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- Electronic Source (eSource)
- Eligibility Criteria
- Endoscopic Retrograde Cholangiopancreatography (ERCP)
What is eConsent? eConsent refers to an electronic solution to obtain informed consent from study subjects.
The regulatory guidance for eConsent is similar to those in paper form but specifies that:
- The information provided during eConsent should be able to be understandable and appropriate for the audience, easy to navigate, and allow for the subject to return to previous sections and be able to continue at another time.
- Other options, such as paper consent, or personnel-assisted informed consent, can be used for people unable to access or use the eConsent for any reason.
- eConsent may be used on-site or remotely.
- Methods should be in place for the volunteers to have the opportunity and time to review the eConsent and ask for any clarifications.
- The eConsent process should have methods in place to ensure understanding of the information.
- The eConsent must be updated to reflect any new findings or changes to the process, and allow the subject the time to review and ask any questions before continuing in the study, or deciding to end their participation.
- Electronic signatures may be used as long as they meet specific requirements to verify the identity.
- The eConsent may be obtained from parents or guardians of pediatric subjects while ensuring there is a method in place to obtain the subject’s assent.
- A paper or digital copy of the eConsent with the signature and date must be provided to the subject.
- The electronic systems supporting eConsent must securely protect the identities, personal information, and study information of the subjects. HIPAA authorization may be obtained alongside the eConsent.
- Paper or digital copies of the eConsent form and any informational media must be submitted to the IRB for approval.
- eConsents must be accessible in the event of an FDA inspection.
What is the advantage of eConsent?
- Increased convenience for the individuals to access the information remotely and on their own time.
- Ability to include multimedia tools to supplement the information provided.
- Multilanguage accessibility.
- Ability to track consent in a convenient and portable manner.
Source: U.S. Department of Health and Human Services, Food and Drug Administration, & Office for Human Research Protections (OHRP). (2016, December). Use of electronic informed consent. Food and Drug Administration. https://www.fda.gov/media/116850/download