[Insert Name]
Chair, Institutional Review Board
Committee for Protection of Human Subjects
[Insert Institution Name]
[Insert Institution Address]

RE: Neurological Emergencies Treatment Trials (NETT) and Exception from Informed Consent (EFIC) Studies.

[Insert Date]

Dear [Insert Name],

[Hub/Center name] was awarded a NIH grant to participate in the Neurological Emergencies Treatment Trials (NETT) network. NETT is a multicenter clinical trials network created in 2006 to study interventions in the earliest phases of emergency care in patients with stroke, neurotrauma, seizures, and other high impact acute neurological conditions. As the principal investigator for our NETT site, I wanted to take this opportunity to tell you more about NETT and the clinical trials that we plan to bring to the IRB.

There is now overwhelming evidence that the opportunity to successfully intervene after brain injury is short and that to be effective new treatments must be tested early, often within minutes or the first hour after onset of symptoms. For this reason, trials conducted in the NETT will sometimes require use of the Federal regulations on Exception to Informed Consent for Emergency Research (21 CFR 50.24). Since exception from informed consent (EFIC) for emergency research involves coordination of investigator and IRB efforts, we would like to start a conversation about how these efforts can be implemented here.

The NETT

This year, [Hub/Center Name] received its first year of NIH/NINDS funding to participate with 16 other U.S. academic medical centers nationwide to create a truly multidisciplinary clinical trials infrastructure involving experts in emergency medicine, neurology, neurosurgery, trauma, critical care, and other disciplines involved in the care of acutely ill or injured patients with neurological emergencies. NETT was formed to answer long standing questions and develop new readily-adoptable evidence-based treatments for these devastating conditions. The NETT infrastructure has distinctive features to achieve its goals. We focus on large simple trial designs using patient-oriented outcomes. To be more representative and inclusive NETT uses a “hub and spoke” design in which we involve other community hospitals as collaborators in appropriate trials. To leverage efficiencies NETT conducts simultaneous trials in different conditions with shared on-call investigators and coordinators, shared electronic project and data management, and shared trial monitoring. NETT is a ground-breaking project that has been written up in the Annals of Neurology and the Annals of Emergency Medicine (articles enclosed).

EFIC

It is expected that a traditional informed consent process will be possible for most trials conducted in the NETT, but some important trials will require exception to informed consent for emergency research (EFIC) as described in theFDA regulation 21 CFR 50.24 and referenced in the HHS secretarial waiver issued under 45 CFR 46.101(i). These rules allow EFIC in trials involving patients in life-threatening situations where current treatments are unproven or inadequate, and in which a meaningful informed consent process is not practicable. Conducting trials with EFIC involves unique requirements for community consultation and public notification. Flexibility in the regulations and subsequent guidance from the FDA and OHRP offer the opportunity to meet the requirements of the rules in several ways, but make assessing adequacy of these efforts challenging. As NETT investigators, our goal is to work with our respective IRB to go beyond the minimal requirements and develop an underlying ethical framework that can be used to continually improve our EFIC processes and to help identify philosophically-anchored assessments. We believe that community consultation is an opportunity for investigators to engage in an expression of respect for subjects, and an opportunity to learn about unexpected values or narratives in the community. We believe that public notification is important to ensure transparency on the part of investigators. By defining these purposes we feel that we can work with you to make better and smarter EFIC processes.

I am seeking to initiate a dialogue with you to help me understand the institution’s past experience with the EFIC protocols and any requirements or preferences the IRB has regarding review and submission of EFIC documents.

I look forward to collaborating with you and the IRB on upcoming NETT trials. Please do not hesitate to contact me with any questions or concerns.

Sincerely,

[Insert local PI name]
[Insert local PI address]
[Insert local PI phone]
[Insert local PI fax]
[Insert local Email]