Research Ethics and Informed Consent

 

 

Research Ethics and Informed Consent Policy

Purpose

The XERON Journal of Medical Research (XJMR) is committed to protecting the rights, dignity, safety, privacy, and well-being of human research participants and to promoting the humane treatment of animals used in research.

This policy applies to clinical research, epidemiological studies, public health research, surveys, medical-record reviews, laboratory investigations, medical education research, case reports, case series, research involving biological materials, health databases, and animal studies.

XJMR is guided by the current World Medical Association Declaration of Helsinki, the recommendations of the International Committee of Medical Journal Editors, and relevant guidance issued by the Committee on Publication Ethics. The current official Declaration of Helsinki was adopted in 2024 and replaces earlier versions for current ethical guidance. (ICMJE)

Ethical Approval for Human Research

Research involving human participants, identifiable human biological material, or identifiable health information should receive approval or formal exemption from an appropriately constituted research ethics committee or institutional review board before the study begins, subject to applicable institutional and national requirements.

The manuscript must state:

  • the full name of the approving committee;

  • the institution associated with the committee;

  • approval or reference number;

  • date of approval, where available;

  • whether written or verbal consent was obtained;

  • whether consent was waived; and

  • the reason for any waiver or exemption.

Authors may be required to upload the ethics approval or exemption letter during submission.

Retrospective approval obtained only after completion of a study will not normally be accepted unless the authors provide a justified explanation and evidence that the relevant committee formally reviewed the matter.

COPE advises journals to require a clear ethics statement and to consider ethics approval, participation consent, use of human information and images, and data-sharing requirements. (Publication Ethics)

Required Ethics Statement

Authors should include an ethics statement in the Methodology section.

Example: Approved study

The study was approved by the Institutional Review Board of [Institution] under approval number [Number] on [Date]. Written informed consent was obtained from all participants before enrolment.

Example: Ethics exemption

The Institutional Review Board of [Institution] determined that this study was exempt from formal ethical review under reference number [Number] because [brief reason].

Example: Waiver of consent

The Institutional Review Board of [Institution] approved a waiver of informed consent because the study involved retrospective analysis of anonymised records and presented minimal risk to participants.

Authors must not declare that approval or consent was “not required” without explaining the institutional or legal basis for that determination.

Informed Consent for Participation

Participation in research should ordinarily be voluntary and based on adequate information provided in language that the participant can understand.

Potential participants should be informed about:

  • the purpose of the research;

  • study procedures;

  • expected duration;

  • foreseeable risks and burdens;

  • possible benefits;

  • available alternatives, where relevant;

  • confidentiality arrangements;

  • funding and relevant competing interests;

  • compensation or reimbursement, where applicable;

  • treatment or compensation for research-related harm, where applicable;

  • the voluntary nature of participation;

  • the right to refuse participation; and

  • the right to withdraw without penalty or loss of entitled care.

The 2024 Declaration of Helsinki states that participants capable of providing consent should receive understandable information about the research and be free to refuse or withdraw without reprisal. (WMA)

Written and Verbal Consent

Written informed consent is normally expected for prospective interventional and clinical research.

Verbal consent may be acceptable where:

  • literacy is limited;

  • written consent is culturally inappropriate;

  • written signatures may create risk;

  • the study presents minimal risk; or

  • an ethics committee has approved the alternative process.

Where verbal consent is used, the manuscript should explain:

  • why written consent was not obtained;

  • how information was provided;

  • how consent was documented;

  • whether a witness was present; and

  • whether the procedure was approved by an ethics committee.

Waiver of Informed Consent

A waiver of consent may be accepted only when approved by an appropriate ethics committee or otherwise permitted under applicable regulations.

The manuscript should explain:

  • why obtaining consent was impracticable;

  • why the research presented no more than minimal risk;

  • how privacy and confidentiality were protected;

  • whether identifiable information was used; and

  • which committee authorised the waiver.

The journal may request documentation supporting the waiver.

Children and Adolescents

Research involving children requires appropriate safeguards.

Authors should report:

  • consent from a parent or legally authorised representative;

  • assent from the child where the child was capable of providing it;

  • the age or developmental criteria used for assent;

  • how information was adapted for the child;

  • whether dissent was respected; and

  • approval from the relevant ethics committee.

Parental permission does not replace the need to seek the child’s assent when the child has sufficient understanding.

Adults Unable to Provide Consent

Research involving individuals who cannot provide valid informed consent requires additional protection.

Consent should normally be obtained from a legally authorised representative. Where the participant can express a preference or provide assent, that preference should be considered and dissent should be respected.

Research involving participants unable to consent should be scientifically justified and approved by an ethics committee. The 2024 Declaration of Helsinki permits carefully regulated research without prior consent in limited circumstances, including certain urgent situations, only where the protocol justifies the inclusion and prior ethics approval has been obtained. (WMA)

Vulnerable Individuals and Communities

Authors must give special consideration to participants who may be vulnerable because of:

  • age;

  • illness or disability;

  • dependency on healthcare providers;

  • limited decision-making capacity;

  • poverty or displacement;

  • institutionalisation;

  • social or educational disadvantage;

  • unequal power relationships; or

  • emergency circumstances.

The manuscript should explain:

  • why inclusion was necessary;

  • what additional protections were used;

  • how coercion or undue influence was avoided;

  • whether compensation was proportionate; and

  • how the research addressed the health needs of the population involved.

The current Declaration of Helsinki emphasises fair inclusion, additional safeguards, and careful assessment of how research benefits, risks, and burdens are distributed. (WMA)

Consent for Publication

Consent to participate in research is different from consent to publish identifiable information.

Written consent for publication must be obtained when an article contains information through which an individual could reasonably be identified, including:

  • clinical photographs;

  • facial images;

  • radiological images containing identifiers;

  • videos or audio recordings;

  • genetic pedigrees;

  • detailed case histories;

  • rare diagnoses or circumstances;

  • dates, locations, occupations, or family details; and

  • combinations of information that could reveal identity.

This requirement applies particularly to case reports and case series.

COPE recommends obtaining publication consent whenever an individual or group may be identifiable, including in reports involving deceased individuals. (Publication Ethics)

Case Reports and Case Series

Authors submitting a case report or case series must confirm that written consent for publication was obtained from:

  • the patient;

  • a parent or legal guardian;

  • a legally authorised representative; or

  • an appropriate representative for a deceased individual.

The manuscript should include:

Written informed consent for publication of the clinical details and related images was obtained from the patient or the patient’s legally authorised representative.

Authors should retain the original signed consent form securely. XJMR will normally require the authors to confirm that valid consent is held rather than routinely collecting and storing the signed document. The journal may request evidence or a blank copy of the form where verification is necessary. This approach is consistent with COPE guidance on medical case reports. (Publication Ethics)

Deceased Patients

The death of a patient does not remove confidentiality and privacy considerations.

Consent for publication should normally be obtained from an authorised representative or next of kin where identifiable details are included.

Authors should:

  • minimise identifying information;

  • consider the interests of surviving relatives;

  • avoid unnecessary disclosure;

  • comply with applicable legal and institutional requirements; and

  • explain how publication consent was addressed.

Patient Privacy and Anonymisation

Authors must remove unnecessary identifying information from manuscripts and supplementary files.

The following should not be included unless scientifically essential and specifically authorised:

  • names;

  • initials;

  • hospital registration numbers;

  • national identity numbers;

  • complete dates of birth;

  • exact addresses;

  • telephone numbers;

  • identifiable signatures;

  • unmasked facial images; or

  • metadata embedded in images or files.

Simply covering the eyes in a photograph may not provide adequate anonymisation.

Changing or inventing patient details to prevent identification is not acceptable when doing so would make the report inaccurate. Instead, authors should remove unnecessary details and obtain appropriate consent.

Medical Records and Retrospective Studies

Studies based on medical records, hospital databases, registries, or routinely collected clinical information should include:

  • ethics approval or formal exemption;

  • information about consent or its approved waiver;

  • explanation of data access;

  • data anonymisation or pseudonymisation procedures;

  • confidentiality safeguards; and

  • justification for the variables collected.

Permission from a hospital department or data custodian does not automatically replace independent ethics review where such review is required.

Surveys, Interviews and Questionnaires

Research involving questionnaires, interviews, focus groups, online surveys, or educational assessments may require ethics approval depending on the participants, data collected, risk level, and applicable institutional requirements.

Authors should describe:

  • recruitment methods;

  • consent procedures;

  • whether participation was voluntary;

  • protection of participant identity;

  • collection of sensitive information;

  • storage and access to recordings or transcripts; and

  • ethics approval or exemption.

Publicly Available and Secondary Data

Use of publicly accessible or previously collected data does not automatically remove ethical responsibilities.

Authors should report:

  • the source of the data;

  • conditions under which data were accessed;

  • whether the data were fully anonymised;

  • whether ethical approval or exemption was obtained;

  • whether secondary use was covered by the original consent; and

  • any restrictions imposed by the data provider.

Research using identifiable or re-identifiable data, biological materials, biobanks, or linked databases may require specific consent and ethical oversight. The 2024 Declaration of Helsinki addresses consent and ethics oversight for storage and foreseeable secondary use of identifiable or re-identifiable information and biological material. (WMA)

Clinical Trials

Prospective clinical trials should be registered in an acceptable public trial registry before or at the time of enrolment of the first participant.

The manuscript should include:

  • registry name;

  • registration number;

  • registration date;

  • date of first participant enrolment;

  • ethics approval details; and

  • any explanation for retrospective registration.

XJMR may request the trial protocol, statistical analysis plan, registration record, ethics documentation, and CONSORT checklist.

ICMJE recommends prospective public registration of clinical trials and requires trial registration as a condition of consideration by journals following its registration policy. (ICMJE)

Research Conducted During Emergencies

Emergency or disaster-related research must not bypass ethical review merely because the situation is urgent.

Authors should explain:

  • why the research could not be delayed;

  • how consent was obtained or waived;

  • how participants unable to consent were protected;

  • what risks were involved;

  • how clinical care remained the priority; and

  • what ethics committee approved the protocol.

Animal Research

Research involving animals must receive prior approval from an appropriate animal ethics or institutional animal care committee.

The manuscript should report:

  • name of the approving committee;

  • approval number;

  • animal species and source;

  • housing and care arrangements;

  • anaesthesia and analgesia;

  • methods used to minimise pain and distress;

  • humane endpoints;

  • method of euthanasia, where applicable; and

  • relevant animal-research reporting guideline.

The journal may reject animal research where the scientific objective does not justify the harm or where appropriate approval and welfare protections are absent.

COPE states that animal research normally requires appropriate ethics approval and that journals should publish clear requirements for ethical statements. (Publication Ethics)

Medical Education Research

Studies involving students, trainees, faculty members, or employees must address potential power imbalances.

Authors should explain:

  • who recruited participants;

  • whether participation affected grades, employment, assessment, or progression;

  • how voluntary participation was protected;

  • whether supervisors had access to identifiable responses;

  • how confidentiality was maintained; and

  • whether an ethics committee approved or exempted the research.

Quality Improvement, Audit and Service Evaluation

Clinical audit, quality improvement, and service evaluation may be governed differently from formal research.

Authors must provide:

  • the institutional classification of the project;

  • confirmation from the relevant authority;

  • ethics approval or exemption where applicable;

  • patient-consent arrangements;

  • data-protection measures; and

  • an explanation of any intervention introduced.

Labelling a project as an audit or quality-improvement activity does not remove the need for ethical review where participants are exposed to research-related risk.

Community and Participant Engagement

Where appropriate, researchers should involve participants or communities in:

  • identifying research priorities;

  • designing the study;

  • developing consent materials;

  • selecting acceptable procedures;

  • interpreting findings; and

  • communicating results.

The 2024 Declaration of Helsinki gives greater emphasis to meaningful engagement with potential participants, enrolled participants, and relevant communities before, during, and after research. (WMA)

Editorial Verification

XJMR may request:

  • ethics approval or exemption letters;

  • study protocols;

  • consent documents;

  • blank publication-consent forms;

  • trial-registration records;

  • permissions from data custodians;

  • evidence of prospective approval;

  • anonymisation procedures; or

  • clarification directly from an ethics committee or institution.

Submission of an ethics approval letter does not guarantee acceptance. Editors may reject a study where ethical safeguards appear inadequate despite formal approval.

Ethical Concerns

Where ethical concerns arise, the journal may:

  • suspend editorial processing;

  • request clarification from the authors;

  • contact all authors;

  • obtain specialist ethics review;

  • request supporting documentation;

  • contact the relevant ethics committee;

  • refer the matter to the authors’ institution;

  • reject the manuscript;

  • publish a correction or expression of concern; or

  • retract a published article where necessary.

The journal will follow a fair process and allow authors an opportunity to respond before reaching a decision, except where immediate action is necessary to protect participants or readers.

Author Declaration

By submitting a manuscript, the authors confirm that:

  • applicable ethical requirements were followed;

  • approval or formal exemption was obtained where required;

  • informed consent was appropriately obtained or waived;

  • participant privacy was protected;

  • consent for publication was obtained where identification was possible;

  • clinical trials were registered where applicable;

  • animal welfare requirements were followed; and

  • all ethics statements provided to the journal are accurate.

False, altered, or misleading ethics and consent documentation may result in rejection, institutional notification, correction, or retraction.

Contact for Research Ethics Enquiries

Research Ethics Contact
XERON Journal of Medical Research
Published by XERON Medical Research

Email: majidhurmaz@yahoo.com
Website: xeronclub.com/ojs2/index.php/XJMR
Country: Pakistan