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Give Input On The Informed Consent Process

Outreach

Helping potential participants understand their rights prior to beginning the informed consent process can help mitigate any concerns that may jeopardize participation. It can be helpful to provide information about the informed consent process before a clinical trial is ready to recruit. Your knowledge of the informed consent process together with your knowledge of your disease community can help you determine the best approach to ensure the process reaches its goal of informed consent. 

  • Provide general information about clinical trials and informed consent on your website.
  • Explain possible future benefits of studies that may not provide immediate benefit to participants, for example what the study hopes to discover, mitigate, or develop.
  • Hold a webinar about informed consent and make it available to those who can’t attend. 
  • Bring in speakers at an upcoming conference who can talk about the informed consent process.
  • Develop InfoGraphs or pamphlets that can be downloaded from your website or mailed to members who may not have easy internet access.
  • Post links to relevant information, events, or webinars provided by large umbrella organizations like NORD, Global Genes, and FasterCures.

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