Informed Consent

One particular concern expressed by EMS researchers is the requirement to obtain written informed consent. Two ethical principles underlying informed consent are that it is free from coercion and that the prospective research subject has time to contemplate whether or not to participate. It may be, particularly in emergency research where therapy has to be initiated in minutes, that neither principle is true.⁹⁹

In the mid-1990’s, the FDA and HHS agreed that there needed to be a method for allowing emergency resuscitation research to occur even when the subject was unable to give consent. Two sets of federal rules were modified within the Department of Health and Human Services regulating obtaining informed consent for medical research. The “General Requirements for Informed Consent” (45 CFR 46.116) are administered by the Office for Human Research Protections (OHRP) and include provisions for the waiver of consent in certain circumstances.

New regulations providing for “Exception from Informed Consent Requirement for Emergency Research” ( 21 CFR 50.24) were developed for activities regulated by the Food and Drug Administration (FDA).¹⁰⁰ The FDA regulations, CFR 21 Part 50, section 50.24, specify the requirements for exception from informed consent for emergency research. The FDA recently released a draft document providing guidance for implementing the rules.

These regulations have created some confusion among EMS researchers. Their implementation has exposed a fundamental problem associated with conducting research with subjects who cannot provide consent: There is a direct and irrevocable tension between the standards of protecting the rights of research subjects and the ability to investigate and improve the care rendered to future patients.

The current federal regulations on research in emergency situations may have the unintended consequence of ensuring that EMS professionals will continue to provide care that has not been properly evaluated. New interventions to treat critical illness will continue to be introduced into the EMS environment, but difficulty in complying with the requirements of the consent regulations may impede the ability of EMS researchers to ensure that they have been studied appropriately first.

Recommendation 8.

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) should work with EMS research stakeholders to evaluate the current requirements for exception from informed consent in emergency situations and to identify those requirements that are serious impediments to conducting EMS research. The FDA, OHRP, and EMS research stakeholders should work together to develop and propose EMS-specific consent strategies as well as appropriate revisions to the existing regulations to reduce the impediments to research while continuing to adequately protect research subjects.

· There should be a national conference that brings together a large variety of EMS research stakeholders and regulators to recommend improvements to the emergency exception to informed consent procedures.

· Based on the recommendations of the FDA and OHRP, Congress should amend the laws governing exception from informed consent for emergency research to reduce the regulatory burden and facilitate research while continuing to protect the rights of research subjects.

· There should be educational programs that explain the consent process and recommend strategies by which EMS researchers can fulfill the requirements.

· Educational programs that describe the difficulties in obtaining consent in the EMS environment, explain the emergency exception from consent process, and promote acceptance by and consistency among Institutional Review Board (IRBs) should be made available to IRB members and administrators.

In those circumstances in which waiver of the written consent requirement is not appropriate, other strategies for streamlining the consent process might be possible. The consent form does not necessarily need to be a multi-page document and using a shorter form may facilitate giving information to the patient. Some researchers have had success with a two-step process in which a structured verbal consent is obtained in the field followed by written consent once the patient arrives at the emergency department.^101,102

It is important to note that some patients, such as those in coma, will never be able to give informed consent. Further, those patients who may be able to give informed consent may still be unduly influenced by the emergent nature of their condition.⁹⁹ EMS researchers must work with their IRBs to develop consent mechanisms that account for these issues and protect these patients while not unfairly excluding them from the research process and the potential benefits of those efforts.

Many areas of prehospital care in need of research involve patients who are competent and not in extremis. Obtaining consent from such patients is comparable to obtaining consent from patients in any other clinical setting. One difference is that the process of obtaining consent from an EMS patient may take place in a public environment and therefore those enrolling the patient in research must take steps to protect confidential patient information.

Certain research populations may continue to be underrepresented in research studies due to real or perceived impediments in obtaining informed consent. These excluded groups can include children, domestic violence victims, sexual assault victims, illiterate and non-English speaking patients, elderly people, potentially pregnant women, mentally or behaviorally challenged individuals, and the drug or alcohol impaired. EMS systems care for a disproportionate share of these patients.¹⁰³ Investigators and institutional review boards should consider this concern when determining the consent requirements for any study and take steps to avoid the inappropriate exclusion of such subjects. Federal policies on the inclusion of women, minorities and children as research subjects are detailed in appendix D.