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Instrument Descriptions:

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titleClick here to expand consent instrument modification instructions:

a.

Upload Consent PDF as Inline image/PDFImage Removed

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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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.

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 if the coordinator signs the consent instrument.

f.

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 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.  

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4. If doing in-person consent ONLY:

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

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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.