Instrument Descriptions:
...
Expand | ||
---|---|---|
| ||
a.Upload Consent PDF as Inline image/PDFOR add free text with image of IRB stamp b. ** Include any discrete fields needed for you consent documentation needs, such as storing images, genetic results, etc: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.d.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. f.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. |
...
4. If doing in-person consent ONLY:
The attestation statement field can be removed from the Documentation of Informed Consent instrument.
...