AHA/ASA Journals are committed to publishing high-quality research and upholding accepted standards of methodological rigor, reproducibility, and transparency.
The following are provided as general guidelines for manuscripts submitted to AHA/ASA journals. Authors are encouraged to review the individual journal Instructions for Authors when submitting a manuscript to a specific journal.
Research & Reporting Guidelines
Manuscripts submitted to AHA/ASA journals 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/
- NIH principles and guidelines for reporting preclinical research http://www.nih.gov/about/reporting-preclinical-research.htm
In addition, during submission, authors reporting preclinical animal research will need to complete a checklist aimed at enhancing rigor, transparency, and reproducibility. Additional information is available during submission and in individual journal Instructions for Authors.
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 in AHA/ASA journals 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 and applies to all clinical trials, including Phase 1 studies. Any research study that prospectively assigns human participants or groups of humans to one or more health-related intervention(s) to evaluate the effects on health outcomes is considered a clinical trial. The special report, The Proposed Rule for U.S. Clinical Trial Registration and Results Submission published in The New England Journal of Medicine, can be consulted for the guidance. 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 the phrase “Clinical Trial Registration Information” at the end of the abstract. Please list the URL, as well as the unique identifier, for the publicly accessible web site on which the trial is registered in this section.
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 a table.
Data Deposition & Data Availability
Authors are asked to ensure that manuscripts adhere to the AHA Journals' implementation of the Transparency and Openness Promotion (TOP) Guidelines (available online at http://www.ahajournals.org/content/TOP-guidelines).
In general, to allow others to replicate and build on work published in AHA/ASA journals, 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.
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.