2.Ethical Guidelines
The Journal of Disability and Oral Health adheres to the following ethical guidelines for publication and research, manuscripts will only be considered for publication if they meet the highest ethical standards. Authors must read and adhere to the following:
International Committee of Medical Journal Editors - Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Statement of Purpose: About the Uniform Requirements. Revision 2010. Full details: www.icmje.org
International Committee of Medical Journal Editors - Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Statement of Purpose: About the Uniform Requirements. Revision 2010. Full details: www.icmje.org
2.1.Published Conflict of Interest Statement
Ethical Considerations in the Conduct and Reporting of Research: Conflicts of Interest www.icmje.org
Ethical Considerations in the Conduct and Reporting of Research: Conflicts of Interest www.icmje.org
‘Public trust in the peer-review process and the credibility of published articles depends in part on how well conflict of interest is handled during writing, peer review, and editorial decision making. Conflict of interest exists when an author (or the author’s institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). These relationships vary from being negligible to having great potential for influencing judgment. Not all relationships represent true conflict of interest. On the other hand, the potential for conflict of interest can exist regardless of whether an individual believes that the relationship affects his or her scientific judgment. Financial relationships (such as employment, consultancies, stock ownership, honoraria, and paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion.
All participants in the peer-review and publication process must disclose all relationships that could be viewed as potential conflicts of interest. Disclosure of such relationships is also important in connection with editorials and review articles, because it can be more difficult to detect bias in these types of publications than in reports of original research. Editors may use information disclosed in conflict-of-interest and financial-interest statements as a basis for editorial decisions. Editors should publish this information if they believe it is important in judging the manuscript’.
2.2.Published Statement on Human and Animal Rights
Ethical Considerations in the Conduct and Reporting of Research: Protection of Human Subjects and Animals in Researchwww.icmje.org
‘When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. When reporting experiments on animals, authors should indicate whether the institutional and national guide for the care and use of laboratory animals was followed’.
Ethical Considerations in the Conduct and Reporting of Research: Protection of Human Subjects and Animals in Researchwww.icmje.org
‘When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. When reporting experiments on animals, authors should indicate whether the institutional and national guide for the care and use of laboratory animals was followed’.
2.3.Published statement of informed consent
Ethical Considerations in the Conduct and Reporting of Research: Privacy and Confidentiality www.icmje.org
Ethical Considerations in the Conduct and Reporting of Research: Privacy and Confidentiality www.icmje.org
Patients and Study Participants
‘Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication. Patient consent should be written and archived with the journal, the authors, or both, as dictated by local regulations or laws. Applicable laws vary from locale to locale, and journals should establish their own policies with legal guidance. Since a journal that archives the consent will be aware of patient identity, some journals may decide that patient confidentiality is better guarded by having the author archive the consent and instead providing the journal with a written statement that attests that they have received and archived written patient consent.
Nonessential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic pedigrees, authors should provide assurance, and editors should so note, that such alterations do not distort scientific meaning.
‘Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication. Patient consent should be written and archived with the journal, the authors, or both, as dictated by local regulations or laws. Applicable laws vary from locale to locale, and journals should establish their own policies with legal guidance. Since a journal that archives the consent will be aware of patient identity, some journals may decide that patient confidentiality is better guarded by having the author archive the consent and instead providing the journal with a written statement that attests that they have received and archived written patient consent.
Nonessential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic pedigrees, authors should provide assurance, and editors should so note, that such alterations do not distort scientific meaning.
The requirement for informed consent should be included in the journal’s Instructions for Authors. When informed consent has been obtained, it should be indicated in the published article’.
2.4.Ethical Considerations in the Conduct and Reporting of Research: Peer Review
www.icmje.org
‘Unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including the scientific process. Peer review is the critical assessment of manuscripts submitted to journals by experts who are not part of the editorial staff. Peer review can therefore be viewed as an important extension of the scientific process. Although its actual value has been little studied and is widely debated (4), peer review helps editors decide which manuscripts are suitable for their journals and helps authors and editors to improve the quality of reporting. A peer-reviewed journal submits most of its published research articles for outside review. The number and kinds of manuscripts sent for review, the number of reviewers, the reviewing procedures, and the use made of the reviewers’ opinions may vary. In the interests of transparency, each journal should publicly disclose its policies and average turn-around times in its Instructions to Authors’.
www.icmje.org
‘Unbiased, independent, critical assessment is an intrinsic part of all scholarly work, including the scientific process. Peer review is the critical assessment of manuscripts submitted to journals by experts who are not part of the editorial staff. Peer review can therefore be viewed as an important extension of the scientific process. Although its actual value has been little studied and is widely debated (4), peer review helps editors decide which manuscripts are suitable for their journals and helps authors and editors to improve the quality of reporting. A peer-reviewed journal submits most of its published research articles for outside review. The number and kinds of manuscripts sent for review, the number of reviewers, the reviewing procedures, and the use made of the reviewers’ opinions may vary. In the interests of transparency, each journal should publicly disclose its policies and average turn-around times in its Instructions to Authors’.
Ethical Approvals
The Journal of Disability and Oral Health is currently reapplying to be a member of the Committee on Publication Ethics (COPE). The Journal of Disability and Oral Health supports and encourages the use of the Consolidated Standards of Reporting Trials CONSORT checklist.
The Journal of Disability and Oral Health is currently reapplying to be a member of the Committee on Publication Ethics (COPE). The Journal of Disability and Oral Health supports and encourages the use of the Consolidated Standards of Reporting Trials CONSORT checklist.
Ethics: Experimentation involving human subjects will only be published if such research has been conducted in full accordance with ethical principles, including:
1.The World Medical Association Declaration of Helsinki (version, 2008) and the additional requirements, if any, of the country where the research has been carried out. The paper should detail the approval of the ethical committee for the study.
www.wma.net/en/20activities/10ethics/10helsinki/
www.wma.net/en/20activities/10ethics/10helsinki/
2.European Medicines Agency July 2002 CPMP/ICH/135/95
ICH Topic E 6 (R1) Guideline for Good Clinical Practice www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
ICH Topic E 6 (R1) Guideline for Good Clinical Practice www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95)
‘Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects’.