Ethical Concerns and the IRB Review Process in Research
This paper examines the ethical concerns and practical burdens associated with the Institutional Review Board (IRB) process, with particular attention to research involving surveys and questionnaires rather than clinical experimentation. Using emergency management and trauma centers in Connecticut as a case study context, the paper argues that current IRB regulations are overly broad, applying uniformly to studies that pose no real risk to human subjects. The paper traces the gradual exclusion of oral histories from IRB requirements as a precedent for further reform, and contends that survey-based research should similarly be exempted, allowing scholars—especially in the social sciences—to conduct and publish timely, valuable research without unnecessary regulatory obstacles.
- Introduction: The IRB Process and Human Subjects Research: IRB oversight introduced amid emergency management research context
- The Burden of Broad IRB Regulations: Broad regulations burden survey and questionnaire research
- Ethical Questions Surrounding IRB Necessity: Questioning IRB necessity for non-experimental social science studies
- Consent, Surveys, and the Nature of Participation: Survey completion as implicit informed consent argued
- The Chilling Effect on Researchers: IRB burdens push researchers toward literature-only methods
- Conclusion: Reforming IRB Requirements: Calls for IRB exemptions to accelerate public research benefits
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What makes this paper effective
- The paper builds a focused, logical argument by using the oral history IRB exemption as a concrete precedent to support extending exemptions to surveys and questionnaires.
- It balances ethical reasoning with practical concerns, showing how overly broad regulations deter researchers and delay the public release of valuable findings.
- Citations are used efficiently to anchor claims about regulatory history and evolving scholarly consensus, lending credibility to what is largely a policy argument.
Key academic technique demonstrated
The paper demonstrates precedent-based policy argumentation: it identifies an existing regulatory change (the oral history exemption) and uses it as logical and institutional grounds for advocating a parallel change. This technique is common in law, public policy, and applied ethics writing, where existing rulings or precedents are leveraged to support reform proposals.
Structure breakdown
The paper opens by contextualizing the research setting and introducing the IRB process. It then critiques the breadth of current regulations before raising ethical questions about whether IRB oversight is warranted for non-experimental research. A focused section addresses how survey participation itself constitutes implicit consent. The paper then examines how IRB burdens discourage researchers from collecting primary data, closing with a call for regulatory reform that would benefit both researchers and the public.
Introduction: The IRB Process and Human Subjects Research
The issue examined in this course was emergency management and trauma centers in the State of Connecticut. By studying this issue, the researcher was exposed to human subjects. Permission to study those subjects had to come from the subjects themselves or from those authorized to give consent on their behalf. Beyond individual consent, however, the broader question of studying human beings for a research project must also be addressed through the Institutional Review Board (IRB) process. There are significant concerns with that process, particularly where quantitative research is involved. The type of study conducted should, in principle, determine whether IRB oversight is necessary, and there have been longstanding concerns that IRB regulations are too strict and that the process is overused. These concerns arise largely from debate over what actually constitutes research into human subjects. Clinical trials of medications or medical procedures would unquestionably be considered human subject research, but the IRB procedure has historically extended to oral histories, surveys, and questionnaires as well — until recently, when oral histories were formally excluded from the requirement (Ritchie & Shopes, 2003).
The Burden of Broad IRB Regulations
The regulations governing human subjects research are burdensome, and a large number of scholars want them changed. The central concern is the sweeping nature of the restrictions created by the IRB process — regulations that apply broadly to anything and everything that relates in any way to using a human being's information in a study. A literature review analysis, for instance, does not require an IRB review (Part 56, 1991; Pope, 2009). However, if surveys or questionnaires are used, the situation changes. Technically, using these instruments does mean that human subjects are involved in the study. The critical distinction, though, is that these subjects are simply being asked for their opinions — they are not being used as experimental subjects in the study itself. A meaningful distinction must be drawn between using a person as a subject in an experiment and using a person's opinion as part of a survey that is compiled with others to provide a researcher with quantitative data from which to draw conclusions.
Ethical Questions Surrounding IRB Necessity
Because there are vast differences between using someone as a subject in a medical experiment and asking them to share information about their experiences, the IRB process raises concerns regarding both ethics and necessity. Is there a genuine need for IRB procedures when a researcher is only administering a survey or distributing a questionnaire? Increasingly, individuals in both the medical and academic communities are answering no. This is especially true in the social sciences, where researchers study other people's responses and reactions rather than subjecting them to physical or medical interventions. That type of research is not focused on medication trials or clinical procedures. By excluding social science work — and research that does not actually use human subjects for anything beyond their oral or written responses to questions — from the IRB requirement, it would be considerably easier for researchers to conduct these types of studies (Ritchie & Shopes, 2003). It would also reduce the time required for studies to receive approval and reach completion, potentially delivering important research findings to the public and to other scholars more quickly (Pope, 2009).
Conclusion: Reforming IRB Requirements
Many researchers approach the IRB process with optimism, viewing it as just one step among many, and are not yet aware of how difficult it can be to secure approval from a review board. By adjusting regulations and removing the IRB requirement for studies that rely on questionnaires and surveys, many more researchers would benefit. The public would benefit as well, because research studies can provide information that is genuinely valuable to people's daily lives — but only when that information is gathered, analyzed, and released in a timely manner. Without the IRB process as a barrier, that release of information can happen more efficiently. There are no legitimate worries about unethical behavior in such cases, because no human subjects are being experimented upon. The researcher is only collecting information that was willingly offered by participants who chose, of their own accord, to respond.
References
Part 56 — Institutional Review Board. (1991). Food and Drug Administration (United States).
Pope, T. M. (2009). Multi-institutional healthcare ethics committees: The procedurally fair internal dispute resolution mechanism. 31 Campbell Law Review, 257–331.
Ritchie, D., & Shopes, L. (2003). Oral history excluded from IRB review: Application of the Department of Health and Human Services regulations for the protection of human subjects at 45 CFR part 46, subpart A to oral history interviewing. Oral History Association.
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