Are Research Ethics Standards Satisfied in Pediatric Journal Publications?
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* 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
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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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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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Human subject protection was first codified in the Nuremberg Principles (1946)1 and subsequently embodied in the Declaration of Helsinki (1964).2 The first US federal requirements for institutional review of research and the development of institutional review boards (IRBs) were announced in 1966 by the Surgeon General in a federal policy statement requiring IRB review for all research performed with Public Health Service grants.3 Today, IRB review is required for all US research involving human subjects that is federally funded, is regulated by the Food and Drug Administration (FDA), or is performed at an institution that accepts federal funds.4 When the subjects are children, additional protections exist to ensure their safety. These additional protections were first proposed by the National Commission for the Protection of Human Subjects in 1977,5 and were codified as subpart D of the federal regulations.6,7 Recently, the FDA has modified its pediatric protections to parallel subpart D.8 In addition, the IRB is also empowered to ensure that appropriate informed consent (IC) is procured.9 When the subjects are children, this often means the procurement of both parental permission, and, when feasible, the child’s assent.6–8 Thus, both IRB review and IC have been required for almost 2 decades in pediatric research.
The requirement to document IRB review and the procurement of IC in published research reports is more recent. The International Committee of Medical Journal Editors (ICMJE), formerly the Vancouver Group, is a group of medical journal editors who established guidelines for manuscript submission to their journals in 1978.10 These guidelines have been revised 4 times, most recently in 2001.11 In the 1981 edition, the ICMJE first required researchers to indicate that the research had IRB review;12 and, in 1991, the ICMJE added that when "informed consent has been obtained by authors, this should be clearly stated in the article."13 These guidelines for manuscript submission have been adopted by >500 journals, often as part of their primary instructions for manuscript preparation.
Previous studies have shown that documentation of IRB review and IC is not consistently done, even in journals that state it as a requirement.14–19 This is even true in research focused on pediatric health.17,19,20 In this article, we sought to determine 1) to what extent research published in 3 peer-reviewed pediatric journals documented IRB approval and IC; and 2) to what extent the researchers who failed to document IRB and IC stated that they had obtained appropriate IRB review and IC from subjects. Our hypothesis was that research in pediatric journals, particularly when the subjects were children, would be meticulous about the procurement and documentation of IRB approval and IC.
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METHODS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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All full-length articles published in the paper edition of 3 pediatric journals (Pediatrics, Journal of Pediatrics, Archives of Pediatrics and Adolescent Medicine) were examined between January and December 2000. These 3 US peer-reviewed pediatric journals are all currently signatories of the ICMJE guidelines. They all have required proper documentation of IRB approval since at least 1983 and IC since 1991. We excluded articles if they did not include empirical data, were case studies or meta-analyses, or did not include at least 1 US researcher or US subjects, to focus on research done in settings that require the researchers to conform to the federal regulations for the protection of human subjects.
The articles included in the study were reviewed to see if they mentioned IRB approval and IC. If either or both of these features were missing from the article, corresponding authors were asked to voluntarily participate in a follow-up survey either via e-mail or by telephone. If an e-mail address could be obtained, a maximum of 3 copies of the survey were sent out, followed by a telephone survey if no response was obtained to the e-mail surveys. If the corresponding author could not be located, another author was contacted either by e-mail or by telephone.
The survey included an explanation that the purpose of the survey was to clarify whether IRB approval and/or IC had been obtained. Furthermore, it was stated that participation was voluntary. If researchers agreed to participate, they could then proceed to answer the questions on the survey.
We examined the rate of IRB approval/waiver and the procurement of IC. We classified IRB approval/waiver into 3 categories. "Presence of IRB review in article" refers to those articles in which IRB approval or exempt status was documented in the article. "Presence of IRB review in survey" consists of those articles in which the researchers responded to the survey stating that they had IRB approval or that they had obtained an IRB-exemption. "Waiver of IRB review" consists of those articles in which the researchers responded to the survey stating that 1) they thought their research was exempt; 2) they did not believe their research needed to go through the IRB because their research used publicly available data; and 3) "No, I did not get IRB approval" without explanation. (E. Weil, personal communication, August 21, 2001) In other words, no survey response was recorded as not having IRB approval or waiver; we assumed that researchers failed to seek IRB approval because they believed that their research was exempt.
Similarly, we classified IC into 3 categories. "Presence of IC in article" refers to those articles which documented that IC mechanisms had been approved or waived. "Presence of IC in survey" consists of those articles in which the researchers responded to the survey stating that their IC mechanisms (including waiver) had been reviewed by an IRB. "Waiver of IC" consists of those articles in which the researchers stated that 1) they had not discussed the issue of IC with their IRB and did not obtain IC because they thought it could be waived; or 2) they failed to obtain IC and offered no reasons. In other words, no survey response was recorded as not having IC mechanisms or waiver; we assumed that researchers who failed to get IC believed that IC could be waived for their research.
All of the studies were classified into 1 of 3 types of research based on how the data were collected: 1) clinical trials/other medical studies included both randomized, controlled studies as well as other medical interventions such as blood tests, anthropomorphic measurements, and modified feedings; 2) behavioral studies included studies that obtained information through written or oral surveys, interviews, standard educational tests, quality assurance projects, and observational studies; and 3) preexisting data or tissue studies included the use of publicly available databases, chart reviews, and the use of preexisting tissue collections. All of the above studies may involve subjects who are or are not identified, a distinction that will be important to the decision of whether or not the research is exempt. We then examined whether the rate of IRB approval/waiver and the procurement of IC varied depending on the type of study that was being reported.
We also divided the research into those studies that included children-subjects versus those studies in which the only subjects were adults (either parents, medical professionals, or other third-parties) to determine if this influenced whether the researchers documented IRB review and IC procedures. This information was necessary to determine the validity of exemption 2 (see Fig 1) which has limited applicability for children-subjects.6 Data were analyzed using the computer program STATA (Stata Corporation, College Station, TX).
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In addition to the survey, an examination of all exempt articles was undertaken. Articles were classified as exempt if: 1) the researchers obtained IRB-exempt status; 2) the researchers stated the research was exempt according to their understanding of the research regulations; or 3) the researchers stated that they did not seek IRB review. The validity of the exemption was determined using the criteria stated in the federal regulations,9 (see Fig 1), and then classified as clearly exempt (met federal regulations requirements); definitely not exempt (failed to meet federal regulations requirements); or probably exempt (cases in which the research would be exempted or not exempted depending on whether the data were linked to identifiers or not). Although all of the research classified as probably exempt could be done using linked or unlinked data, the research methodology as described in the article did not give enough information to make this determination. (L.F.R.) and (R.M.N.) independently reviewed all articles classified as exempt, specifically examining the methodology described in the articles. Reasons for these classifications were based on the criteria enumerated in the federal regulations. In some cases, there was >1 reason to explain why the research was not exempt, but we elected to give only 1 reason for each decision. Differences were resolved through discussion with eventual agreement on all classifications.
We then examined the validity of both IRB and researcher-exempt research. This was to determine the following: 1) what research was classified as exempt; and 2) whether research that sought IRB exemption was more likely to be in accordance with the federal regulation’s exemption criteria compared with research that did not receive IRB review, but was presumed to be exempted by the researcher.
The research was approved by both the University of Chicago Institutional Review Board and the Children’s Hospital of Philadelphia’s Committees for the Protection of Human Subjects. The research was considered minimal risk, and the University of Chicago waived the requirement for documenting written IC of the subjects (the journal articles’ authors). The subjects were informed that the questions were for a research project and that their participation was voluntary, and that data would be presented in the aggregate without any individual or institutional identification.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Five hundred seventy-five original articles published in the 3 journals in the year 2000 were initially reviewed. One hundred ninety-six were excluded either for lacking original data, not having at least 1 US researcher or any US subjects, or for being a case study. Of the remaining 379 articles, 197 (52.0%) documented IRB review, 164 (43.3%) documented IC, and 131 (34.6%) properly documented the presence of both IRB review and IC (see Fig 2). Two hundred fifty-one surveys were sent out (249 to those lacking 1 or both ethical criteria and 2 to those with proper documentation for clarification purposes). Of those that received surveys, 14 declined to participate, 23 were not returned, and 214 were completed for a 90.8% survey response rate. We have IRB data on 92.1% of articles and IC data on 90.8% of articles; and both IRB and IC documentation on 90.2% of articles.
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We examined whether the rate of IRB approval and the procurement of IC varied depending on the type of study that was being reported. The results are reported in Table 1. The highest percentage of IRB approval was found in clinical/medical; the lowest percentage found in preexisting data. Similarly, the highest percentage of IC documentation was found in clinical/medical; the lowest in preexisting data. The last column of Table 1 shows the number of studies on which we have no data. This takes into account those who did not document IRB or IC review in the article and who either did not respond or declined to participate in the survey.
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We then examined the validity of both IRB and researcher-exempt research. The results of the review of exemption claims can be found in Tables 2 through 5. The highest percentage of exemption claims were made for preexisting data (47.6%), and the least number of claims were made for medical/clinical research (7.0%). However, the highest "error" rate for exemptions was seen in medical/clinical research in which 9 of 11 research projects were mistakenly classified as exempt (Table 2). No significant difference was seen between those exemption claims made by institutions (hospital or university IRBs or private organizations) or researchers. Both groups incorrectly categorized the research as exempt in approximately one fourth of the cases (Table 3). There were no significant differences between when a researcher sought IRB exemption versus self-exemption with respect to the type of study, nor whether the classification of exempt in each category was consistent with the federal regulations (Table 4).
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In Table 5, we give the reasons why we classify the exempt research as either clearly, probably, or not exempt, based on the federal regulations (see Fig 1). Two thirds of the studies that were clearly exempt used publicly available databases. Another 21.4% were surveys of adults. All of the studies that were probably exempt could have been done without linked data, but the methodology in the articles did not specify whether the researchers anonymized the data. The most common reason for determining that an exempt study was not exempt was that the study could be done only with identifiable data.
Of the 379 studies examined, 16.9% involved adult subjects (parents, health care providers, and health policy analysts). The level of documentation in these articles for both IRB approval and waiver and IC methodology did not differ significantly from the other studies. Only a handful of studies categorized themselves as quality assurance/quality improvement studies.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Our data show the procurement and documentation of IRB approval and IC in all articles reporting the results of research involving human subjects published in 3 pediatric journals that have required both such procedures since at least 1991 (the Journal of Pediatrics has had this requirement since the early 1980s). This requirement is not applicable to all medical journals. In 1997, Amdur and Biddle21 found that about one quarter of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus did not "present or refer the author to any information related to human research ethics."
In that same issue, Drummond and Yank14 examined 53 articles in 5 major general medicine research journals that described prospective research on humans to determine how often IC and IRB approval were recorded. Although the focus of this editorial article was to argue that reporting IRB approval and IC was the responsibility of both the editor and the researchers, the article revealed the magnitude of the "gap" between the manuscript requirements and the actual manuscript contents. They found that only 53% of the articles stated IC was obtained, and only 42% recorded IRB approval. Both IC and IRB approval were mentioned in only 32% of the articles.14 These data are consistent with what Rikkert et al15 found in their study of geriatric journals a year earlier.
Ruiz-Canela et al16 advanced the debate by examining not only documentation but contacting authors to inquire about whether or not IC and/or IRB approval were obtained when one or both was not mentioned in the article. They reviewed 767 clinical trials published between 1993 to 1995 and found that 64% of the articles documented both IRB approval and IC. They sent follow-up surveys to the remaining authors and were able to document that 22.4% failed to get IRB approval and 20.6% failed to have a means to procure IC. These numbers may be low because 7.7% and 5.6% of data were missing for IRB review and IC, respectively.
We hypothesized that research published in peer-reviewed pediatric journals would conform to research ethics standards given the vulnerability of children as research subjects, and the strict standards demanded of pediatric research in the federal regulations.6,7 However, 2 recent studies showed this was not the case. Bauchner and Sharfstein17 asked whether researchers in child health documented IRB review and IC mechanisms. They examined 561 articles related to child health published in 5 peer-reviewed journals in 1999. Although the pediatric population is considered to be one of the most vulnerable research populations, the authors found that overall only 61% of publications had proper ethics documentation. Sifers et al20 examined all empirical studies published in 4 major journals in child psychology in 1997 and found that parental consent and the child’s assent were documented only in 41.5% and 18.8% of the articles, respectively. Roggin et al19 examined 149 pediatric surgical studies and found that slightly less than one fourth of the studies documented IRB approval. Thus, the documentation of IRB review in child health research was not different from the findings in the literature generally.14–16,18
Our results are within the same range. Of the 379 articles included in our study, only 52.0% documented IRB review and 43.3% documented IC methods directly in the article, and only 34.6% properly documented both. What was notable, however, was the variability in documentation depending on the type of research. One might expect better documentation in clinical trials where the physical risks to subjects are most obvious. This is what we found (see Table 1) when we divided the research into 3 categories (medical/clinical studies, behavioral studies, and preexisting data studies). One might also expect better documentation in research that only included children-subjects although this was previously refuted at least for subjects in pediatric surgery,19 and was not confirmed by our data. And yet, the research ethics standards of the ICJME do not make any such distinctions. IRB review/waiver and IC are required for most research published in these journals, but we found full documentation in only one third of the articles.
Despite the lack of documentation, we found that according to author reports, most research is properly getting IRB review (297/379 studies or 78.4%). Furthermore, we found that those types of research that traditionally require IRB approval and IC (medical studies and clinical trials) were the most likely to document it in the article or state that they had obtained it in response to questioning (91.1%), and least attention was given to obtaining IRB approval in preexisting data studies (60.6%). However, such a hierarchy is problematic: although the likely types of harm differ between these categories, the impact of these harms can be just as significant. Our data suggest that researchers may not consider the potential harm from a breach of confidentiality of identifiable information in both clinical and nonclinical research (ie, surveys, medical records reviews, database analyses).16 These concerns are part of the motivation for the Health Insurance Portability and Accountability Act (HIPAA)22 and the federal regulations that delineate what it requires.23
Twenty-four percent of the articles in our study claimed IRB-exempt status. As can be seen in Table 2, the majority of these exempt claims were made for studies involving preexisting data. We found that between 26.9% and 39.8% of research classified as exempt needed greater IRB review, depending on whether the data in the "probably exempt" category was collected with or without identifiers, respectively. This number could be even higher, depending on the results of those studies that were not included (data missing). Furthermore, the IRBs did not perform better in determining when research was exempt than did the researchers (Table 3), and the performance of the researchers and the IRBs were similar for each study category (Table 4). Both groups incorrectly categorized the research as exempt in approximately one fourth of the cases. This number may be an underestimation depending on whether the studies in the "probably exempt" category were performed with or without data linked to patient identifiers.
We also found that most of the researchers had methods for procuring IC. If we assume that all exempt research may waive IC, then 90.5% had IC mechanisms (Table 1). This overestimates the actual number of proper IC procedures because a significant number of exempt studies, both IRB and researcher-determined, were inappropriately exempt; and therefore, the decision to waive IC would need to be reexamined. The standards for waiving IC are currently in flux because HIPAA will grant patients greater right to know when their health data are being used.23
One limitation to our study is that our results are based on researchers’ answers. We did not confirm their IRB review with their institutional IRB and we did not confirm their claims to procuring IC with subjects. It is possible that the respondents erred in their survey responses. A second limitation is that not all may agree on our inclusion and exclusion criteria. For example, we did not include case studies or reports that described a small number of cases. Although their publication raises important ethical issues,24,25 case studies are neither a systematic investigation nor generalizable and thus do not qualify as research under the federal regulations. In contrast, we did include all studies that described quality improvement and quality assurance projects, although it can be unclear when quality improvement studies are research.26 A third limitation is that we may have misclassified some research such that the hierarchy of what research gets reviewed and what research includes appropriate IC mechanisms may be misleading. Finally, we may have misunderstood the methodology described in the articles and thereby misclassified research as not exempt when it could be exempt.
Although some institutions already require that all research be submitted to the IRB with the IRB having final authority whether or not to exempt a research project, this is currently not true of all institutions as stated by some of our respondents. (E. Weil, personal communication, July 30, 2001, and August 16, 2001). Despite our findings that IRBs and researchers do equally well in determining when research ought to be exempt, we would argue that all research that is judged to be exempt by researchers should be submitted to IRBs because of the actual or perceived conflicts of interests and biases that researchers have in making decisions about research risk27–30 and because IRB review provides an additional, albeit fallible, means of human subjects protection.
We also realize that while IRB approval and IC are important, they are not sufficient to guarantee ethical research. Much work needs to be done to improve the IRB process31,32 and to educate researchers regarding the responsible conduct of research, including the purpose of IRB review and IC. The new federal requirements that all researchers receiving federal funding be certified in research ethics will serve to alert some researchers to the need for IRB approval and what is required for research to be exempt.33 In this regard, institutions should also have a mechanism for continued education of IRB members regarding current research ethics standards as we found that the misunderstanding about federal policies governing research exemption affects IRB members and researchers alike.
The journal peer-review process also can serve to motivate researchers to pay more attention to research ethics standards. Medical journal editors need to become more consistent about their own requirements, and reaffirm the importance of the guidelines established by the ICMJE.11 The documentation of IRB approval and IC should appear in all journal articles reporting research involving human subjects. The journals should require more extensive documentation at the time of submission, and refuse to review articles that fail to conform to these practices.14 All articles involving research with human subjects should document the following in the "Methods" section: 1) IRB review and approval; 2) the classification by the IRB of the research and the reasons for that classification; 3) the IRB requirements for IC (ie, waiver, waiver of written documentation, full IC), and 4) the IRB reasons for the IC requirements. Such a publication requirement would affirm the editors’ commitment to the ethical principles regarding subject protection first established at Nuremberg1 and subsequently embodied in the Declaration of Helsinki2 and the federal regulations.4,6,7
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CONCLUSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Our research found that a sizable minority of pediatric research does not obtain IRB approval/waiver. However, we also found that the lack of documentation of IRB approval and/or IC in 3 pediatric journals does not necessarily indicate that they were not obtained. We found that most research that did not go through an IRB would have been exempt under current guidelines. Despite our findings that IRBs erred as frequently as researchers when classifying research as exempt, we support a policy that would require all research to go through IRB review because it provides an independent assessment of human subjects protection.
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ACKNOWLEDGMENTS |
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Eric Weil is a second-year medical student at the University of Chicago Pritzker School of Medicine. This research was supported by the University of Chicago Office of Medical Education. Mr Weil was working in the MacLean Center for Clinical Medical Ethics, University of Chicago, during the summer in which this research was done.
Robert M. Nelson is an Associate Professor of Anesthesia and Pediatrics at the Children’s Hospital of Philadelphia and the University of Pennsylvania. Dr Nelson is also the Chair, Committees for the Protection of Human Subjects, at the Children’s Hospital of Philadelphia. His work in research ethics is currently funded by a Mentored Research Scientist Development Award in Research Ethics (1 K01 NS02151–04) from the National Institute of Neurological Disorders and Stroke, National Institutes of Health.
Lainie Ross is an Associate Professor of Pediatrics and the College, University of Chicago. Dr Ross is a member of the University of Chicago Institutional Review Board. Her work on research ethics is currently funded by a National Library of Medicine Grant, Children in Medical Research: Ethical and Policy Challenges, NIH 1 G13 LM07472-01.
We thank Carol Stocking for her help with data collection and analysis. We would also like to thank Howard Bauchner, MD, and a second, anonymous reviewer from Pediatrics for their thoughtful comments.
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FOOTNOTES |
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Received for publication Oct 26, 2001; Accepted Mar 27, 2002.
Reprint requests to (L.F.R.) MacLean Center for Clinical Medical Ethics, University of Chicago, 5841 S Maryland Ave, MC 6098, Chicago, IL 60637. E-mail: lross{at}uchicago.edu
Preliminary data from this research was presented at the Pritzker Medical Student Summer Research Conference, August 30, 2001, Chicago, IL.
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PEDIATRICS (ISSN 1098-4275). ©2002 by the American Academy of Pediatrics
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H. Bauchner Protecting Research Participants Pediatrics, August 1, 2002; 110(2): 402 - 404. [Full Text] [PDF]
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