Forms & Templates
Protocol template (updated July 2017)
Informed consent templates
- Template 1: Interventional studies involving drug or devices
- Template 2: Social or behavioral research studies
- Template 3: Establishment of a research registry or database
- Template 4: Case reports, case series, or prospective record review
- Template 5: HUD consent template
- Template 6: Male Reproductive Risks
- Template 7: Female Reproductive Risks
- Template 8: Information Sheet
- Template 9: Waiver or Alteration of Consent
Other Templates:
- Protocol template
- Translation Certification Form
- Sample data collection document
- Unaffiliated Investigator agreement
- Quality Improvement or Research Study Checklist
- IRB Authorization Agreement (IAA)
Non-English Speaking or Reading Population
When some or all of the participants of a research protocol are likely to be non-English speaking/reading populations, the recruitment materials, consent documents, and other study documents (i.e. questionnaires) must be translated into the language understood by the targeted group (45CFR46.116-117 and 21CFR50.20).
When non-English speaking/reading individuals are to be consented, an interpreter must be present to facilitate oral communication in more than one language.
All documents translated from English to another language must receive IRB review and approval before use, to assure that the rights and welfare of research participants are adequately protected. The IRB does not provide translation or interpretation services.
The IRB recommends that document be translated in one of two ways:
(a) Single Back Translation: The translated document is translated back into English. The translator providing the back translation into English must be different from the person who provided the original translation. Each person providing translation service must complete and sign the Translation Certification Form.
(b) Double Translation: Two individuals independently translate the same document from English into another language. An arbitrator reviews both translated documents to determine any differences between the two translated documents. Changes to documents will be made, if applicable. Both Translators must complete and sign the Translation Certification Form.
The IRB encourages the use of certified translator. Written documentation of qualification of each translator must be submitted if they are not certified. The IRB may invite a consultant to review the translated materials to determine cultural appropriateness.