INFO: REDCap: eConsent / Paperless Consent

REDCap eConsent Methods:

There are different types of informed consent documentation processes depending on the type of study. Please review PHRC Policy and Guidance on the Research Navigator. In reference to IRB Guidances for online consent and informed consent, outlined below is how REDCap can be utilized.  Contact EDCSupport@partners.org for additional information.

1. Informed Consent in Online Research 

Download: Guidance on Research Using the Internet > Informed Consent in Online Research

This will require IRB Approval

IRBs may waive the requirement for written documentation of informed consent when the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context or when the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Online research involving adults often meets one of these conditions. A consent procedure in which subjects are provided with a written statement about the research followed by a button to click that states, “I AGREE TO PARTICIPATE IN THIS RESEARCH” is often acceptable.

2. Informed Consent obtained via paper then scanned to electronic certified copy

This does not require IRB Approval

PHRC Guidance for Electronic Storage of Research Documents

HOW TO: Scan and Store Research Documents in REDCap

 

3. Informed Consent where a computer/device can be substituted for paper; study team interaction is same as paper process; also known as Paperless Consent or eConsent

This will Require IRB Approval 

This is a handwritten signature applied to electronic media (21 CFR Part 11)

Executed in REDCap by uploading IRB Stamped/Approved PDF Consent Document w/Signature Field Type.

 

Requirements

The participant/subject/LAR must have access to the internet if you're presenting the consent via online survey

If you want to email the completed signed consent form, you must obtain and validate the participant/subject/LAR email address. You must either enable the REDCap survey Login feature or use SEND SECURE

Please Note that SEND SECURE makes the user click on a link and register an account to access the email body/text

The account initiation can deter participants from accessing and reading the email. See this article on the user experience:  HOW TO OPEN A SEND SECURE EMAIL

See:

REDCap and Send Secure

SEND SECURE FAQ

If you are new to REDCap and unfamiliar with the basic terminology and features, there are short tutorial videos provided on the REDCap site under the ‘Training Resources’ tab to help you.  “Detailed Overview,” “Data Entry Overview” and “Online Designer” are 3 videos that cover much of the basics you will need.

If you have a specific question about this process, please email edcsupport@partners.org for assistance

HOW TO: REDCap eConsent/ Paperless Consent

 

4. Remote/Phone Consent

No 'template' REDCap solution.

Alternative Solutions: Adobe eSign

If the study team is acquiring consent remotely or over the phone, the document will be signed electronically without study staff to witness. This process may require 21 CFR Part 11 compliance with electronic signatures.

The most relied upon definition of an electronic signature is: an electronic sound, symbol, or process attached to or logically associated with a record adopted by a person with the intent to sign the record.

 

5. Electronic Informed Consent (eIC) where a computer/device takes the place of paper and people (everything in online/electronic)

No 'template' REDCap solution.

Requires participant identity management and demonstration of understanding of IC.  This process may require 21 CFR Part 11 compliance with electronic signatures.

 

 

21 CFR Part 11 Signature Definitions

Electronic signature: a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

Handwritten signature: "The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument, such as a pen or stylus, is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark" (21 CFR 11.3(b)(8)).

 

PHRC Guidance for

Guidance on Research Using the Internet > Informed Consent in Online Research

REDCap Project: Consent text is Descriptive Text field + Radio Button / Checkbox: