June 30, 2021
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.
Alternative MGB Secure Solutions to REDCap eConsent:
For any method, you must include the technology used in your IRB submission. For REDCap eConsent, indicate:
For this study, we (study staff) will implement the Mass General Brigham REDCap (Research Electronic Data Capture) eConsent.
1. Informed Consent in Online Research
This requires 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
3. REDCap eConsent / Paperless Consent - Requires IRB Approval.
Where the IRB requires written documentation of informed consent and (due to COVID Research and social distancing) research study requires remote or electronic consent, a REDCap eConsent Template is now available. It can be requested and modified for the following use cases:
- Informed Consent where a computer/device can be substituted for paper; study team interaction is same as paper process
- Remote/Phone/Virtual Meeting Consent
- Electronic Informed Consent (eIC) where a computer/device takes the place of paper and people (everything in online/electronic)
If you have a specific question about this process, please email email@example.com for assistance
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.
21 CFR Part 11 Signature Definitions
eConsent may require 21 CFR Part 11 compliance with electronic signatures. The REDCap support team is putting together Part 11 documentation. See more on the REDCap: Compliance page
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)).