eConsent REDCap Template Instructions

Instrument Descriptions:

Participant Contact Info - This form is used by study personnel to gather information about participants interested in being part of the study.

Manual Consent Upload - This form is used by study personnel to upload signed physical consent documents.

Econsent ICF - This survey is used by an adult subject to collect informed consent.

Econsent Assent - This survey is used by a subject ages 7 -17 to collect informed consent.

Econsent PPF - This survey is used by the parent of a subject under the age of 18 to collect informed consent.

Econsent Legally Authorized Representative (LAR) - This survey is used to collect informed consent by the legally authorized representative of a subject who is unable to provide consent.

Econsent Witness - This survey is used by the witness to a subject who is unable to read or sign the consent form.

Econsent ICF Interpreter - This survey is used by the interpreter for non-English speaking subjects who are unable to read the consent form.

Documentation of Informed Consent - This form is used by study personnel to document attestation (if needed) and the informed consent process to comply with IRB policy for any potential future IRB audit.

Template Modification Instructions:

The template as provided is comprehensive so that it can be used as a starting point for all projects. (I.E., adult, pediatric, etc.) This instructional guide in conjunction with the knowledge articles and training materials should be followed to modify the template to meet study needs.

Please note: The template framework does not mirror the paper consent because of the way the REDCap e-consent framework is designed. When e-consenting for an FDA validated project there is one signature per e-consent instrument.

1. Delete instruments that will not be used:

If using only adult consent:

Delete the Econsent Assent instrument
Delete the Econsent PPF instrument

If using only child consent up to 17 years old:

Delete Econsent ICF instrument

If using only child consent up to 6 years old:

Delete the Econsent ICF instrument
Delete the Econsent Assent instrument

If using only e-Consent with no physical consent page uploads:

Delete Manual Consent instrument

If NOT using LAR:

Delete LAR Instrument

If NOT using Witness:

Delete Witness Instrument

If NOT using Interpreter:

Delete Interpreter Instrument

2. Edit consent instruments to include consent images/text and any additional questions

a. Follow the e-Consent Initial Set-Up knowledge article to build/edit consent instrument and set up e-Consent Framework to meet your project needs.

b. Manual Consent:

If using Manual Consent Upload instrument and multiple forms may need to be uploaded, copy the "Upload copy of signed consent" field as needed to allow for more than 1 upload.

c. Separate Assent Forms:

If you are using separate Assent forms for ages 7-12 and 13-17, please make a copy of the eConsent Assent instrument by selecting “choose Action” on the instrument and click “copy” then label it appropriately. You may want to edit the variable names to match your Assent types.

Resources:

e-Consent Initial Set-Up

e-Consent Version Control

3. Complete survey distribution set up for each electronic consent instrument to be delivered remotely

If participant age is to be used to determine which consent form should be sent (i.e., under age 18 send parental permission form), the participant date of birth (dob) and age (age_at_contact) fields in the Participant Contact Info instrument can be used for survey distribution logic.

Resources:

Survey Setup & Distribution Overview

4. If doing in-person consent ONLY:

The attestation statement field can be removed from the Documentation of Informed Consent instrument.

If you are consenting in-person only for a non-FDA regulated study, you may add multiple signatures to the instrument and e-consent framework as needed. This does not negate the need for the documentation of informed consent if the coordinator signs the consent instrument.