Legally What Happens If I Refuse a Certified Letter by yzy10050


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									Non- English Speaking Subjects
12.7.2006 HR
                                 Saint Louis University

                           Institutional Review Board (IRB)


A. Introduction
When investigators enroll non-English speaking (or limited English proficiency)
subjects, and materials are being 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

Federal regulations1 require that informed consent information be presented “in a
language that is understandable to the subject.” The consent process involves all
communication with the subject about their participation in a research study.
Communication with subjects should be conducted by a translator (who agrees to
serve in this capacity) or a member of the research team who is fluent in both
English and the non-English language native to the subject.

B. Submission to the IRB
   1. How and when to submit translated materials to the IRB
   Study materials translated into the non-English language of the subject(s)
   must be submitted to the IRB. In most cases, it is in the best interest of the
   investigator to submit these materials after the English version receives IRB
   approval. The protocol should note that non-English study materials will be
   translated from IRB approved English versions of study materials. Please
   note that if the IRB requests modifications to the original submissions, the
   translated materials may also be affected (i.e., it will be necessary to verify
   that the changes have been made in the translated materials).

      If a non-English speaking subject population is being added, or the materials
      are submitted after the English versions are approved, materials must be
      submitted with a change-in-protocol form.

      The submission to the IRB must specify who will be available to offer verbal
      translations to the non-English speaking subjects at the time of consent to
      participate in the study and any study visits. For further explanation see
      section C below.

    DHHS 45CFR46.116-117 and FDA 21CFR50.20

Non- English Speaking Subjects
12.7.2006 HR
   2. To obtain IRB approval of non-English consent forms and study

          a. All English study materials (those distributed to subjects) must be
             translated to non-English language of the subject population.

          b. The materials must be translated by a certified or qualified
             translator (i.e. a person native to the language of the subject,
             spoken non-English language for X years, or teaches the language,
             etc.). The qualifications and contact information of the translator
             should be included on a cover letter with IRB submission (see
             sample in Appendix 1).

              NOTE: If a professional (paid service) is used for original
             translation of materials, step c (the verification process) may be
             waived. Please attach a copy of the documentation from the paid
             service to confirm the translation.

          c. The non-English study materials must be reviewed and verified by
             a second person (the verifier) prior to IRB submission if not
             originally translated by a professional or paid service. The verifier
             can not 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 must complete
             and sign the verification form (see sample in Appendix 2). The
             translated documents must be approved by the IRB before they are
             used for the study.

             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 section D below, Local Resources.

   3. Modification to study materials after the study has received initial
       IRB approval
   If modifications are needed to study materials being distributed to non-English
   speaking subjects (e.g. consent form), a change-in-protocol form 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, and the verification form along with revised study
   materials should be completed and submitted to the IRB (changes should be
   shaded or highlighted in yellow and a “clean copy” should be provided for IRB

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12.7.2006 HR

C. Obtaining and Documenting the Consent Process
The IRB also requires that an individual fluent in the subject’s non-English
language be available to verbally translate during study activities. This individual
may or may not be a part of the research team. The application to the IRB must
explain who will be available to conduct translations if a non-English speaking
subject is involved in study activities (see examples below). A detailed
explanation should be provided in the IRB application. Exempt applications
should provide an explanation in sections 2d, 10 and 13. Expedited and Full
Board applications should describe the process in section 15 of the protocol and
other sections of the application where appropriate.

These activities may include, but are not limited to:
  Obtaining and documenting consent
  Answering questions about the study
  Follow-up interactions with the subjects
  Re-consenting of subjects if necessary

When obtaining informed consent from a non-English speaking subject, there are
two options for documenting the informed consent.

    1. IRB Approved Translated Consent Form - If non-English speaking
       subjects are expected to be involved in research activities, then a full
       translated consent form should be used. The process for IRB approval of
       translated study materials is explained in section B above.

    2. Short Form with a Written Summary- If a non-English subject is
       encountered and qualifies to be enrolled in the study, and the investigator
       does not have ample time to have a translation of the full consent form
       completed, a short form may be used. A short form2 is permitted for use
       with a written summary that meets the required elements of the informed
       consent*or an oral translation of the full consent form.
       The short form states that the required elements of informed consent have
       been presented orally (see example in Appendix 3). The short form must
       be written in the native language of the subject.

        A witness to the oral presentation is required. The witness must be fluent
        in both English and the language of the subject. The IRB shall approve a
        written summary of what is to be said to the subject or the representative.

  OHRP requirements –; FDA
requirements -

Non- English Speaking Subjects
12.7.2006 HR
       *Note: the IRB approved English version of the consent document may
       serve as the summary.

       At the time of obtaining informed consent using a short form,
           a. The short form document should be signed by the subject (or the
              subject’s legally authorized representative).

          b. The summary (e.g. the English consent document) should be
             signed by the person obtaining consent as authorized under the
             IRB approved protocol.

          c. When the person obtaining consent is assisted by a translator, the
             translator may serve as the witness.

          d. The witness shall sign both the short form and the summary (e.g.
             the English consent document).

          e. The subject must be given copies of the short form document and a
             written summary of what was presented orally.

D. Local Resources
Below is a list of a few local paid translation services located in the St. Louis
area. Note: 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.

Language Solutions Inc
699 West Woodbine Ave.
St. Louis, MO 63122

International Institute St. Louis

The Language Access Metro Project (LAMP)

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.

Non- English Speaking Subjects
12.7.2006 HR
                                  APPENDIX 1
   Cover Letter- Cut and paste the following template on your department
   letterhead, complete information requested and attach to IRB submission.


Dear Saint Louis University IRB:

The attached submission for [Enter IRB # or title if submitted with original
submission] contains translated materials for distribution to non-English Speaking
subjects. The translated materials include: [List the study documents that have
been translated and are being submitted: i.e., consent form, assent form,
recruitment flyer, etc.,] and have been translated from English to [enter foreign

The documents listed above have been translated from the English version by a
qualified translator, and the translation has been verified by a different qualified
translator to ensure that the context of the documents is consistent with the
English versions. The translators or services we have used are listed below.
[attach documentation – see example 2 in the Appendix].

[Indicate who did the first translation from the English to non-English language,
and then list separately who was the verifier. Include name, contact information,
and qualifications ( i.e., native to the language of the subject, spoken non-
English language for X years, or teaches the language, etc.) for both. NOTE: If
you used a paid service for the original translation, you may not need a verifier,
however, documentation should still be provided that translation was done.]

[Closing comments,]

[PI Signature]

Non- English Speaking Subjects
12.7.2006 HR

                                   APPENDIX 2
   Verification Form- Cut and paste the following template on your department
   letterhead. This form should be completed by the verifier and attached with
   submission to the IRB.

 DATE: __________________________          IRB#:   ___ ___________________

 TO:     _____[verifier]______________     PI:     _______________________

         __________________________        FROM: [PI or study personnel]


Dear Foreign Language Reviewer:

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 PI’s phone number and email] If you have any questions for the IRB,
please call the IRB office at 314-977-7744 or email

Thank you for your assistance!

Please respond within 1 week from the date above. If you need additional
time, please contact our office.

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. See attached.

________________________________                        _______________
Signature of reviewer (verifier)                        Date

Non- English Speaking Subjects
12.7.2006 HR

                                  APPENDIX 3
    Short Form- Cut and paste the following template on your department
    letterhead, complete the information requested and attach it to your IRB
    submission. This is an example directly from OHRP guidance.

                       TO THE SUBJECT

                            Consent to Participate in Research

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 or legally authorized representative       Date
___________________________                                         ____________
signature of witness                                                date

Non- English Speaking Subjects
12.7.2006 HR


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