Guidelines for Methodological Rigor in Preclinical Studies
NEW: As of October 1, 2017, upon submission of revised manuscripts, authors reporting preclinical animal research will need to complete a checklist aimed at enhancing rigor, transparency, and reproducibility. Different checklists will be used for studies in animals and for studies in vitro and the checklist completed for animal studies will be posted online as a supplemental file should the manuscript be accepted. For both checklists, authors are asked to include the corresponding information in the Methods text or in an online supplement. For more information, including example checklists, please see this editorial.
Additional Research & Reporting Guidelines
Manuscripts submitted to Circulation Research should conform to the following guidelines as appropriate:
- CONSORT guidelines for Randomized Controlled Trials http://www.consort-statement.org/
- STROBE (& MOOSE) guidelines for observational studies http://www.strobe-statement.org/
- PRISMA (& MOOSE) guidelines for systematic reviews and meta-analyses http://www.prisma-statement.org/
- STARD guidelines for studies of diagnostic accuracy http://www.stard-statement.org/
- MIAME checklist for genomic and proteomic studies http://fged.org/projects/miame/
Authors are requested to upload the appropriate completed checklist or guidelines document during submission as a supplemental file.
Data Deposition and Data Availability
NEW: Please ensure that your manuscript adheres to the AHA Journals' implementation of the Transparency and Openness Promotion (TOP) Guidelines (available online at http://www.ahajournals.org/content/TOP-guidelines)
Materials and Data Availability
To allow others to replicate and build on work published in Circulation Research, we recommend that authors make materials, data, and associated protocols available to readers. Authors must disclose upon submission of the manuscript any restrictions on the availability of materials or information. We recommend that authors make unique materials (e.g. cloned DNAs; antibodies; bacterial, animal or plant cells; viruses; computer programs) promptly available on request by qualified researchers for their own use. It is reasonable for authors to charge a modest amount to cover the cost of preparing and shipping the requested materials.
Certain types of data are required to be made available to reviewers and publicly accessible upon publication as follows:
- Genomic and Proteomic Studies: Authors of papers that include genomic, proteomic, or other high-throughput data are required to make their data easily accessible to the reviewers and the editors during the review process. You may submit your data to the NCBI gene expression and hybridization array data repository (GEO, http://www.ncbi.nlm.nih.gov/geo/) and provide the GEO accession number; or, you may provide a link to a secure or publicly accessible website that hosts the data. Prior to publication, the data must be submitted and an accession number obtained. Access to the information in the database must be available at the time of publication. GEO has a web-based submission route, suitable for a small number of samples, or a batch submission tool (called SOFT). GEO is accessible from http://www.ncbi.nlm.nih.gov/geo/. Submission FAQ is at http://www.ncbi.nlm.nih.gov/projects/geo/info/faq.html.
- Protein and Nucleic Acid Data: Newly reported nucleotide or protein sequences must be deposited in GenBank (http://www.ncbi.nlm.nih.gov/Genbank/index.html), EMBL (http://www.ebi.ac.uk), or DNA Data Bank of Japan (http://www.ddbj.nig.ac.jp) databases, and an accession number must be obtained. Access to the information in the database must be available at the time of publication. Authors are responsible for arranging release of data at the time of publication. The authors must also provide a statement in the manuscript that this sequence has been scanned against the database and all sequences with significant relatedness to the new sequence identified (and their accession numbers included in the text of the manuscript). Submission to any data bank is sufficient to ensure entry in all.
Guidelines for Clinical Trials
In accordance with the Clinical Trial Registration Statement from the International Committee of Medical Journal Editors (Circulation. 2005;111:1337) and (http://content.nejm.org/cgi/content/full/NEJMe078110), all clinical trials must be registered in a public trials registry at or before the onset of participant enrollment. This requirement applies to all clinical trials that begin enrollment after July 1, 2005.
Research is considered to be a clinical trial if it involves prospective assignment of human subjects to an intervention or comparison group to study the relation between a health-related intervention and a health outcome. Studies that are designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g., phase 1 trials), are exempt. Those who are uncertain whether their trial meets the ICMJE definition of a clinical trial should err on the side of registration if they wish to seek publication.
The registry must be accessible to the public at no charge, searchable, open to all prospective registrants, and managed by a not-for-profit organization. The registry must include the following information: a unique identifying number, a statement of the intervention(s), study hypothesis, definition of primary and secondary outcome measurements, eligibility criteria, target number of subjects, funding source, contact information for the principal investigator, and key dates (registration date, start date, and completion date). The registry sponsored by the United States National Library of Medicine (http://www.clinicaltrials.gov) meets these requirements and is recommended by the editors. Other registries are acceptable if they meet these requirements. In addition to http://www.clinicaltrials.gov, the following registries are recommended by the ICMJE:
In accordance with the ICMJE’s recommendation, we will also accept registration of clinical trials in any of the primary registers that participate in the World Health Organization’s International Clinical Trial Registry Platform. Primary registers are WHO selected registers managed by not-for-profit entities that will accept registrations for any interventional trials, delete duplicate entries from their own register, and provide data directly to the WHO. Please note that registration in any WHO partner registers is insufficient.
The authors will be requested to provide the exact URL and unique identification number for the trial registration at the time of submission. Since this information will be published, we ask that you include a section titled “Clinical Trial Registration Information” at the end of the abstract. Immediately following, please list the URL, as well as the unique identifier, for the publicly accessible web site on which the trial is registered.
Clinical trial reports should also comply with the Consolidated Standards of Reporting Trials (CONSORT) and include a flow diagram presenting the enrollment, intervention allocation, follow-up, and data analysis with number of subjects for each (http://www.consort-statement.org/?o=1011). Please also refer specifically to the CONSORT Checklist of items to include when reporting a randomized clinical trial.
Results posted in the same clinical trials registry in which the primary registration resides will not be considered prior publication if they are presented in the form of a brief abstract (500 words or less) or a table.
|Instructions for Authors|