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Electronic Consents
If you are launching a new protocol and have the IRB approved consent documents:
- Post in #electronic-consents that you need a new electronic consent and attach the consent documents. Include the approval and expiration (if applicable) dates in the post
- Attend BIT Office Hours to discuss the consent
- We will prepare the electronic consent template and give you design access
- When your changes are ready for review, submit the changes and post in the channel
- When the changes are live in the project test each form and post records to the test record(s) in the channel
The Activities instrument tracks and controls which procedures were consented.
They are standardized across the lab and integrated with Oracle. Changes to the Activities and Options instruments must be requested in the channel.
The date of approval and expiration are entered on the Admin instrument and will display on the consent header.
When the dates change because of amendment or continuing review you will need to update the dates.
If your consent does not need continuing review the expiration date is the end of the protocol.
The value for consents not needing continuing review should be entered as follows:
NA, NA - Does not need continuing review
For REDCap to pipe the dates from the admin instrument you need the following text in your header:
Consent Approval Dates: [consent_approve_date] - [consent_expire_date]
If you consent does not have an expiration date the expiration date should be removed:
Consent Approval Dates: [consent_approve_date]
The REDCap eConsent framework gives the option of emailing the PDF of the completed consent to the subject.
This is a protocol-level choice and based on whether it's allowed and/or required by your consent you can enable the emailing or not.
By default and lab decision, this is disabled. If a subject requests a copy of their consent, the CRC will email them a copy.
- The headers (the tables with the study information) on the forms are standardized per IRB requirements so should not be modified.
- The default REDCap formatting needs to be left in place. E.g. the fonts and sizes should not be changed. Changing the formatting can lead to unexpected results on the participant's device.
- You do not want to copy and paste directly from the PDF or Word document. It can introduce formatting issues that break the survey or consent PDF. Paste into a plain text document in TextEdit (Format -> Make Plain Text) or a text editor of your choice. Then copy the plain text and paste into the REDCap editor and format as needed using the formatting interface in REDCap.
- Related to the above, rebuild numbered or bulleted lists using the REDCap text editor to prevent formatting issues in the survey/consent PDF.
- Underlines have a different semantic meaning electronically so should not used for emphasis. Bold or italicize the text as appropriate.
- Post in #electronic-consents that the consent will be amended when you submit the changes to the IRB
- Post the document(s) with tracked changes in the thread
- The existing consent REDCap project will be copied or have editing enabled
- Changes are made to the REDCap project
- Post when IRB approves/you have submitted the changes
- Make sure approval and expiration dates are updated and correct
- For projects WITHOUT the approval date in the title leave the existing approval date(s), add the new one, and update the default value
- Make sure approval and expiration dates are updated and correct
- When the changes are live in the project test each form and post records to the test record(s) in the channel
It is important to fully test the consent forms before administering to the a research participant.
- Create a test record for each consent form and/or age group if using age-based branching logic (consent, assent, etc.)
- Enter all admin/activities variables (the majority of issues with the consent forms are caused by missing admin variables)
- Complete the consent as a survey – same way the participant would
- Ensure you are able to download the completed PDF for archiving
- Verify the completed PDF matches the approved consent
- Post the test records in the channel
It's important to track changes in the consent document so those changes are reflected in the electronic consent.
It's equally important that the only tracked changes in the consent document are content changes. Formatting edits should be done before tracking content changes.
- Start with a clean version of the consent document
- Make sure the consent document matches the electronic version
- Make content changes with tracking
- Please follow steps outlined in the Virtual Research Reference Manual found on Saturn under Clinical Core SOPs.
Consents (including new versions of an existing consent) require signed approval by the PI before use.
PIs can designate someone to approve consents on their behalf (but cannot be the same person designing the consent in REDCap).