VCU Human Research Protection Program (HRPP) Blog

The VCU HRPP is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

Informed Consent Process

by Christine Davison

Informed consent of research subjects is critical, and is more than just a document & signature – it is an ongoing process. Here are a few reminders about the Informed Consent document and process:

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  1. A potential subject must have plenty of time to consider whether or not to participate
  2. Consent Document must be signed unless a waiver is granted.
  3. Informed Consent Document
    1. Must include all 8 elements of consent (Strongly suggest using VCU templates)
    2. Use “lay language” – must be understandable to potential subjects
      1. Language must not overstate benefits or be coercive
    3. No consent document may use exculpatory language to waive legal rights or release the investigator, institution, etc. from liability for negligence.
  4. Process
    1. Initial:
      1. Potential subjects must be consented before enrollment and participation in any research activity.
      2. Screening/Recruitment may require consent or waiver
      3. Give potential subjects information, and make sure it is fully understood
      4. Give potential subjects time to consider and ask questions
      5. Sign Consent form (unless documentation of consent is waived)
    2. Ongoing:
      1. Document the informed consent process
      2. Continue to remind and inform subject throughout study/re-affirm consent
      3. Everyone who consents is enrolled in the study
  5. Waivers of Informed Consent – IRB may waive some or all elements, or documentation if it meets certain requirements. Refer to Page 11 of the Getting Started Guide for more details.
    1. Waiver of Some or All Elements
    2. Waiver of Documentation
  6. Special Populations:
    1. Children – Requires Assent & Parental Permission
    2. LEP (Limited English Proficiency) – Short form or translated consent (See WPP)
    3. Decisionally Impaired Adults – Requires Assent (based on person’s level of competency) and LAR (Legally Authorized Representative) consent
    4. EFIC – Exception from Informed Consent

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