Research ethics committee approval

Authors must provide evidence of Research Ethics Committee approval of the research where relevant. Ensure the correct, full ethics committee name and reference number is included in the manuscript.

If the study was carried out using data from provincial healthcare facilities, or required active data collection through facility visits or staff interviews, approval should be sought from the relevant provincial authorities. For South African authors, please refer to the guidelines for submission to the National Health Research Database. Research involving human subjects must be conducted according to the principles outlined in the Declaration of Helsinki. Please refer to the National Department of Health’s guideline on Ethics in Health research: principles, processes and structures to ensure that the appropriate requirements for conducting research have been met, and that the HPCSA’s General Ethical Guidelines for Health Researchers have been adhered to.

Clinical trials

As per the recommendations published by the International Committee of Medical Journal Editors (ICMJE), clinical trial research is any research that assigns individuals to an intervention, with or without a concurrent comparison/control group to study the cause-and-effect relationship between the intervention and health outcomes. All clinical trials should be registered with the appropriate national clinical trial registry (or any international primary register, if relevant), and the trial registration number should be cited at the end of the abstract. All clinical trial reports must also contain a data sharing statement as per the recommendations of the ICMJE. Statements are to indicate:

• whether individual deidentified participant data will be shared;
• what data in particular will be shared; whether additional, related documents will be available;
• when the data will become available and for how long; by what access criteria data will be shared.

Please see the ICJME announcement for further details and illustrative examples of data sharing statements: ICMJE Data Sharing Statements for Clinical Trials.

Since 1st December 2005, all clinical trials conducted in South Africa have been required to be registered in the South African National Clinical Trials Register. The AJTCCM therefore requires that clinical trials be registered in the relevant public trials registry at or before the time of first patient enrollment as a condition for publication. The trial registry name and registration number must be included in the manuscript.

Please refer to the general guidelines for all papers at the top of this article for additional requirements with respect to ethics approval, funding, author contributions, etc. The format of original research articles should be followed for reporting of clinical trial results.

CONSORT Statement

All papers that describe clinical trials must adhere to the principles outlined in the CONSORT Statement which provides an evidence-based approach to improve the quality of reports of clinical trials. The CONSORT Flow Diagram showing the patients available for the study, those included, and the number at each stage of the study should also be included and the CONSORT Checklist completed and submitted with the manuscript.

Patient Consent

Information that would enable identification of individual patients should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) has given informed written consent for publication and distribution. We further recommend that the published article is disseminated not only to the involved researchers but also to the patients/participants from whom the data was drawn. Refer to Protection of Research Participants. The signed consent form should be submitted with the manuscript to enable verification by the editorial team.

Other individuals

Any individual who is identifiable in an image must provide written agreement that the image may be used in that context in the AJTCCM.

Research with animals
When animals are used as subjects, institutional approval of the protocol is necessary and authors should include a statement in the Methods indicating that investigators complied with the relevant national or international guidelines administered by the author's governmental regulatory body. When no formal ethics review process is available, authors must state that humane care was provided in animal experiments, in accordance with stated relevant guidelines.

Ethnic/race classification

Use of racial or ethnicity classifications in research is fraught with problems. If you choose to use a research design that involves classification of participants based on race or ethnicity, or discuss issues with reference to such classifications, please ensure that you include a detailed rationale for doing so, ensure that the categories you describe are carefully defined, and that socioeconomic, cultural and lifestyle variables that may underlie perceived racial disparities are appropriately controlled for. Please also clearly specify whether race or ethnicity is classified as reported by the patient (self-identifying) or as perceived by the investigators. Please note thatit is not appropriate to use self-reported or investigator-assigned racial or ethnic categories for genetic studies.