Research Involving Human Participants
Any Brieflands submission reporting research on human participants — including their tissue, their data and their records — must have been conducted, and must be reported, to the standards on this page. This applies to interventional and observational studies, questionnaire and interview research, secondary analysis of identifiable data, and case reports.
Declaration of Helsinki
Research must comply with the WMA Declaration of Helsinki — Ethical Principles for Medical Research Involving Human Participants, as amended by the 75th WMA General Assembly, Helsinki, October 2024. Cite the current version; do not cite the 1975 or 2013 texts as though they were current.
Studies conducted before the 2024 amendment should state the version in force at the time.
Ethics committee approval is mandatory
An ethical approval code from a recognised research ethics committee or institutional review board is required, and must be given in the manuscript. Manuscripts submitted without one are rejected at initial screening. How to obtain and where to state the code: Ethical Oversight.
Approval must have been granted before the research began. Retrospective approval does not satisfy this requirement, and a statement that approval “was not required” must name the committee that made that determination.
Informed consent
Documented informed consent is required from every participant, or from their legal guardian or representative. What consent must contain, the rules for identifiable images and video, consent by proxy for children and adults unable to consent, and withdrawal of consent are all set out in Informed Consent.
Vulnerable groups and equity
Where participants are children, pregnant women, prisoners, people with impaired capacity, refugees or others in a position of dependency or disadvantage, the manuscript must explain why that group was necessary to the research question and what additional safeguards were applied. Research must not exploit a population that will not benefit from its results.
Report participants’ sex, gender, age and relevant population characteristics accurately, and justify their inclusion or exclusion — do not treat a narrow sample as universal.
Privacy and data protection
Personal data must be processed lawfully and the manuscript must not contain identifying detail that consent does not cover. Remove names, initials, record and hospital numbers, exact dates and institutional identifiers from text, tables, figures and supplementary files. Data sharing is subject to the same limits: where participant privacy prevents open deposit, say so and give the reason in your Data Availability Statement — see Research Data and Reproducibility.
Clinical trial registration
Clinical trials must be registered in a public registry before the first participant is enrolled, and the registry name and number must appear in the abstract. See Randomized Clinical Trials.
What to state in the manuscript
In the Methods section, and in the cover letter:
- The name of the approving committee and the approval code.
- That informed consent was obtained, and from whom.
- That the study complied with the Declaration of Helsinki and with the applicable national and institutional guidelines.
- For trials, the registry and registration number.
- Any ethical issue the study raised, and how it was handled. Where there is nothing to declare, state “None to be declared”.
Report the study to the guideline for its design and upload the checklist — Reporting guidelines by study design.
Frameworks Brieflands follows
- COPE — Committee on Publication Ethics, of which Brieflands is a publisher member.
- ICMJE — International Committee of Medical Journal Editors.
- EQUATOR Network — reporting guidelines for health research.
Failure to meet these requirements is handled under the ethics committee procedure.
Related: Informed Consent · Ethical Oversight · Animal Rights · Randomized Clinical Trials · Publication Ethics