be qualified to do research • Subjects or researcher can stop study if problems occur

7. DECLARATION OF HELSINKI, 1964 • Declaration • Created by World Medical Association to set a standard for the way human subjects are to be treated in experimentation. • Document lays out the requirements for ethical treatment of human subjects, and was developed as an attempt to self-regulate science. • Basic principles: • Respect for the individual • Right to make determinations and make informed decisions regarding participation in the research both before and during the research • The individual’s welfare always takes precedence over society or scientific needs • Ethical considerations must always take precedence over laws and regulations • If an individual is not able to grant consent or is a minor, than consent for participation should be sought from the guardian who is acting in the individuals best interest.

8. Declaration of Helsinki, 1964 • Basic principles: • Research should be based on a thorough knowledge of the scientific background. • Research should offer a reasonable benefit to the population involved in the research. • Risks and benefits of the research should be carefully analyzed and should not cause further harm. • Research should be conducted by suitably trained investigators. • Research findings should be shared and made publicly accessible.

9. The Belmont Report, 1979 • Differentiates boundaries of “practice” and “research” • Principles • Respect For Persons • Individuals should be treated as autonomous agents (capable of self determination) • Persons with diminished autonomy deserve protection • Beneficence • Do not harm • Maximize possible benefits and minimize possible harms • Justice • Fairness in the distribution of the benefits and burdens of research

10. Belmont Report 1979 • Respect • Informed Consent Process • Respect for Privacy • Beneficence • Good research design • Competent investigators/researchers • Favorable risk-benefit analysis • Justice • Equitable selections of subjects

11. Council for International Organizations of Medical Sciences (CIOMS) • Ethical justification and scientific validity of biomedical research involving human subjects • Ethical review committees • Ethical review of externally sponsored research • Individual informed consent • Obtaining informed consent: Essential information for prospective research subjects • Obtaining informed consent: Obligations of sponsors and investigators • Inducement to participate in research • Benefits and risks of study participation • Special limitations on risk when research involves individuals who are not capable of giving informed consent • Research in populations and communities with limited resources

12. Conducting Research a Foreign Country:Haiti Project • Next step – Ensuring that … • … the decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation.

19. INFORMED CONSENT - SOCIAL PROCESS

20. Conducting Research a Foreign Country:Haiti Project • Informed consent ensures individuals decide: • whether to enroll in research • whether research fits with their values, interests, and goals • For those who cannot consent: • Guardians or surrogates • Ensure research fits with their interests or exposes them to low levels of risk

21. HAITI PROJECT: ISSUES AND CHALLENGES • Underlying assumptions • ability to understand, ask questions, provide voluntary consent. • Vulnerable populations, structural inequities: racism, poverty, low literacy rates, gender issues. • Familiarity with biomedical and behavioral research. • Human rights abuses.

22. HAITI PROJECT: ISSUES AND CHALLENGES • Identifying and partnering with approved IRB’s in foreign country • Obtaining and documenting consent to participate in research by participants who do not speak English • Identifying and hiring “certified”, “female”, “professional” translators • Translating consent forms into the national language of the country where research is being conducted. • Translating and back-translating data collection documents into the national language of the country where the research is being conducted. • Validating suitability, usability and acceptance of consent forms and data collection measures for use in foreign country

23. HAITI PROJECT: ISSUES AND CHALLENGES • Scientific concepts difficult to communicate. • Consent forms lengthy, confusing, difficult to understand. • Translation of consent forms from one language to another problematic. • Potential for coercion. • IRB requirements for informed consent do not always mesh with local realities.

24. Translated Adult Consent Form (Excerpt) English Haitian Creole SANTE AVEK RAPÒ FANM AK TIMOUN AYISYEN KI SIVIV TRANBLEMAN TÈ A.  KONSANTMAN POU PATISIPE NAN RECHECH (Fòm konsantman pou itilize pou patisipan ki genyen 18 an oubyen plis) Ki sa etid la konsenen Etid rechech sa-a konsenen vyolans fizik, emosyonel ak seksyel fanm avek jenn fi Aysyen sinistre ki siviv tranbleman-an te sibi epi kap mande swen lasante nan yon lopital asosye oubyen yon klinik premye nesesite ki nan Potoprens. Bezwen kritik, inivesel apre yon dezas sé manje, lojman, dlo, sekirite avek swen sante. Anplis fanm ak jenn fi vilnerab pou vyolans ak abi, ki enkli vyolans patnè entim (IPV), vyolans seksyel, abi ak neglijans timoun, ansanm avek abi emosyonel nan men patnè oubyen ansyen patnè, manm fanmi, zanmi ak/oubyen etranje apre dezas natirel avek sa moun koze. Genyen prev ke risk vyolans ogmante apre gwo dezsas tankou tranbleman Ayiti a. Pwojet sa-a vize pou devlope, aplike ak evalye estrateji pou anpeche viktim nan fanm ak jenn fi apre dezas tankou tranbleman tè Ayiti a. • Health and Relationships of Haitian Women and Children Earthquake Survivors. • Consent to Participate in Research - 18 yrs and older • What the study is about • This research study is about physical, emotional and sexual violence experienced by internally displaced Haitian women and girl earthquake survivors seeking health care in partner hospital or a primary care clinic in Port au Prince. Critical, universal needs following any disaster are food, shelter, water, safety and medical care. In addition, women and girls are vulnerable to violence and abuse, including intimate partner violence (IPV), sexual violence, child abuse and neglect and emotional abuse by a partner or ex-partner, family member, acquaintance and/or stranger in the aftermath of natural and manmade disasters. There is evidence of an increase in risk of violence after major disasters, such as the Haitian earthquake. This project aims to develop, implement and evaluate strategies to prevent victimization of women and adolescent girls following disasters such as the Haiti earthquake. • Dr. Gloria Callwood, a Registered Nurse, Principal Investigator/Director of the Caribbean Exploratory NCMHD Research Center and Dr. Doris Campbell, also a Registered Nurse Principal Investigator and Co-Administrative Core Director, Caribbean Exploratory NCMHD Research Center, University of the Virgin Islands, St. Thomas, U.S. Virgin Islands, are conducting the study. They can be reached by telephone at 340-683-1172 or 340-693-1178 or by email to gcallwood@uvi.edu or dcampbe@uvi.edu. • Why you are being asked to participate • You are being asked to participate in this study because you are a Creole or French speaking woman (age 18-44) who has been displaced from your community, home and/or family since the Haitian earthquake, January 2010, and have accessed and received health care at a partner primary health clinic or hospitals in Port au Prince. • What you are being asked to do? • The study will involve your report of violence and abuse (types, frequency and perpetrator) before and after the earthquake. You will be asked to complete an anonymous interview (we will not record your name on the interview documents, but will assign you a code number) conducted in a safe, private and convenient location. We will use an audio interview administered using computer assisted technology to obtain responses to questions about violence and abuse including intimate partner violence (IPV), sexual violence, emotional abuse, child abuse and neglect. Further, we will ask about perpetrators of violence and the health consequence and access to services and needed health and social services before and after the earthquake. The audio interview will be conducted by a skilled research assistant who is certified and trained in administration of a private interview on sensitive issues, such as violence, using tablet touch screen computers. • In this study you will be asked to participate in the computer administered interview which will take you about one hour to complete. During the interview you will be asked questions about you, such as education, if you work, if go to school, if you have children, where you live, your health and we will ask the same questions about your husband, partner or boyfriend as appropriate. If you have had an intimate partner in the past year, you will be asked about your intimate relationships (length of relationship, quality of relationship before and after earthquake, stress in relationship before and after earthquake). We will also ask about your experience (types, frequency and perpetrators) of physical, sexual and emotional abuse in the year before and after the earthquake. We will also ask you about your access and use of health care and social services as well as needed services. • The interview will be done in a private place while you are waiting to see the doctor or nurse at the hospital or the clinic. We will stop the interview if you are called to see the doctor or nurse. You can finish the interview after you see the doctor or nurse or we can complete the interview at another time that is convenient for you, here at the clinic or the hospital. • You may be invited for a second interview if you choose to participate in a safety education program to help women learn ways to stay safe and prevent violence and abuse as much as possible. We will do that interview in a private place at the hospital or clinic that is convenient for you. You are not required to complete the second interview to participate in the study. • ______ Yes I am interested in the second interview and you can reach me at • __________________________________________________________ • ______ No I am not interested in the second interview. • Possible advantages and disadvantages of participation • Benefits: There are a few benefits for you if you join this study. You may feel that is it helpful to talk to an interviewer about your experience with violence, your health and experiences before and after the earthquake. If requested, the interviewer may also give you information about resources in the community for women and girls who have experienced violence and/or abuse. • Risks: There are a few risks to you if you join this study. One risk is that you may feel that answering some of the questions is upsetting. If this happens, you do not have to answer that question if you do not want to. You may skip to the next question or you can tell the interviewer that you want to stop the interview. You can choose to withdraw or stop your participation in the study at anytime. You will not be penalized for withdrawing from the study, This means you will not lose access to any services. If you become upset and can not continue or you feel unsafe, our skilled research assistants are available to provide referrals to health care and other service providers for appropriate support and care. • You may be worried that by participating in this study others will find out that your partner or someone else is hurting you. Your participation in the study is confidential and we will not tell anyone outside the research team about your participation unless you ask us to and we have your written permission. • Follow-Up Care: If during the interview you tell the interviewer something about your health or relationship that needs additional medical care or social support we will ask your permission to make a referral to the doctor or nurse or we will give you information about where to go for additional health care or social service help. If you report being abused we will also refer you for assistance and follow-up to appropriate service providers. • For Your Participation: You will receive a $ 6 gift or gift certificate for completing the interview. If you agree to participate in the follow-up violence prevention program and complete the second interview you will receive an additional $6.00 gift or gift certificate. • Study Results: If you are interested in learning more about what we learn from all of the women and girls in the study, the group findings, please let the interviewer know. We will send you the information about the study findings when we are finished the study. • You have choices: • Your participation in this study is voluntary and you can leave or withdraw from the study at anytime. Refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. You may discontinue your participation at anytime without penalty or loss of benefits which you are entitled. Withdrawing from the study or not participating will not affect any future relations with the hospital or clinics where you receive care in Port Au Prince. Questions that you may have before, during, or after the study can be answered by the interviewer or the principal investigators. • If you would like to talk with someone other than the researchers about 1) concerns regarding the study; 2) research participant rights; or 3) other human subjects issues, you may contact Steve Goode, at the University of the Virgin Islands, Office of Sponsored Programs at 340-693-1202 or write to: • Steve Goode • Office of Sponsored Programs • University of the Virgin Islands • # 2 John Brewer’s Bay • St. Thomas, U.S. Virgin Islands 00802 • The information you provide is confidential • The information you share with the researcher(s) and interviewer(s) about you, your health, your family, your partner, your partner’s health, and your intimate relationship will be kept private and will not be discussed with others. • The information you provide will be used for research purposes only. Your name and personal identifying information will not appear on the questionnaires used for the study. You will be given a special code number that will be put on any study record about you. The code will not identify you. All of the information you give us will be kept with the special code number on it and not your name. All of the information from the study will be stored in locked file cabinets and only the principal investigator and research staff will have access to the study information. • You also agree to protect the privacy of others who you know are participating in this study. • Importance of the study • The results from this study will help health care providers know how to better respond to the needs of women and children following a disaster like an earthquake, and help women and children know how to plan for their own safety and health following a disaster if they are displaced because of the conditions following the disaster. The results of this study will also help these health providers develop ways to identify women and young girls who are abused by intimate partners or others, develop the best ways to ask women and girls about exposure to violence and the best ways to help women and girls make decisions and get resources to protect and improve their health and to stay safe. • I may have a copy of this form for my records if I think it’s safe for me to keep. • OR • I will be given a copy of this form to keep for my records. • ……………………………………………………………………………………………………… • I understand that by agreeing to complete the interview I am saying that I fully understand what this study is about, what is being asked of me to do, what I might gain from the study, what my choices are related to participation, and that study volunteers have the right to privacy. My completing the interview indicates that I am willing to participate in the study at this time. • ___________________________________________________________________________ • Name of Participant Date • ______________________________________________________________________________ • Name of Person Obtaining Consent Date: • Revised: 09/2010

25. TRANSLATED ADULT CONSENT FORM (Excerpt) English Haitian Creole kesyon vyolans ak abi ki enkli vyolans patnè entim (IPV), vyolans skesyel, abi emosyonel, abi ak neglijans timoun. Anplis nou pral mande w sou moun ki komet vyolans yo ak konsekans yo sou lasante w, epi aksè pou sevis avek sevis lasante avek sosyal neséesè anvan avek apre tranbleman tè a. Entevyou odio a pral dirije pa yon adjwen rechech espesyalize ki sètifye epi ki fòmé pou fè entevyou prive sou sijè sansib tankou vyolans, avek odinate tablet ki gen ekran touchab. Nan etid sa a nap mande w pou patisipe nan yon entevyou sou odinatè ki pral pran w apeprè inèdtan pou ranpli. Pandan entevyou a nou pral mande w kesyon sou tet ou, tankou etid ou fè, si ou travay, si ou lekol, si ou gen pitit, kote w abite, sante w, epi nap mande w menm kesyon sa yo sou mari w, patnè w oubyen menaj ou kòm apwopriye. Si ou te genyen yon patnè nan ane ki sot pase a, nou pral mande w sou relasyon entim ou (Konbyen tan relasyon a dire, kalite relasyon an anvan avek apre tranbleman an, estres nan relasyon yo anvan avek apre tranbleman an). Nou pral mande w eksperyans ou (kalite, frekans, moun ki komèt yo) sou abi fizik, seksyel avek emosyonel ke ou te sibi pandan ane anvan avek apre tranbleman an. Nou pral mande w tou si ou gen aksè oubyen itilize sevis lasante avek sevis sosyal epi si gen lot sevis ou bezwen. • a safe, private and convenient location. We will use an audio interview administered using computer assisted technology to obtain responses to questions about violence and abuse including intimate partner violence (IPV), sexual violence, emotional abuse, child abuse and neglect. Further, we will ask about perpetrators of violence and the health consequence and access to services and needed health and social services before and after the earthquake. The audio interview will be conducted by a skilled research assistant who is certified and trained in administration of a private interview on sensitive issues, such as violence, using tablet touch screen computers. • In this study you will be asked to participate in the computer administered interview which will take you about one hour to complete. During the interview you will be asked questions about you, such as education, if you work, if go to school, if you have children, where you live, your health and we will ask the same questions about your husband, partner or boyfriend as appropriate. If you have had an intimate partner in the past year, you will be asked about your intimate relationships (length of relationship, quality of relationship before and after earthquake, stress in relationship before and after earthquake). We will also ask about your experience (types, frequency and perpetrators) of physical, sexual and emotional abuse in the year before and after the earthquake. We will also ask you about your access and use of health care and social services as well as needed services.

26. Translated Parental Consent Form (Excerpt) English Haitian Creole PARAN FÒM KONSANTMAN (PARENTAL CONSENT FORM) Moun pou kontak osijè de etid sa a: envestigatè direktè lekòl la. Gloria B. Callwood, PhD., RN/Doris W. Campbell, PhD., ARNP, FAAN Depatman. Caribbean denvestigasyon Research Center (CERC), lekòl vyeya Telefòn nan nimewo. 340-693 1291 oubyen 340-693 1178 INFORMÉ KONSANTMAN POU PATISIPASYON NAN AKTIVITE RECHÈCH Tit:: Pwoteje fanm Ayisyen yo ak timoun tranbleman de tè sivivan vyolans ak abi Ebè ENTWODIKSYON/VO. pitit fi m' te mande pou yo patisipe nan yon etid rechèch yo. Lide de etid sa a se pou dekri prévalence de vyolans fizik, emosyonèl ak seksyèl eksperyans ndedan deplasman fanm Ayisyen yo ak jenn fi sivivan tranbleman de tè a ki ap chèche swen medikal nan lopital ou pran swen timoun klinik la nan Pòtoprens an. Te pitit fi m' te mande pou volontye paske li se yon kreyòl ou Fwansè palan fi ant laj de 12-17 ki te deplase de kominote, lakay li oubyen fanmi depi Ayisyen tranbleman de tè ak gen accessible e te resevwa swen medikal nan yon asosye klinik sante pwensipal ou lopital nan Pòtoprens Enplikasyon li pitit fi m' nan etid sa a pwal kòmanse lè mwen dakò pou yo patisipe e pwal kontinye jiska etid la te konplete nan 2012 jen. Apepwè 250 moun ap envite pou patisipe. PARENTAL CONSENT FORM Whom to Contact about this study: Principal Investigator: Gloria B. Callwood, PhD., RN/Doris W. Campbell, PhD., ARNP, FAAN • Department: Caribbean Exploratory Research Center (CERC) , School of Nursing • Telephone number: 340- 693 1291 OR 340-693 1178 • INFORMED CONSENT FOR PARTICIPATION IN RESEARCH ACTIVITIES • Title:: Protecting Haitian Women and Children Earthquake Survivors from Violence and Abuse • INTRODUCTION/PURPOSE: • My daughter is being asked to participate in a research study. The purpose of this study is to describe the prevalence of physical, emotional and sexual violence experienced by internally displaced Haitian women and girl earthquake survivors seeking health care in the hospital or primary care clinic in Port au Prince. My daughter is being asked to volunteer because she is a Creole or French speaking girl between the ages of 12 – 17 who has been displaced from her community, home and/or family since the Haitian earthquake and have accessed and received health care at a partner primary health clinic or hospitals in Port Au Prince.. My daughter’s involvement in this study will begin when I consent to participate and will continue until the study is completed in June 2012. About 250 persons will be invited to participate. • Procedures: • As a participant in this study, my daughter will be asked about her experiences of violence and abuse (types, frequency and perpetrator) before and after the earthquake. She will be asked to complete an anonymous interview (we will not ask her name) conducted in a safe, private and convenient location. We will use an audio interview administered using computer assisted technology to obtain responses to questions about violence and abuse including violence and abuse by boyfriends, other friends or acquaintances , or strangers, sexual violence, emotional abuse, child abuse and neglect. Further, we will ask about perpetrators of violence and the health consequence and access to services and needed health and social services before and after the earthquake. The audio interview will be conducted by a skilled research assistant who is certified and trained in administration of a private interview on sensitive issues, such as violence, using tablet touch screen computers. The interview on the computer will take about one hour to complete.

27. Translated Parental Consent Form (Excerpt) English Haitian Creole Kòm yon patisipan nan etid sa a, pitit fi m' pral mande osijè de li predikasyon de vyolans e abize (tip, frekans ak auteur) anvan e aprè tranbleman de tè a. Li pral mande pou konplete yon anonim entèvyou (nou pwal pa mande l' non) te kondwi nan yon kote an sekirite, pwive ak pratik. Nou pwal itilize yon entèvyou adyo administre itilize òdinatè ki ede moun teknoloji pou jwenn repons pou kesyon osijè de vyolans e abize enkli vyolans e abize boyfriends, lòt zanmi ou connaissances, ou étrangers, vyolans seksyèl emosyonèl abize bi kont timoun ak pa pran swen. Pli lwen, nou p'ap mande sou trennen de vyolans ak konsekans pou sante ak aksè pou sèvis ak bezwen sante ak sèvis sosyal anvan e aprè tranbleman de tè a. Adyo entèvyou a ap kondi pa yon bòs rechèch asistan ki sètifye epi ki te antrene nan administrasyon an nan yon entèvyou prive sou kesyon sansib la, tankou vyolans, w ap itilize konprime touche ekran konpitè yo. Entèvyou a sou konpitè a pral pran yon sèl moman pou konplete. Li pral tou mande kesyon sou edikasyon l, lekòl, si li gen pitit, kote li rete ak sante l. Nou ap mande l' sou kouman enpak tranbleman de tè sou fanmi l' ak nan relasyon li ak lòt moun. Nou pwal tou mande sou relasyon pwòch ki te nan ane ki sot pase a, ak stress nan relasyon anvan e aprè tranbleman de tè a. Nou pwal tou mande l' sou li predikasyon (tip, frekans ak trennen) de abi fizik, seksyèl ak emosyonèl nan ane a, anvan e aprè tranbleman de tè. Nou pwal tou mande l' sou aksè ak itilizasyon swen sante ak sèvis sosyal osi byen gen bezwen pou sèvis. • June 2012. About 250 persons will be invited to participate. • Procedures: • As a participant in this study, my daughter will be asked about her experiences of violence and abuse (types, frequency and perpetrator) before and after the earthquake. She will be asked to complete an anonymous interview (we will not ask her name) conducted in a safe, private and convenient location. We will use an audio interview administered using computer assisted technology to obtain responses to questions about violence and abuse including violence and abuse by boyfriends, other friends or acquaintances , or strangers, sexual violence, emotional abuse, child abuse and neglect. Further, we will ask about perpetrators of violence and the health consequence and access to services and needed health and social services before and after the earthquake. The audio interview will be conducted by a skilled research assistant who is certified and trained in administration of a private interview on sensitive issues, such as violence, using tablet touch screen computers. The interview on the computer will take about one hour to complete.

28. Translated Children’s Assent English Haitian Creole Pòtoprens. Nou yo ap eseye pou konnen si medam yo ak jenn fi, ki te deplase apwè siklòn a, fè eksperyans fizik, emosyonèl ak seksyèl vyolans depi tranbleman de tè a. Kisa mwen menm ki te mande pou yo fè. Te mande w pou volontye pou etid la paske paran oswa gadyen ou te ban nou pèmisyon pou ka mande w pou yo patisipe e nou gen yon kreyòl ou Fwansè palan fi ant laj de 12-17 ki e vin pou swen medikal e resevwa swen medikal nan yon asosye klinik sante pwensipal ou lopital nan Pòtoprens. Ou kapab kòmanse patisipasyon nan etid la kòm dès ke nou pa gen pèmisyon ou. Nou espere envite a 250 moun pou yo patisipe nan rechèch la pwal konplete nan 2012 jen. CHILDREN’S ASSENT FORM FOR PARTICIPATION IN RESEARCH ACTIVITIES - ages 12-17 years • We are asking you to be in a research study. This form will tell you all about the study and help you decide if you want to be or not to be in the study. Read this paper carefully and ask any questions you have. You might have questions about what you will do, how long it will take, if anyone will find out how you did. When we have answered all of your questions, you can decide to be or not to be in the study. This is called “informed consent.” • What the study is about: •  This study is about women and girls age 12 and older who lived through the Haitian earthquake and come for medical or health care at one of the hospitals or clinics that we are working with in Port au Prince. We are trying to find out if women and young girls, who were displaced from their homes after the hurricane, have experienced physical, emotional and sexual violence since the earthquake.

29. Implications for Global Research

30. Sandra Millon-Underwood,PhD,RN, FAAN University Wisconsin-Milwaukee Doris W. Campbell, PhD., ARNP,FAAN, University Virgin IslandsPhyllis Sharps, PhD., RN,FAAN Johns Hopkins University Desiree Bertrand, MSN, RN & Lorna Sutton, MPA University Virgin Islands PARTICIPANT CONSENTING AND DOCUMENT TRANSLATION INTO THE NATIONAL LANGUAGE