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 structuresto 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.

 

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.