Development, Testing and Audit Findings of an eConsent Process in REDCap Stephanie Oppenheimer, MS SUCCESS Center Erica Ellington, CRA, CHRC University Compliance SCTR Lunch ‘n’ Learn May 23, 2017

What did the stakeholders request? The process should be able to…………. retain flexibility of the Word version, i.e. its role in the application process retain consent approval process workflow mitigate potential audit findings allow for version control

How do you access the template? Create a Project Page

What are the features? Project Setup Page

What are the features? Project Setup Page

What are the features? Online Designer Page

Participant Information Form What are the features? Participant Information Form

Consent Form – Section 1: The Document What are the features? Consent Form – Section 1: The Document

Consent Form – Section 2: Participant Signature What are the features? Consent Form – Section 2: Participant Signature

Consent Form – Section 3: Consenter Signature What are the features? Consent Form – Section 3: Consenter Signature

Consent Form – Section 4: Pro# Statement What are the features? Consent Form – Section 4: Pro# Statement Adds the study Pro# to the signature page Helps with data collection

How does it work? Create the record Enter data to set up the documents for this record

How does it work?

How does it work?

How does it work?

How does it work?

How does it work?

How does it work?

What if you amend the consent? Export and save the consent report to secure location

What if you amend the consent? Download the instruments w/ data (signed documents) Save the file to a secure location

What if you amend the consent? Archive the expired project (remove from active project list) Create a new project Append new project’s title with eIRB amendment tag

Acknowledgements SUCCESS Center Research Stephanie Gentilin, MA, CCRA Matthew Carpenter, PhD Amy Boatright, BS Inst. Review Board Amy Wahlquist, MS Stacey Goretzka, CIP Compliance Erica Ellington, CRA, CHRC

eConsent: A Compliance Perspective SCTR Lunch and Learn University Compliance Office Erica Ellington, CRA, CHRC| Email: ellingte@musc.edu |Phone: 843-792-9098 May 23, 2017

eConsent Compliance So…. A compliance audit is intended to be constructive, service oriented process conducted for several positive reasons…. The large majority of studies selected for audit are random, however more effort is spent on new PI’s, investigator initiated, vulnerable populations and high enrolling studies. Ultimate goal = to help improve the quality of human subjects research So…. Try to think of us as Partners not Adversaries To ensure full compliance with the laws, policies and standards governing human subjects research To identify potential problem areas to be addressed To educate on standards and expectations of research practices and promote Good Clinical Practices This is our premise – that audits should be constructive. We’re trying to achieve several things….

eConsent Compliance These are the main components of every audit….. Review of all Informed Consent Documents and HIPAA authorizations to verify subjects have been properly consented Review of the Regulatory Binder for essential documents Review of Individual Subject Data Records for protocol adherence, safety and confidentiality Verification of data storage and security Overall site operations These are the main components of every audit…..

eConsent Compliance 65% of findings involve the consent document and/or HIPAA authorization Audits 64 Subject Files Reviewed 3,270 Findings 2,077 830 consents 519 HIPAA Authorization

eConsent Compliance: Common Consent Process Findings Dating errors Incomplete dates (portion of the date missing) Person obtaining consent (POC) writing in dates for subjects Incomplete sections Checked instead of initialed Options left empty Signatures Person obtaining consent or subject did not sign the consent Person obtaining consent and subject signature are reversed Subject signs incorrect signature line Incorrect versions of the consent used Crossing out information or writing notes on the consent document Photocopying signatures Older version of HIPAA authorization (privacy notice not initialed) These type of errors could lead to a loss of data!

eConsent Compliance: Audit Process eConsent Audit Reviewed each consent to ensure completion 21 Subjects 17 electronic (0% error rate) 4 paper (75% error rate) Checked future contact section instead of initialing as instructed in the consent document Reviewed audit logs

eConsent Compliance: Takeaways Improves record retention (reduces the number of lost consents and HIPAA authorizations) Documents are immediately and automatically saved to REDCap server upon completion eConsent reduces the risk of informed consent noncompliance by providing better management and documentation of the consent process When properly implemented the eConsent document can not be completed until required fields are completed Provides audit trial

eConsent Compliance: Considerations IRB Application Policy: eConsenting process must be included in the protocol and IRB application as part of the consenting process1

eConsent Compliance: Considerations Set Up Make sure study team has been appropriately trained on eConsent process Make sure the correct version of the consent is being uploaded to REDCap (only approved system at this time) When setting up eConsent use required fields ONLY Use REDCap consult if you have questions about how to set up your eConsent Follow SCTR Standard Operation Procedures when setting up eConsent Test REDCap eConsent multiple times prior to use

eConsent Compliance: Considerations Consenting Process Policy: IRB approved study team member must be present when consenting subjects1 Ensure subject signature is legible Policy: Provide subject with a signed copy of the consent/HIPAA authorization (paper or electronically)1,2 Document the consenting process Document changes in the field comment log when study team accesses consent document Double check eConsent database to ensure consent was properly saved to database prior to the end of encounter with subject Save pdf versions of eConsent on a MUSC secure drive 1Policy: Informed Consent to Participate in Research Policy and Procedures (HRPP 6.1); 2 45 CFR Part 164

Questions?