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E-Consent Resources

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Building a successful e-consent project requires at least intermediate familiarity with REDCap, especially for complex e-consents (e.g. those requiring Part 11 Compliance, those using Short Forms to obtain LEP consent). We recommend an experienced Research Coordinator build the consent project. The research team should test the consent process, end-to-end, as many times as is needed to ensure the project is working correctly and everyone is comfortable with the consent process.

When getting started, ask yourself the following questions:

Does Your Study Fall Under Federal 21 CFR Part 11 Regulations?

If your study requires 21 CFR Part 11 compliance, you'll need to complete the Part 11 Training and Attestation and follow the Part 11 e-consent Guidelines, found below in the Resources section. Please note you must follow the instructions in order to meet the requirements of Part 11 regulations. Also, please note that ONLY the eConsent feature in CHOP's REDCap has been validated for Part 11.

Will you need to obtain assent from some or all participants?

If yes: use fields to control assent signature blocks via branching logic. This means potentially having questions as part of an initial staff data entry form that indicate if subject is able to assent based on age, mental capacity, etc.

Will You be Consenting Limited English Proficiency (LEP) Participants?

If yes, will you use a full translation of your consent form, short forms, or both? Will you use in-person interpreters, remote interpreters (LSA), or both?

Please review the Resource section below for our guidance on e-Consent in languages other than English. Note that we offer downloadable REDCap.zip files for Spanish and Arabic short forms in both pre-2018 and 2018 versions as well as with and without FDA language.

The CHOP IRB website has a general Short Form FAQ and downloadable Microsoft Word files for short forms in a multitude of different languages.

Is Your REDCap Project a Multi-site Study?

  • Use DAGs to control different sites' access to records within your project.
  • If multiple sites will be consenting using the CHOP REDCap project, use Form Display Logic to control which sites have access to which e-consent forms to prevent confusion.
  • Consider if your e-consent process will be the same or not for different sites. For example, will non-CHOP sites use remote interpreters that are not part of LSA? If so, interpreter signature process will need to be amended to obtain non-LSA interpreter signatures.

Does Your IRB-approved Consent Plan Require One Parent/LAR or Two Parent/LAR Signatures?

While less common, some studies are required to obtain two parent (or LAR) consent. In these cases, a second "Parent 2" e-consent form is needed. If obtaining e-consent remotely, the Survey Queue along with some questions directed at the first parent/LAR can control if the second consent form appears directly after the first for signatures (if the second LAR is present and able to sign), or if an invitation for the second consent form needs to be emailed to that LAR (if they are not currently present and able to sign).

 

Before Going Live, Schedule a Meeting with Us

Any new e-consent project will require a meeting with a REDCap administrator. Ready to schedule an e-consent review meeting? Once you have a draft of the e-consent project ready for us to review, submit this e-Consent Intake survey and we'll reach out to schedule.

Resources

The template projects and job aids below are meant as a general guide. Specifics will differ for your project based on your team’s goals and what the IRB has approved. Keep in mind that what's most important is proper documentation of your consent process and a clear trail of adherence to your specific approved process.

Currently Available 2018 Short Form Consent Forms (REDCap instrument zip files)

2018 Short Form Templates

With FDA Language

Without FDA Language

Version

Spanish

Spanish 2018 with FDA

Spanish 2018 no FDA

1-8-19

Arabic

Arabic 2018 with FDA

Arabic 2018 no FDA

1-8-19

Currently Available Pre-2018 Short Form Consent Forms (REDCap instrument zip files)

Pre-2018 Short Form Templates

With FDA Language

Without FDA Language

Version

Spanish

Spanish pre2018 with FDA

Spanish pre2018 no FDA

4-28-11

Arabic

Arabic pre2018 with FDA

Arabic pre2018 no FDA

4-28-11