NIH is seeking information about the process of exception from informed consent

NIH is seeking information about the process of exception from informed consent

NIH Issues Request for Information on Emergency Medicine Research Conducted Under “Exception from Informed Consent Requirements for Emergency Research”

The National Institutes of Health (NIH) has issued a Request for Information(RFI) on optimizing the design and implementation of emergency medical care research conducted under “Exception from Informed Consent Requirements for Emergency Research” (EFIC)requirements and guidelines (https://grants.nih.gov/grants/guide/notice-files/NOT-HL-18-654.html).

NIH is seeking input from the public about their experiences with implementing or participating in emergency medicine research under EFIC, including any challenges they have encountered during such research, as well as suggestions for improving the design and conduct of such research.

Responses to the RFI will help to inform the development of good emergency medical care research practices under EFIC and policies and procedures for the design, implementation, and oversight of NIH-supported emergency medical care research under EFIC.  

Toward this end, NIH invites comments from emergency medicine 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.  The public comment period is open until December 17, 2018.

All interested parties are encouraged to respond to the RFI and/or to disseminate it to colleagues, as appropriate.  

Background:

Emergency medicine research conducted under “Exception from Informed Consent Requirements for Emergency Research” (EFIC; 21 CFR 50.24) is a critically important type of biomedical research.  Despite great strides in emergency medical care, there are still major gaps in our knowledge about how best to treat critically ill patients in the first moments after onset of life-threatening conditions such as cardiac arrest, traumatic brain injury, and hemorrhagic shock.  For instance, every day nearly 1,000 people suffer an out-of-hospital cardiac arrest, and approximately 90% are fatal.[1],[2]  The “therapeutic window” for treating such patients is often very brief—on the order of a few minutes—and effective treatment during this critical period is a major factor in determining ultimate clinical outcome.  

Clinical trials are the major means of generating the evidence base for optimizing clinical practices in the pre-hospital emergency setting. Conducting clinical trials in this setting is particularly challenging due to the narrow therapeutic window for delivering treatment, and also because the condition of the patient often renders them incapable of providing informed consent to participate in the research.  Thus the research is often conducted under EFIC regulations and guidelines.  In light of the vulnerability of this  study population, NIH has an especially important role in oversight of this much-needed research.  

The RFI is part of an ongoing effort to optimize NIH stewardship of emergency medicine research conducted under EFIC and to strengthen public trust in this critical arena of biomedical research.  Toward these ends, NIH is examining current practices for upholding the principles, requirements, and intent of EFIC and collecting data that will contribute to shaping clinical practice in the emergency point-of-care setting.  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.  Input from respondents will help to inform the development of good emergency medical care research practices under EFIC as well as policies and procedures for the design, implementation, and oversight of NIH-supported emergency medical care research conducted under EFIC.

 

Request for Information

 

[2]Chan, Paul S. et al. Circulation 130(21): 1876–1882 (15 Nov 2014)