Informed Consent Policy

Procedures for obtaining, documenting, updating and withdrawing informed consent to research participation and separate consent to publication of identifiable material.

Contents

1. Purpose and types of consent
2. Information before a decision
3. Obtaining and documenting consent
4. Decision support and representation
5. Modified procedures and consent waivers
6. Recordings, additional purposes and further use
7. Separate consent to identifiable publication
8. Updating and withdrawing consent
9. Keeping evidence and providing it to editors
10. Article statement and editorial verification

01. Purpose and types of consent

This policy explains how authors secure and demonstrate informed consent in research submitted to the journal. It covers surveys, interviews, observation, interventions and the use of identifiable information or materials. The scope of ethics review and general safeguards are set out in Ethical Requirements for Research Involving Human Participants.

Consent is a process of understandable information and voluntary decision-making, not merely a signature. Consent to participate, consent to audio or video recording and specified data uses, and separate consent to publish material through which a person can be recognised must be distinguished. One does not substitute for another; where a common document is used, decisions must appear as separate, clearly labelled items.

Permission from an employer, farm manager or community representative does not replace the decision of a participant capable of making it. An author’s agreement to publish an article and accept its licence is likewise not research-participant consent. Obtaining consent does not remove researchers’ obligations to ensure safety and protect rights.

02. Information before a decision

Before seeking consent, researchers must provide accessible information in a language and format the participant understands. The explanation must suit the study; material conditions must not be hidden in complex legal wording or disclosed only after participation begins. Participant information must cover:

• the research purpose, responsible organisation, research team’s role and reason for inviting the relevant participant group;
• the participant’s expected activities, duration, questions, procedures and recordings; the experimental nature of interventions and available alternatives where applicable;
• foreseeable inconvenience and risks, possible benefits without guaranteeing results, expenses, reimbursement and remuneration; for relevant medical research, treatment and compensation for research-related harm;
• the information collected, purposes of use, who will have access, storage arrangements and the retention period or criteria for determining it, intended transfers and further uses;
• planned publication, the extent of anonymisation and reasonably foreseeable limits to confidentiality, including applicable disclosure obligations;
• the right to decline, skip particular questions and stop participating, how to request data removal and any known limits to removal;
• funding and conflicts of interest material to the decision, researcher contacts and an independent route for concerns about participant rights.

The researcher must allow questions, check understanding of material conditions and provide adequate time to decide. Participants should receive a copy of the information and their decision, or an accessible way to retain them, unless this creates an additional risk for them.

03. Obtaining and documenting consent

Consent must precede the relevant participation or use of information, except for properly authorised exceptions. A trained team member must obtain it; where the participant depends on a researcher, the independent consent arrangements in the participant-protection policy apply. Silence or absence of objection alone does not demonstrate consent.

• Written consent: records must identify the project, information version, agreed activities and date; participant or authorised representative and consent-taker signatures must follow the approved procedure.
• Electronic consent: an explicit participant action, an opportunity to read conditions and ask questions, and a verifiable record of the date and version are required. Pre-ticked boxes are unsuitable. Identity verification must be proportionate to risk and must not collect excessive identifiers.
• Oral consent: permitted where consistent with applicable requirements and the approved procedure. The study record must document the decision’s scope, date and person obtaining consent; a witness or recording is used where required. In medical research, non-written consent must be witnessed and documented under the Declaration of Helsinki.
• Anonymous questionnaires: completion may express consent only under a procedure justified in advance and approved where required, after accessible information and voluntary choice. Submitting a form does not itself justify collecting information without informing the respondent.

Names or signatures should not be collected solely as a formality if this undermines justified anonymity; an acceptable alternative must be established before data collection. Audio recording of the consent process itself must not begin without informing the person and obtaining any necessary permission. Author registration in OJS and submission-checklist confirmations do not replace participant consent.

04. Decision support and representation

Illiteracy, disability or a language barrier does not itself establish inability to consent. Accessible formats, interpretation, further explanation and, where needed, independent assistance must be used. Interpreters and witnesses do not decide for the person and must respect confidentiality.

Where applicable rules require a legally authorised representative’s decision, researchers must verify that person’s authority and record the basis of representation. The participant must receive an explanation at an accessible level and give meaningful assent within their understanding where able. Dissent or resistance must be respected; a line manager is not a legally authorised representative merely by holding that position.

The age for independent consent and permissible exceptions are determined by applicable standards, not a universal age threshold imposed by the journal. If a participant gains independent capacity or the right to consent, their own consent must be sought promptly for continued participation. If capacity is lost, further activity must follow the approved protocol and competent-body guidance; an earlier signature is not unconditional permission to continue any procedure.

05. Modified procedures and consent waivers

Exemption from ethics review, dispensing with a signed form and waiving consent have different meanings. Decisions on each applicable exception, its scope and safeguards must be documented by a competent body before the relevant activity. Researchers, editors and reviewers cannot grant such waivers themselves.

When requesting a modification or waiver, researchers must explain why the usual process is impossible or impracticable and consider less restrictive alternatives. For ordinary waivers in health-related research, CIOMS guidance requires the combined conditions of important social value, infeasibility or impracticability without the exception, and no more than minimal risk. Additional legal and ethical requirements remain applicable. Saving time or seeking more responses is not sufficient justification.

Where deferred consent is permitted for an exceptional medical situation, it must have a specific legal basis and prior protocol approval; consent from a representative or a participant who regains capacity must be obtained at the earliest opportunity. This is not general permission to conduct ordinary research without consent.

Research using covert methods must meet the additional restrictions in the participant-protection policy. A research-consent waiver does not automatically authorise publication of recognisable material. A later letter or signature must not be presented as prior consent; authors must report the actual sequence of events.

06. Recordings, additional purposes and further use

Optional audio or video recording, recontact and additional data uses must be offered as separate decisions. Declining an optional component must not prevent participation in the main study. Where recording or specified processing is genuinely essential to a method, this must be explained beforehand along with available alternatives; an essential procedure must not be labelled optional.

Consent to one project does not authorise every later study, disclosure of raw data or transfer to new recipients. Further use must fall within the communicated purposes, access conditions and safeguards. A new purpose outside the agreed scope requires fresh consent or a properly authorised exception before implementation.

Broad consent to future research is possible only on an appropriate legal and ethical basis, with understandable information about categories of use, restrictions, access governance and ways for participants to raise requests. It is not an unrestricted waiver of rights. Open or controlled access to research material is governed by the Data and Reproducibility Policy.

07. Separate consent to identifiable publication

Where research material reasonably permits identification of a participant, the journal requires separate written consent for publication, including an appropriately documented electronic form. This applies to recognisable photographs, video, voice recordings, case descriptions and quotations that identify someone through context. Consent is required where there is reasonable doubt about anonymity. Unnecessary identifiers must be removed even when consent exists.

Participants must be shown the information and materials intended for publication in their intended context; an identifiable patient must be shown the manuscript. The consent record must identify the materials and version authorised. A material expansion of identifiable content requires updated consent.

Before deciding, participants must be told about open availability online, possible redistribution and reuse. The journal applies CC BY 4.0: this licence permits reuse within the copyright permissions granted, subject to its terms, but does not itself remove privacy or image-related rights. Publication consent must not be framed as a surrender of all personal rights or a guarantee of control over others’ copies.

Without required consent, identifiable material must not be published: it must be omitted or appropriately anonymised without distorting scientific meaning. Inability to contact someone and their silence are not permission. For deceased participants, permissibility and representative authority must be assessed under applicable requirements rather than assuming that relatives can consent.

08. Updating and withdrawing consent

Consent must be reconsidered when procedures, risks, data uses or identifiable publication material change substantially. New information must be provided before changed activities; fresh consent and prior ethics committee approval must be obtained where required. Refusal must not lead to punishment or adverse treatment.

Stopping participation, ending further data use and withdrawing publication permission are different requests. Researchers must clarify the person’s wishes, stop the relevant future activities and explain what can be removed or must be retained on a mandatory basis. After irreversible anonymisation, locating an individual record may be impossible; such limits must be explained before consent, not introduced retrospectively.

If consent to identifiable publication is withdrawn before publication, authors must notify the editorial office immediately; the relevant material must be withheld until the matter is properly resolved. Requests after publication are considered with regard to individual rights and correction and retraction rules, with privacy-protection measures where necessary. Removal of every distributed copy must not be promised, and a request does not automatically require retraction of the entire article.

09. Keeping evidence and providing it to editors

The research organisation and designated records custodian are responsible for authentic, secure evidence; the corresponding author must enable editorial verification. Consent forms, coding keys and participant data must have restricted access. Retention and transfer of responsibility follow applicable requirements, the approved protocol and the Data and Reproducibility Policy, taking mandatory personal-data retention limits into account.

The journal normally receives an author declaration and, on request, a blank example of the form or participant information used. Signed documents containing personal data must not be placed in the article, open supplements or a public repository, or supplied unnecessarily to reviewers.

If a particular consent must be verified, editors will agree a secure, proportionate method: confirmation by the responsible custodian, a redacted copy or another sufficient record. Complete forms must not be sent through ordinary channels without prior arrangements and an appropriate basis. In double-anonymous review, author-identifying information is provided separately to editors; participant information remains protected after publication.

10. Article statement and editorial verification

Consent information must be included in the single research ethics compliance statement required by the Research Ethics Policy, with necessary explanation in the methods. A separate duplicate section is unnecessary. Authors must state the consent and documentation methods, representation where needed, grounds for exceptions, and whether separate consent to identifiable publication was obtained.

If consent was unnecessary, authors must explain the specific basis, for example that the work involved no people or identifiable information or material. If consent was required but waived by a competent body, its name, decision date, reference where assigned and decision scope must be provided. “Not applicable” does not replace a waiver explanation, and committee approval alone does not demonstrate that consent was obtained.

Editors may seek clarification and pause consideration or publication pending verification. Missing explanation does not establish misconduct, but failure to obtain required consent may prevent publication. Suspected false forms or declarations are handled under the Allegations of Misconduct Policy; appeals follow the Complaints and Appeals Policy.

Participants, representatives and authors may contact i_m_jurnal@tiiame.uz, identifying the manuscript or article and describing the concern without unnecessary personal information. This policy does not retrospectively create missing consent: earlier studies are assessed with regard to the requirements of the relevant period and participants’ actual rights.

Ethical and methodological references

These documents are applied according to the nature of the research and their respective scope. Medical guidance does not turn an ordinary survey or interview into medical research. This policy specifies consent procedures and operates alongside the journal’s other ethics policies.

• Principles of Transparency and Best Practice in Scholarly Publishing
• WMA Declaration of Helsinki (2024)
• CIOMS International Ethical Guidelines for Health-related Research Involving Humans (2016)
• ESRC Research Ethics Guidance: Consent
• ESRC Research Ethics Guidance: Research with Children and Young People
• ICMJE Recommendations: Protection of Research Participants
• Creative Commons Attribution 4.0 International (CC BY 4.0)