U.S. Department of Health and Human ServicesHHS National Institutes of HealthNIH National Center for Advancing Translational SciencesNCATS
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Give Input On The Informed Consent Process

Communicate with Sponsor

You will know the strengths, limitations, needs, and desires of the target population for a clinical trial better than the Sponsor. Now that you understand the informed consent process and obligations of different settings, you can provide insight into elements of the informed consent process that can be proactively addressed to minimize concerns and increase informed participation. You may discuss:

  • Reading level appropriate for target participants and/or guardians.
  • Language requirements, for example, does a significant part of the population speak a language other than English.
  • Potential concerns of the target participants. For example, participants may be concerned about having to discontinue current treatment or it may be important for them to know if they can still go to school or work during the clinical trial.
  • Predictable acceptability to target participant population if individual results may not be returned. 
  • Clearness of the legal and ethical obligations depending on the setting of research.
  • Expectations of clinical care.
  • Terminology that the target participants or their guardians may or may not understand.

Resources

Consent Requirements
Informed Consent for Clinical Trials U. S. Food and Drug Administration (FDA) (link)
Informed Consent FAQs U.S. Department of Health and Human Services (HHS) (link)
Elements of Informed Consent SageBioNetworks (link)
Research versus Clinical Care
Clinical Research Versus Medical Treatment U. S. Food and Drug Administration (FDA) (link)
Return of results: ethical and legal distinctions between research and clinical care 2013 Published Article