Give Input On The Informed Consent Process
Tips for Success
- Utilize information from natural history studies and patient preference studies to inform an investigational therapy’s Sponsor about any predictable concerns of the study design or eligibility criteria that can be directly addressed in the informed consent.
- Start educational outreach about the informed consent process to your disease community before the clinical trial is ready to begin accepting participants.
- Work with the Sponsor to develop a Frequently Asked Questions document that is relevant to the target participant population.
- Offer resources developed for your members to the Sponsor to help with their outreach efforts.
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