Enrolling patients when you can’t obtain consent.

The ethics of EFIC.

Looking for my next mindless Netflix binge, I decided to dive back into Grey’s Anatomy. I know nurses who cringe when watching the way medical procedures are portrayed at Seattle Grace Hospital, so I thought I might see the show through a new lens now that I’ve worked in healthcare for a few years. Because of my experience in pharma, I found myself wondering how some lifesaving treatments used in the show, specifically those administered to people who are unconscious, come to market.

This led me to learn a little more about EFIC studies – or exception from informed consent studies – and the unique set of rules that govern them. Think about incidents like traumatic brain injuries or status seizures: treatment needs to be administered immediately, but the patient is unable to provide consent and there isn’t enough time to get consent from the proper people.

To perform these studies ethically, the FDA developed a set of regulations requiring sponsors to inform the public that the study is happening in their community, educate the public on how they can opt-out, and provide opportunities for feedback from the public prior to institutional review board (IRB) approval and the start of enrollment. These EFIC-specific regulations fall into two broad categories: community consultation and public disclosure.

Community consultation.

Community consultation regulations exist to provide representatives of each community where the study will take place the opportunity to discuss their opinions on the study. Community consultations require that certain information be shared. At minimum, this includes the study design, patient eligibility criteria, other available treatment options, study length, and more. This is done not only out of respect for the community, but also to provide IRBs with feedback that informs their decision on whether to approve the study.

Public disclosure.

At the initiation of the study, sponsors are required to adhere to public disclosure regulations, which are intended to notify the broader community that the study will be conducted without obtaining informed consent. Other information provided in the public disclosure includes how to opt out, the risks and benefits of participation, and more.

To meet public disclosure regulations, a plan must be developed and shared with the IRB. It must explain how information about the emergency research will be shared with three specific target audiences: communities (geographic and patient populations), the general public, and scientific researchers.

The FDA recommends that study information be disseminated using various tactics, including:

  • Targeted mailings
  • Advertisements and articles in local publications
  • Mentions on the sponsor’s and participating hospitals’ websites
  • Outreach to non-English-speaking or homeless populations who reside in the community
  • Meetings with community, local government, civic, or patient advocacy groups
  • PSAs or interviews on talk radio or television programs
  • Press conferences and briefings
  • Messaging through hospitals’ and institutions’ existing community outreach programs
  • Listings on clinicaltrials.gov
  • Meetings with physician specialists, staff at local hospitals, local and regional community leaders, and first responders (e.g., police, paramedics)

Once the plan has been reviewed and public disclosure implemented, the IRB can approve the study and enrollment may begin.

Not exactly patient recruitment.

Though EFIC studies don’t use traditional methods to recruit patients, the art of understanding both the target population and the best practices for communicating with potential participants is still the foundation of ethical patient enrollment – it’s also at the heart of how Praxis does business. Reach out to learn more about how our in-house PR, creative, and media teams have worked on various campaigns to spread awareness of local health initiatives.

Further reading.

FDA, Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research, April 2013, https://www.fda.gov/media/80554/download

Virginia Commonwealth University Office of Research and Innovation, “EFIC – Exception from Informed Consent,” https://research.vcu.edu/human_research/EFIC_guidance.pdf

Any questions? Want to know more?

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