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PEDIATRICS Vol. 110 No. 2 August 2002, pp. 364-370

Are Research Ethics Standards Satisfied in Pediatric Journal Publications?

Eric Weil, BA^*, Robert M. Nelson, MD, PhD^, and Lainie Friedman Ross, MD, PhD^*,||

^* MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, Illinois
Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania
Department of Anesthesia, University of Pennsylvania, Philadelphia, Pennsylvania
^|| Department of Pediatrics, University of Chicago, Chicago, Illinois

Background. The requirements for institutional review board (IRB) review and informed consent (IC) for research involving human subjects have existed for more than 2 decades. Although many studies document them poorly, most published research undergoes IRB review and has IC procedures. Less is known about research published in pediatric journals, and how child health research is determined to be exempt.

Method. All full-length articles published in the paper edition of 3 pediatric journals between January and December 2000 were examined. Articles were excluded if they were case studies, meta-analyses, lacked empirical data, or did not include at least 1 US researcher or US subjects. The remaining articles were examined to determine if they documented IRB review and IC mechanisms. If either or both of these features were missing, authors were asked to participate voluntarily in a survey. In addition, all exempt articles were examined to determine if the exemptions were in accordance with the federal regulations for the protection of human subjects.

Results. Three hundred seventy-nine of 575 articles met inclusion criteria. One hundred ninety-seven (52.0%) documented IRB review, 164 (43.3%) documented IC, and 131 (34.6%) properly documented the presence of both IRB review and IC. Two hundred fifty-one researchers were surveyed to clarify IRB review and/or IC mechanisms. Approximately 13.5% of the research had not undergone IRB review, and 12.4% had not had their consent methods reviewed by an IRB. We found that between 26.9% and 39.8% of exempted research did not meet federal regulations requirements.

Conclusions. We found that most research underwent IRB review and had a consent mechanism despite the lack of documentation in the articles. We also found that most research that did not undergo IRB review would have been exempt under current guidelines. However, a significant number of IRB- and researcher-exempted research were inappropriately classified. Improving research ethics standards will require additional education for researchers and IRB members, and greater adherence of researchers (and editors) to the journals’ guidelines on these issues.

Key Words: institutional re-view board • informed consent • medical ethics • human ex-perimentation • human subjects • exempt status

Abbreviations: IRB, institutional review board • FDA, Food and Drug Administration • IC, informed consent • ICMJE, International Committee of Medical Journal Editors • HIPAA, Health Insurance Portability and Accountability Act

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Received for publication Oct 26, 2001; Accepted Mar 27, 2002.

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