Enhance Ethical Approaches to Research
In many emergency situations, time is inadequate to allow a critically ill patient or a surrogate decision maker to appropriately consider the risks and benefits of participating in a research study. There are two sets of regulations (Department of Health & Human Services and Food and Drug Administration) concerning the waiver of informed consent for medical research. These two sets of 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 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 provide care that has not been scientifically validated. . 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.
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.