Exception from Informed Consent

Currently, six national emergency medical services (EMS) research agendas emphasize a lack of evidence base for the scope of practice to care for children in out-of-hospital emergencies. For years, leaders in pediatric EMS research have said that some procedures routinely practiced in the field have little or no evidence base to corroborate their efficacy. Many of these same researchers say that those that are routinely practiced may indeed do more harm than good. Clearly, there is support for greater scientific evidence ensuring that the best practices are indeed being implemented in the field.

One way to facilitate rigorous pediatric research is to overcome the difficulty of obtaining informed consent in prehospital emergency care situations. Informed consent is at the front of a battery of protections aimed to ensure that participants in research are fully respected as human beings and made aware of the purpose, procedures, risks, and benefits of a study.

It is possible, however, to waive the informed consent requirement when conducting research in an emergency setting. Exceptions are made if the subject’s medical condition precludes assent, if the intervention must be administered before consent from the subject's legally authorized representative, and if it is not feasible to identify prospectively whether the individual is likely to become eligible for participation. 

HEALTHCARE PROVIDER RESOURCES

Department of Health and Human Services (DHHS) 

• Title 45 Public Welfare, Department of Health and Human Services, Part 46, Protection of Human Subjects (CFR Title 45 Part 46).  These federal regulations ensure that the human subjects of behavioral and biomedical research receive the protections to which they are entitled and to minimize risks to them. Within this document, DHHS outlines general requirements for written informed consent (CFR Title 45 Part 46.116). Here you will also find two subsections on exceptions to written consent: CFR Title 45 Part 46.116 (d)) known as the Waiver or Alteration of Informed Consent Requirements and 45 CFR 46.117(c) known as the Waiver for Written Documentation.

• Title 21 - Food and Drugs, Chapter I - Food and Drug Administration, Department of Health and Human Services, Part 50 Protection of Human Subjects. Like its counterpart at the DHHS, FDA 21 CFR 50.20 is a set of federal regulations that outline the general requirements for informed consent. Within these regulations, there are two sections pertaining to exceptions to informed consent: 21 CFR 50.23 -- Exception from General Requirements (Emergency Use) and 21 CFR 50.24 -- Exception from Informed Consent Requirements for Emergency Research.

• Exception from Informed Consent in CPR Device Trials: Protection of Patients' Rights. This PowerPoint presentation summarizes the requirements for an informed consent waiver in emergency medical research.

• Exception from Informed Consent For Studies Conducted in Emergency Settings: Regulatory Language and Excerpts from Preamble. This resource summarizes the criteria and requirements for waiving informed consent found in the FDA Final Rule (FDA 21 CFR 50.20).

University of Maryland, School of Medicine Human Research Protections Office

• Exceptions to Written Informed Consent in Human Subject Research. Developed by the University of Maryland, School of Medicine Human Research Protections Office, this presentation covers the basics of informed consent and exception from informed consent.

EXAMPLE PRACTICES

Pediatric Emergency Care Applied Research Network (PECARN)

• Pediatric Seizure Study website, hosted by Children’s National Medical Center, is the first pediatric-related study to implement the exception from informed consent process. The website targets healthcare professionals, as well as parents and caregivers of children who are eligible to participate in the study. Learn about study methods, eligibility requirements, parent involvement, and the study’s use of the exception from informed consent process. Information about PECARN, the research network that is managing the study, is also provided.

FAMILY AND CAREGIVER RESOURCES

National Cancer Institute, National Institutes of Health

• A Guide to Understanding Informed Consent. Targeting individuals interested in participating in clinical trials, this guide explains the informed consent process: what to expect, its importance to clinical research participants, and how it fits into a larger system that protects the welfare of people who take part in clinical trials.