Electronic Consent

Updated: 8/15/2025

 

  • Please note, the IRB tipsheet for REDCap eConsent dated 3/3/2025 is now outdated. Please follow the below guidance for all new eConsents moving forward. If your study was already previously approved for eConsent, you can continue following the previous process or transition to this new process if you wish.  

  • The IRB must approve the plan/method to obtain consent electronically, regardless of the platform that is utilized. The electronic consent (eConsent) process must be thoroughly explained within the “Consent” section of the Application. Investigators are required to obtain IRB approval for the eConsent process before implementation for use.  

  • It is the investigator’s responsibility to ensure that the eConsent(s) will exactly match the content of the consent form approved by the IRB. If the consent form is modified over time, it is the expectation that all modifications approved by the IRB are incorporated into the eConsent. If the eConsent platform requires consent forms to be uploaded as PDFs, the investigator must ensure that the current IRB-approved consent form with the IRB approval stamp, is uploaded into the platform and utilized to obtain consent from participants. Submission to the IRB of eConsent-specific documentation, such as screenshots of the platform or links, is generally not required. However, the IRB may request these materials if additional information is needed to aid their review.  

  • At a minimum, the Consent section of the IRB application should describe all of the following elements. If REDCap will be used for eConsent, please review the suggested template language within the REDCap/REDCap Central tab below. This language can also be modified to adapt to other eConsent platforms as needed.:  

All studies  

Additional requirements for FDA regulated studies 

Identify the eConsent platform that will be utilized for the study. 

Confirm that the study will use a Part 11-compliant license or module 

Describe how the IRB-approved consent forms will be uploaded into the eConsent platform (e.g., uploading a stamped PDF, copy-pasting the exact language from the approved form, etc.). 

 

Confirm that the eConsent(s) will include the complete and exact contents of the most current, IRB approved study consent(s). 

 

Specify how consent will be conducted in-person or self-initiated remotely.   

 

Explain how the electronic signature is obtained (typed, written, etc.) 

Confirm that the subject's identity will be verified and their signature will be captured using a method compliant with 21 CFR Part 11 requirements. 

Explain how a copy of the consent will be provided to the participants 

 

  • Please note, if a study is FDA regulated and records data or consent electronically, the study must use a 21 CFR Part 11 compliant platform for electronic records and/or electronic signatures. It is the investigator’s responsibility to ensure that the chosen platform is set up and validated to meet 21 CFR Part 11 regulations. Available platforms that have part 11 compliant features include but are not limited to the following: REDCap Central, Veeva, Florence, Advarra, AdobeSign, DocuSign, IQVIA Complete Consent, etc.   

    • The following table is based on information found on each platform’s website. It is the investigator’s responsibility to ensure that the chosen platform meets all requirements of 21 CFR Part 11. Please keep in mind that the following table is not comprehensive of all available platforms for eConsent. 

    Platform 

    Entire System is Part 11 Compliant 

    Specific Module is Part 11 Compliant 

    REDCap 

     

    X 

    Adobe Acrobat 

     

    X 

    Docusign 

     

    X 

    SiteVault eConsent (Veeva) 

    X 

     

    Florence eConsent 

    X 

     

    Advarra eConsent 

    X 

     

    IQVIA Complete Consent 

    X 

     

    Medidata 

    X 

     

    • Please note, the eConsent should not be revised within REDCap until the IRB approves any amendments associated with consent form changes. Under the new eConsent Framework, the eConsent will go live for participant use immediately once the document is revised and saved within the platform.  

    • The Consent section of the IRB Application should thoroughly describe the REDCap eConsent process that will be used in this study. Please consider using the suggested template language below that can be modified based on your study’s needs. In addition to the elements described above, please also ensure that the IRB Application describes whether the eConsent Framework has been enabled.  

    The patient consent process will be conducted using a REDCap-based electronic consent form.  The consent form has been developed in REDCap, a secure, web-based, HIPAA-compliant, data collection platform with a user management system allowing project owners to grant and control varying levels of access to data collection instruments and data (e.g. read only, de-identified-only data views) for other users. 

     

    This study will utilize the electronic consent (eConsent) framework within the REDCap system. The eConsent forms will be presented to participants electronically, allowing them to review, complete, and sign the consent form online. The system will ensure that all signed forms are archived as PDF snapshots for compliance and future reference. Version control will be strictly maintained, and any changes to the consent form will be resubmitted to the IRB for approval prior to implementation. The information obtained from participants within the REDCap system during the eConsent process will align with the information that would have been collected during the paper consenting process.  

     

    All consent form versions will be managed using the REDCap version control system. Each version of the consent form will be automatically archived upon participant signature. If a new version of the consent form is required, the previous version will be deactivated, and the new version will be submitted to the IRB for approval before use in the study.  

     

    The eConsent(s) will include the complete and exact contents of the most current, IRB approved study consent(s).  

     

    Potential participants will participate in the consent process by (describe method, some examples are included below):  

    1. Being approached in-person at a Vanderbilt Clinic and accessing the REDCap survey via iPad or other portable electronic device  

    1. Self-initiated access of consent forms on personal portable electronic devices using posted QR codes or weblinks on study posters, brochures, or websites.  Self-initiated accessing of consent forms may occur in clinic or at home.  

     

    Include if consent will be obtained in person: During the in-person consent process, patients will be consented by a member of the key study personnel.   

     

    Include if consent will not be obtained in person: For self-initiated consent, contact information will be provided (email and phone) for prospective patients to contact a member of the key study personnel with questions, prior to consent.  

     

    If the study is not FDA regulated, the following language should be used:  

    Participant signatures will be obtained using a (select method: typed signature, PIN number, written signature – via stylus/cursor, etc.). 

     

    If the study is FDA regulated, the following language should be used:  

    The study will use a Part 11-compliant module of Redcap. The identity of the participant will be verified, and participant signatures will be collected using the REDCap 'Scribble Signature' feature, which captures handwritten electronic signatures in compliance with FDA 21 CFR Part 11 and other applicable regulatory standards. 

     

    Multiple stakeholders (e.g., guardians, participants) will sign separate eConsent forms if required by the study protocol.   

     

    Upon completion of the consent, participants will be provided with a copy of their version of the consent document by (select method: downloading directly from REDCap after certification, printing a PDF copy of the consent form in clinic, providing participants with a business card/brochure with the web link to the appropriate version of the consent, provide home address for mailing of a hard copy of the consent).  

     

    • If you are using the in text eConsent option, within the survey instructions portion of the REDCap project setup, please be sure to list the version date exactly as it is listed on the approved consent. If the consent is revised with an amendment, please be sure to revise the version date in the survey instructions to match. Of note, the approval and expiration date do not need to be included in the survey instructions for the in text eConsent option. 

    •  

    • VUMC Institutional Review Board Informed Consent Document For Research 

    Study Title: [enter study title here] 
    Version Date: [enter date (M/D/Y here] 
    Principal Investigator: [enter name of PI here] 

     

    • If you are using the PDF upload option, the approved consent with the approval and expiration date stamp should be uploaded to the REDCap platform to obtain electronic consent.  

    • I am planning to upload stamp pdf files into eConsent platform (e.g. Redcap eConsent Framework). What should I do with fillable fields/checkboxes in my approved consent forms?

      • Fillable fields and checkboxes may be incorporated as fields prior to obtaining signatures in REDCap eConsent. While the display of these fields may differ slightly between the hard copy and eConsent, the investigator must ensure that the language in the eConsent aligns exactly with the IRB-approved consent document. Investigators must ensure that variations in field display are minimized and do not interfere with the subject's understanding.

      • For help related to REDCap set up, please contact redcap@vumc.org. 

     

    Example: Fillable fields 

       Picture 1, Picture 

     

    Example: Checkboxes 

     

    • How should the signature fields be formatted when a LAR or Surrogate signs instead of a participant?

      • First, ensure that the IRB has approved surrogate/LAR consent to be used for this study. If approved, the Word consent document should specify who is signing (Surrogate or Participant). Similarly, it is the IRB’s expectation that the eConsent signature fields should be set up in a way with the same wording to specify the identity of the signer. 

      • How would ancillary consent documents (Consent Addendums for Optional Procedures, Short Forms, HIPAA Forms, etc.) be uploaded to the eConsent platform? 

      • We would expect the approved exact copies of these documents with the IRB approval stamps to be uploaded to the eConsent platform in their approved format (e.g., standalone, part of main consent, etc.) 

       

    General Questions 

    • REDCap - I am submitting a new study that is FDA regulated, and I plan to use REDCap eConsent. What steps should I follow?    
      • As of March 1, 2025, VUMC requires that all newly submitted FDA-regulated studies that plan to use REDCap for electronic records use REDCap Central. REDCap Central is designed to provide a comprehensive compliance framework, ensuring that all regulatory requirements are met. The REDCap Central team can be contacted via email at redcapcentral@vumc.org to discuss using this part 11 compliant system. 
      • If you choose not to use REDCap for your project, another part 11 compliant system must be used if there will be electronic records. Options for other eConsent platforms that can be set up in a part 11 compliant manner include Veeva, Florence, Advarra, AdobeSign, or DocuSign. If you choose to utilize REDCap Central, the eConsent Framework must be enabled, and the PDF upload feature must be utilized. 
    • REDCap - My already-approved study is FDA regulated and is ongoing. I already have approval to use a REDCap eConsent in the standard REDCap system. I am not using REDCap Central. What do I need to do?    
      • As of March 1, 2025, all newly submitted FDA-regulated studies using REDCap for electronic records must use REDCap Central. For studies approved prior March 1, 2025 using standard REDCap system, the PI must contact the REDCap Central team at redcapcentral@vumc.org to address Part 11 compliance responsibilities. As a result of this discussion, a REDCap document named “Appendices for Part 11” must be completed and submitted to the IRB to document the PI’s adherence to Part 11 compliance.  


    Single IRB Questions 

    • How would the eConsent process work for single IRB studies?   
      • The VUMC guidance should be followed for studies where VUMC is the IRB of record. For ceded studies where VUMC IRB is relying on another IRB as the IRB of Record (IoR), we follow the IoR's eConsent process and requirements. If they do not align with VUMC HRPP requirements, we document our process in Local Context forms or IREx site-specific surveys on a case-by-case basis. These are submitted to the IoR for review and approval. For questions on the ceded eConsent process, you may email the sIRB team at: singleirb@vumc.org.   
    • Should the part 1 and part 2 consent documents be uploaded to the eConsent platform separately or combined? 
      • The part 1 and part 2 word documents should be submitted to the IRB separately. Regarding how the approved part 1 and part 2 should be uploaded into the eConsent platform is up to the study team. The part 1 and part 2 consents can be combined into one PDF for upload into the eConsent platform, or the part 1 and part 2 stamped consent PDFs can be uploaded separately. Either way, the information from part 1 and part 2 consents should be presented to participants at the same time, in a similar manner to how a paper consent would be presented.