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Supporting Education and QI in Research (SEQuR)

21. How to Document Informed Consent?

The MMC IRB approved Informed Consent Form signature area should be completed and include dates and (printed name, title, or relationship if applicable). 

The following are the requirements for customary MMC IRB approved consent documents:

  • The participant or representative signs and dates the consent document.
  • The individual obtaining consent signs and dates the consent document.
  • The individual obtaining consent must be qualified by training to answer questions which may arise from the consenting process.
  • If required by a sponsor the subject must initial or initial and date each page.
  • The consenting process should be documented in the subjects medical record and confirm that the consent was obtained prior to any research procedures.
  • If multiple Informed Consent versions are generated in a research study the current version of a consent must be used at the time of consent.
  • Whenever required by the IRB, the participant's or representative's signature is to be witnessed by an individual who signs and dates the consent document.
  • For participants who cannot read and whenever required by the IRB or the sponsor, a witness to the oral presentation signs and dates the consent document.
  • A copy of the signed and dated consent document is to be provided to the participant.

 

The HIPPA required elements should be incorporated into the MMC IRB Informed Consent to do Human Research if applicable, for example; some study procedures are conducted at a HIPAA-covered entity.

 

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Maine Medical Center Research Institute 81 Research Dr Scarborough, ME 04074 (207)396-8100

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