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 statements
- 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.
INFORMED CONSENT STATEMENT
- Any research article describing a study (clinical research and case report) involving humans should contain a statement in the title page clearly stating that all involved persons (subjects or legally authorized representative) gave their informed consent (written or verbal, as appropriate) prior to study inclusion. In general, the New Delhi Publisher requires that any and all details that might disclose the identity of the subjects under study should be omitted or anonymized. In the rare situation that a study participant's identifiable information is crucial to the case presentation, the statement of informed consent is absolutely necessary, unless the participant is deceased. In addition, a copy of any approval document(s)/letter(s) or waiver should be provided to the New Delhi Publisher in PDF format.
- Waiver of informed consent for human study subjects may be justifiable under certain rare and specific conditions, such as for a trial with demonstrated minimal risk or cases of emergency care. Authors may petition New Delhi Publisher for waiver of informed consent, but there is no guarantee that the petition will be granted. In general, New Delhi Publisher favors the requirement of informed consent for all reports of information (anonymized or identifiable) and reserves the right to refuse publication of such if informed consent was not obtained.
Sample wording: All study participants, or their legal guardian, provided informed consent prior to study enrollment.