FREQUENTLY ASKED QUESTIONS
I referred a patient to a study-why am I not entitled to be named as an author in the paper?
I gave advice to the authors but am not a named author on the paper- why am I not entitled to be named as an author on the paper?
I reviewed the paper for the authors and was told by the senior author that my name would appear-now I have been informed that this is not possible-why?
My firm gave financial support to this group of authors-I then assumed that my name would appear on the paper but I am not named.
In accordance with the ICMJE (International Committee of Medical Journal Editors) a named author must comply with all of the following:
1.Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data.
2.Drafting the article or revising it critically for important intellectual content.
3.Final approval of the version to be published
4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Authors should meet all 4 conditions.
Who can be an author in a multi-centre group?
The group should decide which individuals will accept full responsibility for the manuscript. These individuals must comply with all 3 requirements mentioned above for authorship.
The corresponding author must include an appendix which should include the names of all authors in the group. If the paper is accepted, the appendix will appear in print with the paper.
Please note: The acquisition of funding, collection of data, general supervision of the research group alone does not justify authorship.
The order of authorship on the byline should be a joint decision of the co-authors. Authors should be prepared to explain the order in which authors are listed.
Further information re authorship can be found on the icmje website: www.icmje.org
Manuscript submission to journals
Why can I not submit my paper simultaneously to two or three journals?
Would it not speed up the procedure-I could then have the same paper published in various journals.
When you decide to submit your paper you need to fill in a copyright transfer statement (CTS), although journals /publishers have different wordings, the main text on the CTS will mention that in signing you transfer the exclusive rights to reproduce and distribute the article (incl. reprints/translation/photographic reproduction/microform/electronic form), therefore in signing the CTS upon submission one must wait till a decision letter has been received by the EIC re the status prior to submitting the paper elsewhere.
What is a redundant publication?
A paper that is repetitive and overlaps a submission already published or electronically published.
My paper has been published in Japanese, I would like to submit it to an English language journal-is this possible?
This is an interesting question. In accordance with the ICMJE guidelines this is possible BUT all the following conditions must be met:
1. The authors have received approval from the editors of both journals; the editor concerned with secondary publication must have a photocopy, reprint, or manuscript of the primary version.
2. The priority of the primary publication is respected by a publication interval of at least one week (unless specifically negotiated otherwise by both editors).
3. The paper for secondary publication is intended for a different group of readers; an abbreviated version could be sufficient.
4. The secondary version faithfully reflects the data and interpretations of the primary version.
5. The footnote on the title page of the secondary version informs readers, peers, and documenting agencies that the paper has been published in whole or in part and states the primary reference. A suitable footnote might read: “This article is based on a study first reported in the [title of journal, with full reference].”
Permission for such secondary publication should be free of charge.
6. The title of the secondary publication should indicate that it is a secondary publication (complete republication, abridged republication, complete translation, or abridged translation) of a primary publication. Of note, the National Library of Medicine does not consider translations to be “republications,” and does not cite or index translations when the original article was published in a journal that is indexed in MEDLINE.
To summarize-If you published your paper in the Japanese Journal of Ophthalmology you would not be able to submit the paper to a journal specializing in Ophthalmology.
Submitting a letter to the editor:
I read a published paper and disagree with the conclusions-can I send a letter to the editor explaining the disadvantages of the conclusions?
Yes, journals seem to encourage “live correspondence” since although the paper is peer-reviewed by 2 referees (possibly more) and the EIC prior to acceptance, obviously other specialists may have other ideas.
But be aware-the letter is forwarded to the addressed group of authors and a response will follow. The letter will then appear with the response. Try to remain diplomatic in your letter and be aware that the editorial office does have the right to shorten the letter as required.
Further useful information can be found on the web page of the International Committee of Medical Journal Editors. (ICMJE) www.icmje.org
What is the history of the peer-review system?
The History of Peer Review can be dated back to c.e 854-93 when Ishap bin Ali Rahwl published his book "Ethics of the physician" but it was not till 1620 when Sir Francis Bacon published "The New Organon" that topics like the quest for funding, style guides, recording of negative studies amongst others reached the new world. The points brought to light in 1620 are to date still debatable.
Peer Review commenced in 1731 by The Royal Society of Edinburgh with The Royal Society in England following in 1752.
How does the peer-review system function?
If the submitted paper complies with the instructions for authors of the journal the EIC (Editor-in-Chief) will then decide on sending for peer-review. This means sending the paper to two specialists in the field of expertise of the paper. The EIC will not choose someone from the same institute and not from the group of authors. If there are any conflicts of interest with other groups it is the corresponding authors responsibility to advise the editorial office of this upon submission of the paper.
The allocated referees receive up to 21 days to review the paper and send the comments by return to the editorial office.
The EIC will then decide if the manuscript should be returned for revision, rejected or accepted. Sometimes due to a conflict of opinion, a third referee needs to be consulted.
Any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.
What is the history of clinical trials?
The first recorded clinical trial was in biblical times when Daniel ate pulses with some other children, while more children ate meat:
“In the third year of the reign of Jehoiakim king of Judah came Nebuchadnezzar king of Babylon unto Jerusalem , and besieged it…And the king appointed [4 children] a daily provision of the king’s meat, and of the wine which he drank: so nourishing them three years, that at the end thereof they might stand before the king… But Daniel purposed in his heart that he would not defile himself with the portion of the king’s meat, nor with the wine which he drank [and said to the king]… Prove thy servants, I beseech thee, ten days; and let them give us pulse to eat, and water to drink. Then let our countenances be looked upon before thee, and the countenance of the children that eat of the portion of the king’s meat: and as thou seest, deal with thy servants. So he consented to them in this matter, and proved them ten days. And at the end of ten days their countenances appeared fairer and fatter in flesh than all the children which did eat the portion of the king’s meat. Thus Melzar took away the portion of their meat, and the wine that they should drink; and gave them pulse.”
(King James Bible, Daniel Ch1).
Daniel’s requirement for food that differed from the munificent diet given by King Nebuchadnezzar followed current requirements for open-label clinical trials.
The Edinburgh surgeon James Lind (1716-94) investigated the best treatment for scurvy and was probably the first person to have conducted a controlled clinical trial of the modern era.
“On the 20th of May 1747 , I selected twelve patients in the scurvy, on board the Salisbury at sea. Their cases were as similar as I could have them. They all in general had putrid gums, the spots and lassitude, with weakness of the knees. They lay together in one place, being a proper apartment for the sick in the fore-hold; and had one diet common to all, viz. water gruel sweetened with sugar in the morning; fresh mutton-broth often times for dinner; at other times light puddings, boiled biscuit with sugar, etc., and for supper, barley and raisins, rice and currants, sago and wine or the like. Two were ordered each a quart of cyder a day. Two others took twenty-five drops of elixir vitriol three times a day ... Two others took two spoonfuls of vinegar three times a day ... Two of the worst patients were put on a course of sea-water ... Two others had each two oranges and one lemon given them every day ... The two remaining patients, took ... an electary recommended by a hospital surgeon ... The consequence was, that the most sudden and visible good effects were perceived from the use of oranges and lemons; one of those who had taken them, being at the end of six days fit for duty ... The other was the best recovered of any in his condition; and ... was appointed to attend the rest of the sick. Next to the oranges, I thought the cyder had the best effects ...”.
Taken from Dr James Lind’s “Treatise on Scurvy” published in Edinburgh in 1753, and quoted by Dr Peter Dunn (1997;76;64-65 Arch. Dis. Child. FetalNeonatal Ed )
Dr Lind was the most modern of scientists; he reacted to a problem which had not been in existence before improvement in sail engineerin enabled ships to leave land and sail oceans and seas without landing for months. However, like many modern scientists, his interpretation of his clinical trial results was way off the mark; he concluded that citrus fruits cured scurvy because of their action on the digestive processes. How Dr Lind interpreted his results is irrelevant; 50 years later, directly because of James Lind, British sailors’ rations included citrus fruits.
After the report of this scurvy trial in 1753, the number of reports of clinical trials increased. The number of clinical trials reported in journals indexed by the US National Library of Medicine has steadily increased since 1950. During 1974, 175 papers had “clinical trial” in the title and “controlled” in the keywords, this had increased to 215 during 1984, 715 during 1994, and 1945 during 2004.
Summarized from an article by Prof. Susanna J. Dodgson, Director of the Biomedical Writing Graduate Programs, University of the Sciences in Philadelphia , Pennsylvania , USA . For the full article, and other articles about Biomedical Writing and medical writers, firstname.lastname@example.org.
Why is there a need for trial registration?
The main aim of registering trials is to ensure they are published responsibly. Findings that are statistically significant or that favour the sponsor’s product are more likely to be published than negative ones, and such publication bias can skew the results of meta-analyses as can undetected redundant publication. Unambiguous study identification should reduce these effects and make it easier to call companies to account for unpublished studies. Another possible benefit of public trial registers is that they can help patients identify studies for which they might be eligible and thus help recruitment. WHO is also encouraging national trial registers as a means for countries to develop local health research infrastructure. Public access to details of trial design such as primary endpoints should also raise reporting standards and prevent selective or biased reporting.
Another argument in favour of registers is that they will allow researchers to see what other trials are underway and therefore avoid duplication. However, others argue that knowledge of development plans and full details of trial designs could reduce competitive advantage. Commercial companies and academic institutions may therefore be reluctant to make full details available at an early stage.
This had led to discussions about a lock-box system under which sensitive details of trial design are entered at the start of the study but only made public later. This proposal seems unlikely to find favour from the journal editors and WHO, but it may be a useful compromise if companies refuse to release full details.
response supplied by Liz Wager, publication consultant sideview.
Clinical Trial registration
The ICMJE considers trials that began enrollment before July 1, 2005 to be “ongoing” if the investigators were still collecting, cleaning, or analyzing data as of July 1, 2005. Ongoing trials require registration before submission to a journal.
Clinical trials - any research project that prospectively assigns human subjects to intervention or concurrent comparison or control groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, and the like.
Please note-you need to specify the time period of this study in the material and methods section. Since the journals comply with the ICMJE journal requirements all studies from July 2005 must be registered.
Which trials registries are acceptable to the ICMJE?
The ICMJE accepts registration in the following registries:
In addition to the above registries, the ICMJE will also accept registration in any of the primary registries that participate in the WHO International Clinical Trials Portal (see http://www.who.int/ictrp/about/details/en/index.html). Because it is critical that trial registries are independent of for-profit interests, the ICMJE policy requires registration in a WHO primary registry rather than solely in an associate registry, since for-profit entities manage some associate registries. Trial registration with missing or uninformative fields for the minimum data elements is inadequate even if the registration is in an acceptable registry.
Conflict of Interest Statements
When an author or the institution of the author has a relationship, financial or otherwise, with individuals or organizations that could influence the author’s work inappropriately, a conflict of interest may exist. Examples of potential conflicts of interest may include but are not limited to academic, personal, or political relationships; employment; consultancies or honoraria; and financial connections such as stock ownership and funding. Although an author may not feel that there are conflicts, disclosure of relationships and interests that could be viewed by others as conflicts of interest affords a more transparent and prudent process. All authors must disclose any actual or potential conflict of interest. (Source Springer Publishers)
Template which can be used as conflict of Interest Statement:
All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.
In accordance with COPE (Committee of Publication Ethics) all case reports must contain a statement that permission was obtained from the patient for submission of their case to the journal.
Template which can be used for patient disclosure:
Patient Consent-The patient /next of kin/guardian has consented to the submission of the case report for submission to the journal.
Why isn't it possible simply to correct online publications?
Why it isn't possible to make use of the flexibility inherent in the medium of online publication?
If an error is detected in an online publication that has not yet been published in print, why can't the publisher simply replace the incorrect version with a correct one online?
Why can't this corrected version then serve as the basis for the subsequent printed version?
For Springer, and increasingly for the scientific community, the distinction is no longer made between an online and a print publication. The online publication of original research, for instance, is not simply a pre-publication service on the part of the publisher; it represents instead the official publication of these research results for the scientific community. Its unique digital object identifier (DOI) allows this paper to be cited in the scientific literature. As such, it cannot be altered without altering, at the same time, the scientific record.
As soon as an article is published online, it is citable and quotable. If changes are then made, confusion can easily arise, with authors citing different versions of the same publication.
In parallel to its publication at SpringerLink, the article is also sent to more than 80 other recipients. These recipients include bulk users, abstracting & indexing services, consortia, and central linking services such as CrossRef. Since there is no established procedure for guaranteeing that these recipients will incorporate any corrections made, this can lead to the existence of multiple versions of a publication in different environments.
The consistency and reliability of Springer’s online publications is a sensitive topic and is carefully monitored by the authors, journal editors, scientific societies, and other customers that we work with daily. If a user of Springer products notices modifications to an article that are not clearly communicated, this may lead to a loss in trust and damage to the reputation of the publisher.
For all of these reasons, Springer has decided not to make use of all the technical possibilities that online publication offers. It has made this decision to protect the reliability of its products and, by extension, those of the scholarly community.
(response supplied by the production department of Springer publishers)
The editorial office recommends that the corresponding author of papers checks all spellings of authors and ensures that the correct institutions are noted.