Ethical Approval Before Research
Studies involving human participants, identifiable human material, personal health data or animals must have appropriate review and approval before the work begins.
Research Ethics
Human Participants
Animal Welfare
Human and Animal Research Guidelines
UnivColl Publications requires manuscripts involving human participants, identifiable human material, personal data or animals to follow responsible ethical review, consent, privacy, welfare and transparent reporting standards before publication consideration.
IEC/IRB
Human research review
Consent
Participant rights and privacy
3Rs
Animal welfare principles
ARRIVE
Animal reporting readiness
Policy Purpose
Protecting Participants, Animals and the Scholarly Record
Ethical oversight is not a formality. It is a core requirement for responsible academic publishing. These guidelines help authors, editors and reviewers assess whether a manuscript involving human or animal research contains the approval, consent, welfare and reporting information needed for fair editorial evaluation.
The publisher does not replace institutional ethics committees, animal ethics committees, legal authorities or regulatory agencies. However, editors may request clarification, supporting documents or institutional confirmation whenever ethical information appears incomplete, inconsistent or uncertain.
Participant Rights and Welfare
Human dignity, privacy, confidentiality, autonomy and voluntary participation must be protected throughout the research and publication process.
Animal Welfare and 3Rs
Animal studies should be justified scientifically and ethically, and should follow replacement, reduction and refinement principles wherever applicable.
Transparent Reporting
Authors must disclose ethics approval, consent, registration where applicable, animal care standards, reporting guidelines, conflicts, funding and limitations.
Scope of These Guidelines
Manuscripts Covered by This Policy
Authors should apply these requirements whenever the study design, data source, participant population, biological material or animal involvement raises ethical, consent, confidentiality or welfare considerations.
- Biomedical and health research involving human participants
- Clinical, public health, psychology, education, sports, nutrition and social science studies involving people
- Research using identifiable human data, images, records, interviews, surveys or biological material
- Case reports or case series containing potentially identifiable personal information
- Laboratory, preclinical or field studies involving live animals
- Research using animal tissues, samples or data where institutional approval is required
- Systematic reviews or secondary analyses where source studies involve human or animal research
- Any manuscript where ethical approval, consent, privacy or welfare may reasonably be relevant
Human Research Requirements
Author Checklist
Ethics Approval, Consent, Privacy and Participant Protection
Human participant research must be planned, conducted and reported with respect for human dignity, autonomy, privacy, confidentiality and appropriate independent ethics review.
Independent Ethics Review
Authors should obtain approval or documented exemption from an Institutional Ethics Committee, Institutional Review Board or other competent independent review body before participant recruitment, data collection or use of identifiable material.
Informed Consent
Participants should receive understandable information about the study purpose, procedures, risks, benefits, confidentiality, voluntary participation and withdrawal rights. Consent should be documented unless a review body has formally approved a waiver.
Privacy and Identifiable Information
Names, initials, hospital numbers, exact addresses, facial images and other identifying details should not be published unless essential and supported by explicit written consent for publication.
Vulnerable Participants
Research involving children, dependent persons, patients, economically vulnerable groups, institutionalized persons or participants with limited decision-making capacity requires additional safeguards and appropriate consent or assent procedures.
Risk-Benefit Statement
Manuscripts should explain how foreseeable risks, burdens and benefits were considered and how participant safety, dignity and confidentiality were protected.
Data and Sample Use
Secondary use of records, datasets, images, specimens or biological material must comply with consent terms, ethics approval, data protection requirements and institutional rules.
Animal Research Requirements
Welfare, Scientific Justification and Transparent Animal Reporting
Manuscripts involving animals must explain why animal use was necessary, how welfare was protected and which institutional or national standards were followed. Editors may request approval letters, welfare details or reporting checklists where needed.
Important editorial position
Animal research that lacks prior approval, adequate welfare safeguards, humane endpoints or transparent reporting may be returned, delayed or declined until the ethical record is clear.
Animal Ethics Approval
Animal research must be approved by the relevant Institutional Animal Ethics Committee, Animal Ethics Committee or competent oversight authority before the study begins. Approval details must be stated in the manuscript.
Scientific Justification
Authors must justify why animals were needed, why the species/model was appropriate, and how the chosen design answers a valid scientific question.
Replacement
Authors should consider non-animal alternatives, in vitro methods, computer modelling, existing datasets or other approaches that avoid animal use where scientifically appropriate.
Reduction
Sample size should be scientifically justified. Experimental design should avoid unnecessary duplication and use the minimum number of animals needed for reliable results.
Refinement
Methods should minimize pain, distress and lasting harm through humane handling, analgesia/anesthesia where relevant, monitoring, humane endpoints and trained personnel.
Transparent Reporting
Authors should report study design, randomization, blinding, outcome measures, animal characteristics, husbandry, procedures, statistical methods and welfare monitoring clearly enough for editorial assessment.
Submission Readiness
Ethics Documents and Article Statements Checklist
Authors should prepare the documents below before submission and should include clear ethics statements in the manuscript. The editorial office may request copies of approval, exemption, consent or welfare documents during screening or review.
| Submission Type | Documents Authors Should Keep Ready | Statement Expected in Article |
|---|---|---|
| Human participant study | Ethics approval or exemption letter; consent statement; privacy/confidentiality statement; protocol or registration details where applicable | Name of ethics committee, approval number/date, consent process, data protection and participant safeguards |
| Case report or identifiable image | Written consent for publication from patient/participant or legally authorized representative | Statement confirming consent for publication and removal/masking of non-essential identifying details |
| Survey, interview or education research | Ethics review/exemption; participant information sheet; consent or waiver; data anonymity plan | Voluntary participation, consent/exemption, confidentiality and data handling statement |
| Clinical trial or intervention study | Ethics approval; trial registration number; consent documents; protocol; reporting checklist when relevant | Registry name/ID, ethics approval, informed consent, protocol availability and registration timing |
| Animal experiment | Animal ethics approval; facility/oversight details; animal welfare protocol; ARRIVE or equivalent checklist when relevant | Approval body and number/date, animal care standards, species/strain/sex/age, housing, procedures and humane endpoints |
| Secondary data or records study | Ethics approval/exemption; data access permission; de-identification method; consent waiver where applicable | Source of data, approval/exemption, privacy safeguards, access restrictions and limitations |
Reporting and Transparency
Clear Reporting Helps Editors, Reviewers and Readers Assess Trustworthiness
Ethical approval alone is not sufficient. The article must also describe the study in enough detail to allow responsible editorial review and scholarly interpretation.
Human Research Reporting
Authors should use discipline-appropriate reporting guidance such as CONSORT for randomized trials, STROBE for observational studies, PRISMA for systematic reviews, COREQ for qualitative research or relevant field-specific checklists.
Clinical Trial Registration
Clinical trials and prospective intervention studies should disclose registration status, registry name, registration number and timing of registration.
Animal Research Reporting
Animal research manuscripts should follow ARRIVE-style reporting expectations, including study design, sample size, inclusion/exclusion criteria, randomization, blinding, outcome measures and statistical methods.
Data and Materials Transparency
Where legally and ethically possible, authors should provide a data availability statement, explain access restrictions and protect participant privacy or animal welfare-sensitive information.
Copy-Ready Declarations
More Declaration Templates
Human and Animal Research Declaration Templates
Authors may adapt these templates according to the actual approval, consent, institution and study details. False, incomplete or misleading declarations may result in rejection, correction, institutional inquiry or post-publication action.
Template
Human Participant Ethics Approval Statement
The study involving human participants was reviewed and approved by [Name of Ethics Committee/Institutional Review Board], approval number [Approval Number], dated [Date]. The study was conducted in accordance with applicable ethical standards and institutional requirements.
Template
Informed Consent Statement
Written/online/verbal informed consent was obtained from all participants before participation in the study. For participants below the age of legal consent or unable to provide consent independently, consent was obtained from a parent/guardian/legally authorized representative and assent was obtained where applicable.
Template
Consent for Publication Statement
Written consent for publication was obtained for any potentially identifiable information, image, case detail or clinical material included in this manuscript. Non-essential identifying details have been removed or anonymized without altering scientific meaning.
Template
Ethics Exemption Statement
The study was reviewed by [Name of Ethics Committee/Institutional Review Board] and was granted exemption/waiver under [Reason/Category], reference number [Reference Number], dated [Date]. The authors confirm that the study involved minimal risk and complied with applicable institutional requirements.
Template
Animal Ethics Approval Statement
All procedures involving animals were reviewed and approved by [Name of Institutional Animal Ethics Committee/Animal Ethics Committee], approval number [Approval Number], dated [Date]. Animal care and experimental procedures followed applicable institutional and national standards for the care and use of animals.
Template
Animal Welfare and 3Rs Statement
The authors considered replacement, reduction and refinement principles in the design and conduct of the study. Measures were taken to minimize animal pain, distress and lasting harm, including [briefly describe anesthesia/analgesia/monitoring/humane endpoints where applicable].
Editorial Handling
How Ethics Information Is Checked During Publication Workflow
UnivColl Publications may screen ethics statements at submission, peer review, revision, acceptance and post-publication stages. The purpose is to protect participants, animal welfare, authors, editors, reviewers and the integrity of the scholarly record.
Before peer review
The editorial office may request missing ethics approval, exemption, consent, trial registration, animal approval or welfare documentation before assigning reviewers.
During peer review
Editors and reviewers may ask for clarification on participant recruitment, consent, confidentiality, animal welfare, statistical design or reporting completeness.
Before acceptance
Manuscripts with unresolved ethical documentation issues may be held until authors provide adequate clarification or institutional confirmation.
After publication
If serious undisclosed ethical concerns arise, the publisher may investigate, request institutional input, publish a correction/expression of concern or consider retraction as appropriate.
Non-Compliance and Editorial Action
Missing or Misleading Ethics Information May Affect Editorial Decisions
Manuscripts may be returned before review, held during revision, declined, corrected after publication or investigated further if authors do not provide adequate ethics approval, consent, exemption, animal welfare or reporting information. Where serious concerns exist, the publisher may seek clarification from authors, institutions, ethics committees, animal ethics committees or other competent authorities. These actions are taken to protect research participants, animal welfare and the reliability of the published record.
Frequently Asked Questions
Human and Animal Research Ethics FAQ
These answers help authors prepare clear and responsible ethics declarations before submitting to journals or publishing programs managed by UnivColl Publications.
Is ethics approval mandatory for every human research manuscript?
Ethics approval or documented exemption is expected for research involving human participants, identifiable human data, biological material, images, records, interventions, surveys or interviews when institutional or legal requirements apply.
Can authors submit a manuscript if ethics approval was obtained after the study?
Retrospective approval is generally not acceptable for studies that should have been approved before participant recruitment, data collection or animal procedures. Authors must provide a clear explanation and institutional documentation for editorial assessment.
What should be done for identifiable patient images or case details?
Authors should remove non-essential identifying details and obtain written consent for publication when any participant, patient or case may reasonably be identifiable.
What is required for animal research submissions?
Authors should provide animal ethics approval details, species/model information, animal care standards, welfare safeguards, humane endpoints and complete reporting of study design and methods.
Can reviewers or editors request ethics documents?
Yes. UnivColl Publications may request approval letters, exemption letters, consent statements, protocols, animal welfare records, reporting checklists or institutional confirmation when needed.
What happens if ethical concerns are found after publication?
The publisher may seek author clarification, contact institutions or ethics bodies, and issue a correction, expression of concern or retraction depending on the seriousness and evidence available.
Policy Pathway
Related Policies, Author Actions and Trust Pages
This policy is connected with UnivColl Publications' wider publishing ecosystem, including author guidance, editorial independence, publication ethics, metadata readiness and official support routes. Use the related links to move to the next practical step without relying on disconnected or informal information.
Author Guidelines
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Authorship Change Request
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Conflict of Interest
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Submit Manuscript
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Policies and Guidelines
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Publication Ethics
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Peer Review Policy
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Contact Publisher
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Transparency and Responsible Publishing
Policy Use Does Not Create Publication or Indexing Guarantees
UnivColl Publications uses policy pages to support transparent communication, fair editorial handling, author awareness and scholarly record integrity. Submission, payment, policy compliance or support communication must not be treated as a promise of acceptance, indexing, citation, ranking or any third-party database outcome.
Publication Ethics
Editorial and publication decisions should remain evidence-based, policy-led and independent.
No Guaranteed Acceptance
Acceptance depends on scope, originality, review suitability, ethical compliance and editorial decision.
Metadata Ready
Published records may be supported with structured metadata, DOI references and correction workflows where applicable.
Documented Support
Queries should include manuscript ID, DOI, transaction reference or policy concern details where available.