Informed Consent Policy

Informed Consent Policy

The Journal of Experimental and Clinical Anatomy (JECA) requires that all research involving human participants be conducted in accordance with accepted ethical standards and with the prior approval of an appropriate Institutional Ethics Committee (IEC), Institutional Review Board (IRB), or equivalent ethics body, where such approval is required.

Before the commencement of the study, the principal investigator must obtain ethics approval for the research protocol and, where applicable, for the participant information sheet, informed consent form, and any other materials provided to potential participants, unless the study has been formally determined by the relevant ethics body to be exempt from such requirements.

1. General Principles

Participation in research must be voluntary. Individuals invited to participate in research must be given adequate and understandable information about the study and must be allowed sufficient opportunity to decide whether to participate.

Authors must ensure that informed consent procedures comply with applicable ethical, legal, and institutional requirements.

2. Requirement for Informed Consent

For studies involving human participants, authors must state clearly in the manuscript:

  • whether informed consent was obtained;
  • whether consent was written or verbal;
  • whether consent was waived by the relevant ethics committee; and
  • the name of the approving ethics body, where applicable.

If written consent was not obtained, or if consent was waived, the manuscript must explain the reason and confirm that the procedure was approved by the appropriate ethics committee.

JECA may request documentary evidence of ethics approval or a sample consent form with all personal identifiers removed.

3. Information to Be Provided to Participants

The participant information sheet and informed consent document should present information in clear, concise, and understandable language. As appropriate to the nature of the study, the consent materials should include:

  • a statement that the study is being conducted for research purposes;
  • the purpose of the study;
  • a description of the investigational product, intervention, or procedure, where relevant;
  • information on randomization, including the probability of assignment to different study groups, where applicable;
  • a description of the procedures to be undertaken, including any invasive procedures;
  • instructions or responsibilities expected of participants;
  • a statement where the intervention or procedure is investigational or not yet proven;
  • a description of reasonably foreseeable risks, burdens, or discomforts;
  • any expected benefits to participants or, where applicable, a statement that there may be no direct benefit;
  • information on alternative treatments or procedures, where relevant, including potential risks and benefits;
  • information about compensation, treatment, or medical care available in the event of research-related injury, where applicable;
  • details of any financial reimbursement or compensation for participation;
  • any anticipated costs to participants resulting from participation;
  • a statement that participation is voluntary and that participants may refuse to participate or withdraw at any time without penalty or loss of entitled benefits;
  • a statement explaining how confidentiality of records will be protected;
  • information about who may access research records for monitoring, auditing, or regulatory oversight, in accordance with applicable confidentiality protections;
  • a statement that participants will be informed of any new information that may affect their willingness to continue participation;
  • contact details for obtaining further information about the study, participants’ rights, or research-related injury;
  • the circumstances under which participation may be discontinued by the investigators, where applicable;
  • the expected duration of participation; and
  • the approximate number of participants involved in the study, where relevant.

Not all elements will apply to every study; however, the information provided must be appropriate to the type, complexity, and risk level of the research.

4. Verbal Consent and Waiver of Consent

Where written informed consent is not feasible, verbal consent may be acceptable only if permitted by applicable ethical standards and approved by the responsible ethics committee.

Similarly, a waiver of consent may be acceptable only where it has been formally approved by the relevant ethics committee and is consistent with applicable legal and ethical requirements.

In such cases, authors must explain in the manuscript:

  • why written consent was not obtained or why consent was waived; and
  • which ethics committee approved this approach.

5. Consent for Publication

If a manuscript contains information, images, videos, case details, or other material from which an individual may be identifiable, authors must obtain explicit consent for publication from the participant or the participant’s legal representative.

This applies particularly to:

  • case reports;
  • clinical photographs;
  • radiologic or pathology images linked to identifiable cases;
  • videos;
  • pedigrees; and
  • detailed descriptions of rare conditions or circumstances that may permit identification.

Identifying information must not be published unless publication is scientifically justified and explicit consent for publication has been obtained.

6. Privacy, Confidentiality, and Anonymity

Authors must protect participant privacy and confidentiality at all stages of the research and publication process.

Records that can identify participants must be handled confidentially and in accordance with applicable privacy and data protection laws. Where results are published, reasonable steps must be taken to ensure that participants cannot be identified unless explicit publication consent has been obtained.

Authors are encouraged to follow the privacy and confidentiality guidance of the International Committee of Medical Journal Editors (ICMJE) where applicable.

7. Editorial Review and Documentation

JECA reserves the right to request, at any stage of editorial review:

  • evidence of ethics committee approval;
  • confirmation of informed consent procedures;
  • a redacted sample consent form; and
  • documentation relating to consent for publication.

Failure to provide satisfactory documentation may result in rejection of the manuscript or withdrawal of acceptance.

8. Journal Rights

JECA reserves the right to reject any manuscript where the consent process is unclear, inadequately documented, ethically insufficient, or inconsistent with accepted international standards, even where formal ethics approval has been reported.