Open Access Biomedical Publisher Using Post Publication Peer Review
This is an important article examining a loophole in publication requirements whereby some medical society research submissions are not required to include information about IRB approval and are subsequently published in a medical journal supplement. Ethics committee approval is vital to ensure the safety of human research subjects, and promotes the values of respect for person, beneficence and justice -- important values for all who are conducting human research to share.
I agree with the authors that medical societies should require documentation of ethics committee approval with all abstract submissions. For researchers who have already obtained IRB approval, the requirement to submit a copy of the approval letter is not arduous. While implementing this change may cause some discontent at first, this requirement may over time encourage researchers to seek IRB approval earlier and also encourage greater transparency human research. To ease implementation of this change, medical societies could notify those submitting work to their meetings 1-2 years in advance of the change. Thank you to the authors for bringing attention to this important loophole.
I have conducted human subject research and submitted my work in both abstract and original article formats.
This is an interesting study that examines a loophole in human subjects research ethical review requirements. It is interesting that IRB approval is not a requirement for abstract publication in many medical society meetings, thus exposing a path through which potentially unethical research may be supported through publication. While much of this research rarely reaches full publication as a research article/letter (most likely end up as abstracts that are not catalogued in PubMed or EMBASE), lack of IRB approval requirements in this setting may produce an incentive for researchers to ignore important steps in a transparent research process.
Requiring IRB approval information at the initial abstract submission stage for medical society meetings would likely make the process more difficult for researchers. While I agree that it would be ideal for IRB information to be submitted for human subjects research in all cases, I also wonder about the role of the abstract reviewers who initially screen submitted research for possible presentation at the meetings. Is there any available literature regarding instructions to these reviewers in this setting? Although less decisive than implementing a strict requirement for IRB approval in human subjects research, more stringent screening by these abstract reviewers may promote the acquisition of IRB approval in many of these cases.
I also wonder how international medical societies (i.e., European or Asian) would compare to societies based in the United States.
Thank you for this interesting article which addresses an increasingly important topic.
Co-author on paper which discusses IRB approval requirements by journals for human subjects research.
I found the article very interesting and informative - the medical community often seems to presume that the institutions of peer review and ethics review ensure high quality and ethical soundness in published material. However, as with nearly all institutional processes, these review mechanisms may be susceptible to loopholes The paper does a good job at detecting a loophole in the ethics review process, and while the JAAD study data presented in the paper suggests that while most material that enters the publication process by this route actually received adequate institutional review, there is also ample suggestion that the loophole is actually utilized: a large fraction of the papers under discussion (about 19 papers, or more than 10% of the total papers under consideration) displayed suspicious patterns of behavior when the journal sought information (e.g. withdrew, or never resubmitted, or said that no review was obtained.) The JAAD survey raises a number of questions: these include: 1) why did some authors fail to get ethics board approval? 2) what is the level of awareness of this loophole in the scientific community? 3) what would the effects of a change in the rules here be?
Some interesting follow-ups to the article might include 1) trying to gauge awareness and utilization of this loophole in the scientific community, and 2) determining an appropriate level of review for these documents: is a full-fledged ethics board review in order, or should there be a more streamlined process for these items?
I have a law degree from Harvard and have experience dealing with ethics issues in the past.
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