Ethical Oversight

Journal of Midwifery (JOM) upholds rigorous ethical standards for research involving pregnant people, birthing individuals, newborns, women across the life course, and communities. Reflecting JOM’s aims and scope (midwifery practice, pregnancy, childbirth, postpartum, newborn care, women’s and reproductive health; ASJC 2919) and alignment with SDGs 3, 4, 5, 10, and 16, this policy sets requirements for ethics review, informed consent, participant safety, privacy, and responsible conduct.

1. Introduction

  • Ethical oversight protects participants, promotes trustworthy evidence, and safeguards the scholarly record.

  • This policy applies to all submissions that involve human participants (including neonates and minors), human data or tissue, community-based or health-systems research, clinical trials, quality improvement projects reported as research, and—where relevant—animal studies.

  • JOM follows international standards (e.g., Declaration of Helsinki; relevant field-specific guidelines) alongside national/regional regulations.

2. Description

  • Ethics review: Independent review by a recognized Research Ethics Committee/Institutional Review Board (REC/IRB) is required when human participants, identifiable data, or prospectively collected clinical interventions are involved.

  • Informed consent: Participants (or legally authorized representatives) must give freely given, specific, informed consent. In obstetric and neonatal contexts, special protections apply (Section 3).

  • Vulnerable and key populations: Pregnant people, neonates/infants, minors, individuals with limited decision-making capacity, survivors of violence, marginalized groups, and low-literacy communities require additional safeguards.

  • Sensitive topics: Sexual and reproductive health, intimate partner violence (IPV), reproductive coercion, mental health, and stigma-laden conditions demand enhanced privacy and risk-mitigation protocols.

  • Data protection: Confidentiality, de-identification, secure storage, and lawful data transfers are mandatory; controlled access is used when open sharing is not appropriate.

  • Clinical trials: Prospective registration and oversight (e.g., DSMB where applicable) are required.

  • Images and case reports: Written consent to publish identifiable information is mandatory.

3. Policy

3.1 Human participants: ethics approval and consent

  • Provide REC/IRB approval identifier, committee name, and date. If exempt/waived, include the official determination and rationale.

  • Obtain written informed consent; if verbal consent is used (e.g., low-literacy settings), explain the process, witness procedures, and records.

  • Consent materials must be understandable (language level, translation verified); provide interpreters when necessary.

3.2 Pregnancy, childbirth, postpartum, and reproductive health

  • Describe risk–benefit assessments for the pregnant person and fetus/newborn; justify procedures and monitoring.

  • Ensure continuity of care: participation must not compromise standard clinical care or emergency access.

  • For intrapartum research, specify safeguards during labor (e.g., timing to avoid undue pressure).

3.3 Neonates, infants, and minors

  • Obtain parental/guardian consent; seek age-appropriate assent where feasible.

  • For neonatal research, justify minimal risk or prospect of direct benefit; detail pain mitigation and monitoring.

3.4 Sensitive and high-risk contexts (IPV, sexual health, stigma)

  • Include risk mitigation (private recruitment, safety scripts, referral pathways).

  • Prohibit procedures that could increase harm (e.g., partner notification without consent in IPV contexts).

  • Ensure confidential contact methods and secure data handling.

3.5 Community engagement and equity

  • For community-based studies, describe engagement/consultation (advisory boards, co-design) and how the work advances equity and inclusion consistent with SDGs.

  • Respect indigenous or local data governance and benefit-sharing norms where applicable.

3.6 Data protection and privacy

  • De-identify datasets; store keys separately; restrict access on a need-to-know basis.

  • For cross-border transfers, confirm a lawful basis and safeguards.

  • Align manuscript Data Availability Statements with approvals and consent (see Data & Reproducibility policy).

3.7 Clinical trials

  • Prospective registration (e.g., WHO-recognized registry) is required; report the registration number in the manuscript.

  • Describe monitoring (e.g., DSMB), stopping rules, and adverse event reporting.

  • Trial protocols and statistical analysis plans should be accessible (pre-registration or repository).

3.8 Retrospective chart reviews and minimal-risk studies

  • State the REC/IRB determination (exempt/waiver/approval) and legal basis for using records; describe de-identification and security.

3.9 Images, videos, and case details

  • Obtain written consent to publish for any identifiable patient images or unique case details.

  • If fully non-identifiable, state how anonymity was assured (cropping, masking, removal of metadata).

3.10 Animal studies (if applicable)

  • Provide protocol approval identifiers and adherence to ARRIVE or relevant guidelines; justify species choice, numbers, and humane endpoints.

3.11 AI/automated tools in clinical decision contexts

  • Disclose any use of AI decision support; confirm human clinical oversight and validation appropriate to the setting (see AI policy).

  • Do not deploy experimental tools as standard of care without appropriate oversight and consent.

3.12 Compliance and editorial actions

  • Missing or inadequate ethics information may delay peer review or acceptance.

  • Serious deficiencies may trigger investigation under Allegations of Misconduct and can result in rejection, correction, expression of concern, or retraction.

4. Technicalities to Achieve and Materialise the Policies

4.1 Required statements in the manuscript

Include under “Ethics” (or Methods):

  • REC/IRB: committee name, approval ID, date (or exemption/waiver with justification).

  • Consent to participate: model (written/verbal), translators/witnesses, and storage of consent records.

  • Consent to publish: for identifiable images/cases.

  • Trial registration: registry name and number (for interventional studies).

  • Risk mitigation: IPV/sensitive-topic protections, referral pathways.

  • Data availability: repository/DOI or controlled-access pathway consistent with consent.

4.2 Documents to upload at submission (as applicable)

  • REC/IRB approval/exemption letter (on official letterhead, signed/dated).

  • Blank consent forms (participation and, if needed, consent to publish).

  • Protocol and statistical analysis plan (or registry link).

  • Data protection plan (de-identification, storage, access controls).

  • Community engagement statement (for CBPR or community health studies).

4.3 Special situations

  • Emergency care: explain how consent was handled (e.g., deferred consent) and safeguards for refusal/withdrawal.

  • Multi-site studies: list all RECs/IRBs or the lead ethics review and reliance agreements.

  • Low-literacy settings: use teach-back methods, pictorial aids, impartial witnesses; record processes.

  • Compensation: describe reimbursements and how undue influence was avoided.

  • Translation: certify consent and instruments were accurately translated/back-translated.

4.4 Post-publication

  • Report post-publication ethics concerns via jom@med.unand.ac.id; JOM may issue corrections, expressions of concern, or retractions and notify institutions/funders when appropriate.

Related and supporting policies

Contact

Ethics queries and submissions of approvals/consents: jom@med.unand.ac.id

Back to Publication Ethics main page: https://jom.fk.unand.ac.id/index.php/jom/ethics