Last updated November 6, 2014

Declaration of Helsinki

The Declaration of Helsinki is a set of ethical principles for medical research involving human subjects. Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Manuscripts not conforming to the principles of the Declaration of Helsinki should not be accepted for publication.  Each research study involving human subjects must conform to the ethical norms and standards in the Declaration of Helsinki, including  ethics committee approval statement, clinical trial registration statement, and informed consent statement. For clinical research articles (including articles in columns of case control study, clinical trials study, observational study, prospective study, randomized clinical trial, randomized controlled trial, retrospective cohort study, and retrospective study) considered for publication in this journal, author(s) must provide the following three documents before the final acceptance of the manuscript.

1 Ethics committee approval statement

The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. Before the study begins, the study protocol must be submitted to local ethics committee for approval. Author(s) must provide the ethics committee approval statement in PDF format, which will be published together with the manuscript. Faxed or printed version is not acceptable.

2 Clinical trial registration statement

Every clinical trial involving human subjects must be registered in a publicly accessible database before recruitment of the first subject to provide reliable information to members of the public, health care providers, researchers and sponsors, guaranteeing that the design and conduct of clinical trials are transparent and making the registered clinical trials publicly available for free query and evaluation. Author(s) must provide the name of the trial registry and the clinical trial registration number (in PDF format; for example, Clinical trial information: NCT00382018), which will be published together with the manuscript. Faxed or printed version is not acceptable.

3 Informed consent statement

Each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The study can be conducted only after ensuring that the potential subject has understood the information and obtaining the potential subject’s freely-given written informed consent. Author(s) must provide the signed written informed consent in PDF format, which will be published together with the manuscript. Faxed or printed version is not acceptable.