Information for Researchers

  • Translation Process

    If a researcher intends to enroll subjects who do not adequately read the English language, informed consent documents should be translated into a language comprehended by the potential subjects. 

    The English version of approved study documents, including informed consent documents, should be approved by the IRB before the documents are translated into languages other than English. This will avoid duplicate work in case modifications have to be made to the English versions before they are approved by the IRB.

    Once the English documents have been approved by the IRB, the investigator may create documents in other language(s) intended for use. The translated documents must be approved by the IRB before they may be used.  Documents are eligible for IRB approval if translated under the following policies [NOTE – Only for studies whose management has been outsourced to Western Institutional Review Board (WIRB), the applicable translation policy is that defined by WIRB]:

    1)  The translation may be made by a certified translator approved to conduct such business by the university.  Such translations must be accompanied by a signed translator certification statement including the date of the translation. This process may be used all studies but it is required for studies involving an IDE or IND.  This requirement for certified translations for FDA research  involving drugs or devices is consistent with the FDA requirement that a translated document be accompanied by an "Affidavit of Accuracy”

    2)  The translation may be made by a “back translation” method (see below) for submission to the IRB.  This process may be used for all studies that do not involve an IDE or IND.

    3)  The translation may be made by a qualified translator.  Included in these qualifications is that the translator be fluent (i.e. can speak, read and write) in the language.  The translator must attest that the translated informed consent accurately reflects the IRB-approved English informed consent and provide the date of the translation.  The translator must also submit to the HSRO a signed statement describing his/her qualifications to make this translation from one specific language into another.  This process may be used only for studies that are approved by the IRB as 'exempt'.   [NOTE – The signed statement should define that the translation is true, accurate, and correct "to the best of my knowledge and ability".]

     

  • Back Translation Process

    Back-Translation Process

     

    For studies not involving an IDE or IND, a “back-translation” of IRB-approved documents is permitted.  This process requires:

    1)  A “forward” translation from the IRB-approved English document to the target language by a translator who is fluent in both languages.

    2)  A “back” translation of the “forward” translation into English.  This must be done by a translator fluent in both languages who is someone different from the translator who provided the “forward” translation.  The back translator must create the translation independent from the “forward” translation and must attest to the fact that he/she has not seen the original English consent form

    3)  Review and approval of both the forward and back translations for accuracy and completeness by the IRB

    "Forward" and "back" translations should each be made by qualified translators.  Included in these qualifications is that the translators are fluent (i.e. can speak, read and write) in the target language. 

    The "forward" and "back" translators must each attest that the translation he/she made was done independent of the other translation, is accurate and provide the date of the translation.  The "back" translator must also attest to the fact that he/she did not see or refer to the English document when making his/her translation. 

    Each translator must also submit to the HSRO a signed statement describing his/her qualifications to make this translation from one specific language into another.  [NOTE – The signed statement should define that the translation is true, accurate, and correct "to the best of my knowledge and ability".]

    The "forward" and "back" translations, the IRB-approved English documents and the information from the translators should be submitted to the HSRO for forwarding to the IRB for review and approval.  The IRB Chair or designee may approve the translated documents or may refer them to the convened IRB for review and approval.

  • Translators

    The HSRO does not recommend any particular translator, rather the list below represents translators and translation services that have been set up as vendors with the University of Miami. Alternatively, any certified translator may be used when certified translations are required.

    TransPerfect Translations Services
    Shaun Walker
    Account Manager
    200 S. Biscayne Blvd., Suite 850
    Miami, FL 33131
    Telephone: 305-347-3344
    Fax: 305-347-3222
    Email: shwalker@transperfect.com
    Morella Diaz 
    Telephone: 305-525-0625
    Email: morediaz@aol.com
    DREAMS INNOVATORS, INC.
    Dalia Brown, Pres.
    ATA-certified English-Spanish
    Telephone: 786-390-1046
    E-mail: dreams.innovators@hotmail.com
    Confluent Translations
    Charlene Nagi
    Telephone: 412-539-1410
    E-mail: cnagy@confluenttranslations.com
    The Language Corner
    Soledad H. Judge
    Telephone: 305-788-3167
    E-mail: soledad@thelanguagecorner.com
    Pro Translating
    Julie Gonzalez
    Telephone: 305-371-7887
    E-mail: jgonzalez@protranslating.com
    Interpreters Unlimited (IU) 
    dba Accessible Communications for the Deaf 
    Sayed Ali
    Telephone: 800-726-9891
    E-mail: sayed.ali@iugroup.com