GUIDANCE DOCUMENT FOR ENROLLING SUBJECTS WHO DO NOT SPEAK ENGLISH Aurra Health Care s Research Subject Prtectin Prgram (RSPP) This guidance dcument will utline the prper prcedures fr btaining and dcumenting infrmed cnsent/authrizatin frm ptential research subjects wh d nt speak and/r read English. Federal regulatins fund at 45 CFR 46.116 and 46.117 (DHHS) and 21 CFR 50.20 (FDA) require investigatrs t present study infrmatin t a ptential research subject in a language the subject can understand, and, in mst cases, agreement t participate in research must be dcumented in writing. The Aurra IRB permits tw methds fr btaining and dcumenting infrmed cnsent/authrizatin frm subjects wh d nt speak r read English. Methd 1 (Preferred Methd): Prspective translatin f the IRB-apprved cnsent/authrizatin and written materials When a researcher anticipates enrlling nn-english speakers in a research study, the best practice is t have the English language cnsent/authrizatin frm and written subject materials translated and apprved by the IRB in advance. An IRB-apprved translated cnsent/authrizatin must be available in advance when: the research study targets a ppulatin with a significant percentage f nn-english speaking individuals (e.g., research invlving recent immigrants, a study perfrmed in a gegraphic area with a large ppulatin f nn-english speakers, etc.); r the investigatr rutinely prvides medical care fr thse wh d nt speak English. Cnsent/authrizatin dcument A qualified medical translatr shuld prepare the translated dcuments, which must be reviewed and apprved by the Aurra IRB befre they are used. 1. Obtain IRB apprval f the English language cnsent/authrizatin first. 2. Submit a mdificatin t the IRB that includes the fllwing: a. Infrmed cnsent/authrizatin translated int the target language. Nte: d nt translate the header, fter, and last page (risk/benefits/alternative signature page) f the ICF. These must remain in English. b. Any subject materials (e.g., diary cards, study questinnaires, r ther written study instructins), translated int the target language. c. Statement r certificatin f translatin. The statement must list the translatr s name and qualificatins, and must indicate the versin date f the dcuments that were translated Cnsent/authrizatin discussin If the Persn Obtaining Infrmed Cnsent is NOT a qualified interpreter per the Crss Cultural Services prcess (Aurra plicy 170): A qualified interpreter must facilitate the infrmed cnsent/authrizatin discussin, either in persn r by phne. An impartial witness must be present in persn fr the entire cnsent/authrizatin discussin. The witness must be smene wh understands bth English and the subject s language. In Page 1 f 5
rder t ensure impartiality, the witness must nt be the subject s family member r a member f the research team. The subject will sign the translated cnsent/authrizatin dcument acknwledging their cnsent fr participatin in the study as well as authrizatin fr cllectin, use and disclsure f their PHI fr research. The witness will sign the witness signature line f the translated cnsent/authrizatin dcument. By signing, the witness is attesting that the infrmatin in the cnsent/authrizatin frm and any ther written infrmatin was accurately explained t, and apparently understd by, the subject r the subject s legally authrized representative, and that infrmed cnsent was freely given by the subject r the subject s legally authrized representative. The interpreter may serve as the witness if s/he is willing t d s. This must be clarified with the interpreter befre beginning the infrmed cnsent discussin. If the Persn Obtaining Infrmed Cnsent IS a qualified interpreter per the Crss Cultural Services prcess (Aurra Plicy 170) and is familiar with the specifics f the research study, s/he may cnduct the cnsent/authrizatin discussin withut the need fr an interpreter r an impartial witness. This situatin is analgus t the situatin where the cnsent discussin is cnducted in English if the subject reads/speaks the English language. It is recmmended that a statement be included in the research recrd that the interpretatin tk place, alng with the name f the interpreter, and the interpreter s belief that the subject understd the study infrmatin and had all f his/her questins answered. If the research study invlves additinal visits, an interpreter must be present, in persn r by phne, fr each subsequent study visit. The interpreter will help ensure the subject s questins have been answered and the subject remains willing t cntinue participatin in the research study. Dcument that this ccurred in the research recrd. Methd 2: Use f an IRB-apprved shrt frm Overview Fr the ccasinal and unexpected nn-english speaking subject, a shrt frm cnsent may be used. Hwever, Aurra Health Care and federal regulatrs strngly discurage the rutine use f this methd. It truncates and limits the infrmed cnsent prcess nrmally assciated with research participatin. Nte that a valid, written (signed) HIPAA authrizatin, r a waiver f authrizatin/ elements f authrizatin frm the Privacy Bard fr Research [Aurra IRB]) must be btained in the Shrt Frm prcess. An interpreter relays the study infrmatin rally, while a shrt frm cnsent in the target language summarizes the basic elements f infrmed cnsent in accrdance with 45 CRF 46.117(b)(2). The use f a shrt frm cnsent dcument helps t ensure access t research participatin fr all peple, regardless f their ability t cmmunicate in English. Shrt frms in the fllwing languages are available n the RSPP website (www.aurra.rg/irb): Hmng Russian Serbian/Bsnian/Cratian Spanish Vietnamese Page 2 f 5
If yu need a shrt frm in a language ther than thse listed abve, the English shrt frm must be translated int the target language, and the translatin must be apprved by the Aurra IRB befre use. Please cntact the RSPP ffice at (414) 219-7744. Cnsent discussin If the Persn Obtaining Infrmed Cnsent is NOT a qualified interpreter per the Crss Cultural Services prcess (Aurra plicy 170): A qualified interpreter must facilitate the infrmed cnsent discussin, either in persn r by phne. An impartial witness must be present in persn fr the entire cnsent/authrizatin discussin. The witness must be smene wh understands bth English and the subject s language. In rder t ensure impartiality, the witness must nt be the subject s family member r a member f the research team. If the Persn Obtaining Infrmed Cnsent IS a qualified interpreter per the Crss Cultural Services prcess (Aurra Plicy 170) and is familiar with the specifics f the research study, s/he may cnduct the cnsent/authrizatin discussin withut the need fr an interpreter r an impartial witness. This situatin is analgus t the situatin where the cnsent discussin is cnducted in English if the subject reads/speaks the English language. HIPAA authrizatin In rder fr subject PHI t be cllected, used and disclsed fr purpses f the research, either a written (signed) HIPAA authrizatin must be btained frm the subject, r a waiver f authrizatin r elements f authrizatin (dcumentatin) must be granted by the Privacy Bard fr Research [Aurra IRB]. It is nted that there are certain studies where a waiver f authrizatin/elements f authrizatin (dcumentatin/signature f the subject) may be apprpriate. Fr example, if yu are cnducting a phne cnsent prcess with a prspective subject and yu have already requested a waiver f dcumentatin f cnsent a waiver f dcumentatin f authrizatin may als be apprpriate. Hwever, in instances where yu are cnducting in-persn cnsent discussin with the ptential research subject, a case fr a waiver f authrizatin/elements f authrizatin wuld mst ften nt be apprpriate given that the practicability cnsideratin necessary fr the waiver apprval wuld be difficult t argue. If yu are requesting a waiver f authrizatin/elements f authrizatin in the shrt frm prcess, yu must cmplete the 502A frm. Nte the Aurra IRB acting as the Privacy Bard fr Research will determine whether the waiver criteria are satisfied. If yu use chse t btain written authrizatin frm the subject, the Aurra IRB and the Aurra Privacy Officer have agreed upn the fllwing: Because the elements f HIPAA authrizatin are nt translated int a language that the subject understands, the elements f HIPAA authrizatin must be verbally presented t the prspective subject by a qualified interpreter in a language understd by the subject. Nte that this requirement is fulfilled by the interpreter s verbal presentatin f the Summary dcument t the prspective subject. In rder t btain written authrizatin, the subject must sign the English versin f the summary dcument. Prcess fr using the Shrt Frm prcess 1. Each use f the shrt frm must be prspectively apprved by the Aurra IRB. Cmplete Step 1 f the frm Request fr use f a shrt frm cnsent, which can be fund n the RSPP website (www.aurra.rg/irb). Sign and either send a hard cpy t the IRB ffice r scan and email t IRB.Office@aurra.rg. Page 3 f 5
Dcument n the Request frm whether yu are btaining a valid written (signed) authrizatin frm the subject r if yu are requesting a waiver f authrizatin/elements f authrizatin. If yu are requesting a waiver f authrizatin/elements f authrizatin in the shrt frm prcess, yu must cmplete a 502A frm fcusing n the questins in sectin V (waiver criteria). Nte the Aurra IRB acting as the Privacy Bard fr Research will determine if the cnditins f the waiver f authrizatin/elements f authrizatin are satisfied. If yu are ging t btain a valid written (signed) authrizatin frm the subject, the elements f the authrizatin must be incrprated int the required Summary dcument that is presented verbally t the prspective subject. There are tw ptins that can be used fr the Summary dcument: The Aurra IRB preferred ptin: The English language versin f the mst current IRB apprved cnsent/authrizatin dcument is used as the Summary dcument. (If the cnsent/authrizatin dcument is t be used as the Summary dcument, yu d nt need t attach it t the request, since it has already been apprved by the IRB.) A new written (English) summary f the study infrmatin may als be created. Per DHHS regulatins and AAHRPP accreditatin standards (II.3.F), this summary must embdy the basic and required additinal elements f cnsent, including a summary f the study prcedures. In additin t the cnsent elements, this dcument must als include the elements f a valid HIPAA authrizatin. As this dcument des nt have IRB apprval, this Summary dcument must be attached t the Request frm. The Aurra IRB must prvide apprval f this dcument befre it is used t enrll the research subject. When quick turnarund is needed: The IRB will make every effrt t review the request in advance f the anticipated cnsent date listed in Step 1. Hwever, fr requests needing same-day apprval, please call the ffice (414-219-7744) as sn as yu knw yu will be making the request t let us knw the situatin. If yu encunter a situatin utside f business hurs where yu need apprval immediately, please page the IRB manager at 414-222-4792 fr verbal apprval. Submit the frm as sn as pssible. Indicate n the frm that verbal apprval was already given. 2. The IRB chair r designee will review the Step 1 request and cmplete Step 2 (shrt frm use apprved/denied). The frm will be returned t yu with the determinatin marked and signed. 3. Once yu have received the apprval f the Aurra IRB t use the shrt frm cnsent prcess: a., dwnlad the crrect versin f the shrt frm frm the RSPP website and insert the Aurra IRB number in the header (Nte: d nt change the versin date) and fill in the blue highlighted areas f the cnsent with the investigatr s cntact infrmatin. This translated shrt frm dcument shuld be prvided t the prspective subject during the cnsent discussin. b. The Summary dcument (including the elements f HIPAA authrizatin) must be verbally presented t the prspective subject by a qualified interpreter (per Aurra Plicy 170) in a language that the subject understands. The Summary dcument is used t guide the cnsent/authrizatin discussin abut study participatin. 4. After cnducting the cnsent/authrizatin discussin with the subject, cmplete Step 3 f the Request frm, ntifying the IRB f the utcme f the prcess. If the subject agreed t participate, attach a cpy f the signed shrt frm with persnal identifiers redacted and answer the questins in the frm. Page 4 f 5
5. The IRB chair r designee will assess the study based n several factrs (risk level, study duratin, etc.) t determine whether a translatin is required, and will cmplete Step 4 f the Request frm t ntify the site f the determinatin. 6. If translatin is required: a. The cnsent/authrizatin dcument and any written materials t be prvided t the subject during the study must be translated as sn as pssible. b. The translated dcuments must be submitted t the IRB as a mdificatin. If a spnsr s translatin f their infrmed cnsent template is submitted, please als include an English versin f the dcument fr reference. c. Translated materials must be prvided t the subject as sn as pssible nce they are apprved. The subject des nt need t sign the translated cnsent/authrizatin dcument. If there will be a significant gap in time befre the subject s next visit, it is acceptable t send the dcuments t the subject via certified mail. Nte the date sent and the date f cnfirmed receipt in the research recrds. d. Fr future revisins, ICFs must nly be translated when a site is expecting t enrll additinal nn-english speakers r when there is a current, active subject wh is impacted by the change(s). It is nt necessarily t cntinually update a translated ICF when there are n subjects currently active wh speak that language, and nne expected t enrll. Dcumentatin f Cnsent/Authrizatin Once the subject has agreed t participate: The subject must sign and date the translated shrt frm cnsent dcument as well as the English Summary dcument. The witness must sign and date the translated shrt frm cnsent dcument and the English Summary dcument. The Persn Obtaining Infrmed Cnsent must sign and date the English Summary dcument.. Give cpies f the signed shrt frm cnsent dcument and the English Summary dcument t the subject. Retain the riginals f the dcuments in the investigatr s study research recrds. File cpies f the dcuments in the subject s medical recrd, in accrdance with Aurra plicy. It is recmmended that a statement be included in the research recrd that the interpretatin tk place, alng with the name f the interpreter, and the interpreter s belief that the subject understd the study infrmatin and had all f his/her questins answered. Future research visits If the research study invlves additinal visits, an interpreter must be available, in persn r by phne, fr each subsequent study visit. The interpreter will help ensure the subject s questins have been answered and the subject remains willing t cntinue participatin in the research study. Dcument this in the research recrd. If an interpreter is nt available fr a particular visit due t unfreseeable prblems, reschedule the visit, if pssible. If the visit cannt be rescheduled, make every attempt t have smene present wh can speak the subject s language. Dcument the situatin in the research recrd and reprt it t the IRB as a minr vilatin at the time f cntinuing review. Fr mre infrmatin: FDA guidance: A Guide t Infrmed Cnsent (see Nn-English Speaking Subjects sectin): http://www.fda.gv/regulatryinfrmatin/guidances/ucm126431.htm OHRP guidance: Obtaining and Dcumenting Infrmed Cnsent f Subjects Wh D Nt Speak English http://www.hhs.gv/hrp/plicy/ic-nn-e.html Page 5 f 5