There are two primary barriers that have inhibited the development of a strong research program in EMS. They are a paucity of well-trained researchers with an interest in EMS research and a lack of reliable funding sources to support research. There are also three identifiable secondary barriers to EMS research. They are: a lack of recognizing the need for evidence-based practice; standardizing, accessing and sharing data; and complying with the current established ethical requirements for human research.
To some extent, there is a chicken and egg phenomenon at work within the two primary barriers to developing a comprehensive EMS research program. For example, funding agencies understandably prefer to place their funds with researchers who have a track record of proven productivity. However, since there are not many proven researchers with interests in EMS problems, few funds flow into EMS-related research. On the other hand, academic institutions are reluctant to support the professional development of new, EMS-focused researchers because they cannot identify likely funding sources with a history of supporting EMS research.
Primary Barriers: Developing Researchers
As a discipline of medicine, EMS needs to develop a larger cadre of experienced investigators. Novice investigators need formal research training and the opportunity to work with experienced mentors. EMS researchers must collaborate with social scientists, economists, health services researchers, epidemiologists, operations researchers, and other clinical scientists to increase the expertise available for, to generate novel hypotheses in, and to improve the quality of investigations.
Researchers affiliated with medical schools and large teaching hospitals perform most EMS studies because those institutions have the necessary research infrastructure. They offer Institutional Review Board review as well as assistance with obtaining grants and negotiating contracts. They have large libraries with many resources. Statisticians, epidemiologists, methodologists, database managers, and software engineers are available for consultation. Emergency physicians, cardiologists, surgeons, pediatricians, and other specialists who have interests in specific areas of EMS are available for collaboration. Opportunities exist for EMS researchers to collaborate with other disciplines and with industry in many different areas of scientific evaluation. Public health initiatives, injury prevention, development of new technologies, and health economics are examples of areas in which such opportunities exist. Prospective EMS researchers who do not have easy access to the traditional academic research setting may be able to establish relationships with public agencies or private corporations and build their research careers through those venues.
Most EMS researchers have little or no formal training in research methodology.1 Many colleges and universities have programs that could provide training to interested EMS professionals. For example, graduate degree programs in research and public health are widely available and could easily be tailored to meet the needs of students with specific EMS interests. One good model of such training programs is the Robert Wood Johnson Foundation Clinical Scholars Program. There are examples of successful collaboration between academic institutions and EMS agencies to provide EMS fellowship training to interested physicians. The Society for Academic Emergency Medicine and the Medtronic Physio-Control Corporation have supported an EMS fellowship program since 1990, and most graduates of that program have pursued careers in EMS research. Still, these training opportunities are limited in their availability.
Recommendation 1.
A large cadre of career EMS investigators should be developed and supported in the initial stages of their careers. Highly structured training programs with content directed toward EMS research methodologies should be developed.
·
Fellowship
training programs capable of producing at least five EMS researchers per year
are needed. Federal agencies are potential funding sources for these
fellowships. Ideally, fellowship programs should be at least two years in length
and should produce individuals with training and expertise in both research
methods and funding acquisition. A doctoral degree (PhD, MD, etc.) should be a
prerequisite for entry into the training programs. Program funding that includes
institutional overhead and provides funds to ensure that research projects can
be accomplished during the fellowship is essential. Individual training grants
specifically targeted to EMS specific topics and system evaluation should be
available.
Strong
consideration should also be given to developing a few centers of excellence in
EMS related research. These centers would use their financial resources to build
the necessary infrastructure to successfully complete EMS related research. That
infrastructure would necessarily include experienced investigators, information
systems support, strong links with the local and regional EMS providers, and
training opportunities for novice investigators.
Protected time
for faculty engaged in research is not adequate in most academic Departments of
Emergency Medicine and degree granting institutions offering EMS provider
education. Protected time is necessary to ensure research productivity.
Developing faculty requires making an investment in them. Academic departments
need to invest in EMS research by supporting adequate release time for
researchers, and senior faculty should invest in EMS research by serving as
mentors to novice researchers. EMS centers of excellence would provide support
for release time to permit faculty to engage in research.
Several important EMS problems have a relatively low frequency of events. This is true for clinical, systems and education issues. These questions will need to be addressed using a multi-center collaborative approach. While a number of such trials have been completed in recent years, these efforts need to be expanded.81 It would be useful to develop one or more EMS research coordinating centers to pull together the resources necessary to organize and manage multi-center clinical trials.
Recommendation 2.
Centers of Excellence should be created to facilitate EMS research. These Centers will bring together experienced investigators, institutional expertise, and resources such as budgetary and information systems support. Centers will develop and maintain strong working relationships with local and regional EMS providers. As the focal point of these resources, Centers of Excellence will be the catalyst for collaboration between EMS systems and investigators. Such an environment will enable quality research to flourish.
· One or more federal agencies should encourage the submission of proposals to develop at least five EMS Centers of Excellence. Each successful applicant should be funded for five years and be evaluated for renewal in a competitive application process. At least $1M should be devoted to development of research programs and infrastructure at each Center every year. Each Center should be located within an academic institution with ties to fellowship programs, career faculty researchers, multidisciplinary expertise, training programs, and other resources necessary to create research infrastructure.
· One or more federal agencies should issue requests for proposals for at least two regional EMS research centers. The centers will organize and manage multi-system studies. The centers will form a network to facilitate access to data. Each center should operate on a five-year funding cycle with a competitive renewal process at the end of each five-year phase.
As a unique body of knowledge is developed, EMS will become recognized as a medical subspecialty. Credentialing within the subspecialty will carry with it an obligation to advance the knowledge base of EMS. An increasing numbers of researchers will be drawn into the field, and academic institutions will develop the necessary infrastructure to support their activities. The resultant interactions between faculty, colleagues, fellows, and students will create a milieu resulting in an increased number of people with excellent EMS research skills. As these academic programs develop they will attract new researchers who will want to obtain advanced training and advanced degrees in research. The research produced by these well-trained EMS researchers will contribute to the continued growth of the subspecialty.
Primary Barriers: Funding
Improved monetary compensation for EMS research would help motivate researchers to look at EMS issues. Additional training grants would be useful to encourage the development of experts in both EMS research and a number of areas related to emergency medical systems, such as injury prevention, health services research, and operations management. As the number of well-trained researchers increases, a reliable stream of funding will be needed to support their activities. That stream of funding will necessarily come from a variety of sources. Public funds along with corporate and foundation support will all be needed.
A strong argument can be made that the government should fund the majority of the research into the effectiveness of EMS since EMS is largely paid for with taxpayer monies and since there is almost certainly a pay off in terms of improved efficiency and effectiveness of care. Of the 794 papers identified as likely related to EMS published in 1999 and cited on PubMed, only 30 (3.8%) had at least some support from the United States Public Health Service (PHS). Indeed, 1999 was a record year for PHS support of published EMS research (Figure 3).
Other
areas of medicine appear to get more governmental research support than EMS. For
example, in 1999 there were 5862 articles with a MeSH heading of breast
neoplasms; 892 (15.2%) were PHS supported. There were 1468 articles cited in
PubMed in 1999 with a MeSH heading of acquired immunodeficiency syndrome. Of
those, 209 (14.2%) were at least partially supported by the PHS. There were 3003
articles with a MeSH heading of myocardial infarction, and 230 (7.7%) of them
were PHS supported.
Two diseases with a large impact on both the general health of the public and the design of EMS systems are sudden cardiac arrest and major traumatic injuries. In 1999, there were 13,430 articles with a MeSH heading of heart arrest, of which 828 (6.1%) were PHS supported. There were 4776 articles with a MeSH heading of multiple trauma, and only 86 (1.8%) of those were PHS supported. It is clear that the amount of current funding is inadequate to support real progress in reducing the morbidity and mortality from both of these diseases that kill a large number of Americans each year. The NIH has begun to recognize this fact and held the PULSE Conference in June 2000 to explore ways to increase the funding devoted to attacking the problem of sudden cardiac arrest. A similar initiative is needed to increase funding for research on treatment of injury.
Recommendation 3.
Federal agencies that sponsor research should acknowledge their commitment to EMS research.
·
The federal
government should increase its commitment and support of EMS research.
·
A joint
announcement, similar to that issued for EMS Research concerning children (PA-01-044),
should be issued to provide opportunities for conducting EMS research under the
sponsorship of a group of Federal agencies and to broadly describe the areas in
which research is warranted. Each sponsoring agency should delineate and
prioritize specific areas of interest and provide detailed information regarding
application upon request.
·
The number of
fully federally funded controlled clinical trials conducted in the EMS setting
should increase by 25% each year for five years beginning in FY 2003.
EMS researchers must also begin to compete for funding that is not specifically earmarked for prehospital care. Because EMS has the potential to provide services to individuals experiencing almost every disease process, the pool of appropriate funding sources may be quite large.
The federal government should not be the only organization funding EMS research. Charitable foundations often offer unique and flexible funding, some of which should be dedicated to EMS research. State EMS lead agencies traditionally have not performed EMS research, but they should develop a serious commitment to improve patient care based upon evidence generated by high quality research. Ideally, they should collaborate with at least one academic institution with expertise in EMS research. This collaboration will give state regulators, provider agencies, and EMS professionals access to individuals with expertise regarding grant applications and local research related issues. This academic collaborator should also offer guidance to the state lead agency on EMS research policies.
Recommendation 4.
States, corporations, and charitable foundations should be encouraged to support EMS research.
·
State lead EMS
agencies should promote prehospital research and facilitate the development of
relationships and resources necessary for such studies.
·
Corporations
and charitable foundations should provide funds for EMS related research.
To successfully compete for both public and private funding, whether earmarked for EMS or not, it will be important for the specialty of EMS to develop a cadre of qualified peer reviewers for granting agencies. As more researchers with EMS backgrounds gain experience with major granting agencies, they will be selected as peer reviewers. This will help facilitate EMS research in the long run as these qualified reviewers will be able to educate other members of grant application review committees about the importance of EMS research programs. A full description of the process of peer review is available on the NIH web site at http://www.drg.nih.gov/review/peerrev.htm.
Secondary Barriers: Recognizing the Need for EMS Research
Although it may not be similar in magnitude to the other barriers to EMS research, the lack of appreciation for the importance of EMS research can be detected throughout all aspects of the EMS system. There is a common belief that EMS research is not important as a basis for system evaluation and improvement. This belief is detrimental to efforts to improve the system based on scientific evaluation.
Recommendation 5.
The efforts of EMS professionals, delivery systems, academic centers, and public policy makers should be organized to support and apply the results of research.
·
NHTSA should
adopt a curriculum for EMS educators that teaches critical review of the
scientific literature.
·
The National
Fire Academy should continue to offer courses that convey the importance of EMS
research and detail specific strategies by which fire services can facilitate
EMS research.
·
Federal
agencies should adopt or develop a curriculum for EMS administrative officers
that will instill the importance of evidence-based decision-making, reduction of
medical errors, and introspection into the culture of EMS organizations.
·
Appropriate
research principles should be included in the core content of EMS education of
first responders, EMT-Basics, EMT-Intermediates, and EMT-Paramedics.
·
National and
state accrediting agencies for EMS educational programs should require that
familiarity with the scientific literature be an essential component of EMS
education programs.
·
Academic
institutions should develop training pathways for EMS professionals interested
in pursuing a research career.
· EMS agencies should contribute to the research process by agreeing to collaborate with academic institutions. Collaboration should include assistance with field data collection and patient enrollment in research studies.
The Culture of EMS
The misunderstanding within the EMS community of the importance of research is multi-factorial. EMS professionals often view research as an academic exercise with little applicability to patient care. EMS administrators have difficulty understanding the links between research and system operations. EMS education programs frequently do not emphasize the role of research in shaping EMS practices, perhaps because instructors themselves do not understand the significance of research. The general public and most policy makers have little understanding about the actual services provided by EMS agencies, and thus they are also unlikely to recognize the need for research to improve those services.
An organized effort on the part of EMS professionals, delivery systems, education centers and public policy makers is needed to take advantage of the available EMS research opportunities and to support research endeavors for the benefit of the public. Adoption of a new mindset must be followed by specific actions designed to encourage the integration of research into the framework of EMS. Providers must see practical applications of the concepts gleaned from field research. EMS administrators must support research if the use of evidence based decision making is to become integrated throughout the system. EMS educational programs must show students the need for collecting and analyzing data in order to provide a scientific basis for EMS patient care. Finally, regulatory agencies must encourage collaboration, use of technology for data capture, linkage with outcomes and analysis, and self-evaluation as means to improve EMS systems.
EMS Systems
EMS agencies need to provide appropriate mechanisms for interested individuals to use their research skills. EMS systems must also commit to collaborating with academic centers. Academic collaboration is a crucial link in creating a process that can translate research into improvements in patient care and system efficiency. In essence, society needs the EMS equivalent of the teaching hospital: the teaching EMS system. Unfortunately, there are few, if any, incentives for participating in such an arrangement.
EMS Education
Insufficient academic commitment to EMS research has also been identified as an important impediment to progress in the development of a body of scientific knowledge necessary for the support of EMS practices.1 Those educational institutions that chose to offer EMS training programs must integrate research into the process of developing entry-level EMS professionals. Successful integration requires using scientific evidence as the basis for education and fulfilling the traditional academic role of contributing to the evidence base.
The amount of education about research principles currently provided to EMS professionals is limited at best. Education about EMS research is virtually non-existent in most EMT-Basic programs. Although research methodology is part of the National Standard Curriculum for EMT-Paramedics, most EMS educational institutions provide little time for it in their training programs. Some degree granting paramedic education programs do include a research component in their curricula, and a few require students to complete a research project prior to completion of the program.
Educational programs are not teaching research principles because many EMS educators are not knowledgeable about the process of research and therefore are unable to teach others. There are few resources available to assist EMS educators in teaching this material. Two national efforts aimed at improving the research education of prehospital providers are the EMS research workshops offered by National Association of EMS Physicians and the Prehospital Care Research Forum. These entry level one or two day courses are offered at national EMS conferences or by themselves for interested sponsoring organizations.
Education programs for EMS providers must keep pace with the evolving basis for clinical practice. The curricula developed by the U.S. Department of Transportation National Highway Traffic Safety Administration which provide the basis for education of first responders, EMT-Basics, EMT-Intermediates, and EMT-Paramedics should be revised to include improved objectives regarding research principles. These objectives must emphasize the need to teach the importance of research as well as the principles involved in conducting EMS-related research, and should become a part of the routine education of EMS field providers and managers. The objective is not to develop every EMS provider into an EMS researcher but to help all personnel understand the need for research to enable them to be supportive.1 These educational efforts should provide a working understanding of the research process and not simply encourage memorization of methodological criteria and statistical terminology.
Exposure to the scientific literature should also be an essential component of EMS education programs. The curricula should include an introduction to the critical appraisal of scientific articles and methods for asking and answering clinical questions. The curricula should also introduce the student to the methods that practicing health care professionals use to update their knowledge and practice patterns, including routine reading of scientific journals.
EMS education systems must be compatible with an academically based approach to EMS education that parallels the education process of other allied health professions. These concepts have been addressed in the EMS Education Agenda. Academic institutions that sponsor EMS education programs must make a commitment to supporting EMS research.
The process of teaching a novice EMS professional, including skill and knowledge acquisition and retention, has not been adequately studied. EMS educators in traditional academic settings are uniquely positioned to evaluate both the content of EMS curricula adequacy and the effectiveness of teaching techniques.
The Public and Policy Makers
Public policy makers must also participate in the cultural changes necessary to establish an evidence base for EMS practices. State lead EMS agencies should support statutory changes that encourage evidence based prehospital care. They should promote public health services research and facilitate the development of relationships and resources necessary for such studies.1 States need to adopt standardized data collection strategies and use technology to link prehospital patient care information with outcome data.
State lead agencies must move away from a role focused on regulating the processes of delivering care and evolve into agencies providing insightful leadership and technical assistance. One way to accomplish this is by participating in the evaluation of patient and system outcomes. One example of how a regulatory body can evolve is the Joint Commission on Accreditation of Healthcare Organizations. That organization is changing its focus from process regulation to outcomes measurement. These changes are controversial, and they are not easy to implement. However, they ought to lead to significant improvements in patient outcomes.82
Finally, as competition for health care dollars increases, individual, corporate, or governmental purchasers of health care services are interested in documentation of the effectiveness of the system and the impact of EMS on public health. The public’s knowledge of EMS-related issues, including funding, level of care provided, equipment, system expectations and standards must be increased. These issues should become key factors driving EMS research.
EMS Professionals
Individual providers need to embrace research as the basis for prehospital practices, and at least some of those providers should become active participants in the research process. EMS agencies should encourage and support participation of their employees in these endeavors. A research career track should be developed for those EMS professionals who have the desire to participate in research, and systems can actively work to support researchers by creating research-related positions. Likewise a commitment to supporting the research process should be an integral part of the responsibilities identified in the medical director’s job description.
Recommendation 6.
EMS professionals of all levels should hold themselves to higher standards of requiring evidence before implementing new procedures, devices, or drugs.
Secondary Barriers: Information Systems
There are a number of problems in storage and retrieval of information that impede EMS research. These include differing data definitions, inadequate hardware and software infrastructure, database linkages, and statistical implications of large databases.83
Recommendation 7.
There should be standardized data collection methods at local, regional, state, and national levels. These data must be devoid of information that allows individual patient identification. All EMS provider agencies should adopt the Uniform Prehospital Data Elements for data collection.
· NHTSA should sponsor a process to revise the Uniform Prehospital Data Elements at least every ten years.
·
State lead EMS
agencies should require all EMS organizations in their jurisdictions to collect
and submit to the state the Uniform Prehospital Data Elements at a minimum, and
states should report that information to a national EMS data repository.
·
Federal
agencies should promote the development and maintenance of a national EMS data
repository to facilitate comparison of EMS system designs on the effectiveness
of care delivery and improving patient safety.
Data
Definitions
An EMS researcher may need to obtain information from a number of different EMS agencies and hospitals. This makes research more difficult because different organizations will often use the same terms in different ways. In technical terms, they are using different data definitions.
An example may help to make this clear. A researcher who is interested in the care of victims of motor vehicle crashes would like to know the total time interval from the occurrence of a crash until the driver arrived at the hospital. This researcher wishes to compare patients in suburban areas with those in rural areas. Since the time of the crash is not recorded automatically, the researcher decides to use the time that the first person called 911 as a surrogate marker for the time of the crash. In one community, the computer aided dispatch system saves the time at which a call begins to ring at the public safety answering point and labels that data point as the “911 call time”. In another community, the computer aided dispatch system records the time at which the call is answered by the EMS dispatcher after the call was transferred from an operator at the public safety answering point. That agency also uses the label “911 call time”. A researcher who did not know the specific mechanisms for collecting and labeling data used by these two EMS agencies could be easily misled into thinking that both agencies were recording the same event, when in fact these are two distinct time points.
Clinical research activities have been enhanced by efforts to standardize prehospital data acquisition. Standardized templates and definitions for the reporting of prehospital cardiac arrest data have been developed.84 Similar reporting standards have been developed for pediatric cardiac arrest85 and trauma data.86
There are two major federally sponsored data definitions that describe data points that could be collected on each patient encounter. These are the Uniform Prehospital Data Elements developed by NHTSA87 and the Data Elements for Emergency Department Systems (DEEDS) developed by the Centers for Disease Control.88 The development of the Uniform Prehospital Data Elements and Definitions in 1993 was a crucial step to structure evidence about the efficacy of prehospital care.87 Sadly, few EMS systems have adopted these criteria; and most agencies are still unable to link prehospital data with outcome information. Only 25 states require EMS provider agencies to use most or all of these data elements. The DEEDS document was developed by the Centers for Disease Control to address the same data labeling issues for emergency department encounters.88 Despite evidence that these data-standardization tools may not be used to their full potential, their existence is encouraging.89
Widespread use of both the DEEDS data definitions and the Uniform Prehospital Data Elements would enhance EMS research. The challenge is in convincing EMS agencies to embrace a new system. While administrators may benefit from the ability to advance the quality improvement process and perform system benchmarking, implementation of these systems is costly. At this time, there is not a compelling advantage to using the newer systems for those actually providing care to patients.
Hardware and
Software Infrastructure
The computer revolution is happening in medicine. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) will prompt a massive investment in electronic documentation. The regulations implementing HIPAA require additional security measures for medical record information, including medical records held by EMS agencies. Research review is permitted under these regulations, but HIPAA imposes new requirements in addition to existing privacy regulations. See the Code of Federal Regulations 164.514(i) for additional information.
Most EMS agencies and emergency departments still use paper records with multiple copies. Paper records present many problems for researchers. Both the originals and the copies are often illegible. Some of the time points recorded, which may be considered as hard data by researchers, are actually estimates by the caregivers.90 If a patient is transferred between hospitals, the paper records may not make the trip with the patient.
Electronic medical record systems are being developed for use in emergency medicine and EMS. However, the design of these products will unquestionably affect the quality of the data. If the products are cumbersome to use, then the health care providers operating them may provide incomplete data in order to simply achieve their immediate goal of completing the data entry process.91 As the process of product development continues, software designers will likely incorporate standardized data definitions like the DEEDS data dictionary and the Uniform Prehospital Data Elements. So, as less documentation is done on paper and more is automated, the use of these established data definitions will increase and the ability of EMS researchers to abstract patient data will be enhanced.
Data Set
Linkages
EMS systems should track patient outcomes into the hospital and beyond. One method for obtaining patient outcome data in EMS is to link together large databases that describe different stages of the continuum of patient care. For example, a statewide EMS database might be linked with a financial dataset that describes inpatient hospital charges, and that database may in turn be linked to a death registry. In theory, such linkages allow researchers to follow a patient from the prehospital phase, through hospitalization, and after discharge. In fact, such linkages are challenging to create. The patient’s name is often stripped out of datasets to preserve confidentiality and other identifying information, such as the patient’s home address, may be missing because those providing care did not have it at the time the records were created. To tackle this problem, enterprising researchers developed a technique called probabilistic matching.93 EMS investigations have used this technique, including examination of the impact of EMS on children with special needs94 and linking hospital trauma registry data with prehospital records.95
In addition to the technical challenges posed by incomplete data, the best outcome variables may not be recorded in available data sets. Since medical records and database structures are designed independent of specific research questions, key information is often incomplete or simply altogether absent. One temptation is to use the information that is present in the database in an attempt to get as close to the answer as possible. The problem is that this approach can give results that are not meaningful because the most appropriate outcome variables have not been measured.
Another problem is that elements of the health care system may be reluctant to share information. Maintaining patient confidentiality is a major issue. For example, matching a zip code and date of birth in a large database can uniquely identify about 15% of subjects. Some privacy advocates maintain that if a researcher can use a data set to violate the privacy of even one person, then the data should not be collected.
Patient privacy is an important issue in EMS research. Recently the Department of Health and Human Services has developed recommendations to protect against the disclosure of identifiable patient information. The impact of these new privacy regulations on the linking of patient data and its availability for research purposes remains to be seen. These rules may become an additional obstacle to the effective evaluation of prehospital interventions; or they may establish a level of privacy protection that adequately alleviates concerns among the public, thus facilitating advances in clinical research.
One potential solution to the problem of maintaining patient confidentiality is to assign a longitudinal patient identifier. For example, in the State of Washington, trauma patients are given a bracelet with a unique identifying number that remains with the patient throughout the process of care. That number is kept with the medical record but the patient’s name and address is not maintained at the state level, thus preserving confidentiality since the unique number but not patient identifying data moves from the hospital or EMS agency to the state.
Another important regulatory issue that needs to be considered by researchers is a proposed change in the freedom of information law that would allow requests for access to raw research data collected for federally funded research projects. This proposal has several implications. For one, the confidentiality of the study subjects might be compromised. There is also a potential problem with protection of the raw research data from a legal discovery process. If EMS systems and health care providers are going to undertake serious evaluations of their practices in order to improve the care they provide to their patients, they must be assured that the information gathered in that process won’t subsequently be used to support litigation against them.96 One possible solution to this problem would be the availability of a “federal certificate of confidentiality” issued by the Office of Management and Budget.
It is useful to link outside data, like law enforcement records about motor vehicle crashes, to EMS and hospital data.97 It is also sometimes helpful to link to payment data sets, such as those used in the medical expenditure panel study or the payment databases of health insurance plans. These linkages also raise confidentiality concerns that must be addressed by EMS researchers.
Statistical
Implications of Large Databases
Since there are only one or two large datasets of EMS patients in any state, there are important statistical implications. As more questions are asked, it is increasingly likely that a result will be positive based upon chance alone and not a real difference. Since there is not a second dataset with which to validate the results, it becomes impossible to tell which positive results are meaningful and which are statistical flukes. When EMS researchers conduct studies involving large state-based data sets, they will need to validate those studies by repeating them in other states or at a different time.
Secondary Barriers: Ethical Concerns
Principles
Adhering to ethical research principles results in higher quality research, ensures that all individuals are respected, and protects vulnerable people. The ethics of conducting research in the EMS environment are sometimes complicated by time urgency and decreased patient competency.98 Despite these challenges, EMS related research has to follow the same basic ethical guidelines as any other human subjects research.
The Federal government has assumed the lead role in protecting the rights of human research subjects. The Office of the Inspector General of the Department of Health and Human Services (HHS) recently published a report on the status of protecting the rights of research subject. The Office of Human Research Protections (OHRP) is charged with assuring compliance with ethical guidelines. Grant reviewers, funding agency staff, clinicians, journal editors, and other researchers all share in the responsibility to protect human subjects.
EMS researchers must fulfill all of the requirements for human research delineated at the federal, state, local, and institutional level. Federal regulations have been developed with hospital and outpatient based clinical research in mind. As a result, researchers may often view these requirements as impediments to conducting prehospital research. While burdensome to the researcher, the process of ethical review often will result in an improved research plan because of the structure provided by the process and by suggestions from the reviewers.
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.
IRBs and EMS Research
Some institutional review boards are unfamiliar with the scope of prehospital emergency medical care and thus may have difficulty understanding the issues associated with conducting research in that environment. The prospective EMS investigator needs to become familiar with the local IRB guidelines and process. Through positive interactions with the IRB, a researcher can help educate the members about EMS issues; and, together, the researcher and the IRB can develop study or consent methodologies that meet the needs of the investigator while fulfilling current legal requirements.
One possible concern that might be raised by an IRB is that study enrollment will delay patient transport. It is incumbent upon the investigator to determine the risks associated with such a delay. For most prehospital patients, those risks are minimal. The researcher may have to overcome preconceptions among IRB members that all patients who call EMS need rapid response and transport.
An IRB might also express concern about altering the existing standard of care for a prehospital study. Yet, little that is considered “standard care” has ever been rigorously evaluated in the prehospital setting. It is considered ethical to alter or remove a non-evidence-based pattern of care in order to evaluate prehospital practices, so long as such studies are designed to minimize the risks to subjects. Two notable examples of this practice are the study of pneumatic anti-shock garments in which the garments, long part of standard care for trauma patients, were removed from ambulances as part of a study evaluating their efficacy50 and the pediatric intubation study in which children were allocated to receive either bag-valve-mask ventilation or endotracheal intubation.18
Concerns about altering standard of care can be addressed, at least in part, through the use of data and safety monitoring boards.104 Such entities are set up as part of the study design and review the data at predetermined interim periods to assess for any untoward affects of the study. This can be accomplished without breaking the blinding scheme and without giving the researchers any indication of the study results. If it appears that a study is resulting in unacceptable risks to patients, the data and safety monitoring board can stop it. The concept of such boards is not new; their use by EMS researchers is simply one technique that might be successful for addressing IRB concerns.
Valuing
Individual Autonomy
Current ethical
guidelines, as written, value individual autonomy over other competing values.
At the same time, the only way to ensure public and government support for
research activities is to ensure the safety of all research subjects. In
overcoming the barriers to EMS research posed by ethical constraints, EMS
researchers must follow the federal law while at the same time championing
rational revision of the regulations.
Reaching this goal will require consensus among regulators, researchers,
clinicians and the general public.
Sources for complete information about ethical standards and IRB requirements are listed in appendix C of this document.
