Submited on: 15 Sep 2010 06:33:14 PM GMT
Published on: 14 Sep 2010 10:34:09 PM GMT
 

1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Partly
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? Yes
7 Can you suggest any reductions in the paper, or deletions of parts? No
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? Yes
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:

    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.

  • Competing interests:
    None
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:

    I have conducted human subject research and submitted my work in both abstract and original article formats.

  • How to cite:  Gamble R .Exposing A Loophole: Journals Not Requiring Ethics Committee Review For Published Meeting Abstracts[Review of the article 'Exposing a Loophole: Journals Not Requiring Ethics Committee Review for Published Meeting Abstracts ' by Dellavalle R].WebmedCentral 2011;2(4):WMCRW00678
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Exposing a Loophole: Reviewer Commentary
Posted by Dr. James Jensen on 03 Jan 2011 10:48:02 AM GMT

1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Yes
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? Yes
7 Can you suggest any reductions in the paper, or deletions of parts? No
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? Yes
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:

    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.

  • Competing interests:
    None
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    Yes
  • References:
    Freeman S, Lundhahl K, Schilling L, Jensen J, Dellavalle R. Human research review committee requirements in medical journals. Clinical & Investigative Medicine, North America, 31, Feb 2008.
  • Experience and credentials in the specific area of science:

    Co-author on paper which discusses IRB approval requirements by journals for human subjects research.

  • How to cite:  Jensen J .Exposing a Loophole: Reviewer Commentary[Review of the article 'Exposing a Loophole: Journals Not Requiring Ethics Committee Review for Published Meeting Abstracts ' by Dellavalle R].WebmedCentral 2011;2(1):WMCRW00320
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Good article - some possible followup topics
Posted by Mr. Jason Gillum on 10 Dec 2010 06:52:12 PM GMT

1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Yes
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? No
7 Can you suggest any reductions in the paper, or deletions of parts? No
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? Yes
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:

        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? 

  • Competing interests:
    No.
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:

    I have a law degree from Harvard and have experience dealing with ethics issues in the past. 

  • How to cite:  Gillum J .Good article - some possible followup topics[Review of the article 'Exposing a Loophole: Journals Not Requiring Ethics Committee Review for Published Meeting Abstracts ' by Dellavalle R].WebmedCentral 2011;1(12):WMCRW00219
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Exposing a Loophole: Review
Posted by Ms. Rosemara Hughart on 03 Nov 2010 04:49:43 AM GMT

  • Other Comments: It is interesting, to say the least, that there are different avenues of publishing journal articles, some of which require ethics review and others that do not. In my opinion, this article is important to bring this loophole to the awareness of other physicians reading these journals. I believe that most people, including myself, would assume that all articles in the same journal should be held to the same standards whether they are ethical standards or otherwise. In larger trials it is likely that IRBs at the research teams home institution would have to pass these experiments first, but as the article states smaller research abstracts including case series would not have been previously reviewed by an ethics committee. One other point to make is that by virtue of presenting at meetings where multiple experts are present, this in and of itself is somewhat of a screening process as I believe if something was noticeably unethical it would be brought to the presenter's attention. Having said this, I still believe there should be no bias in the ethical review of these articles as compared to articles coming from other avenues of submission.
  • Competing interests:
    None
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:
    None
  • How to cite:  Hughart R .Exposing a Loophole: Review[Review of the article 'Exposing a Loophole: Journals Not Requiring Ethics Committee Review for Published Meeting Abstracts ' by Dellavalle R].WebmedCentral 2011;1(11):WMCRW00107
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  • Other Comments: The idea of a loop hole to publish ethically-controversial articles is an interesting concept. A stronger argument could be made if you were able to demonstrate that the abstracts being published are in fact ethically unsound. This could be accomplished by only looking at published abstracts that later did not pass the IRB standards. Adapting the paper in this way would provide greater support for the discussion which states that ?articles with potential ethical shortcomings continue to be published.? Regardless, this is an interesting idea. Hopefully this article will highlight the potential for abuse that this gap in regulation provides.
  • Competing interests:
    None
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:
    None
  • How to cite:  Dowling M .Exposing A Loophole: Journals Not Requiring Ethics Committee Review For Published Meeting Abstracts [Review of the article 'Exposing a Loophole: Journals Not Requiring Ethics Committee Review for Published Meeting Abstracts ' by Dellavalle R].WebmedCentral 2011;1(11):WMCRW0099
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  • Other Comments: This article is suitable for publication and brings much needed exposure to a heated topic. While many researchers feel IRB/ethical review boards are difficult to natvigate and time consuming, most agree they are imperative to protect research subjects. In this study, all 27 journals required ethical review board approval for publication, yet loopholes still existed and articles were published without evidence of approval. It is disappointing that even among the reputable journals that mandate IRB approval, the ethical approval is still being bypassed. This study advocates for more accountability, transparency. Excellent background summary detailing historic developmeent of ethical review boards/IRBs. This article has well designed methods and statistical analysis, presents a balanced discussion for/against more strict regulations, and discusses limitations for each arguement. Authors should consider publishing the names of all 27 journals in a separate chart, in addition to the included list of journals who have loopholes. Thank you for your insightful, eye-opening, scientific evaluation on this topic.
  • Competing interests:
    none
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:
    None
  • How to cite:  Huff L S.Exposing A Loophole: Journals Not Requiring Ethics Committee Review For Published Meeting Abstracts [Review of the article 'Exposing a Loophole: Journals Not Requiring Ethics Committee Review for Published Meeting Abstracts ' by Dellavalle R].WebmedCentral 2011;1(10):WMCRW0082
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