Request for Information: Optimizing the Design and Implementation of Emergency Medical Care Research Conducted Under Exception from Informed Consent Requirements for Emergency Research (EFIC) Requirements and Guidelines

Notice Number: NOT-HL-18-654

Key Dates
Release Date: September 21, 2018
Response Date: December 17, 2018

Related Announcements
None

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institutes of Health Office of Emergency Care Research (NIH OECR)

Purpose

As part of its ongoing stewardship, NIH is considering ways to enhance NIH-supported emergency medical care research conducted under “Exception from Informed Consent Requirements for Emergency Research” (EFIC; 21 CFR 50.24) requirements and guidelines.  Through this Request for Information (RFI), NIH is asking for input that will help to inform:  1) the development of good emergency medical care research practices under EFIC and 2) policies and procedures for the design, implementation, and oversight of NIH-supported emergency medical care research conducted under EFIC.  NIH invites comments from researchers, prehospital providers/emergency medical services personnel, patients and their family members, patient advocacy groups, healthcare providers, and others with an interest in emergency medical care research conducted under EFIC.

Background

NIH has a longstanding commitment to supporting emergency medical care research, including studies conducted under EFIC requirements and guidelines.  This research helps provide the much-needed scientific evidence base for shaping clinical practice in the emergency point-of-care setting and has led to improvements in patient outcomes after life-threatening medical events such as cardiac arrest and severe neurotrauma.  

EFIC requirements are set forth in 21 CFR 50.24 and apply to limited types of research activities involving patients who are in critical need of emergency medical intervention, but who cannot give informed consent because of their life-threatening medical condition, and to circumstances in which it is not feasible to obtain consent from the patient’s legally authorized representative within the limited time necessary to administer the research intervention so that it has its potential therapeutic benefit.  Clinical trials conducted under EFIC are considered justified when there are no known available treatments or when available treatments are unproven or unsatisfactory.  Although the primary goal of these clinical investigations is research, a critical requirement for this type of research is that there must be sufficient evidence to support the potential for the intervention to provide direct benefit to the critically ill patients that may otherwise not be available outside the research setting.

Clinical investigations conducted under this exception have a high regulatory and ethical threshold for being approved.  Additionally, there must be public disclosure and community consultation to inform the affected communities of the planned research and to engage them in a dialogue about the research in order to demonstrate respect and to address concerns that may be raised by the community.  Prospective informed consent from the potential participant or their legally authorized representative must be obtained when feasible.  When not feasible, the research participant and/or their legally authorized representative will be informed about the research at the earliest time feasible and will be provided an opportunity to discontinue their participation in the research at any time without penalty or loss of benefits.  An independent safety monitoring board also exercises additional oversight of the clinical investigation beyond that provided by the NIH, FDA, and the Institutional Review Board.  For more information, see the regulation and FDA guidance on EFIC.

Information Requested

As part of its ongoing stewardship, NIH is considering ways to enhance NIH-supported emergency medical care research conducted under EFIC requirements and guidelines.  Toward this end, NIH is seeking input from the public about their experiences with implementing or participating in emergency medical care research conducted under EFIC, including any challenges they have encountered during such research, as well as suggestions for improving the design and conduct of such research.

NIH seeks comments on any or all of the following topics:

  • The most challenging aspects of implementing emergency medical care research conducted under EFIC across a range of local settings (e.g., urban, suburban, rural), including suggestions for tools and training that might be useful for addressing these challenges
  • Ways to enhance training to better equip prehospital providers/emergency medical services personnel to participate in emergency medical care research conducted under EFIC guidelines (e.g., research protocol implementation, including patient enrollment, family notification and data collection), and strategies for evaluating such approaches across a range of local settings (e.g., urban, suburban, rural)
  • Approaches to obtaining family member permission for the patient’s participation in emergency medical care research conducted under EFIC, and strategies for evaluating such approaches
  • Approaches to family presence during emergency medical care research conducted under EFIC and strategies for evaluating such approaches, including the impact of family presence and needs/experiences of family members in this setting
  • Practices for effectively communicating with the participant’s legally authorized representative (LAR) regarding research being conducted under EFIC, including strategies for informing the LAR of impending enrollment of the patient into EFIC research when the LAR is immediately/readily available so that consent can be obtained
  • Practices for community consultation and public disclosure regarding emergency care research conducted under EFIC across a range of local settings (e.g., urban, suburban, rural) and strategies for assessing the effectiveness of such approaches

Your comments can be submitted anonymously.  Regardless of whether you identify yourself by name, it would be helpful if you describe your role/experience/interest in emergency medical care research conducted under EFIC to help us better understand the thoughts of particular groups.  For example, please indicate if you are an investigator, EMS personnel, patient, Legally Authorized Representative or family member of a patient, patient advocate, etc.

How to Submit a Response

All responses to the RFI must be submitted via email to emergencyresearchEFIC@nih.gov by December 17, 2018.  Please include the Notice Number (NOT-HL-18-654) in the subject line. 

Responses to this RFI are voluntary.  Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response.  The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it.  The Government will not pay for the preparation of any information submitted or for the Government’s use of such information.  No basis for claims against the U.S. Government shall arise as a result of a response to this RFI or from the Government’s use of such information.

NIH looks forward to your input and we hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

Email: emergencyresearchEFIC@nih.gov