Editorial
Information for Readers and Authors
I
Nancy C. Chescheir, MD
Dr. Chescheir is the Editor-in-Chief of Obstetrics & Gynecology; e-mail: [email protected]. Financial Disclosure The author did not report any potential conflicts of interest. © 2014 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins. ISSN: 0029-7844/14
VOL. 124, NO. 1, JULY 2014
n this month’s issue of Obstetrics & Gynecology, an updated version of the “Instructions for Authors” is published and becomes effective. These updated guidelines are intended to: 1) increase clarity regarding authorship and 2) decrease confusion regarding adherence to our policy that requires researchers to register their clinical trials in a public trial registry before the enrollment of the first participant. This document includes changes that are also important for the journal’s readership. The journal’s overarching goal is to assure authors and readers that, as much as reasonably possible, our published articles are unlikely to be false representations of work done. In addition, we believe the clinical trial registration policy, among its many benefits, assures volunteer participants that their time and potential risks will end up contributing to medical knowledge. Academic success is measured at least in part by evidence of scholarship, marked by authorship. Research and publication of results rarely are done by a single individual, and significant contributions should be recognized. However, not all such contributions constitute authorship of the manuscript. Gollogly and Momen1 describe several dilemmas in defining authorship of scientific articles. The first is ghost authorship, in which a person writes a significant portion of the article but gets no credit. This may be because he or she is junior to the lead author and feels obliged for some reason to do so, or a professional writer may have been hired by a company to write the article, but authorship is assigned to a respected senior individual, often in the setting of an industry-sponsored article. Gift authorship occurs when someone, typically senior to the author, is included as an author without making direct and substantial contributions to the work. An example might be a department head who provided funding for the research but did no direct work on the specific research reported in the article. Another example would be including a friend or colleague on the article to bolster his or her career even though he or she made no direct contributions to the work. In an effort to limit these unethical practices and to emphasize the responsibility for ethical publishing for authors, the International Committee of Medical Journal Editors (ICMJE) has published recommendations regarding authorship,2 which we have adopted (Box 1). Before final acceptance of a manuscript for publication in Obstetrics & Gynecology, each proposed author and co-author must submit a completed author agreement form. On this form, each author is asked to indicate which criteria are reflective of his or her role. If it is determined that the individual does not meet all of the criteria for authorship, the corresponding author will be given the opportunity to acknowledge the individual, but he or she will not be listed as an author. Unfortunately, we live in a time of publication misadventures, with falsified data, authorship disputes, plagiarism, and misrepresentation of results commonly occurring. I receive a daily reminder of this by way of a blog titled “Retraction Watch,”3 which chronicles these misadventures. In 2013, the BMJ 4 proposed that the lead author of each article submit a signed transparency declaration. As of January 2014, Obstetrics & Gynecology has adopted this strategy. The statement that must be submitted by each lead
OBSTETRICS & GYNECOLOGY
5
Box 1. ICMJE Recommendations for Authorship The ICMJE recommends that authorship be based on the following four criteria: Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND Drafting the work or revising it critically for important intellectual content; AND Final approval of the version to be published; AND 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. ICMJE, International Committee of Medical Journal Editors.
author of a research manuscript is: “The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.” The last major change in the updated Instructions for Authors clarifies the journal’s policy regarding clinical trial registration. In 2004, the ICMJE proposed that all clinical trials must be registered before the enrollment of the first participant.5 There are several aims of this requirement. First, it addresses the bias against publishing negative results. The trial registries require that results of the research, whether published or not, are included in the trial registry. Trial registry also allows researchers, authors, and the public to identify ongoing and completed clinical trials to include in systematic reviews or metaanalyses, to know what work is currently being done to avoid unnecessary duplication and conserve research resources, and to find trials for patients who may wish to participate. In addition, trial registries document changes in protocols, which may alter the research question or data validity. Unfortunately there is some confusion about what constitutes a clinical trial. The ICMJE adopted the World Health Organization’s definition of a clinical trial in June 2007: “‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.’ Healthrelated interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and processof-care changes).”6
6
Chescheir
Information for Readers and Authors
The public registry most commonly used by authors who submit manuscripts to Obstetrics & Gynecology is the National Institutes of Health’s Clinicaltrials.gov registry. This registry meets the requirements described in Section 801 of the U.S. Food and Drug Administration Amendments Act.7 It specifically notes that applicable clinical trials include those of drugs, biologics, and devices. Further, it specifically notes that behavioral interventions are excluded, which conflicts with the ICMJE’s definition. At Obstetrics & Gynecology, we have decided to follow ICMJE’s guidance and definitions related to clinical trials owing to the significant potential benefits of trial registration. Going forward, we will be including behavioral studies in the definition of clinical trials that require registration. All clinical trials that involve drugs, devices, or procedures must be registered in an approved public registry at or before enrollment of the first patient for us to consider the manuscript for publication. This is not a change in our policy. We are phasing in this requirement for behavioral studies. From now through December 31, 2015, behavioral clinical trials must be registered, but this can occur after the trial has begun enrolling patients. After January 1, 2016, the journal will require that behavioral studies be registered at or before the time of first patient enrollment. Without registration as outlined above, we will not consider the manuscript for publication. While these refinements may seem overly proscriptive to some, they align our journal with international standards that protect authors, researchers, readers, and participants in research. Your feedback, as always, is welcome. REFERENCES 1. Gollogly L, Momen H. Ethical dilemmas in scientific publication: pitfalls and solutions for editors. Rev Saúde Pública 2006;40. Available at: http://dx.doi.org/10.1590/S0034-89102006000400004. Retrieved April 24, 2014. 2. International Committee of Medical Journal Editors. Recommendations for the conduct, report in, editing and publication of scholarly works in medical journals: roles and responsibilities of authors, contributors, reviewers, editors, publisher and owners: defining the role of authors and contributors. Available at: http://www.icmje.org/recommendations/browse/roles-andresponsibilities/defining-the-role-of-authors-and-contributors. html. Retrieved April 24, 2014. 3. Retraction watch. Available at: http://www.retractionwatch.com. Retrieved April 20, 2014. 4. Altman DG, Moher D. Declaration of transparency for each research article. BMJ 2013;347. Available at: http://www.bmj. com/content/347/bmj.f4796. Retrieved April 24, 2014. 5. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the
OBSTETRICS & GYNECOLOGY
International Committee of Medical Journal Editors. JAMA 2004;292:1363–4.
Available at: http://www.icmje.org/about-icmje/faqs/clinical-trialsregistration/. Retrieved April 24, 2014.
6. International Committee of Medical Journal Editors. Clinical trials registration. What is the ICMJE definition of a clinical trial?
7. ClinicaTrials.gov. Submit studies. Available at: http://clinicaltrials. gov/ct2/manage-recs/fdaaa6. Retrieved April 24, 2014.
ACOG Fellows and Journal Subscribers: Get Obstetrics & Gynecology for Free on your iPad The Green Journal app is available for the iPad® from Apple’s App StoreSM. To view journal content, ACOG Fellows and journal subscribers must first register and activate an account at www.greenjournal.org.
If You Have Not Registered at Greenjournal.org: 1. On www.greenjournal.org, click on the gear box at the top right corner of the screen and select Register. 2. On the registration screen, choose a username and password and enter your e-mail address. (Usernames must be at least 6 characters in length and contain no spaces or symbols; passwords must be at least 8 characters in length and contain at least one number and one letter.) 3. Click Continue to go to the next step of user registration. 4. On the next screen, enter your name and address and click Continue. 5. The next registration screen asks for additional information about you and your practice to help us recommend articles and rich media that suit your area of specialty. After entering this information, indicate your acceptance of the End User License Agreement and click Complete Registration. 6. After you complete the registration, you will receive an e-mail from the site asking you to confirm your registration. Click on the link in the e-mail within 48 hours. 7. The link in the e-mail leads to a web page where you will be asked if you want to activate your online subscription. Click on Yes! I am a subscriber and want to activate my online subscription(s). 8. Enter your ACOG Member ID or subscriber ID in the field at the bottom of the next screen. Be sure to enter all characters; note that the last digit for ACOG members is the letter “I,” not the number “1.” Then click on Activate Subscription.
If You Have Registered at Greenjournal.org But Not Activated Your Subscription: 1. On www.greenjournal.org, click on the gear box at the top right corner of the screen and select Log In. 2. Click on Activate Your Subscription at the top right of the page. 3. Enter your ACOG Member ID or subscriber ID in the field at the bottom of the next screen. Be sure to enter all characters; note that the last digit for ACOG members is the letter “I,” not the number “1.” Then click on Activate Subscription. You are now registered for full-text access on both the app and the journal web site! When you access the Green Journal app on your iPad, you will be asked to enter the username and password that you created at www.greenjournal.org. Need Help? Contact the Editorial Office at 202-314-2317 or [email protected]. Apple and iPad are trademarks of Apple Inc., registered in the U. S. and other countries. App Store is a service mark of Apple Inc. rev 7/2014
VOL. 124, NO. 1, JULY 2014
Chescheir
Information for Readers and Authors
7
Information for Readers and Authors
I
Nancy C. Chescheir, MD
Dr. Chescheir is the Editor-in-Chief of Obstetrics & Gynecology; e-mail: [email protected]. Financial Disclosure The author did not report any potential conflicts of interest. © 2014 by The American College of Obstetricians and Gynecologists. Published by Lippincott Williams & Wilkins. ISSN: 0029-7844/14
VOL. 124, NO. 1, JULY 2014
n this month’s issue of Obstetrics & Gynecology, an updated version of the “Instructions for Authors” is published and becomes effective. These updated guidelines are intended to: 1) increase clarity regarding authorship and 2) decrease confusion regarding adherence to our policy that requires researchers to register their clinical trials in a public trial registry before the enrollment of the first participant. This document includes changes that are also important for the journal’s readership. The journal’s overarching goal is to assure authors and readers that, as much as reasonably possible, our published articles are unlikely to be false representations of work done. In addition, we believe the clinical trial registration policy, among its many benefits, assures volunteer participants that their time and potential risks will end up contributing to medical knowledge. Academic success is measured at least in part by evidence of scholarship, marked by authorship. Research and publication of results rarely are done by a single individual, and significant contributions should be recognized. However, not all such contributions constitute authorship of the manuscript. Gollogly and Momen1 describe several dilemmas in defining authorship of scientific articles. The first is ghost authorship, in which a person writes a significant portion of the article but gets no credit. This may be because he or she is junior to the lead author and feels obliged for some reason to do so, or a professional writer may have been hired by a company to write the article, but authorship is assigned to a respected senior individual, often in the setting of an industry-sponsored article. Gift authorship occurs when someone, typically senior to the author, is included as an author without making direct and substantial contributions to the work. An example might be a department head who provided funding for the research but did no direct work on the specific research reported in the article. Another example would be including a friend or colleague on the article to bolster his or her career even though he or she made no direct contributions to the work. In an effort to limit these unethical practices and to emphasize the responsibility for ethical publishing for authors, the International Committee of Medical Journal Editors (ICMJE) has published recommendations regarding authorship,2 which we have adopted (Box 1). Before final acceptance of a manuscript for publication in Obstetrics & Gynecology, each proposed author and co-author must submit a completed author agreement form. On this form, each author is asked to indicate which criteria are reflective of his or her role. If it is determined that the individual does not meet all of the criteria for authorship, the corresponding author will be given the opportunity to acknowledge the individual, but he or she will not be listed as an author. Unfortunately, we live in a time of publication misadventures, with falsified data, authorship disputes, plagiarism, and misrepresentation of results commonly occurring. I receive a daily reminder of this by way of a blog titled “Retraction Watch,”3 which chronicles these misadventures. In 2013, the BMJ 4 proposed that the lead author of each article submit a signed transparency declaration. As of January 2014, Obstetrics & Gynecology has adopted this strategy. The statement that must be submitted by each lead
OBSTETRICS & GYNECOLOGY
5
Box 1. ICMJE Recommendations for Authorship The ICMJE recommends that authorship be based on the following four criteria: Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND Drafting the work or revising it critically for important intellectual content; AND Final approval of the version to be published; AND 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. ICMJE, International Committee of Medical Journal Editors.
author of a research manuscript is: “The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.” The last major change in the updated Instructions for Authors clarifies the journal’s policy regarding clinical trial registration. In 2004, the ICMJE proposed that all clinical trials must be registered before the enrollment of the first participant.5 There are several aims of this requirement. First, it addresses the bias against publishing negative results. The trial registries require that results of the research, whether published or not, are included in the trial registry. Trial registry also allows researchers, authors, and the public to identify ongoing and completed clinical trials to include in systematic reviews or metaanalyses, to know what work is currently being done to avoid unnecessary duplication and conserve research resources, and to find trials for patients who may wish to participate. In addition, trial registries document changes in protocols, which may alter the research question or data validity. Unfortunately there is some confusion about what constitutes a clinical trial. The ICMJE adopted the World Health Organization’s definition of a clinical trial in June 2007: “‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.’ Healthrelated interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and processof-care changes).”6
6
Chescheir
Information for Readers and Authors
The public registry most commonly used by authors who submit manuscripts to Obstetrics & Gynecology is the National Institutes of Health’s Clinicaltrials.gov registry. This registry meets the requirements described in Section 801 of the U.S. Food and Drug Administration Amendments Act.7 It specifically notes that applicable clinical trials include those of drugs, biologics, and devices. Further, it specifically notes that behavioral interventions are excluded, which conflicts with the ICMJE’s definition. At Obstetrics & Gynecology, we have decided to follow ICMJE’s guidance and definitions related to clinical trials owing to the significant potential benefits of trial registration. Going forward, we will be including behavioral studies in the definition of clinical trials that require registration. All clinical trials that involve drugs, devices, or procedures must be registered in an approved public registry at or before enrollment of the first patient for us to consider the manuscript for publication. This is not a change in our policy. We are phasing in this requirement for behavioral studies. From now through December 31, 2015, behavioral clinical trials must be registered, but this can occur after the trial has begun enrolling patients. After January 1, 2016, the journal will require that behavioral studies be registered at or before the time of first patient enrollment. Without registration as outlined above, we will not consider the manuscript for publication. While these refinements may seem overly proscriptive to some, they align our journal with international standards that protect authors, researchers, readers, and participants in research. Your feedback, as always, is welcome. REFERENCES 1. Gollogly L, Momen H. Ethical dilemmas in scientific publication: pitfalls and solutions for editors. Rev Saúde Pública 2006;40. Available at: http://dx.doi.org/10.1590/S0034-89102006000400004. Retrieved April 24, 2014. 2. International Committee of Medical Journal Editors. Recommendations for the conduct, report in, editing and publication of scholarly works in medical journals: roles and responsibilities of authors, contributors, reviewers, editors, publisher and owners: defining the role of authors and contributors. Available at: http://www.icmje.org/recommendations/browse/roles-andresponsibilities/defining-the-role-of-authors-and-contributors. html. Retrieved April 24, 2014. 3. Retraction watch. Available at: http://www.retractionwatch.com. Retrieved April 20, 2014. 4. Altman DG, Moher D. Declaration of transparency for each research article. BMJ 2013;347. Available at: http://www.bmj. com/content/347/bmj.f4796. Retrieved April 24, 2014. 5. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the
OBSTETRICS & GYNECOLOGY
International Committee of Medical Journal Editors. JAMA 2004;292:1363–4.
Available at: http://www.icmje.org/about-icmje/faqs/clinical-trialsregistration/. Retrieved April 24, 2014.
6. International Committee of Medical Journal Editors. Clinical trials registration. What is the ICMJE definition of a clinical trial?
7. ClinicaTrials.gov. Submit studies. Available at: http://clinicaltrials. gov/ct2/manage-recs/fdaaa6. Retrieved April 24, 2014.
ACOG Fellows and Journal Subscribers: Get Obstetrics & Gynecology for Free on your iPad The Green Journal app is available for the iPad® from Apple’s App StoreSM. To view journal content, ACOG Fellows and journal subscribers must first register and activate an account at www.greenjournal.org.
If You Have Not Registered at Greenjournal.org: 1. On www.greenjournal.org, click on the gear box at the top right corner of the screen and select Register. 2. On the registration screen, choose a username and password and enter your e-mail address. (Usernames must be at least 6 characters in length and contain no spaces or symbols; passwords must be at least 8 characters in length and contain at least one number and one letter.) 3. Click Continue to go to the next step of user registration. 4. On the next screen, enter your name and address and click Continue. 5. The next registration screen asks for additional information about you and your practice to help us recommend articles and rich media that suit your area of specialty. After entering this information, indicate your acceptance of the End User License Agreement and click Complete Registration. 6. After you complete the registration, you will receive an e-mail from the site asking you to confirm your registration. Click on the link in the e-mail within 48 hours. 7. The link in the e-mail leads to a web page where you will be asked if you want to activate your online subscription. Click on Yes! I am a subscriber and want to activate my online subscription(s). 8. Enter your ACOG Member ID or subscriber ID in the field at the bottom of the next screen. Be sure to enter all characters; note that the last digit for ACOG members is the letter “I,” not the number “1.” Then click on Activate Subscription.
If You Have Registered at Greenjournal.org But Not Activated Your Subscription: 1. On www.greenjournal.org, click on the gear box at the top right corner of the screen and select Log In. 2. Click on Activate Your Subscription at the top right of the page. 3. Enter your ACOG Member ID or subscriber ID in the field at the bottom of the next screen. Be sure to enter all characters; note that the last digit for ACOG members is the letter “I,” not the number “1.” Then click on Activate Subscription. You are now registered for full-text access on both the app and the journal web site! When you access the Green Journal app on your iPad, you will be asked to enter the username and password that you created at www.greenjournal.org. Need Help? Contact the Editorial Office at 202-314-2317 or [email protected]. Apple and iPad are trademarks of Apple Inc., registered in the U. S. and other countries. App Store is a service mark of Apple Inc. rev 7/2014
VOL. 124, NO. 1, JULY 2014
Chescheir
Information for Readers and Authors
7
