Ethics approval and informed consent

We have produced clinical guidelines to provide researchers, doctors, and patients—as well as the editors and readers of the NRFHH to which we submit our data—confidence that we are publishing comprehensive, impartial, and accurate information about our studies. These principles are meant to ensure we constantly publish publications morally and responsibly.

Submission to NRFHH should ensure that Clinical trial reports adhere to the Consolidated Standards of Reporting Trials (CONSORT) and include outlining subject enrolment, allocation to an intervention, follow-up, and data analysis. Please explicitly refer to the CONSORT Checklist of details to include in randomised clinical trial reports.

Demographic information, including sex and race or ethnicity, should be included when discussing the findings of epidemiologic analyses or clinical trials unless it is clearly stated that no sex—or race or ethnicity-based differences were present.

Ethics Committee Permission

The Institutional Review Board for Human and animal studies must approve all research involving humans and animals. These regulations may vary from country to country, and country-specific regulations must be adhered to. The institutional ethical and protocol numbers should be included in the manuscript.
Suppose the World Medical Association's (WMA) and the Declaration of Helsinki's ethical principles for medical research involving human subjects were adhered to. In that case, this should be indicated in the methods section of the manuscript. Refer to the WMA Declaration Policy.
Any study involving animals for research should have the protocol approved by the Institutional Committee on Animal Sources, where the procedures adhere to the ethical standards of the responsible committee on experimentation.

Trial Registration

All clinical trials in the study must be registered in a public trials registry at or before the beginning of participant enrolment following the Clinical Trial Registration Statement from the International Committee of Medical Journal Editors (Circulation. 2005;111:1337). Clinical trials are research studies that prospectively assign individuals or groups to one or more health-related interventions to assess the effects on health outcomes.

The registry must be free to access, searchable, available to all potential registrants, and run by a non-profit organisation. A unique identification number, a description of the intervention(s), a study hypothesis, a definition of the primary and secondary outcome measurements, eligibility requirements, the intended number of participants, the funding source, the principal investigator's contact information, and important dates must all be included in the registry (registration date, start date, and completion date).

Registries acceptable by NRFHH are as follows
1. http://www.clinicaltrials.gov
2. http://isrctn.org
3. http://www.umin.ac.jp/ctr/index/htm/
4. http://www.anzctr.org.au/Default.aspx

Authors will be requested to include the exact URL and unique identification number for the trial registration and add “Clinical Trial Registration Information” at the end of the abstract.