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Electronic Informed Consent (eIC)

As a leader in technology to support human subject protection, Schulman takes a flexible approach in the review of non-traditional informed consent procedures that involve electronic components, understanding that each study, population, and platform is unique.

This approach results in a collaborative review experience so that, in the end, study subjects are afforded the best opportunity to understand the research.

Schulman has worked with a variety of eIC (or eConsent) platforms, and our processes are built to complement any platform.

How to Submit eIC with Initial Submission

  • Login to eTools and select Start a New Form, then select Initial Submission.
  • When prompted, indicated any plans to use an eIC.
  • Include instructions for the method by which the IRB can provide comments on the eIC.
    • If a traditional paper form will be available to subjects, this document can be used to facilitate IRB feedback and/or revisions.
    • When there is no traditional paper form being used, submission of the eIC content in an editable MS Word document can be used to communicate IRB feedback and/or revisions.
  • Submit a digital file or hyperlink of the eIC, if available.

How to Submit eIC to a Schulman Approved Study or Make Changes to an Approved eIC

  • Login to eTools and select Start a New Form, then select Study or Site Changes, Revisions or Amendments.
  • When prompted, indicated the plan to use the eIC.
  • Include instructions for the method by which the IRB can provide comments on the eIC.
    • If a traditional paper form will be available to subjects, this document can be used to facilitate IRB feedback and/or revisions.
    • When there is no traditional paper form being used, submission of an editable MS Word document can be used to communicate IRB feedback and/or revisions.
  • Submit a digital file or hyperlink of the eIC, if available.

When there is significant new information that would impact a subject’s willingness to continue to participate, and there is not sufficient time to update the eIC, consider submitting a paper informed consent and/or “dear subject” notification to communicate updates to the subjects in an accelerated manner.

For more information on the review process and submission steps, please review our Electronic Informed Consent (eIC) Guidance.

If you have any questions regarding timelines for review of your specific submission, please contact your Study Manager or call 513-761-4100.