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Informed Consent Using the "Short Form”

Informed Consent Using the "Short Form”. The Starting Point. Belmont Report 1) Respect for persons 2) Beneficence 3) Justice. Is there a regulatory requirement?. 21 CFR 50.25

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Informed Consent Using the "Short Form”

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  1. Informed Consent Using the "Short Form”

  2. The Starting Point Belmont Report 1) Respect for persons 2) Beneficence 3) Justice

  3. Is there a regulatory requirement? 21 CFR 50.25 “The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.”

  4. Outline of Presentation: • What are short forms? • When can a short form be used? 3) What are the required signatures with short forms? 4) What must be approved by the IRB before using the short form?

  5. 1) What are short forms? • A short form is an abbreviated consent form document designed to assure that the basic elements of informed consent have been met. • It is submitted to the IRB via a revision

  6. The following short forms are included on our website: • Arabic • Croatian • French • Hmong • Khemer • Lao • Oromo • Russian • Somali • Spanish • Vietnamese

  7. The short form is not study specific. • It summarizes the elements listed in 21 CFR 50.25

  8. The elements are presented to the subject by a translator, who interprets the IRB approved English language consent. • A witness is present for the oral presentation. If the subject cannot understand English, then the witness should understand the subject’s preferred language.

  9. 2) When can a short form be used? • The short form is intended for consenting a non-English speaking subject that is unexpectedly encountered

  10. If there is a possibility that additional non-English speaking subjects may be encountered, then a revision should be prepared to submit a translated version of the IRB approved English language consent. TIP: Documentation of translator’s credentials.

  11. A translator should be present at each study visit.

  12. 3) What are the required signatures with short forms? • The subject signs the short form • The witness signs the short form

  13. Who signs the English version of the consent? • The witness • The person obtaining consent The person obtaining consent cannot also be the “witness.”

  14. Are there other requirements? • The subject should receive a copy of both the short form and the informed consent document which was presented orally by the translator.

  15. 4) What must be approved by the IRB before using the short form? • The short form itself • Translations of all forms to be completed by the subject (if time allows)

  16. Conclusion • Use of the short form, in conjunction with an oral presentation by an interpreter, in the presence of a witness, satisfies the requirement for documentation of informed consent.

  17. If more than one non-English speaking subject is expected, it is recommended that a translated version of the IRB approved consent should be submitted for approval.

  18. Always contact the IRB in advance so that we can work with you to process the submission in a timely manner.

  19. Questions? Mitchell Robertson, IRB Manager Tel: 312 503-1411 Email: mrobertson@northwestern.edu Main line for the NU IRB Office: 312 503-9338 General questions: IRB@northwestern.edu

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