Exception from Informed Consent
According to the American Medical Association, informed consent is more than simply getting a patient to sign a written consent form. It is, instead, a process of communication between a patient and healthcare provider that ultimately results in the patient's authorization or agreement to undergo a specific medical intervention or participate in a clinical trial. Informed consent is at the forefront of a battery of protections aimed to ensure that research participants are fully respected as human beings and made aware of the purpose, procedures, risks, and benefits of a study.
But what happens in the emergency care setting? When patients face time-sensitive and potentially life-threatening conditions, it may be impossible to achieve this level of understanding prior to medical interventions or study enrollments. This is especially true among pediatric patient populations: depending on their age, cognitive capabilities, and clinical conditions, children may be in no position to authorize potentially life-saving experimental treatments.
The result is that children experiencing health emergencies are rarely the subjects of research trials. This means that EMS procedures routinely practiced in the field may have little or no evidence base corroborating their efficacy; in fact, some may even present more risks than benefits to pediatric patients. In order to increase the scientific evidence behind emergency medical care, “exception from informed consent” becomes tantamount to research efforts.
This concept amounts to a waiver of the informed consent requirement under certain conditions when conducting clinical trials in the emergency setting. Patients may be eligible for exception: if their medical condition preclude assent, if the intervention must be administered before consent can be obtained from their legally authorized representative, and/or if it is not feasible to prospectively identify whether they are likely to become eligible for study participation.
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HEALTHCARE PROVIDER RESOURCES
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EXAMPLE PRACTICES: Model Programs Pediatric Emergency Care Applied Research Network (PECARN)
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DATABASE SEARCHES
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Family & Caregiver Resources
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HEALTHCARE PROVIDER RESOURCES
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PECARN Primer: A Guide for Research Coordinators in the Pediatric Emergency Care Applied Research Network. Intended primarily for research coordinators and research assistants involved with PECARN, this primer includes a section on research ethics. Informed consent is one of the key concepts addressed, along with autonomy, non-maleficence, beneficence, and confidentiality. (September 2008)
American Academy of Pediatrics
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Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations. This American Academy of Pediatrics (AAP) policy statement contains a section on emergency research. There, the Academy details the requirements for proceeding with research using the exception from informed consent. It also explains additional requirements for emergency research studies, such as the development and implementation of a plan for community consultation and public disclosure. (April 2010)
American College of Emergency Physicians
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Code of Ethics for Emergency Physicians. In this policy statement, the American College of Emergency Physicians (ACEP) recognizes an overarching provider duty to obtain informed consent from patients seeking emergency care. However, the College also acknowledges that emergency physicians may treat without security informed consent when immediate intervention is necessary to prevent death or serious harm. (June 2008)
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Research Involving Individuals with Questionable Capacity to Consent. The National Institutes of Health (NIH) created this resource in order to provide investigators and institutional review boards (IRBs) with points to consider (a) in fulfilling ethical and federal regulatory requirements to ensure the protection of the rights and welfare of research subjects who -- due to impairments in their capacity to give informed consent -- may be vulnerable to coercion or undue influence and (b) in maintaining appropriate awareness of the ethical challenges associated with research involving this vulnerable population. (November 2009)
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Annotated Compendium of NIH Resources on Informed Consent. Developed by the NIH’s Clinical Research Policy Analysis and Coordination (CRpac) program, this compendium contains a comprehensive list of informed consent resources available online from the NIH’s various Institutes and Centers (ICs). Among the resources are informed consent templates, frequently asked questions, guidance created by specific ICs, and other relevant materials. (November 2007).
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Research Involving Children. Issued by the NIH in 1998, the “Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects” mandates that all human subject research supported or conducted by the NIH must include children, unless there are scientific and ethical reasons not to. This document outlines the policy, along with justifications for exclusion. (March 1998).
U.S. Department of Health and Human Services
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Code of Federal Regulations (CFR) Title 45, Part 46. These federal regulations from the U.S. Department of Health and Human Services’ Code of Federal Regulations (CRF) ensure that the human subjects of behavioral and biomedical research receive the protections to which they are entitled, and aim to minimize risks. Within this document, HHS outlines general requirements for written informed consent (CRF Title 45, Part 46.116).
The regulations also provide two subsections on exceptions to written consent: the Waiver or Alteration of Informed Consent Requirements (CFR Title 45 Part 46.116 (d)), and the Waiver for Written Documentation (45 CFR 46.117(c)). In addition, Subpart D of 45 CFR part 46 details additional protections for children participating in human subjects research. (Revised January 2009)
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Code of Federal Regulations (CFR) Title 21, Chapter 1, Part 50. Title 21 (Foods and Drugs), Chapter 1 (Food and Drug Administration), Part 50 (Protection of Human Subjects) in the CFR contains 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. (April 2009)
U.S. Food and Drug Administration
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Exception from Informed Consent in CPR Device Trials: Protection of Patients' Rights. This PowerPoint presentation from the Food and Drug Administration’s (FDA) Office of Device Evaluation succinctly summarizes the requirements for an informed consent waiver in emergency medical research. (September 2004)
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Exception from Informed Consent For Studies Conducted in Emergency Settings: Regulatory Language and Excerpts from Preamble. This informational resource summarizes the criteria and requirements for waiving informed consent as found in the FDA’s Final Rule (FDA 21 CFR 50.20). (Accessed April 2010)
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Draft Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research. This guidance applies to research studies involving FDA regulated products (drugs, biological products, and medical devices). It assists sponsors, clinical investigators, and IRBs in the development and conduct of research in emergency settings when an exception from the informed consent requirements is requested under Title 21, Code of Federal Regulations, Section 50.24 (21 CFR 50.24) and understanding their responsibilities for communicating with, and submitting information to, the FDA. (July 2006)
U.S. Office for Human Research Protections
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Informed Consent FAQs. These informed consent Frequently-Asked-Questions provide guidance that represents the Office of Human Research Protection’s (OHRP’s) current thinking and recommendations on the topic. Some FAQs specifically address issues in child assent, in addition to exception from informed consent requirements. (November 2008)
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Research Involving Children FAQs. This second set of FAQs from OHRP addresses special requirements, parental permission, and informed consent regulations and waivers as related to research involving children. (Accessed April 2010)
EXAMPLE PRACTICES
Pediatric Emergency Care Applied Research Network (PECARN). PECARN is the first federally-funded pediatric emergency medicine research network in the United States. The network conducts high-priority, multi-institutional research on the prevention and management of acute illnesses and injuries in children and youth of all ages; it is supported by cooperative agreements between four academic medical centers and the Health Resources Services Administration / Maternal and Child Health Bureau / Emergency Medical Services for Children Program (HRSA / MCHB / EMSC).
PECARN is currently conducting a randomized, double-blinded trial to determine the differences in efficacy and safety between two benzodiazepines (medications) commonly prescribed in the field for pediatric status epilepticus (seizure). The study is in response to the FDA’s request under the Best Pharmaceuticals for Children Act, and uses the Exception from Informed Consent provided by the FDA.
To learn more the study, visit the Pediatric Seizure Study website hosted by Children’s National Medical Center. Targeting healthcare professionals, as well as parents and caregivers of children who are eligible to participate in the study, this site provides detailed information about study methods, eligibility requirements, parent involvement, and the exception from informed consent process. Further study details are available through the NIH at http://clinicaltrials.gov/ct2/show/NCT00621478.
FAMILY AND CAREGIVER RESOURCES
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Ethical Conduct of Clinical Research Involving Children. This Institute of Medicine Committee on Clinical Research Involving Children report examines research ethics as related to the policies and practices designed to protect the safety and well-being of children enrolled in clinical trials. Chapter 5, titled “Understanding and Agreeing to Children’s Participation in Research,” is specifically designed for parents and caregivers. (2004)
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A Guide to Understanding Informed Consent. Targeting individuals interested in participating in clinical trials, this NIH National Cancer Institute 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. (March 2006)
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Children’s Assent to Clinical Trial Participation. This guide is aimed at parents considering enrolling their children in a clinical trial. It discusses the issues surrounding a child’s agreement to participate in a research study, including parental involvement in the process, legal responsibilities, and when assent of the child is and is not necessary. (May 2005)
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Children and Clinical Studies. Developed by the NIH National Heart, Lung, and Blood Institute (NHLBI), this website contains resources for parents and caregivers addressing the importance of research in kids and rights of families in studies. (January 2010)