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.
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 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.
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).
Ethically, there is a fundamental concern with IRBs as currently structured. They are designed to ensure that human subjects are treated fairly and safely in research studies. IRBs also work to ensure that each human subject or research participant signs a consent form affirming their agreement to participate in the study. Each subject must consent voluntarily, and must have a clear understanding of what they are agreeing to. Those consent forms must often be retained for a specified period of time and, because they frequently contain personal information, must be secured by the researcher. This requirement makes sense for medical trials and other forms of experimentation, but it does not translate logically to surveys and questionnaires. By completing a survey or questionnaire, participants are, in effect, giving their consent for that information to be used by the researcher. If they did not consent to such use, they would simply decline to fill out the form offered to them.
When researchers plan studies, they can often discover new and important information by doing more than simply reviewing existing literature. Unfortunately, a growing number of researchers are gravitating toward the literature review method today precisely because it does not require them to engage with the IRB process. As soon as they decide to involve current human beings in their study for the purpose of data collection, they must face IRB procedures and regulations. Many are simply unwilling to do this, because they see no need for that level of oversight when research involves only surveys or questionnaires. By excluding oral history from the IRB review process, a path has already been cleared for extending similar exclusions to other forms of oral and written information gathered for research purposes — without requiring consent forms or full IRB compliance.
"Survey completion as implicit informed consent argued"
"IRB burdens push researchers toward literature-only methods"
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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