Anesthesia & Analgesia Policy on Institutional Review Board Approval and Informed Consent for Research

The current Anesthesia & Analgesia Guide for Authors makes the following statement about our requirements for human research and the role of the Institutional Review Board (IRB): “On the basis of the Declaration of Helsinki, Anesthesia & Analgesia requires that all manuscripts reporting clinical research state in the first paragraph of the Methods section that: The study was approved by the appropriate IRB, and Written informed consent was obtained from all subjects, a legal surrogate, the parents or legal guardians for minor subjects, or the requirement for written informed consent was waived by the IRB.”1 This statement does not clearly address audits and case reports. What is an audit? Do audits represent a special type of investigation that does not require IRB approval? Under what circumstances do case reports meet the definition of research? Steven Yentis, Editor-in-Chief of Anaesthesia, has defined the difference between “research” and “audits” in this way: “Research tells us what works best and audit tells us whether we're doing it or not.”2 In his thoughtful editorial, Dr. Yentis notes the risks of circumventing IRB approval by characterizing “research” as “audits,” urging investigators to focus on “what is being done, not what it is called.”2 As explained below, Anesthesia & Analgesia's policy is anchored in the formal definition of research, and thus the distinction drawn by Dr. Yentis is not relevant. Of course, from the perspective of Anaesthesia it is very relevant, since Dr. Yentis is the Editor-in-Chief. I invited Dr. Yentis to share his perspective and rationale, which appears in this month's issue of Anaesthesia.3 His editorial is reproduced in this issue of Anesthesia & Analgesia.4 I encourage readers to consider both views, which address an important question in publication ethics. The juxtaposition of editorials also illustrates the respectful dialog among journal editors in our specialty. The Oxford English Dictionary defines research as “the systematic investigation into and study of materials and sources to establish facts and reach new conclusions.”5 This is consistent with the definition advanced in the Belmont Report: “the term research designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).”6 This also agrees with the current definition used by the United States Department of Health and Human Services: “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”7 There are 2 components of these definitions of research: systematic investigation, and the creation of generalizable knowledge. Audits, by definition, are systematic investigations of health care delivery and outcomes. The act of submitting an audit for publication demonstrates intent to create generalizable knowledge. Audits submitted for publication satisfy both components of the definition of research. Therefore, audits submitted for publication constitute human research. Human research requires IRB approval. There are no exceptions. All “audits” submitted for publication in Anesthesia & Analgesia must have IRB approval. IRB review and approval can take many forms. In addition to conventional IRB review, some IRBs have categories of research that are considered exempt from review. This is acceptable, provided that the IRB has reviewed the protocol, or the proposed publication, and has provided the investigator with written documentation that the study is exempt from further review. This provides written assurance that the IRB has considered the study, the ethical aspects of the research and the proposed publication, and has approved submitting the results for publication. In the case of an audit, this documentation from the IRB would typically be obtained after the investigators have completed the audit, at the time that they realize there are results worth publishing. Informed consent is a separate issue. Informed consent is frequently waived for retrospective research. Anesthesia & Analgesia will likely defer to an IRB granting permission to waive informed consent for a retrospective study. Our expectation is that prospective studies will be conducted with IRB approval and written informed consent. Only under exceptional circumstances, and only with IRB approval and a clear written explanation of the rationale underlying such a decision, would Anesthesia & Analgesia consider publication of a prospective trial conducted without written informed consent. Occasionally we receive research reports stating that patients gave “verbal consent.” Because verbal consent provides no record of the process of consent, or even that consent took place, Anesthesia & Analgesia does not recognize verbal consent as a valid category of subject consent. All studies utilizing verbal consent should be described in the submission as being conducted with an IRB-approved waiver of written consent. Case reports usually do not require IRB approval because they are not systematic investigations. However, we occasionally receive case reports describing the administration of experimental drugs or the utilization of experimental devices involving one or more patients. We consider these case reports to be research, because the intent of the author is to create generalizable knowledge, even though the research barely qualifies as systematic. As a result, IRB approval is required for case reports involving experimental drugs or devices. Based on these considerations, Anesthesia & Analgesia adopts the following requirements for IRB approval and informed consent for research: Research is a systematic investigation for the creation of generalizable knowledge. Submitting any investigation for publication demonstrates intent to create generalizable knowledge. Audits submitted for publication constitute human research. Case reports involving experimental drugs or devices constitute human research. Human research requires IRB approval. There are no exceptions. The IRB is responsible for determining the requirement for informed consent. Anesthesia & Analgesia only recognizes written informed consent, or an IRB-approved waiver of written informed consent. The Editorial Board of Anesthesia & Analgesia reserves the right to reject a manuscript if the research is perceived as unethical, even if it has local IRB approval.