This policy sets out the additional ethical requirements that apply to all research and clinical material involving human participants published in SJOG. It complements, and should be read with, the journal’s Publication Ethics and Malpractice Statement.
Requirements at a Glance
| Requirement | What authors must do |
|---|---|
| 1. Ethical approval | Approval by an appropriate IRB/research-ethics committee, compliance with the Declaration of Helsinki, and the approval number stated in the Methods. |
| 2. Justification | Justify involving a vulnerable population, showing the question could not be equally addressed otherwise and that risks, pain, and distress were minimised. |
| 3. Informed consent | Written consent from every participant; for minors, assent plus parental/guardian consent; where capacity is lacking, consent from a legally authorised representative. |
| 4. Research in pregnancy | For studies involving the maternal–fetal dyad or any fetal/neonatal intervention, describe the specific safeguards for both the woman and the fetus/neonate, and the committee’s basis for approval. |
| 5. Clinical-trial registration | Prospective registration in a recognised public registry before first enrolment; registration number in the abstract (ICMJE). |
| 6. Consent for identifiable material | Written consent for publication of any identifiable images or details — including ultrasound, operative, histopathologic, neonatal, or perineal images; identifiers omitted unless essential and consented; features masked. |
| 7. Privacy for sensitive conditions | Strict confidentiality, with particular care for pregnancy loss, infertility, HIV/STI, and gynecologic malignancy; data sharing complies with privacy law. |
Consent for Publication of Identifiable Material
For any manuscript containing identifiable information or images of a patient — including photographs of the face or other distinctive features, or identifiable obstetric/gynecologic clinical details — authors must obtain explicit written consent for publication from the patient (or a legally authorised representative) and must state that such consent was obtained. Identifying details (names, initials, record numbers, dates) must be omitted unless essential and covered by consent; identifying features in images should be masked unless specifically consented otherwise.
Research During Pregnancy
Because an intervention studied in a pregnant woman may affect the fetus, protocols must address the interests of both. Authors should describe how the ethics committee weighed potential benefit and risk to the woman and to the fetus/neonate, the monitoring arrangements, and the consent process. Emergency research conducted without prior consent must describe the committee-approved safeguards (e.g. deferred consent where permitted).
Phlox Institute: Indonesian Medical Research Organization
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E-mail: sjog.editor@gmail.com · Phone: +62 877-8809-0173 · e-ISSN 2986-9838
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