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Supporting Education and QI in Research (SEQuR)

12. How Do I Create a Consent/Assent Document?

The guidance document for Informed Consent and an Informed Consent Template can be found at http://www.mmcri.org/SOP in IC 701 SOP and IC 701B. If an alternative format is preferred or required, i.e., by the Sponsor, include a cover memo with the submission justifying its use. To ensure the Informed Consent document is complete please review the; "Informed Consent Element Checklist".

 

In instances where the subject is not legally capable of giving informed consent (e.g., minors) or where the subject is cognitively impaired, adequate provisions must be provided for soliciting the assent of the subject when in the judgment of the Investigator, the subject is capable of providing assent.

 

Assent means a subject's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

In determining whether subjects are capable of assenting, the Investigator and the MMC IRB shall take into account the age, maturity, and psychological state of the subject involved. This judgment may be made for all subjects to be involved in research under a particular protocol, or for each subject, as appropriate. When the MMC IRB determines that assent is required; it shall also determine whether and how assent must be documented.

 

To better assist investigators in drafting and editing consent and assent forms, you can contact administrative support for the MMC IRB at 207-396-8240 or Supporting Education and Quality in Research (SEQuR) at 207-396-8242 both are available to ensure that the materials are appropriate for the proposed Human Research and compliant with regulatory requirements.

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

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