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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 the informed consent process to comply with IRB policy for any potential future IRB audit.
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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.
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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:
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If using only adult consent:
If using only child consent up to 17 years old:
If using only child consent up to 6 years old:
If using only e-Consent with no physical consent page uploads:
If NOT using LAR:
If NOT using Witness:
If NOT using Interpreter:
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2. Edit consent instruments to include consent images/text and any additional questions
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a. Upload Consent PDF as Inline image/PDF
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OR add free text with image of IRB stamp
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b. ** Include any discrete fields needed for you consent documentation needs, such as storing images, genetic results, etc:
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c. Ensure e-Consent Framework in the survey settings for each consent instrument is configured correctly as per guidelines found in e-Consent Initial Set-Up.
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NOTE: Never delete the Documentation of Informed Consent instrument.
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Step 1) Create your development project using the template
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There are 2 to start from when requesting a project:
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Step 2) Add discrete fields
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If using the Extensive Template delete any instruments not needed for your study (assent, LAR, PPF, Interpreter)
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Participant Contact Info - This form is used by study personnel to gather information about participants interested in being part of the study. 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.  Manual (paper) Consent Upload - This form is used by study personnel to upload signed physical consent documents. 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. e. In-Person Only Consent: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 (attestation instrument) if the coordinator signs the consent instrument. f.
eConsent Adult - 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. Separate Assent Forms:If you are using seperate separate Assent forms for ages 7-12 and 13-17, please make a copy of the Econsent 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:
3. Complete survey distribution set up for each electronic consent instrument to be delivered remotely
Survey Setup & Distribution Overview
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eConsent Parent Permission Form (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 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 (attestation) - This form is used by study personnel to document attestation and the informed consent process to comply with IRB policy for any potential future IRB audit.
If doing in-person consent ONLY:The attestation statement field can be removed from the Documentation of Informed Consent instrument |
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Step 3) Enable e-consent framework and version
Follow the knowledge article e-Consent Initial Set-Up (steps 2-4) to set up e-Consent Framework and version to meet your project needs. Lastly, test the process as if you were a participant!
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