Research is paramount to developing new lifesaving techniques and providing an evidence base to support EMS-related practices. Previous surveys of EMS providers have shown that prehospital research is considered vitally important in the advancement of EMS.1,2 Recent interviews with EMS providers involved in a prehospital research study revealed similar sentiments. Specifically, providers described their work in research as necessary and critical for the field of EMS to grow and move forward.
EMS providers and agencies have important strengths, skills, experience and organizational structures that can be beneficial to research. However, it isn’t a setting that’s designed with the primary mission of conducting research. This doesn’t mean that research in a prehospital emergency setting isn’t possible; it means that careful planning is needed to develop research protocols that fit with an agency’s goals and mission, and can be conducted within the constraints of the organizational structure, policies and procedures.
Are you interested in your EMS agency getting involved in research? Whether you’ve developed a research question on your own or have been approached to participate in a study by a pharmaceutical company or device-maker, another EMS agency or academic medical center, you should consider the following important things before getting started.
We’ve put together a set of helpful tips to guide you and your agency through the first steps, which we gathered from EMS providers at an agency with a history of involvement in research, and discussions with agency administrators and university emergency investigators and coordinators. These tips are meant to provide a structured approach to consider a research project; help identify and determine the roles and responsibilities of staffers in the planning, budgeting, training and conduction of research; establish consistent and open communication between agency staffers and external research partners (e.g. principle investigators and research coordinators); and establish and maintain good research protocol documentation.
Your agency can get involved in research in a couple of ways, including partnering with an outside agency, company, organization or institution, or developing the research internally within your agency. The following tips are for working with a partner as well as developing the research internally. Table 1, (p. 58), includes some research terms that might be helpful to you as you get started.
The First Steps
The first thing you should do is determine whether what you’re considering becoming involved in is a research study or another type of evaluation or project. If it is a research study, you need to figure out if it could be classified as a human subjects research study because of the additional ethical considerations, rules and regulations that would need to be followed.
Consider this scenario: Your agency is asked by a company to try a new device. This may or may not be research depending on the details. If the device is already approved by the U.S. Food and Drug Administration (FDA) for this indication, and you’ll be trying it for all appropriate patients to see if it would work well for your agency, this is likely to be a simple product evaluation or quality process. You might gather information based on such questions as: Did it work for you; how did the EMS providers like it or what is the cost benefit to the device? But this isn’t research.
However, if the same company has asked you to help test a device that isn’t FDA approved or had been approved but they wanted to study how it worked in a new setting, this would likely be research. And although you may want to track whether a new clinical protocol is working well or being followed at your agency, this is likely a quality assurance or quality improvement project rather than research.
These types of evaluations are important but don’t usually meet the criteria for a human subjects research study. The following two questions determine whether what you’re considering becoming involved in meets the definition of human subjects research:
1. Is it a systematic investigation designed to develop or contribute to generalizable knowledge?
2. Does it involve living individuals (human subjects)?
Is the Study Appropriate for You?
Once you’ve decided that it is research you’re considering becoming involved in, your next step should be determining whether the proposed research study is right for your agency. This process includes a consideration of the topic area. Is it important to you or your agency? Is it answering a question that would be beneficial to either the field of EMS or a specific need you may have identified?
Also consider the time requirements, logistics and manpower involved. Ask to read the protocol and discuss it with the investigators, ensuring all your questions are answered. Before your agency agrees to be part of a study, it’s important that the necessary people at your agency are on board. This usually includes the medical director, administrators and representation from the EMS providers. Having a clear understanding of the expectations will save you a lot of time and trouble in the long run.
Determine Your Agency’s Role
A broad spectrum of research exists, ranging from analysis of data collected as part of daily operations to testing of new drugs or treatment interventions, including medical devices. Likewise, involvement of your agency or designated staffer can vary from providing a set of data to a principle investigator (PI) to being a primary investigator. A few of the common roles include the following:
Investigator: The investigator, you’re involved from the conception and design of the study to the conducting of the protocol and the analysis, to reporting your results and conclusions. It’s the investigator(s) who decide what the scientific question is and how to gather the necessary information to answer that question.
Data source: In most EMS agencies, data can be extracted for a specific time period from an already existing database (retrospective), or it can be collected as part of daily operations–going forward (prospective). For instance, an investigator may want to retrospectively look at when and where certain types of emergency response calls, such as seizures or chest pain, have occurred over the past two years. As part of the research, your agency would provide a data set from your database for the investigator to analyze.
Data collector: You may be asked to obtain an extra piece of information or record the information in a special way. For example, you may be asked to obtain an extra set of vital signs or tube of blood.
Intervention conductor: Intervention trials are clinical trials that compare one treatment to another or one procedure to another. EMS providers can participate by executing the intervention in the field according to the research protocol. Roles and responsibilities will vary depending on the research protocol, and each carries specific responsibilities and ethical obligations.
Recognize Knowledge, Skills, Expertise & Limitations
EMS providers have a specific skill set that includes medical knowledge, the ability to perform special procedures in the field and know-how with triage and clinical protocols. These skills can play an important role in clinical research. However, it’s also important to obtain the necessary research skills to properly and confidently participate in conducting the research. If you’re new to research, partnering with an experienced clinical researcher and sharing skills can benefit both the outside investigator and your agency.
IRB review and approval: By law, research that’s federally funded or mandated and involves people and /or their information requires review by a federally registered ethics board called an Institutional Review Board (IRB).3,4 Many institutions have chosen to review all research no matter who’s funding the study. Individual agencies can have their own IRB or can pay a for-profit IRB to review a study. If you’re partnering with a university investigator, it may be possible to have their university’s IRB cover the EMS agency.
An important part of the ethical review is how participants will be informed about the study. Informed consent–an individual’s agreement to participate in a study after hearing the details, risks and benefits–is paramount to protecting human subjects in research. The kind or extent of the consent can vary depending on the type of research and its risks. All individuals involved should have a general understanding of the ethics of conducting research with people (or handling their information).
Someone within the agency should pay particular attention to the requirement for IRB review and approval. This may be one area in which it may be best to rely on a seasoned investigator to provide this expertise and training.
Costs & Benefits
The cost of conducting a research study can vary tremendously depending on what’s being done. For instance, gathering previously collected clinical data or downloading data may have minimal cost for the time required to compile the data. On the other hand, a clinical trial has a higher cost because of the increase in workload associated with clinical trials for EMS providers. This includes not only time to actually conduct the study, but also time for training and paperwork.
Supplies or laboratory costs may also exist. Often these costs can only be estimated, but they should be itemized and budgeted as carefully as possible. If you’re working with an outside investigator, then have a frank discussion regarding your costs. Depending on the funding, they may not be able to fully cover the costs. If you determine after negotiating that the costs can’t be covered, then consider whether the benefits of doing the study balance the costs. The benefits of a study may be even harder to estimate because they’re often nonmonetary and involve improving care, recognition, career advancement, and creating or strengthening partnerships.
Communication
With any relationship, communication is critical. Collaboration in research requires investigators, research coordinators, medical directors, agency administrators, designated contact person(s) and EMS providers to establish and maintain communication within and outside the agency.
Internal communication begins with how you’ll decide whether your agency should participate in the research. Once you’ve decided to participate, you should establish clear lines of communication, such as who will be the main contact person for the study and how information will be distributed to all involved. Consider ways that other information is transmitted, including newsletters, flyers, posters and e-mail. Think about developing a research committee that includes administrators, EMS providers and other representatives from the agency who can meet on a regular basis to review protocol enrollment and problems that may occur. Make sure important information from these meetings is shared with the other individuals involved.
It’s also important to establish good external communication. If you’re working with an outside investigator, agency or company, it’s a good idea to invite them to the research committee meetings. Establish ground rules and a working partnership. Take the stance that you’re all in it together. Endeavor to foster good relationships with outside investigators and research coordinators. Don’t play the blame game; it’s counterproductive and may affect subject enrollment. If problems arise, try to determine the cause. But more importantly, look for ways to prevent it from happening again.
Logistics
Look at the protocol and think through how the steps in the research procedure fit with your usual practice. The more the study fits with usual practice, the easier it will be to incorporate it into your agency’s daily operations. Consider each step and determine whether it’s different from your daily operations; if so, what’s the easiest and best method to implement the research protocol?
For example, if a study drug is to be administered or a special kit for drawing the blood is involved, think about where it would make sense to put it based on who’s going to need access to it and where they’ll need it. If you need to collect extra information, such as timelines or vital signs, how will you record it? Can it be worked into your usual documentation? If this is a field study, ask the providers in the field (e.g., field training officers) to assess the logistical aspect of executing the research protocol. Field training officers (FTOs) and providers have firsthand experience and will be the ones directly involved in implementing the research protocol, so they should be comfortable with it.
For some studies, you may be able to contribute to the actual design of the study. But for most studies with several participating centers, you may not be able to influence the design of the study. However, you can make sure that the protocol can fit into your operating procedures.
Training
Characteristics of EMS systems may require special attention in the planning of training. Shift work and a non-centralized work setting make scheduling group training difficult. Including methods routinely used for clinical or operational trainings may make this easier. For example, say you traditionally use a train-the-trainer approach, where field officers are trained on a new piece of equipment or procedure, and then train other providers. Consider building this approach into the research training.
Also, make the training unique to the study. In other words, create different training plans for different research studies. More complicated interventions may require more in-depth training, and interventions that require little deviation from the daily routine may require a shorter, less in-depth approach. It’s also a good idea to recognize the different methods in which adults learn. For example, some adults prefer visual learning. This type of learning can be delivered in either a class setting, or via video or webinar. Other individuals learn better with hands-on experience.
It’s important to note that all providers should receive hands-on training if the study involves a new procedure, equipment or delivery device. You can use a variety of training methods, but the information should be shared consistently. Ensure individuals can complete each section of the training without interruption and with the ability to review as needed, regardless of whether the training is a scheduled, in-person class setting, a video to watch independently or a hands-on practicum. Conducting training between calls can lead to missed information, and improper and reduced enrollments.
Timing of training: The timing of the research protocol training is also essential when becoming involved in EMS research. Regardless of the study’s duration, training should be planned, conducted and completed as close to the study start date as possible. Large time gaps (e.g., three to six months) between training and implementation of a research study can lead to unwanted differences in how the research protocol is conducted.
The research protocol may require providers to deviate from their normal routines for implementing standard protocols, so ongoing training is important. If there’s a delay in starting a protocol, or if there’s a considerable lag between a provider’s training and their first enrollment, ongoing training is even more crucial. It can include helpful hints, review of enrollments and reminders.
Also consider how new providers will be trained on the research protocol, such as incorporating its training with your agency’s standard orientation process. Ensuring providers feel confident in conducting the study throughout its duration will facilitate provider willingness to participate and improve accuracy of the study data.
Training content: Obviously, those involved in the conduct and enrollment of subjects in research must be trained in the correct procedures and techniques. However, other topics can improve participation and conduct of the study.
Providers should know why a study is being conducted, understand the rationale behind the study and know what researchers are hoping to learn. Providers should know the basics of how a drug or device works and how it differs from what they’re already using. They also need to know the ethical principles that guide research with people and how this study is meeting that criteria.5
Understanding reasons behind inclusion and exclusion criteria will make it easier for providers to accurately determine whether to enroll someone. Therefore, training objectives should include, but aren’t limited to, a comprehensive overview of the research protocol, including the background and significance of the study; comprehension of the basic ethical principles guiding human subjects research and as needed exception from informed consent research; knowledge and understanding of inclusion and exclusion criteria; understanding of how to properly use, maintain and store (or dispose of) research-related materials; and demonstration of proper documentation of the research protocol information.
Summary
Just as clinical care has requirements for documentation, so does research. Having a contract or memorandum of understanding with research partners outside your organization can establish responsibilities and expectations of all parties, and can provide the groundwork for a solid partnership. Keeping a regulatory binder with all required forms, such as protocol versions, consents, IRB approvals, contracts and signature pages, will keep the study organized.
Before beginning a trial, determine how study data will be recorded. For multicenter
studies, there are often prepared case-report forms to be completed. If there aren’t any prepared forms, then create one to ensure that all data is collected and documented (time, date and recorder). Follow regulations regarding how long study documents must be maintained after the study is completed. These regulations may vary depending on the type of study, so be sure to determine this before discarding any documents.
As you can see, you have many things to consider when getting involved in research. If this is your agency’s first attempt at getting involved in research, it may be beneficial for you to partner with an EMS agency experienced in conducting research, a product manufacturer interested in testing a product or an academic institution. A seasoned investigator can guide you through what may seem like a complicated process. Eventually, as your agency gains experience, you’ll be
able to take on greater responsibility in the research process. JEMS
Authors’ note: This study was funded by Grant 5RC1NR011536-02 from the National Institute of Nursing Research (NINR) and UL1RR031990 from the National Center for Research Resources (NCRR) and NIH Roadmap for Medical Research, National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NINR or NCRR or the National Institutes of Health.
References
Fox J, Day S, Reynolds L, et al. Post-clinical trial survey of emergency medical services providers: Research experience and attitudes. Air Med J. 2010;29(1):34—
Schmidt TA, Nelson M, Daya M, et al. Emergency medical service providers’ attitudes and experiences regarding enrolling patients in clinical research trials. Prehosp Emerg Care. 2009;13(2):160—
U. S. Department of Health and Human Services. (Jan. 15, 2010). Code of Federal Regulations 45 CFR46. In U.S. Department of Health and Human Services. Retrieved Aug. 30, 2011, from www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
U.S. Food and Drug Administration. (July 5, 2011). FDA Regulations Relating to Good Clinical Practice and Clinical Trials. In U. S. Food and Drug Administration. Retrieved Aug. 30, 2011, from www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.
Ryan KJ, Brady JV, Cooke MD, et al. (April 18, 1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. In Office of Human Subjects Research. Retrieved on March 9, 2011, from http://ohsr.od.nih.gov/guidelines/belmont.html. knowledge and understanding of inclusion and exclusion criteria; understanding of how to properly use, maintain and store (or dispose of) research-related materials; and demonstration of proper documentation of the research protocol information.
This article originally appeared in October 2011 JEMS as “Getting Started with Research: Tips for Success.”
Table 1: Getting Started: Important Research Terms
Research: This is the systematic process of collecting and analyzing information to increase understanding of a specific question(s) being asked. Research can answer EMS questions about medications, devices, procedures, systems, etc. It’s generalizable, meaning it provides results that can be expected to hold true for similar people or situations.
Research protocol: A research protocol is a document that describes exactly how a research study is to be conducted. It includes information, such as the purpose of the study, who can and can’t be enrolled in the study, the specific method of how the study is to be done, what information (data) is to be collected and how the information (data) can be analyzed. A research protocol must be adhered to as is and can only be amended with approval from by a regulatory board, such as an Institutional Review Board (IRB).
Human subjects research: Research that involves living individuals about whom an investigator obtains information (data) through intervention or interaction with the individual or has access to private information about the individual. This type of research can include a wide variety research from review of previously collected records to complicated clinical trials.
Institutional Review Board (IRB): An Institutional Review Board is a committee that has been formally designated to approve, monitor and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of individuals who participate in research. In the U.S., regulations by the Food and Drug Administration and Department of Health and Human Services Office for Human Research Protections have empowered IRBs to approve, require modifications in planned research prior to approval or disapprove research. All federally funded human subjects research must be reviewed and approved by an IRB with a federal wide assurance (FWA). This assurance is the institution’s guarantee to the federal government that all applicable laws and regulations will be followed.
Implied consent: This isn’t a research term; implied consent is used by healthcare providers on a daily basis. The thought is that a reasonable person would want to be taken care of. EMS providers don’t ask for permission or get a signed consent, which gives permission to backboard, start an IV or give a medication. In fact, in some situations, the individual only signs when refusing or declining care or transport.
Informed consent: This consists of presenting an individual or legally authorized representative (LAR) with such information as purpose and duration of the study, expectation of participants, foreseeable benefits and risks, compensation/reimbursement, confidentiality and voluntary participation, and allowing the individual or LAR to make an informed decision regarding participation in the study. For most studies, this requires the interested individual or LAR to sign a document of consent. Some state laws require that a witness also sign. In some circumstances, the researcher can ask the IRB for a waiver of consent or documentation of consent.
Exception from Informed Consent (EFIC): EFIC research is a type of research that doesn’t require the consent of an individual before being enrolled in a study. This is a special type of research with strict criteria governed by federal regulations. EFIC research is seen in the field of EMS because eligible individuals are often unable to give informed consent due to their current physical and/or mental condition (e.g., cardiac arrest, seizure or trauma).
State regulations: States may have their own special requirements that must also be followed. These requirements are in addition to, not in place of, federal regulations.
Regulatory binder: This is an organized binder (either electronic or hard copy) that contains all study-related documentation in one place including study protocol, a clean copy of consents, IRB correspondences (study approval, amendments, continuing review and informal correspondences), adverse events, protocol violations, advertising/recruitment tools, standard operating procedures and grant information.
Table 2. Federal Regulations
The Common Rule: The Federal Policy for the Protection of Human Subjects, also known as the “Common Rule,” was issued and added to the Code of Federal Regulation (45 CFR 46) in 1991. This federal regulation establishes protections for participants in research, including identifying requirements for researchers obtaining and documenting informed consent; requirements for IRB membership, function, operations, review of research and record keeping; and requirements for ensuring compliance by research institutions.
The Common Rule also includes additional protections for certain vulnerable groups of people, such as children, prisoners and pregnant women. The Common Rule applies to 17 federal agencies, but it doesn’t apply to federal agencies who haven’t signed the agreement. The DHHS has signed the agreement, so all federally funded EMS research must follow the requirements contained in the Common Rule.
The Final Rule: Federal regulations developed by the FDA (21 CFR 50.24) in 1996 to closely govern the practice of EFIC research. The Final Rule identifies specific criteria for EFIC research and requirements for its use.
Other Federal Regulations: Although the Common Rule and Final Rule serve as foundational regulations to protect participants of research, a number of federal agencies have developed additional regulations that must be followed when receiving research funding from a particular department. Examples include the Department of Defense and the Department of Education.
