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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 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.

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c. Separate Assent Forms:

If you are using separate Assent forms for ages 7-12 and 13-17, please copy the Econsent Assent instrument and 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.