Researchers submitting studies involving human participants must meet the following requirements:
- Obtain prior approval for human subjects research by an institutional review board (IRB) or equivalent ethics committee(s)
- Declare compliance with ethical practices upon submission of a manuscript
- Report details on how informed consent for the research is obtained (or explain why consent is not obtained)
- Submit, upon request from the journal, documentation from the review board or ethics committee confirming approval of the research.
- For clinical trials, provide trial registration details, the study protocol, and CONSORT documentation
- Confirm that an identified individual has provided written consent for the use of that information
In the ethical statement, authors should declare any potential risks to individuals or individual privacy or affirm that in their assessment, the study posed no such risk.
Our policies for clinical trial submissions are designed to promote transparency and reproducibility and to ensure the integrity of the reporting of patient-centered trials. Compliance with our policies is required at submission for a manuscript to proceed.
Editors and reviewers should carefully review trial protocols and registration details and assess manuscripts according to CONSORT or other relevant guidelines. Most clinical trial submissions will also be reviewed by a statistician.
Concerns about clinical trial submissions should be brought to the attention of the editorial office as quickly as possible.
Clinical trial reports must adhere to the relevant reporting guidelines for their study design, such as CONSORT for randomized controlled trials, TREND for non-randomized trials, and other specialized guidelines as appropriate.