Ethical Oversight of Research

AHRIE (Applied Health Research, Innovation & Education) requires all published research to respect the rights, dignity, safety, welfare, privacy, and autonomy of participating individuals and communities and the welfare of animals used in research.

Ethical responsibility rests with the authors, their institutions, and the bodies that approved and supervised the study. Editorial acceptance does not replace applicable legal, institutional, or professional obligations.

Applicable principles and standards

Research must comply with:

• the laws and regulations of the country in which it was conducted;

• the requirements of participating institutions;

• the decisions of the competent ethics committee;

• the current version of the World Medical Association Declaration of Helsinki;

• international recommendations applicable to the type of research;

• AHRIE’s editorial policies.

No institutional or national authorization may be used to reduce fundamental ethical protections for participants.

Ethics committee approval

Manuscripts reporting research involving humans, personal data, medical records, identifiable biological samples, or animals must report approval by an independent ethics committee when applicable.

The statement must include:

• the committee’s full name;

• its institution;

• the approval number or code;

• the approval date, when available;

• confirmation that the research followed the approved protocol.

Approval must be obtained before the research begins. Retrospective approval granted after a study has started is not equivalent to prior ethical review.

AHRIE may request copies of the approval, protocol, consent documentation, or other records. These materials will be treated confidentially.

Exemption from ethics review

When a committee determines that a study is exempt from review or consent, authors must state:

• the name of the committee or authority granting the exemption;

• the basis for the exemption;

• its documentary reference or number, when available.

Authors must not independently declare a study exempt when regulations require that determination to be made by a competent committee or authority.

Research that may require ethical review

Ethical review is not limited to clinical trials. It may apply to:

• observational and epidemiological studies;

• retrospective research using medical records or databases;

• surveys, interviews, and focus groups;

• educational research;

• community or public-health research;

• qualitative studies;

• secondary use of data or samples;

• studies involving clinical images;

• research conducted through digital platforms, devices, or social media;

• development and evaluation of artificial-intelligence systems using human data;

• research involving vulnerable groups.

When in doubt, authors should consult the appropriate ethics committee before beginning the study.

Informed consent to participate

When required, participants must provide free, prior, understandable, and documented informed consent.

Authors must state in the manuscript:

• whether informed consent was obtained;

• whether it was written, verbal, or electronic;

• who provided it;

• any waiver approved by the ethics committee.

Consent to participate in research does not automatically constitute consent to publish identifiable information.

Refusal to participate or withdrawal of consent must not result in punishment or unjustified loss of rights or care.

Case reports and identifiable information

Clinical case reports and case series require informed consent for publication whenever information, images, or characteristics could enable identification.

The consent process must explain that the material may become publicly available online and accessible internationally.

Authors must:

• remove identifying details that are not scientifically necessary;

• avoid names, initials, medical-record numbers, and unnecessary dates;

• protect photographs, diagnostic images, pedigrees, and clinical descriptions;

• retain consent documentation in accordance with applicable law and institutional policy;

• provide written confirmation to AHRIE that consent was obtained and archived.

Masking only the eye region in a photograph does not guarantee anonymity. When reasonable doubt exists concerning identifiability, consent for publication must be obtained.

Changes made to protect identity must not distort scientific meaning.

Children, adolescents, and other vulnerable populations

Research involving minors must meet applicable requirements for permission from parents or legal representatives and obtain participant assent when appropriate to age, maturity, and applicable regulations.

Additional safeguards must be applied when participants or communities have a limited ability to provide free consent because of medical, cognitive, social, economic, institutional, educational, or cultural circumstances.

The inclusion of vulnerable populations must be scientifically justified and not based solely on convenience of access.

Privacy, confidentiality, and data protection

Authors must implement appropriate measures to protect personal and sensitive data during collection, storage, analysis, transfer, publication, and preservation.

Manuscripts must not contain unnecessary identifiable information. Data use must be compatible with:

• the consent provided;

• the approved protocol;

• personal-data protection legislation;

• institutional and confidentiality agreements;

• AHRIE’s Research Data Policy.

When data cannot be shared publicly for ethical or legal reasons, the restriction must be explained in the Data Availability Statement.

Biological samples, biobanks, and databases

Studies using human samples, biobanks, registries, or databases must report:

• their source;

• applicable ethics approvals;

• the conditions of consent;

• authorization for secondary use;

• privacy and governance safeguards;

• any restrictions on access or reuse.

The acquisition and transfer of materials must be lawful, traceable, and respectful of the rights of participants and source communities.

Clinical trials

Every clinical trial must be prospectively registered, before enrollment of the first participant, in a public registry recognized by the WHO International Clinical Trials Registry Platform or accepted by the ICMJE.

The manuscript must include:

• registry name;

• registration number;

• link to the registry record;

• explanation of any relevant change from the original protocol or registration.

Retrospective registration does not replace prospective registration. When exceptional circumstances exist, authors must explain them, and consideration will remain at the editors’ discretion.

Communities and culturally distinct groups

Research involving Indigenous communities, culturally distinct groups, or historically underrepresented populations must respect their rights, values, and forms of organization.

When applicable, manuscripts should describe:

• community engagement and consultation;

• collective authorization in addition to individual consent;

• agreements concerning the use of data, samples, or knowledge;

• mechanisms for communicating findings;

• safeguards against stigmatization, exploitation, or harmful interpretation.

Animal research

Studies involving animals must:

• have approval from the appropriate institutional committee;

• comply with national and institutional standards for animal care and use;

• scientifically justify the species, design, and number of animals;

• apply the principles of replacement, reduction, and refinement;

• describe welfare, supervision, and handling measures;

• report the study in accordance with the ARRIVE 2.0 guidelines.

The manuscript must identify the committee, institution, and approval code. Unjustified absence of ethics approval may prevent publication.

Environmental and biological safety

Research involving organisms, biological agents, potentially hazardous materials, or environmental effects must comply with applicable biosafety, occupational-safety, and environmental-protection requirements.

Authors must report relevant institutional authorizations when applicable.

Ethical conduct during publication

Authors must immediately report any protocol deviation, relevant event, withdrawal of ethics approval, or matter that could affect the study’s safety, rights, or validity.

Concealing or falsifying approvals, consent, or ethical information will be considered a serious breach.

Editorial assessment

AHRIE may:

• request additional ethics documentation;

• consult independent specialists;

• suspend evaluation while a concern is clarified;

• reject studies that fail to meet ethical requirements;

• contact relevant institutions or committees;

• correct, issue an expression of concern, or retract an article after publication.

Ethics committee approval does not oblige AHRIE to publish a study. The editorial team may determine that research fails to meet the journal’s standards despite institutional approval.