Research Ethics Policy

RESEARCH ETHICS POLICY
Research Ethics Policy
 
1. General Principles

The Da Nang Journal of Medicine and Pharmacy (DJMP) is committed to considering and publishing only research conducted in accordance with principles of research ethics, respect for persons, protection of research participants, data confidentiality, scientific integrity, and applicable legal requirements.

For medical research involving human participants, authors must ensure that study planning, conduct, and reporting are consistent with internationally recognized ethical principles, including the World Medical Association Declaration of Helsinki, 2024 revision, together with applicable laws and ethical guidance in the jurisdiction where the research was conducted.

2. Research Involving Human Participants

Research involving human participants must respect:

• The rights, dignity, and safety of participants;
• Autonomy and self-determination;
• Appropriate balance of benefits and risks;
• Privacy and confidentiality;
• Fair selection of participants;
• Appropriate protection of vulnerable individuals and groups.

The rights, welfare, and safety of research participants must take priority throughout the research process.

3. Ethics Committee Approval

For research requiring ethical review, authors must obtain approval from an appropriate research ethics committee, institutional review board, or other authorized independent ethics review body before the study is conducted, in accordance with applicable requirements.

Where applicable, the manuscript should state:

• Name of the ethics committee or approving body;
• Approval number or reference code;
• Date of approval, where applicable;
• Other relevant information as required.

DJMP may request authors to provide the ethics approval document or related supporting documentation during editorial assessment.

4. Exemption from Ethical Review

If a study is exempt from ethical review or approval under the rules of an authorized body, authors must clearly state the basis for the exemption and, when requested, provide supporting documentation.

Authors should not independently determine that a study “does not require ethics review” merely because it is considered low risk.

Where uncertainty exists, DJMP may request clarification or confirmation from an authorized ethics committee or institution.

5. Informed Consent for Participation

Where applicable, participants must be provided with sufficient information and give voluntary, informed consent before participating in research.

The consent process must be appropriate to the study design, participant population, and applicable legal and ethical requirements.

For individuals who are unable to provide valid informed consent, consent from a legally authorized representative and additional protective measures must be obtained where required by applicable ethical and legal standards.

6. Privacy and Confidentiality

Authors must protect the privacy and confidentiality of research participants. Identifying information such as:

• Names;
• Identifiable initials;
• Medical record numbers;
• Addresses;
• Facial images;
• Personal identifiers;
• Other characteristics that may identify a patient or participant.

Such information must not be published unless it is scientifically necessary and appropriate consent has been obtained.

7. Consent for Publication of Identifiable Information

Consent to participate in research and consent for publication are distinct requirements.

Where an article, particularly a case report, case series, or clinical image, contains potentially identifiable patient information or images, authors must obtain appropriate consent for publication, usually in writing.

Masking the eyes in a patient image does not automatically guarantee anonymity. Where there is doubt about whether anonymity can be maintained, appropriate informed consent for publication should be obtained.

8. Vulnerable Participants

Research involving vulnerable populations must include appropriate additional protections. Depending on the context, such groups may include:

• Children;
• Individuals unable to provide valid informed consent;
• Patients dependent on caregivers or healthcare institutions;
• Individuals experiencing socioeconomic disadvantage;
• Groups at increased risk of coercion, exploitation, or undue influence.

Authors must explain the scientific justification for including such groups and ensure that appropriate protections are in place.

9. Research Using Medical Records and Health Data
• Medical records;
• Healthcare databases;
• Electronic health data;
• Personal data;
• Secondary data;
• Registry or biobank data.

Research using these data sources must comply with relevant requirements for ethics, privacy, confidentiality, and data protection.

The fact that data existed before the study does not automatically remove the need for ethical review. Authors must report ethics approval or exemption where applicable.

10. Human Biological Materials

Research involving human tissue, blood, DNA, clinical specimens, or other human biological materials must comply with applicable ethical and legal requirements concerning:

• Collection;
• Storage;
• Use;
• Reuse;
• Sharing;
• Protection of information relating to the individual providing the material.
11. Animal Research

For research involving animals, authors must ensure that the study complies with applicable institutional and national standards for the care and use of animals in research.

The manuscript should report ethics approval for animal research where required.

12. Clinical Trials

DJMP recommends, and where applicable requires, that clinical trials be registered in a publicly accessible registry consistent with international standards and Journal requirements.

The manuscript should provide:

• Name of the trial registry;
• Trial registration number;
• Link or identifying information for the registration record where appropriate.

Clinical trial registration should be completed before or at the time the first participant provides consent to participate.

13. Study Registration and Data Sharing

For study types that require prospective registration, protocol registration, or a data-sharing plan under applicable laws, funders, or standards, authors must provide the relevant registration information.

For clinical trials, DJMP encourages authors to provide a Data Sharing Statement where appropriate.

14. Honest and Complete Reporting

Ethics committee approval does not remove the authors’ responsibility for honest reporting or for ensuring that the study was ethically appropriate.

• Study design and methods;
• Participant selection;
• Interventions;
• Adverse events where relevant;
• Data;
• Results;
• Biases and study limitations.

DJMP retains the right to independently assess whether the conduct and reporting of a study are consistent with the Journal’s ethical standards.

15. Research That Does Not Meet Ethical Requirements

If concerns arise regarding compliance with research ethics, DJMP may:

• Request an explanation from the authors;
• Request the ethics committee approval document;
• Request consent forms or related documentation;
• Suspend peer review or editorial processing;
• Seek expert advice;
• Contact an appropriate institution or authority where necessary;
• Reject the manuscript;
• Take post-publication action if concerns are identified after publication.

The existence of an ethics approval does not obligate DJMP to accept a study if the Journal has reasonable grounds to conclude that the study does not meet appropriate ethical standards.

16. Ethics Statement in Published Articles
Suggested wording where ethics approval was obtained
Research Ethics: This study was approved by the Research Ethics Committee of [institution], approval No. [number/code], dated [date]. Informed consent for participation was obtained in accordance with applicable requirements.
Suggested wording where the study was exempt from ethics review/approval
Research Ethics: This study was confirmed by [ethics committee/institution] as exempt from ethical review/approval, reference No. [if applicable], dated [date].