If researchers or others have questions about the need to register a specific study, they should err on the side of registration or consult the editorial office of the journal they wish to publish the study in. <> Extra or supplementary materials and technical details can be placed in an appendix where they will be accessible but will not interrupt the flow of the text, or they can be published solely in the electronic version of the journal. 0000002057 00000 n NIH Definition of a Clinical Trial. The ICMJE does require public, prospective registration of clinical trials of all interventions, including devices. Clinical Trials Registration. The ICMJE accepts registration in the following registries: In addition to the above registries, starting in June 2007 the ICMJE will also accept registration in any of the primary registries that participate in the WHO International Clinical Trials Portal (see https://www.who.int/clinical-trials-registry-platform/network/primary-registries). Keep up-to-date Request to receive an E-mail when the Recommendations are updated. For all other items, the time frame for disclosure is the past 36 months. Perceptions of conflict of interest are as important as actual conflicts of interest. Dr Marcum reports receiving support from grants K07AG033174 and P30AG024827 from the National Institutes of Health and R01HS018721 from the Agency for Healthcare Research and Quality. Before-and-after images should be taken with the same intensity, direction, and color of light. An appropriate statement should be added to the text to inform readers that this additional information is available and where it is located. Disclosure of Interest (Updated February 2021) Please note: Your completed form is NOT to be submitted to the ICMJE and it cannot be saved to the ICMJE website. 4,8,9 > Human Subject Regulations Decision Charts. This page summarizes the clinical trial registration and results information submission requirements described in Section 801 of the Food and Drug Administration Amendments Act of 2007 (PDF), known as FDAAA 801. Provide a context or background for the study (that is, the nature of the problem and its significance). The following are general requirements for reporting within sections of all study designs and manuscript formats. > Regulations, Policy & Guidance Because the relevance of such variables as age, sex, or ethnicity is not always known at the time of study design, researchers should aim for inclusion of representative populations into all study types and at a minimum provide descriptive data for these and other relevant demographic variables. However, the ICMJE does not have the resources to translate, to back translate, or to review or approve reprinted/translated versions of the documents. Name all entities with whom you have this relationship or indicate none (add rows as needed) Specifications/Comments (e.g., if payments were made to you or to your institution) Time frame: Since the initial planning of the work 1 All support for the present manuscript (e.g., funding, Disclosure of Financial and Non-Financial Relation-shipsandActivities,andCon ictsofInterest 1. Journals that in the past have References cited only in tables or figure legends should be numbered in accordance with the sequence established by the first identification in the text of the particular table or figure. Authors should avoid entering into agreements with study sponsors, both for-profit and non-profit, that interfere with authors access to all of the studys data or that interfere with their ability to analyze and interpret the data and to prepare and publish manuscripts independently when and where they choose. For more information ?o^seUu}yO&/Sz !_:a zCT4B~Y@vSp U. Other interests may also represent or be perceived as conflicts, such as personal relationships or rivalries, academic competition, and intellectual beliefs. For research that started after September 1st, 2015, the journal requires all clinical trials that prospectively assign human subjects to medical interventions, comparison groups, or control groups for the purpose of examining the potential health effects of such interventions, to be registered in one of several free, publicly accessible, non-profit See Authorship Criteria and Contributions. To minimize such errors, references should be verified using either an electronic bibliographic source, such as PubMed, or print copies from original sources. Name all entities with whom you have this relationship or indicate none (add rows as needed) Specifications/Comments (e.g., if payments were made to you or to your institution) References should follow the standards summarized in the NLMs Sample References webpage and detailed in the NLMs Citing Medicine, 2nd edition. The ICMJE has not endorsed nor approved the contents of this reprint/translation. Race and ethnicity are social and not biological constructs; authors should interpret results associated with race and ethnicity in that context. Will the ICMJE consider clinical trial results posted at ClinicalTrials.gov in compliance with the Food and Drug Administration Amendments Act of 2007 to be prior publication? 0 The Archives of Physical Medicine and Rehabilitation publishes original, peer-reviewed research and clinical reports on important trends and developments in physical medicine and rehabilitation and related fields.This international journal brings researchers and clinicians authoritative information on the therapeutic utilization of physical, behavioral and Temperatures should be in degrees Celsius. the time frame for disclosure is the past 36 months. The titles of journals should be abbreviated according to the style used for MEDLINE (www.ncbi.nlm.nih.gov/nlmcatalog/journals). Financial relationships (such as employment, consultancies, stock ownership or options, honoraria, patents, and paid expert testimony) are the most easily identifiable, the ones most often judged to represent potential conflicts of interest and thus the most likely to undermine the credibility of the journal, the authors, and of science itself. Users should cite this official version when citing the document." However, editors of journals that follow the ICMJE recommendations may consider posting of more detailed descriptions of trial results beyond those included in ClinicalTrials.gov to be prior publication. If the study was done involving an exclusive population, for example in only one sex, authors should justify why, except in obvious cases, (e.g., prostate cancer). Authors should define how they determined race or ethnicity and justify their relevance. NIH Definition of a Clinical Trial. Disclosure of Interest (Updated February 2021) Please note: Your completed form is NOT to be submitted to the ICMJE and it cannot be saved to the ICMJE website. Thus, the ICMJE will not consider results data posted in the tabular format required by ClinicalTrials.gov to be prior publication. Because abstracts are the only substantive portion of the article indexed in many electronic databases, and the only portion many readers read, authors need to ensure that they accurately reflect the content of the article. 2022 International Committee of Medical Journal Editors. Clinical Trials Registration. In concert with the ICMJE, JAMA Network requires, as a condition of consideration for publication, registration of all trials in a public trials registry that is acceptable to the ICMJE (ie, the registry must be owned by a not-for-profit entity, be publicly accessible, and require the minimum registration data set as described by ICMJE). The spelled-out abbreviation followed by the abbreviation in parentheses should be used on first mention unless the abbreviation is a standard unit of measurement. Disclosure Forms The ICMJE form only needs to be submitted for the corresponding author at the time of the original submission. The ICMJE has not endorsed nor approved the contents of this reprint/translation. ICMJE member journals require that authors use this form, and ICMJE encourages other journals to adopt it. 0000003845 00000 n Overview Back to top. Access decision charts that are consistent with the pre-2018 Requirements. ICMJE journals will consider trials beginning on or after July 1, 2005 only if registration occurred before the first patient was enrolled ("prospective registration"). Titles in tables should be short but self-explanatory, containing information that allows readers to understand the table's content without having to go back to the text. An authors complete disclosure demonstrates a commitment to transparency and helps to maintain trust in the scientific process. Send an email to register@clinicaltrials.gov with your question or explaining the problems you are encountering. Hdn0y 13000 W. 87th St. Parkway. Identify precisely all drugs and chemicals used, including generic name(s), dose(s), and route(s) of administration. A research study in which one or more human subjects are prospectively assigned prospectively assigned The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms In June 2007 the ICMJE adopted the WHO's definition of clinical trial: "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." For radiological and other clinical and diagnostic images, as well as pictures of pathology specimens or photomicrographs, send high-resolution photographic image files. The second set of decision charts is dated June 23, 2020 and titled, Human Subject Regulations Decision Charts: 2018 Requirements, and is consistent with the 2018 Requirements. General information about an article and its authors is presented on a manuscript title page and usually includes the article title, author information, any disclaimers, sources of support, word count, and sometimes the number of tables and figures. To make the best decision on how to deal with a manuscript BMJ Global Health needs to know about any competing interests authors may have; this includes any commercial, financial or non-financial associations that may be relevant to the submitted article.Authors must download and complete a copy of the ICMJE Conflict of Interest disclosure form. ICMJE journals will consider trials beginning on or after July 1, 2005 only if registration occurred before the first patient was enrolled ("prospective registration"). American College of Clinical Pharmacy. Lenexa, KS 66215-4530. Letters, numbers, and symbols on figures should therefore be clear and consistent throughout, and large enough to remain legible when the figure is reduced for publication. Some but not all journals check the accuracy of all reference citations; thus, citation errors sometimes appear in the published version of articles. Original research, systematic reviews, and meta-analyses require structured abstracts. The ICMJE is cooperating with the WHO effort and will adopt WHO policy with respect to registry language. In concert with the ICMJE, JAMA Network requires, as a condition of consideration for publication, registration of all trials in a public trials registry that is acceptable to the ICMJE (ie, the registry must be owned by a not-for-profit entity, be publicly accessible, and require the minimum registration data set as described by ICMJE). When submitting a manuscript to the Clinical Journal of Gastroenterology, all authors are required to disclose any financial relationship within the last 3 years with biotechnology manufacturer, a pharmaceutical company, or other commercial entity that has any interest in the subject matter, materials, or process(es) discussed in the manuscript. 0000002556 00000 n Reporting guidelines have been developed for different study designs; examples include CONSORT for randomized trials, STROBE for observational studies, PRISMA for systematic reviews and meta-analyses, and STARD for studies of diagnostic accuracy. The format required for structured abstracts differs from journal to journal, and some journals use more than one format; authors need to prepare their abstracts in the format specified by the journal they have chosen. A research study in which one or more human subjects are prospectively assigned prospectively assigned The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms 0000014435 00000 n When authors submit a manuscript of any type or format they are responsible for disclosing all relationships and activities that might bias or be seen to bias their work. Tables capture information concisely and display it efficiently; they also provide information at any desired level of detail and precision. disclosure of all relationships in which there is a potential or actual conflict of interest, even if it not directly relevant to the submitted form has been modified by the ICMJE following consultation with authors and editors. All authors are required to complete an Authorship Form and Publishing Agreement. All authors are required to complete an Authorship Form and Publishing Agreement. Although references to review articles can be an efficient way to guide readers to a body of literature, review articles do not always reflect original work accurately. the time frame for disclosure is the past 36 months. If a figure has been published previously, acknowledge the original source and submit written permission from the copyright holder to reproduce it. DEVICE STATEMENT Please check off ONE statement below that pertains to your submitted work. This so-called IMRAD structure is not an arbitrary publication format but a reflection of the process of scientific discovery. 0000001706 00000 n Telephone: (913) 492-3311 0000009344 00000 n Figures should be made as self-explanatory as possible, since many will be used directly in slide presentations. The Methods section should aim to be sufficiently detailed such that others with access to the data would be able to reproduce the results. Reviewers should be asked at the time they are asked to critique a manuscript if they have relationships or activities that could complicate their review. Give references to established methods, including statistical methods (see below); provide references and brief descriptions for methods that have been published but are not well-known; describe new or substantially modified methods, give the reasons for using them, and evaluate their limitations. Fewer references to key original papers often serve as well as more exhaustive lists, particularly since references can now be added to the electronic version of published papers, and since electronic literature searching allows readers to retrieve published literature efficiently. Do not repeat in detail data or other information given in other parts of the manuscript, such as in the Introduction or the Results section. Overview Back to top. The ICMJE has developed a Disclosure Form to facilitate and standardize authors disclosures. ICMJE Form for Disclosure of Potential Conflicts of Interest Lembke 1 The purpose of this form is to provide readers of your manuscript with information about your other interests that could influence how they receive and understand your work. BMC is a member of the Committee on Publication Ethics (COPE) and endorses the World Association of Medical Editors (WAME) Policy Statement on Geopolitical Intrusion on Editorial Decisions.BMC also endorses the International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing and Publication Do not repeat all the data in the tables or figures in the text; emphasize or summarize only the most important observations. endstream The statutory requirements have been in effect since September 27, 2007, have been codified at section The pre-2018 Requirements were originally promulgated in 1991, and subsequently amended in 2005. Journals that in the past have The ICMJE has developed a uniform Disclosure Form for use by ICMJE member journals, and the ICMJE encourages other journals to adopt it. Registries should consult the WHO International Clinical Trials Registry Platform. Purposeful failure to report those relationships or activities specified on the journals disclosure form is a form of misconduct, as is discussed in section III.B. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Journals vary on whether they ask authors to cite electronic references within parentheses in the text or in numbered references following the text. Discuss the influence or association of variables, such as sex and/or gender, on your findings, where appropriate, and the limitations of the data. 345 0 obj Disclosure Forms The ICMJE form only needs to be submitted for the corresponding author at the time of the original submission. Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Common data elements are standardized terms for the collection and exchange of data. Suite 100. The ICMJE also recommends that, when a registration number is available, authors list that number the rst time they use a trial acronym to refer to the trial they are reporting or to other trials that they mention in the manuscript. Distinguish prespecified from exploratory analyses, including subgroup analyses. For all other items, the time frame for disclosure is the past 36 months. Public trust in the scientific process and the credibility of published articles depend in part on how transparently an authors relationships and activities, directly or topically related to a work, are handled during the planning, implementation, writing, peer review, editing, and publication of scientific work. Please refer to the registry that you choose to register in for instructions about the registration process for that specific registry. Since blots are used as primary evidence in many scientific articles, editors may require deposition of the original photographs of blots on the journal's website. 1. 4,8,9 HtSM&+1n_3*%rrmz ^=9xNQesxjt!C!S>xL} cAsUj+tjX-^%Gd\ )Ty5Eeq!"h"URAty#>0lF`o'#NFgL01gxa_Yi$k=}(m%-o+F-$1f$+gPrY$xIfU_}xHm`0/aq% 6f&ijI%v wXtA_67pS2: World Headquarters . Save the form on your own computer and check with the journal you are submitting to for specific instructions on how to submit your completed form to them. Reviewers must disclose to editors any relationships or activities that could bias their opinions of the manuscript, and should recuse themselves from reviewing specific manuscripts if the potential for bias exists. CDEs are metadata; they describe the type of data collected, not the data itself. Authors should consult with the journal to which they plan to submit their work. 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. All authors are required to complete an Authorship Form and Publishing Agreement. Authors may be required to provide the journal with the agreements in confidence. Participants a. Individuals may disagree on whether an authors relationships or activities represent conflicts. 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