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 (Circulation. 2005;111:1337) and (http://content.nejm.org/cgi/content/full/NEJMe078110), all clinical trials in Circulation: Genomic and Precision Medicine must be registered in a public trials registry at or before the onset of participant enrollment. This requirement applies to all clinical trials that began 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. 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). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. As previously, purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. We will start to implement the expanded definition of clinically directive trials for all trials that began enrollment on or after July 1, 2008. Those who are uncertain whether their trial meets the expanded ICMJE definition 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 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 fourth heading in your abstract: "Clinical Trial Registration Information". Please list the URL, as well as the unique identifier, for the publicly accessible website 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 less) or a table.
Guidelines for Meta-Analyses
- See "Meta-analysis of Observational Studies in Epidemiology: A Proposal for Reporting," JAMA. 2000; 283: 2008-2012.
Guidelines for Studies on Diagnostic Tests
- See "The STARD Statement for Reporting Studies of Diagnostic Accuracy: Explanation and Elaboration," Ann Intern Med. 2003; 138: 40-44.
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: http://www.ncbi.nlm.nih.gov/projects/SNP/ and http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Snp
- 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.
- 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. Nonessential 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 Genomic and Proteomic Studies
- Preparation of Data Submitted: Data should follow the MIAME checklist (for more information see http://www.mged.org/Workgroups/MIAME/miame_checklist.html).
- Accessibility of Data: 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, 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 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). GEO is accessible from http://www.ncbi.nlm.nih.gov/geo/. The submission FAQ is available at http://www.ncbi.nlm.nih.gov/projects/geo/info/faq.html.
Guidelines for Proteins 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).
National Center for Biotechnology Information
8600 Rockville Pike, Building 38A
Bethesda, MD 20894
Tel: (301) 496-2475
On the web at: http://www.ncbi.nlm.nih.gov/Genbank/index.html
- EMBL Nucleotide Sequence Submissions
European Bioinformatics Institute
Hinxton, Cambridge CB10 1SD, UK
Tel.: 44-1223-494401; Fax: 44-1223-494472
On the web at: http://www.ebi.ac.uk
- 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
On the web at: http://www.ddbj.nig.ac.jp
- Submission to any data bank is sufficient to ensure entry in all.