Why Ethics Approval?

The first question many researchers will ask themselves when approaching the ethics review process is “Why do I have to do all this?” Researchers may reason that because they don’t believe they are doing anything harmful, they should not need to engage with what can be seen as a cumbersome ethics review process.

Unfortunately, researchers do sometimes cause harm, either accidentally or deliberately. For instance, during the 1996 meningitis outbreak in Kano, Nigeria, a Pfizer (New York USA) research team treated 200 children with either Trovan or Ceftriaxone antibiotics - 11 children died, including five given Trovan and six given Ceftriaxone. ^{Reference O’Mathuna1} A subsequent hearing concluded that there were a number of violations to ethical research, including lack of ethics approval, lack of acceptable informed consent, therapeutic misconceptions, and the researchers leaving the research site prematurely. ^{Reference Okonta2} A Nigerian government report alleged that Pfizer had acted unethically and broken international law. ^{Reference O’Mathuna1} Pfizer was subsequently sued in the United States courts and settled the case out of court without admitting fault. ^{Reference Okonta2} In other research with refugees, participants in various qualitative research projects reported that they felt exploited by researchers, that their names and photographs were published without authorization, and that promised feedback was never received. ^{Reference Pittaway, Bartolomei and Hugman3} One participant said the researchers “stole our stories” and they “would never work with researchers again.” ^{Reference Pittaway, Bartolomei and Hugman3} Unethical research has an immediate impact on participants and may have long-term impacts on the research enterprise.

Research ethics reviews and approval processes are designed to protect research participants and their communities, as well as serving as a quality check for human research. Research quality is improved when research is done ethically. Research quality and reputation suffer when researchers cut corners.

What is Human Subjects Research?

The United States National Institutes of Health (NIH; Bethesda, Maryland USA) defines a human subject as “a living individual about whom an investigator (whether professional or student) conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” ⁴

The term “research participant” has been gaining favor over “research subject” and was adopted as the preferred term in the October 2024 revision of the Declaration of Helsinki, widely regarded as the cornerstone document on human research ethics. ⁵ For that reason, “research participant” will be used here.

Prehospital and Disaster Medicine requires that all submissions, regardless of the submission category, which report on research that includes human participants or animal subjects, provide evidence of ethics approval from an accredited research ethics review committee (or Institutional Review Board; IRB) that was obtained prior to the conduct of the research. This includes all types of research areas (eg, clinical, educational, biological, social sciences, etc) involving primary data acquisition from human participants, such as chart reviews, interviews, surveys, questionnaires, email correspondence, or virtual meetings. The requirement also extends to conference abstracts published as a supplement in the journal.

Authors of studies that analyze only publicly available data - such as systematic reviews of published research or analysis of news media reports - are not required to provide evidence of research ethics approval. People with access to data because of their clinical, educational, employment, or other role should not assume they can also access that data for research purposes. For example, an educator may view student assignments for academic purposes, or a clinician may view patient records for therapeutic purposes. However, they should have research ethics approval to use that same data for research purposes. The data are originally provided for educational or clinical purposes and are not publicly available (eg, to other researchers), and therefore research ethics approval (and probably informed consent) will be required to use that data for research purposes.

Who Can Approve a Study?

Often, it is unclear to researchers exactly who has the power to approve a research study. In essence, ethical approval must come from an appropriate body that is licensed to give approval for human research. Most commonly, these approvals come from academic institutions, such as the researchers’ home university. Many humanitarian international agencies, such as the World Health Organization (WHO; Geneva, Switzerland) or the International Committee of the Red Cross (ICRC; Geneva, Switzerland), as well as some large nongovernmental organizations (NGOs), such as Médecins sans Frontières (MSF; Geneva, Switzerland), have their own research ethics approval bodies. National ethics boards or a country’s Ministry of Health may be available to provide the best advice on obtaining research ethics approval when an academic institution or large international organization is not involved. Note that when research is conducted internationally, the Declaration of Helsinki states that research protocols must be approved by research ethics committees in both the researchers own country and in the country where the research will be conducted. ⁵

While obtaining research ethics review can be difficult - particularly for humanitarian research - this should never be taken as an excuse to do research without the appropriate ethics approval. Researchers should anticipate ethics review and approval as a known and important step and plan their studies and timelines accordingly. The ethics review process can, unfortunately, be lengthy, often because ethics review committees can be poorly resourced and usually rely on reviewers providing reviews voluntarily. Therefore, researchers should seek out information on submission deadlines and typical review times and plan accordingly. This is particularly the case if ethics approvals are required in more than one country, such as with collaborative international research.

The urgent need to initiate disaster research can be another challenge, especially when the ethics review process is anticipated to be lengthy. However, research ethics committees can develop procedures by which they can pre-screen research protocols planned in advance to facilitate and expedite final ethics review if required in a disaster or other crisis. ⁶

What are Common Types of Reviews?

Terminology surrounding the ethics review process can appear mysterious to researchers. Different committees and jurisdictions may use different terms, and researchers should clarify what each organization means by its terminology. The following are common meanings for some of the common terms.

Full review indicates that all members of a licensed research ethics committee will review and vote on the entire research study in order for it to be approved. A full review typically occurs during a meeting of the full committee and therefore will have to wait for an opening on the committee’s meeting schedule. Studies approved under full review are generally of higher risk than other studies. Note that risks to participants or researchers include more than physical risks and can include psychological, social, reputational, or economic risks.

Expedited reviews are typically available for lower risk studies where a complete ethics application is submitted to the committee, but it is reviewed by one committee member (or a small subgroup of members) and a decision on its approval can be reached outside of a committee meeting. Many research ethics committees also have formal procedures for a more streamlined review of lower risk studies.

Exemptions are given by the ethics committee when a short summary of the study is reviewed by a member of the committee and who determines that the study is of such low risk that a full ethics submission and review is not necessary. Importantly, researchers should note that only the qualified research ethics committee gives the exemption. A common misconception persists that researchers themselves can classify their research as exempt and avoid application to the research ethics committee. Exemptions are best thought of as a special type of ethics approval, and researchers should request documentation of that approval which can then be provided to journal editors.

Waiver of consent is a component of the ethics approval process where researchers can request that they do not ask study participants to provide consent to participate in the study or allow their data to be used in the study. Various justifications can be provided for consent waivers, and researchers will be expected to provide support for their requests as part of their applications. ⁶ Again, researchers should note that only a qualified research ethics committee can approve a waiver of consent - researchers themselves do not approve such waivers.

Prehospital and Disaster Medicine requires authors to submit confirmation of ethics approval for all human participant (and animal) research. This must include either (A) the name of the research ethics committee providing the ethics approval and the reference number for the approval, or (B) the name of the research ethics committee providing the exemption with a copy of the exemption letter uploaded as a supplementary file. In addition, both the title page and the text of the final manuscript must provide details of the ethics approval or exemption.

What About Educational Research Studies?

Educational research studies with human participants require research ethics approval. The social sciences have a long history of research, and, while often not demanding the same type of ethics review as more invasive studies (such as implementing a new experimental drug), educational studies can put participants at some degree of risk and are forms of human research which are therefore voluntary. More detailed descriptions of educational research ethics are available from many organizations, including the American Educational Research Association (AERA; Washington, DC USA) and the British Educational Research Association (BERA; London, United Kingdom). ^7,8

Educators often have access to data, such as student grades or performance indicators, by the nature of their work. Commonly, this occurs when the educational intervention is part of the students’ curriculum and the data are required for the operational purpose of the education program. However, when these same data are used for research, a conflict of interest develops. Research ethics review and approval allows for an external review of the study to evaluate the protocol for any potential ethical challenges and how they are addressed by the researchers. For example, students may feel pressured into performing tasks not necessary for their education, or certain students may be advantaged or disadvantaged, even inadvertently, by research procedures. Researchers should view the ethics review process as a formative exercise designed to facilitate and improve the study for both the researcher and the participants.

Prehospital and Disaster Medicine classifies all educational studies that involve human participants as human research that requires ethics approval.

What are Some Common Misconceptions?

Several common misconceptions appear frequently in submissions to Prehospital and Disaster Medicine.

Firstly, many authors mistakenly believe that if the final report contains only aggregated or de-identified data, no research ethics review is needed. This can occur for instance when researchers review patient charts but only present a summary of what is found, not specific details of any individual patient. However, studies involving identifiable data (even if the report does not) are still considered human participant research and require approval from an appropriate research ethics committee.

A second common misconception is that if participants give consent, ethics approval is not needed. While informed consent is an important part of ethical research, it does not preclude the need for ethics approval.

Thirdly, a misperception can exist that ethics is a hurdle to overcome only because ethics approval is needed to publish in peer-reviewed journals. We believe that ethics is an important element of all phases of the research process, and therefore researchers should be considering the ethical issues of their research during study conception and design, while data are being collected, and during the publication or other dissemination process. In other words, ethics is integral to all stages of research. Evidence of ethics approval is required, not only for published manuscripts, but for all dissemination of the study results: posters, oral abstract presentations, blog posts, field reports, commentaries, editorials, or sharing on social media.

Fourthly, authors sometimes believe a simple statement that they followed certain guidelines (such as the Declaration of Helsinki) is sufficient to document ethics approval. Following ethics guidelines is not the same as receiving ethics approval. Researchers are professionally responsible to be ethical regardless of whether their projects have a legal and regulatory requirement to receive ethics approval. Prehospital and Disaster Medicine requires evidence of ethics approval from an appropriate research ethics committee for all research with human participants and/or animals.

What About the Frustration?

Unfortunately, the ethics review process has developed a reputation for being a tedious, repetitive, and frustrating process for researchers. For instance, researchers complain that research ethics committees or “institutional review boards have lost sight of their original purpose of protecting human subjects, focusing instead on bureaucratic minutiae.” ^{Reference Jones, Grady and Lederer9}

While the primary responsibility of research ethics committees is the protection of human participants, committees should strive to provide prompt responses to researchers that aim to provide constructive feedback that can help facilitate rigorous and important research findings.

How Can Virtues Contribute?

Research ethics should be thought of as more than just a regulatory procedure. Research ethics is not only about compliance and informed consent, though these are important aspects. Research should be designed around and conducted in accordance with ethical virtues that include fairness, respect, care, and honesty. ^{Reference Schroeder, Chatfield, Singh, Chennells and Herissone-Kelly10} The concept of virtue in research urges us to look beyond the results of the research, and general and ethical principles, and to examine the character qualities of the researchers themselves.

While the ethics review process is often viewed as purely an administrative process, it should also serve as a time for researchers to reflect. Henry Beecher’s 1966 article led to an emphasis on informed consent in clinical research. In his article, he noted that while informed consent is important, the most reliable safeguard to ethical research involving humans is: “the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.” ^{Reference Beecher11} This reflection brings us back to consider what it means to be an honest and caring researcher.

Such an emphasis on virtue takes us beyond mere compliance with ethics review procedures. It points to the importance of ethics throughout the research process. Investigators will then be concerned to promote honesty, and other virtues, as a habit for the whole team. That will help ensure that the informed consent process is conducted with ethical rigor. This also helps ensure that data are collected rigorously and results presented with honesty, thus promoting scientific rigor. In such ways, research methods and research ethics go hand-in-hand to promote the best possible research findings. This is why Prehospital and Disaster Medicine is renewing and clarifying its commitment to ensuring all its research publications have evidence of appropriate ethics approvals.