Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Instrument Descriptions:

...

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.

...

Expand
titleClick here to expand consent instrument modification instructions:

a. Upload Consent PDF as Inline image/PDF

Image RemovedImage Added

OR add free text with image of IRB stamp

Image RemovedImage Added

b. ** Include any discrete fields needed for you consent documentation needs, such as storing images, genetic results, etc:

Image RemovedImage Added

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.

Image RemovedImage Added

d. 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. Separate Assent Forms:

If you are using seperate 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.  

Resources: 

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

...