Ethical Oversight Policy

Digital Health & Telemonitoring Advances is committed to ensuring that research considered for publication is conducted and reported with appropriate respect for human dignity, participant welfare, privacy, confidentiality, scientific integrity, and responsible research practice.

Ethical oversight is treated as an integral component of scholarly evaluation rather than as a procedural formality. Authors are responsible for determining and complying with the ethical, institutional, professional, and legal requirements applicable to their research. Where independent ethics review, informed consent, regulatory authorization, clinical-trial registration, or other ethical approval is required, appropriate information must be reported transparently in the manuscript.

The journal may request supporting documentation where clarification is necessary and may decline, suspend, correct, or otherwise act on a manuscript where substantial ethical concerns remain unresolved.

1. Scope of Ethical Oversight

This policy applies, where relevant, to research involving:

• human participants;

• patients and healthcare users;

• identifiable personal information;

• medical or health records;

• surveys and interviews;

• behavioral or psychological data;

• biological or physiological measurements;

• wearable and sensor-generated information;

• telemonitoring data;

• mobile-health data;

• electronic health records;

• digital biomarkers;

• artificial intelligence and machine-learning datasets;

• clinical interventions;

• digital-health interventions;

• vulnerable populations;

• secondary use of sensitive data;

• medical devices;

• remote-care technologies;

• clinical trials;

• animal research where applicable; and

• other research activities requiring ethical or regulatory oversight.

The type and level of ethical review required may vary according to the study design, jurisdiction, participant population, data involved, and degree of potential risk.

2. Responsibility of Authors

Authors bear primary responsibility for ensuring that their research was conducted ethically and that all required approvals, permissions, and participant protections were obtained before or during the study as applicable.

Authors should ensure that:

• research procedures comply with applicable ethical requirements;

• necessary ethics approval has been obtained;

• informed consent has been obtained where required;

• participant confidentiality has been protected;

• identifiable information is handled appropriately;

• vulnerable populations receive appropriate safeguards;

• data are collected and processed lawfully and ethically;

• conflicts of interest are disclosed;

• ethical limitations are reported transparently; and

• statements concerning ethical approval are accurate and verifiable.

Publication by the journal does not transfer responsibility for ethical compliance from the authors to the editors, reviewers, or publisher.

3. Independent Ethics Review

Research involving human participants or identifiable human data should receive review and approval from an appropriately constituted ethics committee, institutional review board, research ethics committee, or comparable independent body where such review is required.

The manuscript should normally identify:

• the approving committee or review body;

• the institution where appropriate;

• the approval or reference number, where available; and

• relevant approval date or status where necessary.

Authors should not claim that ethical approval was obtained unless such approval was actually granted by the responsible body.

4. Ethics Approval Statement

Where ethics approval applies, the manuscript should contain a clear statement describing the ethical oversight received.

An appropriate statement may include:

This study was reviewed and approved by [Name of Ethics Committee/Institutional Review Board], approval number [XXXX].

Where an approval number was not issued, authors may state this accurately rather than inventing or omitting information.

Editors may request documentary evidence of approval where concerns or ambiguities arise.

5. Research Exempt From Formal Ethics Review

Certain studies may be exempt from formal ethics review under applicable institutional or national rules.

Where authors claim exemption, they should state:

• the reason for exemption;

• the authority or framework under which the exemption applies; and

• whether an institutional ethics body formally confirmed the exemption, where applicable.

Authors should not independently declare a study exempt where formal determination by an ethics body is required in their jurisdiction.

An exemption from committee review does not remove the obligation to conduct and report research responsibly.

6. Retrospective Studies

Retrospective analyses of medical records, administrative data, clinical databases, or previously collected patient information may still require ethical review or formal exemption depending on applicable requirements.

Authors should disclose:

• the source of the data;

• whether ethics approval or exemption was obtained;

• whether informed consent was required or waived;

• how privacy was protected; and

• any restrictions governing access or reuse.

The retrospective nature of a study should not automatically be treated as justification for absence of ethical oversight.

7. Informed Consent to Participate

Where required, participants should provide informed consent before participation in research.

Consent procedures should be appropriate to the:

• nature of the study;

• participant population;

• potential risks;

• data collected;

• planned use of information; and

• applicable ethical and legal framework.

Authors should report whether consent was written, electronic, verbal, or otherwise obtained where this information is relevant to evaluating the study.

Where consent was waived by an authorized ethics body, the manuscript should state this appropriately.

8. Consent for Publication

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

Where a manuscript contains information through which an individual could reasonably be recognized, authors should obtain appropriate consent for publication where required.

Identifiable information may include:

• photographs;

• videos;

• detailed clinical histories;

• distinctive medical circumstances;

• facial images;

• personal quotations;

• audio recordings;

• location information; or

• combinations of details that could permit identification.

Removing a participant's name alone may not be sufficient to ensure anonymity.

9. Privacy and Confidentiality

Authors must protect the privacy and confidentiality of research participants.

Personally identifiable information should not be included in manuscripts, supplementary material, datasets, images, or public repositories unless disclosure is ethically justified, legally permissible, and appropriately consented to.

Authors should apply appropriate safeguards to:

• patient records;

• remote-monitoring data;

• biometric data;

• geolocation information;

• device identifiers;

• contact information;

• health histories;

• behavioral data;

• audio and video recordings; and

• other sensitive personal information.

The principle of data minimization should be considered when reporting participant information.

10. Digital Health and Telemonitoring Data

Research involving telemonitoring systems may generate continuous or highly detailed information about individuals.

Authors should consider ethical issues relating to:

• continuous surveillance;

• collection frequency;

• location tracking;

• device-generated data;

• physiological measurements;

• behavioral monitoring;

• data transmission;

• third-party platforms;

• cloud storage;

• unauthorized access;

• patient awareness;

• data retention; and

• secondary use.

Participants should not be exposed to unnecessary privacy or security risks merely because information is collected through digital technologies rather than conventional clinical methods.

11. Wearable and Sensor Research

Studies involving wearable, implantable, ambient, or connected sensors should consider both physical and informational risks.

Relevant considerations may include:

• safety of the device;

• burden of continuous monitoring;

• reliability of measurements;

• data security;

• informed consent;

• participant autonomy;

• unintended collection of information;

• incidental findings; and

• withdrawal from monitoring.

Authors should explain significant safeguards where these issues are material to the study.

12. Artificial Intelligence and Algorithmic Research

Research involving artificial intelligence, machine learning, predictive algorithms, generative AI, or automated decision systems should receive ethical consideration appropriate to the potential risks involved.

Authors should consider, where relevant:

• origin and lawful use of datasets;

• privacy and confidentiality;

• informed consent;

• demographic representation;

• algorithmic bias;

• discriminatory outcomes;

• fairness;

• transparency;

• explainability;

• model limitations;

• human oversight;

• clinical safety;

• generalizability;

• automation bias;

• potential misuse; and

• consequences of erroneous predictions.

A technically accurate model should not automatically be described as ethically acceptable or clinically safe.

13. Human Oversight of Automated Systems

Where artificial intelligence or automated systems influence clinical recommendations, triage, diagnosis, monitoring, treatment, or other healthcare decisions, authors should describe the role of human oversight where relevant.

The manuscript should distinguish clearly between:

• automated outputs;

• clinician interpretation;

• human decision-making; and

• final responsibility for clinical action.

Research should not obscure meaningful human involvement where this is necessary for safety, accountability, or appropriate interpretation.

14. Vulnerable Populations

Research involving individuals or communities who may have reduced autonomy, heightened susceptibility to harm, or unequal power relationships requires particular ethical attention.

Such populations may include, depending on the context:

• children and adolescents;

• individuals with impaired decision-making capacity;

• economically disadvantaged populations;

• institutionalized individuals;

• patients with serious illness;

• older adults with cognitive impairment;

• marginalized communities; and

• other groups requiring additional safeguards.

Authors should explain relevant protections and justify inclusion of vulnerable populations where appropriate.

15. Research Involving Children and Minors

Studies involving children or minors should comply with applicable ethical and legal requirements.

Where required, authors should obtain:

• permission from a parent or legally authorized representative; and

• assent from the child or minor when developmentally and ethically appropriate.

Digital technologies designed for children may raise additional concerns regarding privacy, behavioral tracking, profiling, targeted communication, and long-term retention of health information.

These issues should be addressed where relevant.

16. Research Involving Individuals With Limited Decision-Making Capacity

Where participants may have impaired or limited capacity to provide informed consent, appropriate safeguards should be implemented.

These may include:

• assessment of decision-making capacity;

• involvement of legally authorized representatives;

• participant assent where possible;

• minimization of risk;

• justification of inclusion; and

• independent ethical review.

The interests and welfare of the participant should remain central to study design and reporting.

17. Surveys, Interviews, and Qualitative Research

Survey, interview, focus-group, and qualitative studies may involve sensitive personal information even where no clinical intervention occurs.

Authors should consider:

• voluntary participation;

• informed consent;

• confidentiality;

• anonymity;

• secure data storage;

• publication of quotations;

• risk of indirect identification; and

• handling of sensitive responses.

Participants should not be identifiable through quotations or contextual details unless appropriate consent has been obtained.

18. Secondary Use of Existing Data

Research using previously collected datasets should respect the conditions under which the data were originally obtained and any applicable restrictions on secondary use.

Authors should consider:

• original participant consent;

• ethics approval;

• data-use agreements;

• data ownership;

• privacy protections;

• licensing conditions; and

• whether re-identification is reasonably possible.

Public availability of data does not automatically eliminate all ethical responsibilities concerning their use.

19. Publicly Available Digital Data

Research involving online platforms, social media, public forums, patient communities, or other digitally accessible information may still raise ethical concerns.

Authors should consider:

• reasonable expectations of privacy;

• sensitivity of the information;

• identifiability of individuals;

• platform terms;

• potential harm;

• consent considerations; and

• whether quotations could enable identification.

The fact that information can technically be accessed online does not necessarily mean that unrestricted research use or republication is ethically appropriate.

20. Medical Records and Electronic Health Records

Studies involving medical records or electronic health records should implement appropriate safeguards for confidential patient information.

Authors should describe, where relevant:

• authorization for access;

• ethics approval or exemption;

• de-identification procedures;

• data security;

• linkage procedures;

• retention;

• consent or waiver; and

• restrictions on data sharing.

Access to clinical records for legitimate care purposes should not automatically be interpreted as authorization to use those records for research.

21. Clinical Trials

Interventional clinical research should comply with applicable ethical, regulatory, and reporting requirements.

Where applicable, authors should provide:

• ethics approval;

• informed consent information;

• trial registration details;

• registration number;

• intervention description;

• predefined outcomes;

• adverse-event information; and

• relevant protocol information.

Applicable clinical trials should be registered prospectively in an appropriate publicly accessible trial registry.

22. Protocol Deviations

Material deviations from an approved study protocol should be disclosed where they affect participant safety, ethical oversight, methodology, or interpretation.

Authors should explain:

• the nature of the deviation;

• why it occurred;

• whether ethics approval for the change was obtained where necessary; and

• its potential effect on the study.

Undisclosed changes that materially affect the interpretation of findings may raise research-integrity concerns.

23. Medical Devices and Digital Therapeutics

Research involving medical devices, digital therapeutics, software used for medical purposes, remote-monitoring devices, or clinically deployed digital systems should comply with applicable ethical and regulatory requirements.

Authors should distinguish clearly between:

• exploratory prototypes;

• research systems;

• validated devices;

• authorized medical products; and

• routine clinical technologies.

Publication in the journal should not be presented as regulatory approval or certification of a product.

24. Patient Safety

Digital-health research should consider foreseeable risks to patient safety.

Potential concerns may include:

• incorrect alerts;

• missed deterioration;

• false reassurance;

• inaccurate sensor measurements;

• delayed clinical response;

• algorithmic error;

• system downtime;

• connectivity failures;

• inappropriate automated advice; and

• overreliance on technology.

Where such risks are relevant, authors should explain how they were assessed and managed.

25. Incidental Findings

Digital monitoring, genomic information, imaging, artificial intelligence, wearable technologies, or large-scale health-data analysis may generate findings beyond the original research objective.

Where foreseeable, researchers should consider how clinically significant incidental findings will be:

• evaluated;

• communicated;

• referred;

• documented; or

• withheld where disclosure would be inappropriate.

The approach should be consistent with the study protocol, informed-consent process, and applicable ethical guidance.

26. Data Security

Authors conducting digital-health research should implement safeguards proportionate to the sensitivity and volume of data collected.

Relevant safeguards may include:

• controlled access;

• encryption;

• pseudonymization;

• de-identification;

• secure transfer;

• access logging;

• authentication;

• restricted storage; and

• appropriate retention procedures.

The manuscript need not disclose technical details that would themselves create security risks.

27. Cross-Border Research and Data Transfer

International digital-health research may involve participants, researchers, servers, healthcare providers, and data processors located in different jurisdictions.

Authors are responsible for considering applicable requirements relating to:

• research ethics;

• data protection;

• cross-border transfer;

• participant consent;

• institutional authorization; and

• data-access agreements.

Compliance with the requirements of one country does not necessarily remove responsibilities arising in another jurisdiction involved in the research.

28. Community and Population-Level Research

Digital public-health research may involve communities or populations rather than individually recruited participants.

Where relevant, authors should consider:

• community interests;

• stigmatization;

• discrimination;

• group privacy;

• representativeness;

• equitable distribution of benefits and risks; and

• potential misuse of population-level findings.

Ethical responsibility may extend beyond protection of individually identifiable participants.

29. Animal Research

Where the journal considers research involving animals in connection with biomedical technology, sensors, devices, or related digital-health applications, authors should comply with applicable institutional and national animal-welfare requirements.

The manuscript should identify relevant ethical approval where required and describe efforts to minimize unnecessary harm.

Animal research should have a clear scientific justification relevant to the journal's scope.

30. Ethical Use of Images, Audio, and Video

Clinical photographs, screenshots, medical images, audio recordings, video recordings, or other identifiable multimedia material should be handled responsibly.

Authors should ensure that:

• publication is ethically justified;

• identifiable information is minimized;

• consent for publication has been obtained where required;

• unnecessary personal information is removed; and

• images have not been manipulated in a misleading manner.

Masking the eyes in a facial photograph may not by itself provide adequate anonymity.

31. Participant Compensation and Incentives

Where participants receive compensation, reimbursement, incentives, devices, subscriptions, or other benefits, the arrangement should not constitute inappropriate pressure to participate.

Significant incentives should be considered as part of the ethical review where applicable.

Authors should disclose relevant arrangements when they are necessary to understand participant recruitment or potential bias.

32. Conflicts of Interest and Ethical Oversight

Financial, commercial, institutional, or personal interests may affect the design or interpretation of digital-health research.

Authors should disclose relevant relationships involving, for example:

• medical-device manufacturers;

• software developers;

• digital-health companies;

• pharmaceutical organizations;

• data providers;

• technology platforms;

• healthcare organizations; and

• research funders.

Disclosure of a conflict does not automatically make research unethical, but transparency is necessary for appropriate editorial assessment.

33. Funding and Sponsor Influence

Authors should disclose the source of research funding and, where relevant, the role of the sponsor.

The manuscript should identify whether a funder or commercial organization participated in:

• study design;

• data collection;

• analysis;

• interpretation;

• manuscript preparation; or

• the decision to submit for publication.

Researchers should retain appropriate scholarly independence when reporting research findings.

34. Ethical Considerations in Industry-Sponsored Research

Research involving commercial digital-health systems, proprietary platforms, medical devices, or industry-owned data may raise additional concerns.

Authors should disclose relevant commercial relationships and should not present marketing or promotional claims as independent scientific conclusions.

Where access to underlying data is restricted by a sponsor, such restrictions should be disclosed where they materially affect research transparency.

35. Ethical Assessment During Editorial Screening

Editors may evaluate whether a manuscript provides sufficient ethical information before it proceeds to peer review.

Where necessary, the editorial office may request:

• ethics approval documents;

• clarification of consent procedures;

• trial registration information;

• evidence of exemption;

• data-use authorization;

• participant-information materials;

• explanation of privacy safeguards; or

• other relevant documentation.

A manuscript may be held from peer review until significant ethical questions have been resolved.

36. Responsibilities of Peer Reviewers

Reviewers should alert the editor confidentially if they identify potential ethical concerns.

These may include:

• absence of required approval;

• inadequate consent;

• participant privacy concerns;

• inappropriate research involving vulnerable groups;

• unsafe intervention procedures;

• questionable data collection;

• undisclosed conflicts of interest;

• potential fabrication of ethics information; or

• other matters affecting ethical acceptability.

Reviewers should not independently contact participants, ethics committees, institutions, or authors regarding suspected ethical concerns unless authorized by the journal.

37. Editorial Independence in Ethical Decisions

Ethical concerns should be assessed independently of:

• author reputation;

• institutional prestige;

• nationality;

• commercial relationships;

• publication fees;

• citation potential; or

• potential publicity.

No manuscript should receive favorable treatment because of commercial or institutional influence.

Similarly, ethical review should not be applied discriminatorily according to the geographic location or professional status of the authors.

38. Ethical Concerns Identified Before Publication

Where a significant ethical concern arises before publication, the journal may:

• request clarification;

• request supporting documentation;

• obtain additional expert advice;

• suspend peer review;

• seek information from the responsible institution;

• reject the manuscript; or

• take another proportionate editorial action.

The appropriate response will depend on the nature of the concern and the available evidence.

39. Ethical Concerns Identified After Publication

Ethical responsibility continues after publication.

Where credible concerns arise regarding participant protection, consent, ethics approval, privacy, data use, clinical safety, or other ethical matters, the journal may conduct further assessment.

Possible outcomes may include:

• clarification;

• correction;

• Expression of Concern;

• retraction; or

• another appropriate post-publication notice.

The journal's objective is to maintain the integrity of the scholarly record while ensuring fair consideration of the evidence.

40. Suspected Fabrication of Ethics Approval

False claims concerning ethics approval, consent, trial registration, or regulatory authorization are treated as serious research-integrity concerns.

Where such concerns arise, the journal may request original documentation and may communicate with the stated ethics body or responsible institution where necessary.

A manuscript may be rejected or a published article subject to post-publication action if materially false ethical information is established.

41. Research Conducted Without Required Approval

Where research appears to have been conducted without ethical approval that was required at the time of the study, retrospective approval may not necessarily resolve the original ethical deficiency.

The journal will consider:

• applicable requirements;

• participant risk;

• institutional findings;

• explanations from the authors;

• whether an exemption genuinely applied; and

• the effect of the concern on the integrity and acceptability of the research.

Each case will be considered on its evidence.

42. Documentation and Verification

Authors should retain relevant ethical documentation for an appropriate period according to institutional, regulatory, and legal requirements.

The journal may request verification where legitimate concerns arise.

Submission of falsified or altered documentation constitutes a serious publication-integrity concern.

43. Complaints and Ethical Concerns

Readers, participants, researchers, institutions, or other stakeholders may raise concerns regarding the ethical conduct of research published or under consideration by the journal.

A concern should, where possible, identify:

• the relevant manuscript or article;

• the ethical issue;

• supporting evidence; and

• sufficient information for reasonable assessment.

Good-faith concerns will be considered on their substance.

44. Confidentiality of Ethical Investigations

Ethical concerns are handled with appropriate confidentiality.

Information may be shared with:

• authors;

• editors;

• independent experts;

• research institutions;

• ethics committees;

• regulatory authorities; or

• other responsible bodies

only where involvement is reasonably necessary for proper assessment or where disclosure is legally required.

The journal will avoid unnecessary public allegations while a matter remains unresolved.

45. Relationship With Research Misconduct

An ethical problem does not automatically establish deliberate research misconduct.

The journal will seek to distinguish among:

• administrative omission;

• misunderstanding of requirements;

• inadequate ethical reporting;

• negligent research practice;

• serious ethical noncompliance; and

• intentional falsification or misconduct.

Where intentional deception or serious research-integrity concerns are suspected, the matter may also be evaluated under the journal's Research Misconduct Policy.

46. Relationship With Data Policies

Ethical oversight of research data should be interpreted together with the journal's Research Data Sharing Policy, Data Availability Policy, and Privacy Policy.

Public data sharing should not override legitimate responsibilities concerning:

• confidentiality;

• participant consent;

• privacy;

• legal restrictions;

• security;

• sensitive health information; or

• third-party rights.

Where unrestricted sharing is ethically inappropriate, authors should state the applicable restriction transparently.

47. Relationship With AI Usage Policy

Where artificial intelligence tools are used in research, authors should also comply with the journal's AI Usage Policy.

Ethical disclosure may be particularly important when AI systems are used for:

• clinical decision support;

• automated diagnosis;

• risk prediction;

• participant recruitment;

• image generation;

• synthetic-data generation;

• data analysis;

• behavioral profiling; or

• patient-facing communication.

Human authors remain responsible for ethical decisions and the accuracy of reported research.

48. Policy Application

Ethical requirements differ among research designs and jurisdictions. The journal therefore does not apply a single procedural requirement indiscriminately to every submission.

Instead, editors consider whether the ethical safeguards and disclosures are appropriate to the nature of the research.

Authors should provide sufficient information to allow reviewers and editors to understand why the chosen ethical approach was appropriate.

49. Responsibilities of Editors

Editors are responsible for:

• considering ethical concerns impartially;

• requesting clarification where necessary;

• maintaining confidentiality;

• seeking specialist advice when appropriate;

• managing conflicts of interest;

• distinguishing reporting deficiencies from serious ethical concerns;

• communicating with institutions where justified; and

• taking proportionate editorial action where ethical problems affect the scholarly record.

Editors should not attempt to replace formal institutional investigations where issues require authority or evidence beyond the journal's legitimate role.

50. Continuing Ethical Responsibility

Publication does not end the ethical responsibilities of authors or the journal.

Authors should notify the journal if they later identify information indicating that:

• consent was invalid;

• participant confidentiality was compromised;

• ethics approval information was inaccurate;

• significant safety information was omitted;

• unauthorized data were used; or

• another material ethical concern affects the publication.

The journal will determine whether clarification or formal post-publication action is necessary.

Commitment to Ethical Research and Publication

Digital Health & Telemonitoring Advances seeks to publish research that combines scientific and technological advancement with respect for participants, patients, communities, data rights, healthcare safety, and responsible scholarly practice.

The journal recognizes that digital health and telemonitoring can create ethical challenges that extend beyond traditional clinical research, particularly in relation to continuous monitoring, artificial intelligence, privacy, cybersecurity, automated decision-making, data reuse, and health equity.

Authors, reviewers, editors, and the publisher share responsibility for identifying and addressing ethical concerns. Through transparent ethical reporting, appropriate independent oversight, participant protection, responsible data practices, and proportionate editorial action, the journal seeks to support trustworthy scholarship and responsible innovation in digital healthcare.