Office of Clinical Research
Traditionally consent is captured in person, on paper, unless a waiver of documentation of consent or consent itself has been granted by the reviewing IRB. However, electronic tools may be used to captured informed consent. Below are various tools that may be used and some considerations as to when to best use them.
DocuSign is a vendor supported application that meets 21 CFR Part 11. The following White paper addresses this from a system validation and change control process. Click here
Additionally, validation reports from the vendor are received monthly and can be accessed by contacting OCR directly.
- Recommended tool for studies under an IND or IDE
- HIPAA and Part 11 compliant validated
- Can be used seamlessly for patients or LAR
- Facilitates in person or telemedicine/ phone visit and documents consent process
- Can be uploaded directly into PennChart
- Usability for other trial documentation – DOA, etc.
- Cost associated with use
Information from Docusign on Part 11 Compliance
Online training required. Please submit an access request form and ticket to the helpdesk if you are interested in using the application.
- Recommended for all studies that are NOT under an IND/IDE
- HIPAA compliant for e-signatures
- Easy self-service workflows- upload the consent and manage sending to subjects
- Subject signs and document accessible by research team for additional signature
- Need team to have active REDCap and PMACS accounts
- There is no cost associated with use of the application
Contact REDCap user support if you are interested in using email@example.com or the main OCR inbox for more information.
- Recommended for studies involving PennMedicine patients with active MPM and where documentation of consent is waived
- Consent form can be uploaded into MPM and directed to patient
- Direct messaging back and forth with the patient
- Can provide consent and then engage in survey or other MPM directed activities
- No advisable for LAR consents
- There is no cost associated but your study does need to be built in PennChart,
- Contact OCR or the MPM PennChart research team if you are interested in using
- Epic/PennChart Consents
- No advisable for LAR consents
- There is no cost associated but your study does need to be built in PennChart
- Contact OCR or the MPM PennChart Research team if you are interested in using
- Epic/ Pennchart Consents
- Consents functionality built with PennChart
- HIPAA compliant/ lives within the patient EMR
- Need study built in PennChart and patient associated to the study
- Utilizes tablet or other hospital device
iConnect App Bakery
Recommended for studies where the population and study lend itself to smartphone application use
- This is a DIY web-based, research study app builder that requires no
- HIPAA compliant
- Participants download the app and use it to sign consent, and send automatically back to the study team
- App specifications are built through a web interface. Apps created are compatible for both iOS and Android and can be added to the Google and Apple app store within a very short time frame.
- The vendor company, TrialX, has an existing BAA with Penn Medicine, removing the need for research teams and departments to have their own vendors vetted through IS.
- Subsidized, sliding- scale prices making this a cost effective option for research teams.
To request a demo, contact the Office of Clinical Research at firstname.lastname@example.org
Additionally the IRB, and OCR, have developed guidance around remote consent which also highlights situations in which consent may be altered due to infection control measures, remote use of an LAR and including best practices for documentation. Even though consent may be obtained remotely and/or using electronic means that does not mean that the full informed process will not take place; it should. It is recommended that a consent note be written in PennChart, or in source files, to document who obtained consent, how it was obtained and what was discussed.
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