Administration and Leadership, Patient Care

Institutional Review Boards Ensure EMS-Based Studies Have Ethical Oversight

Issue 1 and Volume 41.

You and your partner want to compare two different ways to treat an arrhythmia or you’ve developed a new airway device and want to study it. Can you?

The most important thing to know before doing any research is that preapproval must be obtained from an institutional review board (IRB). The IRB is a committee of physicians and non-physicians who review and approve research.1,2

This board has two primary responsibilities: 1) protecting the rights of patients in clinical research trials, including assuring that patients can make informed decisions free from coercion, maintaining their individual privacy and minimizing risks; and 2) balancing the welfare of the general public against the risk to the study participants.2

HISTORY OF IRBS

The concept of human-subject research protection came after years of violations of basic human rights. After WWII, the Nuremberg Code was developed to try Nazi war criminals,3 a large portion of whom were physicians who tortured subjects in the name of research. Subjects were placed in freezing water in order to test different rewarming techniques, had bacteria injected into inflicted wounds or directly into the bloodstream to test different antibiotics, and endured bioterror weapons tests, like mustard gas, to study effects and treatments.

The three main principles set forth in the Nuremberg Code that have become the foundation for current research regulations are: 1) voluntary informed consent; 2) favorable risk/benefit analysis; and 3) the right to withdraw without negative repercussions.

The 1964 Declaration of Helsinki was the next major milestone in conducting ethical research, adding that the interests of research subjects should be placed above the interest of society and that every subject should get the best known treatment.3

Despite these efforts to institute a code of research ethics, there were still several studies throughout the 1950s and 1960s that caused national outrage, most notably the Tuskegee syphilis study. This experiment was funded by the United States Public Health Service to investigate the clinical course of untreated syphilis. When the study was initiated in 1932, there was no known treatment for syphilis.

There were two major ethical problems with the Tuskegee syphilis study. Many of the participants were uneducated, poor African- American sharecroppers who didn’t understand that they weren’t receiving treatment and were being studied merely to explore the course of their illness. Perhaps worse, penicillin was developed during the course of the experiment and turned out to be a highly effective treatment against syphilis; however, none of the study participants were treated so as to not interfere with the study.3

The Tuskegee study caused a significant distrust of the medical research field and eventually helped lead to the Belmont Report identifying three core principles for research involving human subjects: 1) respect for persons (subject autonomy and informed consent); 2) application of research; and 3) selection of subjects.4

INFORMED CONSENT

A major role of an IRB is to ensure all participants are able to voluntarily consent to a research study free from coercion. When obtaining consent, it’s vital to be accurate and complete with respect to describing the risks and benefits of research participation.

Consent should ideally be given by the patient, but that may not always be possible, especially in studies that involve EMS where the patient must be severely injured or ill in order to be enrolled.5,6 In these cases a surrogate, such as a preassigned legally authorized representative or power of attorney (POA), may provide consent. Some states may be more restrictive in defining the types of studies that allow surrogate consent. The order of consent authority, in lieu of the patient, is typically guardian (for a minor), POA, spouse, adult children, parent, and adult siblings.4

In some instances, there may not be time to obtain consent from either an obtunded patient or a surrogate. But that doesn’t mean research can’t be performed. The IRB can issue a waiver of consent.

In 1996, the Department of Health and Human Services created guidelines for research without obtained informed consent.7,8 These guidelines require that:

  • The subject be in a life threatening condition;
  • Available treatment modalities are thought to be insufficient;
  • The subject must be unable to consent, and there’s not time to contact a surrogate;
  • There’s a possibility of benefit to the subject;
  • Community consultation and public disclosure occur; and
  • The local IRB approves the study.

Typically, community consultation requires a public forum meeting for community members to express their understanding and concerns. Public disclosure and dissemination of information to the public usually takes place by the use of mass media: television, radio or the Internet.9

There are a few reasons for informed consent exemptions. Case studies, which report on the outcome of one or more individuals, are often not recognized as “a systemic investigation,” and will likely not be overseen by an IRB.10 Quality improvement (QI) projects also don’t typically need IRB approval, as the information stays within an EMS system.

If the information gathered from a QI project is then submitted for publication, however, it will require IRB approval because it now “contributes to generalizable knowledge.”11

Other types of studies exempt from informed consent include those that use information from public databases or anonymously returned questionnaires. Research that doesn’t have any personal identifiers, such as names, geographic locations smaller than a state, dates (including birth dates and dates of admission), medical record or EMS run numbers, may also be exempt.11

CONFLICT OF INTEREST

There are several situations that place an EMS researcher at risk for a conflict of interest. A common conflict of interest is when a researcher has either a professional or financial interest in something related to the study; that is, someone involved in the study could gain personally or financially.

Financial conflicts of interest can be tricky to manage. If an EMT or paramedic has a personal or financial connection to a newly invented device, for example, he or she may need to restrict themselves from the project. This may require having a neutral researcher handle the data and interpretation to insert as little bias as possible.2

It’s critical researchers recognize potential conflicts of interest, disclose them, and work with the IRB and research team to minimize them.

SUBMITTING TO AN IRB

The first step in the submission process is to develop a clinical question and formulate a hypothesis. This requires doing some background research to help support the clinical question and find out if there’s any related research. This may also require obtaining an expert opinion about whether the question is a valid one.The study design needs to be sufficient to answer or support a question; otherwise the study is subjecting patients to risk without providing any possible benefit.

The risk/benefit analysis is a very important factor to consider. Risks deal with the chances of harm (physical, psychological, social or economic) that might occur as a result of the research study. This includes subjecting patients to painful tests and procedures or giving medication with limited knowledge of side-effects. These risks shouldn’t substantially outweigh the risks that already exist from standard treatment.

Benefits can be divided into two categories: 1) possible benefit to the patient; and 2) benefits to society as a whole when knowledge of a certain subject is advanced. If the subject is likely to benefit from a study, the IRB may accept a higher threshold of risk.

If the study isn’t likely to benefit the patient, there needs to be a careful assessment of the ethics behind a study

If your EMS system isn’t affiliated with a university or medical center, most city and county services can use their governing municipalities’ IRB. Private services may have to rely on a commercial IRB for an impartial review.

CONCLUSION

All human-subjects research must be overseen by an IRB and comply with the three main principles behind human-subject research: 1) respect for persons (informed consent); 2) beneficence (explaining the risks vs. potential benefits); and 3) justice (fairness in enrollment without discrimination).

Research can be complicated when informed consent isn’t a possibility. In cases where consent can’t be obtained, a waiver of consent can be obtained through the IRB. Secondary considerations in these situations include carefully weighing the risks and benefits to patients, providing information to the public, as well as a forum where the community can ask questions and express concerns. EMS systems not already affiliated with an IRB may have options through their municipality or a commercial IRB. However, if IRB approval is obtained, it’s important researchers be aware of the ethics involved when conducting human-subject research.

EMS Today conference

Learn more from Corey Slovis at the EMS Today Conference & Expo, Feb. 25–27, in Baltimore, Md. EMSToday.com

REFERENCES

1. Rice TW. How to do human-subjects research if you do not have an Institutional Review Board. Respir Care. 2008;53(10):1362–1367.

2. Schwenzer KJ. Practical tips for working effectively with your Institutional Review Board. Respir Care. 2008;53(10):1354–1361.

3. Rice TW. The historical, ethical, and legal background of human-subjects research. Respir Care. 2008;53(10):1325–1329.

4. Neff MJ. Informed consent: What is it? Who can give it? How do we improve it? Respir Care. 2008;53(10):1337–1341.

5. Salzman JG, Frascone RJ, Goddin BK, et al. Implementing emergency research requiring exception from informed consent, community consultation, and public disclosure. Ann Emerg Med. 2007;50(4):448–455.

6. Watters D, Sayre MR, Silbergleit R. Research conditions that qualify for emergency exception from informed consent. Acad Emerg Med. 2005;12(11):1040–1044.

7. Mosesso VN, Con DC. Using the exception from informed consent regulations in research. Acad Emerg Med.2005;12(11):1031–1039.

8. Morris MC. An ethical analysis of exception from informed consent regulations. Acad Emerg Med. 2005;12(11):1113–1119.

9. Vohra T, Chebl RB, Miller J, et at. Improving community understanding of medical research: Audience response technology for community consultation for exception to informed consent. West J Emerg Med. 2014;15(4):414–418.

10. National Institutes of Health Office of Human Subjects Research. (Jan 15, 2009.) Code of Federal Regulations, Title 45, Part 46. Protection of human subjects. Retrieved July 1, 2015, from www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101.

11. Neff MJ. Institutional Review Board consideration of chart reviews, case reports, and observational studies. Respir Care 2008;53(10):1350–1353.

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