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June 1997
Institutional Review Board Approval and Publication of Human Research Results
Amdur RJ, Biddle C; JAMA 1197; 277: 909-914.
[ see abstract below ]
and accompanying editorial
Rennie D, Yank V; JAMA 1997; 277: 922-3
[ editorials do not have abstracts ]
The Declaration of Helsinki is the standard reference for the rules of ethical conduct of studies involving human beings. It is based on the premise that any patient has the right to make an un-coerced, reasoned decision on whether or not to participate in a study, all of which is encompassed in the practice of "informed consent." The authors of this article examined how the consistency with which various medical journals translate the ethical imperatives of Helsinki into practice.
They examined 102 research journals and found great variability, and in the majority there was no mention of obtaining and disclosing of Institutional Review Board (IRB) approval or informed consent. Based on these rather striking observations, the authors offer six recommendations related to journals and their authors.
- The 'instructions for authors' section of every biomedical journal should contain a clear and detailed description of the ethical standards that are required to publish research projects involving human subjects.
- In the United States, documentation of IRB approval should be a requirement for the publication of research involving human subjects. When a human research project has been exempt from IRB review, its reasons for exemption should be clearly stated in the manuscript.
- With research from countries that have a system of research regulation analogous to the United States' IRB system, documentation of approval by the analogous committee should be a requirement of the publication of research involving human subjects.
- With research from countries that do not have an IRB or an analogous system or research regulation, investigators should be required to formally acknowledge that they are familiar with the Declaration of Helsinki and that applicable studies have been conducted in accordance with the Declaration.
- Journal editors should standardize their requirements for publication. Steadfast adherence to uniform criteria for submitting a paper for publication (e.g., the "Uniform Requirements") is highly desirable.
- When journals expect authors to refer to the Uniform Requirements for ethical standards of research involving human subjects, this should be made unequivocally clear in the published instructions for authors section, and reference sources for the Uniform Requirements should be provided.
In an editorial in the same edition of this article, Rennie and Yank agree with the recommendations of Amdur and Biddle. They emphasize that the most important recommendation of all is that editors standardize their ethical requirements for publication and make these requirements much more explicit than is presently the case. In addition, Rennie and Yank offer five recommendations of their own:
- The International Committee of Medical Journal Editors (ICMJE) should change the pertinent phrase on disclosure to "indicate that the procedures followed were in accordance with the ethical standards" for human experimentation established by the Declaration of Helsinki. The ICMJE might consider stating explicitly that authors should consult the Declaration for guidance on matters of ethics in human experimentation.
- Journals should cite the Declaration of Helsinki, rather than the Uniform Requirements, as the reference document on questions of ethical study design, implementation, and disclosure. Journals might contemplate reprinting the Declaration.
- Researchers should consult the Declaration of Helsinki when designing, conducting, and reporting research on humans.
- Journals should consider stating explicitly in their instructions for authors that manuscripts will be considered only if the research they describe meets the ethical rules for human experimentation enshrined in the Declaration of Helsinki, namely, those of "approval of an IRB or human experimentation committee" and "informed consent." It would be useful to add this requirement to editorial and peer reviewer checklists. If the editors have doubts, the authors should be asked to furnish the written IRB approval.
- Journals should be consistent in their disclosure of IRB approval and informed consent in the "Methods" sections of published articles.
It is clearly emphasized in this edition of JAMA that although journals are very explicit in their instructions of how manuscripts should be compiled and presented scientifically, the same degree of discipline and consistency should be applied to the matter of ethical protection. It may be of interest to our readers that included in this edition of JAMA is also a reprint from the World Medical Association of the Declaration of Helsinki (pp. 925-926).
It will clearly be of growing importance that the publisher, author, and reader incorporate the formal elements of patient protection in the publication and research process.
Return to the Current Literature Review Front Page, or read the abstract:
ABSTRACT
Objective: To determine if journals' instructions for authors require that manuscripts being considered for publication indicate that studies involving human subjects had appropriate institutional review board (IRB) approval.
Design: A descriptive study of the ethical guidelines published in the Instructions for Authors sections of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus.
Intervention: Literature review.
Main Outcome Measure: Policy regarding IRB approval of studies that involve human subjects.
Results: Of the 102 journals surveyed, 48 (47%) require IRB approval of studies involving human subjects as a prerequisite for publication, and 25 (24%) do not present or refer the author to any information related to human research ethics. Of the remaining journals, 15 (15%) referred authors to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, 3 (3%) to the Declaration of Helsinki, and 10 (10%) simply indicated that informed consent should be obtained.
There was only 1 medical specialty (anesthesiology) in which all the representative journals presented the same ethical requirement. In the 48 journals that clearly required IRB approval of studies, 37 (77%) documented IRB approval with a statement in the manuscript, 7 (15%) required a separate signed statement from the author, and 4 (8%) did not mention a method of documentation.
Conclusions: The results of this study suggest that about half of the 102 English-language biomedical research journals listed in the 1995 Abridged Index Medicus do not publish guidelines indicating that IRB approval of studies involving human research subjects is a requirement for publication. The manner in which publication requirements related to ethical standards are presented in biomedical research journals is extremely variable.
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