The following should be carefully reviewed prior to submission.
Guidelines for Clinical Trials:
- In accordance with the Clinical Trial Registration Statement from the International Committee of Medical Journal Editors (ICMJE) (Circulation. 2005;111:1337-1338.), all clinical trials submitted for publication in Hypertension 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 medical intervention and a health outcome. Studies that are designed for other purposes, such as to study pharmacokinetics or major toxicity studies (e.g., phase 1 trials) are exempt.
- 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 registries listed below are approved by the ICMJE:
- United States National Library of Medicine
- International Standard Randomized Controlled Trial Number (ISRCTN)
- University Hospital Medical Information Network (UMIN)
- Australian Clinical Trials Registry (ACTR)
- Netherlands Trial Register
Clinical trials maybe listed with other registries, but these registries must meet the above-mentioned requirements.
- The authors will be requested to provide the exact URL and unique identification number for the trial registration at the time of submission. This information will be published in a footnote on the first page of the article.
- 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. 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.
Genomic and Proteomic Studies:
All papers reporting gene expression profiling data must comply with the Minimum Information About Microarray Data Experiments (MIAME) standard. Authors of papers that include genomic, proteomic, or other high-throughput data are required to make their data easily accessible for 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) and provide the GEO accession number, or you may provide a link to a secure or publicly accessible website which 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). Submission FAQ.
Guidelines for Protein and Nucleic Acid Sequences:
Newly reported nucleotide or protein sequences must be deposited in GenBank or EMBL 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).
GenBank Submissions, National Center for Biotechnology Information, 8600 Rockville Pike, Building 38A, Room 8N-805, Bethesda, MD 20894, Tel: (301) 496-2475
- EMBL Nucleotide Sequence Submissions
European Bioinformatics Institute, Hinxton Hall, Hinxton, Cambridge CB10 1SD, UK, Tel.: 44-1223-494401; Fax: 44-1223-494472; e-mail: firstname.lastname@example.org
- DNA Data Bank of Japan
Center for Information Biology, National Institute of Genetics, Mishima, Shizuoka, 411, Japan, Tel.: 81-559-81-6853; Fax: 81-559-81-6849
Submission to any data bank is sufficient to ensure entry in all.
Guidelines for Human Phenotype-Genotype Association or Linkage Studies:
- Reporting issues:
- Report process for selecting genes and SNPs.
- Report Hardy-Weinberg statistics or p-values and method of calculating same.
- Refer to existing public domain websites for the Human Gene Ontology name and the rs number for SNPs.
- Describe genotyping methods. If numerous primers have been used, please include them in an online supplement.
- False positive and false negative concerns. Given well-described problems with both false positive and false negative associations, phenotype-genotype association studies should meet some or all of the criteria below:
- Phenotype is clearly defined, is heritable, and if a quantitative phenotype is reported, reproducibility data are provided or referenced.
- The sample size is adequate to detect a SNP or haplotype with a modest effect. For genotype-trait associations, provide an estimate of the effect size that could be detected with power 0.80 or higher with the allele frequency and sample size reported.
- Since multiple statistical testing methods are frequently used in genotyping-phenotyping studies, please include specifics of the primary model(s) tested. Non-essential secondary models may be published as electronic data supplements. Clinically relevant confounders should be included in multivariable models or residuals.
- Review criteria for human linkage studies. Manuscripts should include the following:
- Identifying plausible candidate genes under the linkage peak.
- Follow-up fine mapping to narrow the region of linkage, and/or genotyping some of the candidate genes under the linkage peak.
- Replication data from another sample.
Guidelines for Studies on Diagnostic Tests:
Guidelines for Meta-Analyses:
Guidelines Drugs and Reagents:
Give generic rather than trademark names of drugs. The generic chemical identification of all investigational drugs must be provided. The complete name and location of the manufacturer must be supplied for all reagents, equipment, and devices used in the Methods.