Declarations and Ethical Considerations
Ethical Considerations
This section must provide statements ensuring compliance with ethical standards for research involving human or animal subjects. If your manuscript includes studies with human participants, animals, or case reports/case series, you are required to include the following: Ethical Approval: Authors must specify the name of the Ethics Committee or Institutional Review Board (IRB) that provided approval for the study, along with the corresponding approval number or ID. | ![]() |
Ethical Waivers: If an ethical waiver was obtained for the study, this must be clearly mentioned, including the justification for the waiver. Additionally, authors must confirm that the research was conducted in accordance with the principles of the Declaration of Helsinki, revised in 2013, or equivalent ethical standards.
Informed Consent: Authors are required to state that written informed consent was obtained from all participants involved in the study. If the journal requests documentation of consent, these must be provided. In cases where verbal informed consent was obtained, the authors should provide reasons for why written consent could not be obtained.
Consent for Minors or Vulnerable Populations: For case reports or case series involving minors, children, or infants, authors must confirm that informed consent was obtained from legally authorized representatives, parents, or guardians. If verbal consent was obtained in these cases, the reasons for this must also be stated.
Privacy and Confidentiality: As part of the right to privacy, identifying details of participants—such as names, initials, images, or hospital numbers—should not be included in recordings, descriptions, or photographs unless it is scientifically necessary. If such information is essential, authors must ensure that written informed consent has been obtained from the participants. If consent has not been acquired, all identifying information must be removed from the manuscript and supplementary materials prior to submission.
Guidelines for Ethical Statements
| Subject | Scenario | Suggested Statement of Compliance |
|---|---|---|
| Animals: Include the statement of compliance with standards of research involving animals. | If your research includes animals, you must include a compliance statement in line with the standards for animal research. | "All procedures performed in studies involving animals were in accordance with international, national, and/or institutional guidelines for the care and use of animals." |
| If your study did not involve animals, but there is an assumption that animals could have been used. | "This article does not involve any studies on animals conducted by the authors." | |
| Humans: Include the statement of compliance with standards of research involving humans. | If your study does not include human participants, a statement should still be provided. | "This article does not involve any studies on human participants conducted by the authors." |
| If your research involves human participants (such as survey or interview a are conducted with human participants) and required ethics approval. | "An application for ethical approval was submitted to the [Ethics Committee/Institutional Review Board], and approval was granted on [date]. The ethics approval number is [approval number]." | |
| If your research involved human participants but you received an ethics waiver. | "Ethical approval for this study was waived by the [Ethics Committee/Institutional Review Board] due to [reason for waiver]. The waiver number is [waiver number]." | |
| Additional Statements: If your research involves humans, two additional statements must be included. | Include statements on adherence to ethical standards and informed consent. | "All procedures involving human participants complied with the ethical standards of the institutional and/or national research committees, and followed the guidelines of the 1964 Helsinki Declaration and its later amendments." "Informed Consent: [Written/Verbal] informed consent was obtained from all participants. If verbal consent was obtained, the reason(s) for not obtaining written consent must be provided." |
Acknowledgements Structure
Acknowledgements
The Acknowledgements section should appear after the Conclusions section and must include formal and required statements of gratitude and disclosures. This section acknowledges those who contributed to the research but do not meet the criteria for authorship. Contributions may include intellectual assistance, technical support (including writing and editing), or provision of special equipment or materials. It is the author's responsibility to ensure that everyone named in the Acknowledgements has agreed to be mentioned.
In addition to acknowledgements, authors should provide the following information under separate subheadings:
- Competing Interests
- Author Contributions
- Funding Information
- Data Availability Statement
- Disclaimer
Competing Interests
This section should disclose any competing interests that might influence or bias the research presented in the manuscript. If none exist, authors should explicitly state this. If the journal has specific policies on competing interests, those should be followed.
For example:
- "The authors declare that they have no competing interests."
Alternatively, if there are competing interests:
- "The author(s) [specify] received funding from [source] that may influence the findings in this study. The author(s) have fully disclosed these interests and an approved management plan is in place to mitigate potential conflicts."
Some Examples of Competing Interest Statements
| Scenario | Suggested Competing Interest Statements |
|---|---|
| Example 1 | "The authors declare that they have no financial or personal relationships that could have inappropriately influenced the content of this article." |
| Example 2 | "The authors have disclosed a financial and/or business interest in [company/entity] that may be affected by the results of this publication. They have fully disclosed these interests and implemented a plan approved by the institution to manage any potential conflicts of interest." |
| Example 3 | "[Author initials] developed the theoretical framework, performed the analytical calculations, and conducted the numerical simulations. Both [author initials] contributed to the final manuscript. [Author initials] supervised the project." |
| Example 4 | "[Author initials] and [author initials] conceived and designed the experiments. [Author initials] and [author initials] conducted the experiments, simulations, and sample preparation. [Author initials] took the lead in writing the manuscript, while all authors provided critical feedback and contributed to the analysis." |
| Example 5 | "[Author initials] and [author initials] designed the computational framework and performed the calculations. Both [author initials] contributed to the manuscript, while [author initials] led the overall study design and direction." |
| Example 6 | "[Author initials] designed and conducted the experiments, derived the models, and performed the data analysis. [Author initials] assisted with specific measurements and simulations. The manuscript was co-authored by all contributors in consultation with each other." |
| Example 7 | "[Author initials] devised the project, developed the conceptual framework, and performed most of the technical calculations for the suggested experiment. [Author initials] validated the numerical results. All authors contributed to discussions and manuscript writing." |
| Example 8 | "[Author initials] and [author initials] designed the study. [Author initials] and [author initials] performed the experiments and simulations. The data was analyzed by [author initials] and the paper was drafted with contributions from all authors." |
| Example 9 | "[Author initials] and [author initials] directed the research project. [Author initials] conducted the experiments and analyzed the data. Theoretical framework development and manuscript writing were led by [author initials] with input from all team members." |
| Example 10 – Funding | "The authors, [author initials], have received research funding from [organization/entity] for this study. [Author initials] also serves as a consultant to [company/entity] related to this research. The terms of this relationship have been reviewed and approved by [institution] in line with their conflict of interest policy." |
| Example 11 – Support | "[Author initials] received research support from [sponsor], including equipment provided by [entity]. [Author initials] also has an equity interest and serves as a consultant for [entity]. The institution has reviewed and approved this arrangement to ensure objectivity in research." |
| Example 12 – Editorial Board Member (before peer review) | "[Author initials] serves as a member of the editorial board for this journal but has no other competing interests to declare." |
| Example 13 – Editorial Board Member (after peer review) | "The authors declare that they have no financial or personal relationships that could have inappropriately influenced the writing of this article. [Author initials], who serves as a member of the editorial board for this journal, was not involved in the peer review or decision-making process for this manuscript." |
Author Contributions Statements
All authors must meet the criteria for authorship as outlined by the authorship policy and author contribution statement guidelines. Below are examples of how authorship contributions may be outlined. Please adapt them to match your specific situation.
| Scenario | Suggested Author Contribution Statements |
|---|---|
| Example 1 | [Author initials] and [Author initials] conceived the initial idea for the research. [Author initials] developed the theory and carried out the computations. [Author initials] and [Author initials] verified the analytical methods. All authors discussed the results and contributed to the final manuscript. |
| Example 2 | [Author initials] and [Author initials] performed the experiment. [Author initials] wrote the manuscript with support from [Author initials]. [Author initials] and [Author initials] fabricated the [specific sample], and [Author initials] supervised the project. |
| Example 3 | [Author initials] developed the theoretical framework, performed the analytical calculations, and conducted the numerical simulations. Both [Author initials] and [Author initials] contributed to the final version of the manuscript. [Author initials] supervised the project. |
| Example 4 | [Author initials] and [Author initials] conceived and designed the experiments. [Author initials] and [Author initials] performed the experiments and planned the simulations. [Author initials] prepared the samples, and [Author initials] analyzed the data. [Author initials] took the lead in writing the manuscript, with feedback from all authors. |
| Example 5 | [Author initials] and [Author initials] designed the model and computational framework, then analyzed the data. [Author initials] performed the calculations and led the manuscript writing. [Author initials] supervised the research and was responsible for the study’s overall direction and planning. |
| Example 6 | [Author initials] designed and performed the experiments, derived the models, and analyzed the data. [Author initials] assisted with [specific measurements], while [Author initials] helped carry out the [specific simulations]. [Author initials] and [Author initials] wrote the manuscript in consultation with [Author initials]. |
| Example 7 | [Author initials] conceived the project and developed the main conceptual ideas. [Author initials] performed the majority of the technical calculations for the proposed experiment. [Author initials] verified the numerical results, and [Author initials] proposed additional experimental validation. All authors contributed to writing the manuscript. |
| Example 8 | [Author initials] and [Author initials] designed the study. [Author initials] and [Author initials] performed the [specific experiments]. [Author initials] and [Author initials] conducted the simulations. [Author initials] analyzed the data, and [Author initials] wrote the paper with input from all authors. |
| Example 9 | [Author initials] and [Author initials] directed the project, performed the experiments, and analyzed the data. [Author initials] and [Author initials] created the simulations. [Author initials] developed the theoretical framework. All authors contributed to writing the article. |
| Example 10 | [Author initials] performed the measurements, [Author initials] and [Author initials] supervised the project, and [Author initials] processed the experimental data. [Author initials] performed the analysis, drafted the manuscript, and designed the figures. [Author initials] manufactured the samples, and [Author initials] characterized them using [specific techniques]. All authors contributed to the final manuscript. |
| Example 11 | [Author initials] and [Author initials] contributed to the research design, data analysis, and manuscript writing. All authors provided input to the final version of the manuscript. |
Funding Information Statements
All research articles must include a funding acknowledgment statement under the heading "Funding Information". The name of the funding agency should be written out in full, and the grant number should be included in square brackets.
Below are examples of how funding information can be presented:
| Scenario | Suggested Funding Statements |
|---|---|
| Example 1 | "The author(s) acknowledge receipt of the following financial support for the research, authorship, and/or publication of this article. This work was supported by the [Medical Research Council] under grant number [specify]." |
| Example 2 | "This research was funded by [organization/entity/trust], grant number [specify], with additional support from the [fund/institution], grant number [specify], and [council], grant number [specify]." |
| Example 3 | "The authors received no financial support for the research, authorship, and/or publication of this article." |
Data Availability Statements
All research articles must include a Data Availability Statement. Below are examples of how to format the data availability information based on different scenarios:
| Availability of Data | Suggested Data Availability Statements |
|---|---|
| Data openly available in a public repository with DOIs | "The data supporting the findings of this study are openly available in [repository name, e.g., ‘figshare’] at [http://doi.org/DOI], reference number [reference number]." |
| Data openly available in a public repository without DOIs | "The data supporting the findings of this study are available in [repository name] at [URL], reference number [reference number]." |
| Data derived from public domain resources | "The data supporting the findings of this study are available in [repository name] at [URL/DOI], reference number [reference number]. These data were derived from the following public domain resources: [list resources and URLs]." |
| Data available within the article or its supplementary materials | "The authors confirm that the data supporting the findings of this study are available within the article and/or its supplementary materials." |
| Data generated at a central, large-scale facility, available upon request | "Raw data were generated at [facility name]. Derived data supporting the findings of this study are available from the corresponding author, [initials], upon reasonable request." |
| Embargo on data due to commercial restrictions | "The data supporting the findings of this study will be available in [repository name] at [URL/DOI] after a [6-month] embargo following the date of publication to allow for the commercialisation of research findings." |
| Data available on request due to privacy/ethical restrictions | "The data supporting the findings of this study are available from the corresponding author, [initials], upon request. Due to [privacy/ethical] restrictions, the data are not publicly available." |
| Data subject to third-party restrictions | "The data supporting the findings of this study are available from [third party]. Data restrictions apply due to the terms under which the data were obtained. Data are available [from the authors/at URL] with permission from [third party]." |
| Data available on request from the authors | "The data supporting the findings of this study are not openly available due to [sensitivity reasons, e.g., human subject data] and can be requested from the corresponding author, [author initials], subject to [repository access conditions]." |
| Data sharing not applicable – no new data generated | "Data sharing is not applicable to this article as no new data were created or analyzed during this study." |
Disclaimer Statement
A disclaimer should indicate that the views expressed in the submitted article are solely those of the author(s) and do not represent the official stance of their affiliated institution or funding body.
| Scenario | Suggested Disclaimer Statement |
|---|---|
| Example 1 | "The views and opinions expressed in this article are those of the [author/authors] and are the result of independent professional research. These views do not necessarily represent the official policy or position of any affiliated institution, funder, agency, or of the publisher. The [author/authors] are solely responsible for the article’s content, findings, and conclusions." |
Some Frequently Asked Questions
Q1. What are Competing Interests, Author Contribution, Funding, Data Availability, and Disclaimer Statements, and Why Are They Important?
These types of statements are essential for transparency and ethical rigor in academic research and publishing. They provide clarity on the roles, funding, conflicts of interest, data accessibility, and disclaimers related to the work. Here's why each is important:
| 1. Competing Interest Statements: This statement declares whether any author has financial or non-financial interests that could be perceived as influencing the research outcomes. It is crucial to avoid any conflicts of interest that may undermine the credibility or impartiality of the research. | Example: "The authors declare no competing financial interests. Author A received a grant from [Organization X], but this funding did not influence the design, conduct, or reporting of this research." |
| 2. Author Contribution Statements: This statement outlines the specific contributions each author made to the research. It’s essential for recognizing individual roles and avoiding disputes over authorship. It also ensures accountability for the research process. | Example: "Author A conceptualized and designed the study. Author B conducted the formal analysis and drafted the manuscript. Author C provided supervision and critical revisions. All authors approved the final version of the manuscript." |
| 3. Funding Statement: This provides transparency about the sources of financial support for the research. It helps readers understand the financial backing behind the study and whether any sponsor may have influenced the research's design or outcomes. | Example: "This work was supported by [Funding Body] under grant number [XXXXX]. The funding agency had no role in the study design, data collection, or decision to publish the results." |
| 4. Data Availability Statement: This informs the reader where and how the data underlying the research can be accessed. It is critical for ensuring the reproducibility and transparency of research findings. | Example: "The data that support the findings of this study are available in [Data Repository] at [DOI or URL], with access provided under the terms of [data sharing agreement or license]." |
| 5. Disclaimer: A disclaimer clarifies that the views or opinions expressed in the research are those of the authors and do not necessarily reflect the views of the institution or funding body. It serves to limit liability and clarify authorship responsibility. | Example: "The views expressed in this article are solely those of the authors and do not represent the views of [Institution or Sponsor]. The sponsor had no influence on the content of this publication." |
Why These Statements Are Important:
- Transparency: They allow readers to evaluate potential biases or conflicts of interest.
- Accountability: They clarify individual contributions and responsibilities.
- Reproducibility: Data availability and funding disclosures ensure that other researchers can verify findings.
- Legal and Ethical Compliance: Disclaimers and competing interest statements align with publication ethics and protect the research from legal complications.
These statements are often required by journals to ensure the integrity and openness of scholarly communication, allowing the scientific community to trust the research outcomes.
Q2. What are Ethical Considerations in Research and Why Are They Important?
Ethical considerations in research refer to guidelines and protocols that ensure the safety, well-being, and rights of research participants—whether human, animal, or otherwise. These considerations also maintain the integrity and transparency of the research process. Ethical approval is usually granted by an Institutional Review Board (IRB) or Ethics Committee, and it ensures that the research meets legal, social, and moral standards.
Ethical considerations are important for several reasons:
- Protecting Participants: Ensures that participants are not subjected to harm, exploitation, or violations of privacy.
- Compliance with Laws: Guarantees that research adheres to local and international regulations and ethical guidelines.
- Maintaining Public Trust: Demonstrates that the research is conducted in a responsible and morally acceptable manner, which is essential for credibility.
- Preventing Misuse: Avoids misuse of data and ensures respect for human dignity and animal welfare.
Examples of Writing Ethical Considerations
| 1. Ethical Considerations: Research animals and/or animal-derived materials that require ethical approval | Example Statement: "This study involved the use of animal-derived materials. Ethical approval was obtained from the [Institutional Animal Care and Use Committee (IACUC)] at [University/Research Institute], with protocol number [XXXXXX]. The research adhered to the [specific ethical guidelines or regulatory standards], and all efforts were made to minimize animal suffering." |
| 2. Ethical Considerations: Human embryos, gametes and/or stem cells | Example Statement: "The research involved human embryos and stem cells, and ethical approval was granted by the [Ethics Committee] under the protocol [XXXXXX]. All procedures were conducted following the [Country-specific guidelines, e.g., UK Human Fertilisation and Embryology Authority (HFEA)] guidelines, ensuring that informed consent was obtained from all donors." |
| 3. Ethical Considerations: Human research participants | Example Statement: "This study involved human participants, and ethical approval was obtained from the [University/Institution’s Ethical Review Board] (Protocol Number: [XXXXXX]). All participants provided informed consent prior to their involvement, and their anonymity and confidentiality were ensured throughout the study. The study adhered to the principles of the Declaration of Helsinki." |
| 4. Ethical Considerations: Waiver received as research was not human or animal research, or the study was determined to be on non-human subject research (e.g., use of historical archives) | Example Statement: "No ethical approval was required for this study as it did not involve human or animal subjects. The research utilized historical archives and was exempt from ethics approval, as confirmed by the [Ethics Committee] under waiver number [XXXXXX]. All sources of archival data were publicly available." |
These statements are used in academic papers to ensure that the research has followed ethical guidelines, highlighting the approval or exemption obtained. Including these sections is important to gain trust from the scientific community, the general public, and potential collaborators.
Q3. When Are Ethical Consideration Statements Required?
Ethical consideration statements are required whenever research involves human participants, animals, sensitive materials (such as embryos, stem cells, or personal data), or any other ethical implications. These statements ensure that the research adheres to ethical standards and regulations, protecting the rights and welfare of those involved in the study.
Here’s a breakdown of when such statements are necessary:
- Research Involving Animals or Animal-Derived Materials: When research involves animals or materials derived from animals, ethical approval from an Institutional Animal Care and Use Committee (IACUC) or equivalent is required. Researchers must show that their study minimizes harm and follows ethical guidelines for the humane treatment of animals.
- Research Involving Human Embryos, Gametes, or Stem Cells: Studies involving these highly sensitive materials must be approved by a specialized ethics board (such as the Human Fertilisation and Embryology Authority in the UK). These materials are considered ethically sensitive due to their potential to become human life, so rigorous ethical oversight is essential.
- Research Involving Human Participants: If human subjects are involved, researchers must obtain approval from an Institutional Review Board (IRB) or Ethics Committee. The statement should confirm that the study was conducted according to ethical guidelines (e.g., the Declaration of Helsinki) and that participants' informed consent was obtained, ensuring their privacy and well-being.
- Non-Human or Non-Animal Research (e.g., Historical Archives): Even when a study does not involve humans or animals, authors may still need to provide a waiver or a statement indicating that the research did not require ethical approval. This is typically the case for research using public databases, archival materials, or computational studies where there are no live subjects.
Q4. Why Do Authors Have to Add Ethical Consideration Statements?
- Compliance with Journal and Institutional Policies: Many academic journals and institutions require that ethical considerations be addressed before a paper can be accepted. These statements assure editors, reviewers, and readers that the research was conducted in a legally and ethically compliant manner.
- Protecting Research Participants: The ethical statement ensures that the rights, safety, and dignity of all human and animal participants are protected. It shows that the study followed guidelines to prevent harm, obtain informed consent, and protect privacy and confidentiality.
- Accountability and Transparency: Adding an ethical consideration statement increases transparency, demonstrating that the research process has been scrutinized by an independent ethics body. This builds trust between researchers and the wider community, including participants, readers, and collaborators.
- Promoting Integrity in Research: Ethical approval upholds the standards of scientific integrity. It ensures that researchers avoid unethical practices such as data manipulation, participant exploitation, or harm to animals or humans. Ethical consideration statements signal the integrity of the research process.
- Meeting Legal Requirements: In some regions and institutions, ethical approval is legally required before conducting certain types of research. A failure to obtain or declare ethical approval can lead to legal consequences, retraction of published work, or damage to the researcher’s reputation.
In short, authors must add ethical consideration statements to demonstrate that their research was conducted responsibly and in compliance with both ethical guidelines and legal standards. These statements form a key part of ethical transparency in the research process.
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