Consenting

Consenting

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

Online training required. Please submit an access request form and ticket to the helpdesk if you are interested in using the application.

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REDCap

  • Recommended for any studies
  • Benefits
    • HIPAA and part 11 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 redcap@mail.med.upenn.edu or the main OCR inbox for more information.

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MyPennMedicine

  • Recommended for studies involving PennMedicine patients with active MPM and where documentation of consent is waived
  • Benefits
    • 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

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iConnect App Bakery

  • Recommended for studies involving PennMedicine patients with active MPM and where documentation of consent is waived
  • Benefits
    • 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

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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.