Society for Clinical Research Coordination and Management

Society Scoops!

June 8th, 2022 - SCOOPS

SCRCM SCOOPS: Informed Consent: Who, What, Where, When, How

Session Overview:

Informed consent is an ongoing active process though which a researcher communicates key aspects surrounding research participation to a subject and a subject voluntarily communicates willingness to participate.  Informed consent starts at the time of the first research related interaction and continues through to the completion of subject’s participation. Navigating the ongoing consent communications throughout the course of a research study can be challenging for both the research staff and the research subject.


This session will provide a review of fundamental informed consent requirements, as well as, discussion of best practice and key stakeholder perspectives surrounding the conduct of the consent process over time.  Aspects of consent including patient facing education on the concept of clinical research and building patient trust in the research enterprise will be included. Clinical situations involving varying approaches to supporting effective and efficient informed consent will be presented.  Practical implications involved with when and how to approach subjects for ‘re-consent’ will be included.  Elements of consent pertaining to expectations for return of research results will be considered.    


Learning Objectives:

After completing this session, attendees will be able to:

  • Knowledge
    • Define ‘informed consent,’ the key stakeholders involved, and associated ‘process’ as related to human subject research with accuracy
    • Identify key federal regulatory code which sets forth informed consent requirements including in text references
    • Identify complex clinical situations which necessitate alteration to the standard informed consent process including at least two examples
    • Identify the time points at which timely re-consent is required and methods for updating participants with accuracy
  • Skill
    • Navigate to University of Pennsylvania resources governing expectations for informed consent
    • Describe what it means to participate in clinical research using patient-oriented lay terms
  • Behavior
    • Integrate concepts related to trust-building into research consent process
    • Adjust current practice to meet minimum regulatory and institutional expectation

For the presentation slides, Click HERE

For the presentation recording, Click HERE