Eco-Vector Publishing Ethiс Policy
Contents
Publisher’s Rights and Responsibilities
- Experiments involving animals
Biomedical research involving obtaining information on the genetic data of a research participant
Ethics in Social Sciences and Humanities
- Informed Consent
Aspectsof privacy, family life, and values of research participants
Ethical principles ofresearch involving historical and cultural monuments
- Research Compliance with International Regulations
Rights and Responsibilities of journal makers
Publisher’s Rights and Responsibilities
Editorial Independence
The Publisher must adhere to the principle of editorial independence and not interfere in the review of incoming materials or publication decisions.
The Publisher must be assured that potential profits from advertising or reprinting do not influence the Editors’ decisions [1,2].
For the advertising policy, see here.
Publisher’s Error Detection Rules
If the Publisher discovers that the content or conclusions of a published paper are erroneous, the Editor should be informed immediately thereof and provided with convincing evidence [1, 3-5].
If such information is received from Authors or readers of the journal, the Publisher and Editor must mutually inform each other.
The Publisher shall ensure prompt publication of a correction, retraction, withdrawal, or deletion of the paper, as appropriate, in accordance with Committee on Publication Ethics rules [4-6].
The error detection rules are detailed here.
Cooperation
The Publisher shall promote the best publishing practices, in particular:
Active cooperation with regional and international professional associations;
Issuing translated books on publishing in Russian;
Assistance to the Editorial Boards in interacting with other journals and/or Publishers if this facilitates the performance of the Editor’s duties;
Providing advisory support to the Editorial Boards, particularly when reviewing claims to the ethical component of materials published by the journal, with strict adherence to the principles of independence;
Providing legal support if this facilitates the performance of the Editor’s duties;
Facilitating the compliance with all good research practices and publishing appropriate standards (link to DD).
Archiving
The Publisher shall maximize the preservation of scientific data by implementing the best practices for archiving information.
The Publisher shall promote the electronic backup and preservation of access to the journal’s contents [7].
If the journal is no longer published, the relevant information should be posted on the Publisher’s and the journal’s website [7].
In case of a withdrawal, retraction, deletion of a paper, or detection of errors in the already published paper, the Publisher must facilitate the retention of all versions of that publication (detailed here).
For these reasons Eco-Vector takes part in several international data preservation programms. We archive all published content in Portico — the digital preservation service has been independently audited by the Center for Research Libraries (CRL) and certified as a trusted, reliable digital preservation solution that serves the needs of the library community (following the general metrics found in their Trustworthy Repositories Audit & Certification).
Also all Eco-Vector's journals use the PKP Preservation Network (PKP PN) to digitally preserve all the published articles. The PKP PN is a part of LOCKSS (Lots of Copies Keep Stuff Safe) program offers decentralized and distributed preservation, seamless perpetual access, and preservation of the authentic original version of the content.
Authors’ Rights and Responsibilities
Only those persons who have made a significant contribution to the conception of the work, the development, execution, and/or interpretation of the results of the presented study, as well as to the process of writing the manuscript (including scientific and stylistic editing and design in accordance with the requirements of the journal) may be the Authors of the publication.
When submitting a manuscript to the journal, Authors shall ensure that:
All participants who made a significant contribution to the reported study are presented as Co-Authors;
Those who did not participate in the study are not listed as Co-Authors;
All Co-Authors have seen and approved the final version of the paper and agreed to its submission for publication—this shall be confirmed by the signatures of all Authors in the cover letter.
All Authors must disclose in their manuscript any financial or other relevant interests that might be construed to influence the research findings or its interpretation.
Authors undertake not to publish the submitted manuscript with other Publishers and notify the Editorial Board if the manuscript is submitted to another Publisher.
Authors shall adhere to:
Instructions for submitting a manuscript to the journal;
Instructions contained in the letters received and the deadlines indicated;
Instructions on proofreading.
Deviation from these instructions will be considered by the Publisher as unethical behavior, and the Editor-in-Chief will be notified accordingly.
The Author shall be given the right to retract the paper at any stage of its consideration. The retraction procedure should be described on the journal’s website.
The Author may be granted the right of appeal if the manuscript is rejected. The appeal procedure should be described on the journal’s website.
Editors’ Rights and Responsibilities
The Editors are personally responsible for making publication decisions.
In making publication decisions, the Editor may confer with other Editors and Reviewers.
All editorial decisions shall be made without regard to the race, gender, age, sexual orientation, religious belief, ethnic origin, citizenship, or political philosophy of the Authors.
The Editor and the Editorial Board shall not unnecessarily disclose information on the manuscript under consideration to anyone other than the Authors, Reviewers, possible Reviewers, other Academic Advisors, and the Publisher.
Editors recuse themselves from reviewing manuscripts if there are conflicts of interest due to competitive, collaborative, and other interactions and relationships with Authors, companies, and possibly other organizations related to the manuscript.
The Editor shall not use unpublished materials disclosed in the submitted manuscript in the Editor’s own research without the written consent of the Author.
The Editor, together with the Publisher, shall take adequate response measures in case of ethical complaints concerning the reviewed manuscripts or published papers. Such measures may generally include interacting with the Authors of the manuscript and arguing the relevant complaint or claim, but may also involve interaction with relevant organizations and research centers whose interests may have been affected.
Reviewers’ Rights and Responsibilities
Any selected Reviewer who feels unqualified to review the study reported in a manuscript or knows that its prompt review will be impossible should notify the Editor and excuse him/herself from the review process.
A Reviewer shall not participate in the review of manuscripts if there are conflicts of interest due to competitive, collaborative, and other interactions and relationships with any of the Authors, companies, or other organizations related to the submitted paper.
Reviewers should inform the Editor if they find significant similarities or overlaps between the manuscript under consideration and any other published paper within the Reviewer’s scientific purview.
Reviewers shall not use unpublished materials from the submitted manuscripts in the Reviewer’s own research without the written consent of the Author.
Reviewers must keep information or ideas obtained during the review process confidential and not use them for personal gain.
Reviewers shall not discuss the manuscript with any person not authorized by the Editor.
Reviewers should avoid personal criticism of the Author and try to give an objective assessment of the manuscript.
Copyeditors and Proofreaders
The copyeditors and proofreaders, when working with manuscripts accepted for publication, shall rely on the existing lexical and grammatical norms set out in the relevant dictionaries, monographs, and manuals.
Layout Editors
When preparing the original layout of the paper, the Layout Editor shall be guided by the standards adopted by the Publisher, based on current standarts and international publishing practices.
Publication Ethics
A manuscript shall be retracted from publication if the Editorial Board finds a violation of publication ethics at any stage of the review or prepress.
If such a violation is revealed by readers after publication, the paper shall be retracted.
The protocol for the Editorial Board’s actions in such situations should be described on the journal’s website.
If the rejection of a manuscript entails additional sanctions against the Authors, this should be described on the journal’s website as well.
The Publisher must consider the following acts of the Author to be violations of publication ethics:
Unauthorized borrowings;
Simultaneous submission of a manuscript to several journals;
Concealment of a conflict of interest;
Assessment of the Reviewers’ professional qualities;
Illegal co-authorship;
Multiple publications.
Unauthorized Borrowings
Unauthorized borrowings may exist in many forms, from presenting someone else’s report as the Author’s, copying or paraphrasing essential parts of someone else’s report (without attribution), to claiming one’s own rights to the results of someone else’s research.
Mentions of the findings of other authors must be accompanied by references to the relevant primary sources ― to be included in the list of references.
Citations from a text previously published elsewhere must be formatted as a QUOTED SPEECH with an indication of the original source.
Authors should cite publications that were important in conducting the research covered in the manuscript, thereby acknowledging the contributions of others to the research.
Unauthorized borrowings must be identified:
Through scientific peer review;
Through the Plagiarism detection systems;
After the publication of manuscripts, upon the fact of the readers’ applications.
Informal data (e.g., obtained during a conversation, correspondence, or discussion with third parties) may be used or presented only with the written permission of the original source.
Information obtained from confidential sources should not be mentioned in the manuscript without the explicit written permission of the Author who is directly related to the confidential sources.
Simultaneous submission of a manuscript to several journals or submission of already published data under a different title
If the Editorial Board uncovers the fact that the same manuscript was submitted to several journals at the same time, the manuscript shall be rejected.
Secondary publication of certain types of papers (e.g., translated articles) may be acceptable in some cases with specific stipulations. When submitting a manuscript for secondary publication, the Authors should notify the Editorial Board thereof and justify in detail the expediency of such publication. For secondary publications, the settlement of copyright issues must be decided on a case-by-case basis. The general rules for preparing a manuscript for a secondary publication are the following:
Indication of the full bibliographic reference to the primary publication;
Retention of the original bibliography of the primary publication.
Concealment of conflicts of interest
All Authors must disclose in their manuscript ― declare in the appropriate section of the manuscript ― any financial or other relevant interests that might be construed to influence the findings or interpretation of their research [8].
Examples of potential conflicts of interest to be disclosed are given below:
Receiving financial rewards for participating in the research or writing of a manuscript;
Any affiliation (contract work, consulting, equity assets, fees, and expert opinions) with organizations that have a direct interest in the subject matter of the research or review;
A patent application or registration for research findings (copyright, etc.);
Receiving financial support for any of the stages of conducting the research or writing a manuscript (including grants and other forms of financial support).
Information on conflicts of interest received from the Authors of manuscripts should be available only to the Editorial Board when deciding whether to publish the manuscript. Such information on conflicts of interest shall then be published as part of the full text of the paper.
When writing this part of the manuscript, the Publisher recommends using the interactive form available at https://admin1.journals.elsevier.com/media/bpwkqcoc/coi_disclosure.pdf
Assessment of the Reviewers’ Professional Qualities
The assessment of the Reviewers’ professional qualities shall be the sole prerogative of the Editorial Board.
An Author’s attempts to assess the Reviewers’ competence shall result in the rejection of the manuscript.
Retraction of Papers
Retraction of an already published paper is a measure of last resort and is applied in case facts are revealed that were not known during the reviewing process [9,10].
Reasons for retracting a paper may include:
· Incorrect borrowings (plagiarism) in the publication;
· Duplicate publications;
· Falsifications or fabrications in the paper (e.g., falsification of experimental data);
· Errors in the original data;
· Serious errors in the paper (e.g., misinterpretation of results) that call into question its scientific value;
· Incorrect composition of the Authors (none of the Authors are qualified or persons who do not meet the authorship criteria are included);
· Concealed conflicts of interest (and other violations of publication ethics);
· Republication of the paper without the consent of the Author;
· A review procedure that was not performed.
Retraction Mechanism
1. Authors, Readers, Reviewers, Editors, and Publishers may initiate the retraction of a paper by writing to the Editorial Board of the journal in which the paper was published.
2. The Retraction Commission shall consider the appeal and notify the parties concerned of the initiation of the procedure.
3. The Retraction Commission shall decide to retract the published paper if there are sufficient facts in favor of its retraction.
4. The Retraction Commission shall notify the initiator of the retraction about the results in writing.
5. If the Commission decides to retract a paper, the journal shall publish information that the paper has been retracted with an indication of its metadata.
6. If papers from the journal are indexed by any databases, a letter shall be sent to these databases that the paper was retracted with the reasons for the retraction.
7. The Editorial Board shall be free to make its own decisions on additional sanctions, such as adding the Authors to the journal’s “blacklist” for a certain or indefinite period.
Appeals
The Editorial Board may grant Authors the right to appeal editorial decisions on the acceptance or rejection of papers.
The protocol of actions of the Editorial Board in case of receiving an appeal shall be described on the journal’s website.
Appeal Mechanism
1. If the Author does not agree with the decision of the Editorial Board on the acceptance or rejection of the paper, the Author may appeal to the Editorial Board in writing, clearly indicating the reasons for the appeal.
2. The Author’s appeal shall be considered by the Conflict Resolution Commission.
3. The Editorial Board may change its
decision in the following cases:
— The Author provided additional findings that were not considered in the
initial review of the paper.
— The Author
provided additional materials to the manuscript, which were not considered
during the initial review of the paper.
— The Author provided information on the conflict of interest, which was not
provided during the initial review of the paper.
— The Author expressed concern about a biased review.
4. If there are sufficient grounds, the Conflict Resolution Commission shall make a proposal to the Editorial Board to change or uphold the initial decision on the publication of the paper.
5. If necessary, the Editorial Board may engage an additional Reviewer to make the final decision.
6. The decision on the acceptance or rejection of the paper based on the results of the revision of the primary decision shall be made by the Editorial Board.
7. The decision of the Editorial Board based on the results of the revision of the primary decision shall be final and not subject to re-appeal.
Ethics of biomedical research
If the study involves animals or humans as research subjects, the manuscript shall indicate that all stages of the research comply with the laws and regulations of the research organizations and approved by the appropriate ethics committees.
Experiments involving animals
When conducting research involving animals, the Authors should be guided by:
· The International Guiding Principles for Biomedical Research Involving Animals [11-15];
· Directive 2010/63/EU of the European Parliament and the Council of the European Union of September 22, 2010 on the Protection of Animals Used for Scientific Purposes [16];
· The European Convention on the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (ETS No. 123) and the Guide for the Care and Use of Laboratory Animals (Article 5 of the Convention) [17];
· The Principles and Practice in Ethical Review of Animal Experiments Across Europe [18].
Research conducted within the territory of the Russian Federation must comply with the rules of Good Laboratory Practice [19].
Biomedical research involving human subjects
Any biomedical research involving human subjects must be designed with respect to the basic ethical principles [20-22] stated in:
· The Belmont Report [23], as well as in international legal acts;
· The World Medical Association (WMA) Helsinki Declaration on Ethical Principles for Medical Research Involving Human Subjects (2013) [24];
· The Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects (2016) [25], as well as national laws consistent with these principles;
· A model law adopted by the Inter-Parliamentary Assembly of the Commonwealth of Independent States [26].
Personal Data
Identifiable (personal) information, including patient names and initials or hospital numbers, shall not be published in written descriptions, photographs, and genetic pedigrees unless the information is of great scientific or historical value and the patient (or parent or guardian) gives written consent for its publication [27].
When describing a clinical case, the patient should be presented with the manuscript intended to be published.
Ethical guidelines for handling personal data in biomedical research involving human subjects must comply with legal acts, such as the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Health-Related Research Involving Humans (2016)―in particular, Guideline No. 12 “Collection, Storage and Use of Data in Health-Related Research” [25] ― as well as the Russian Federal Law on Personal Data (No. 152-FZ), implemented on July 27, 2006 [28].
Research involving vulnerable populations
Vulnerable and disadvantaged people and groups may not always be able to protect their interests when interacting with researchers. Accordingly, researchers cannot take for granted that conventional procedures for obtaining information and consent will provide self-determination for people or protect them from undue stress.
Researchers collecting information on the characteristics and behaviors of individuals and groups should be cautious in using classifications or labels that may lead to unwarranted generalizations and stigmatization of certain social groups.
Vulnerable populations: biomedical research involving women of reproductive age
We note that neither the World Medical Association (WMA) Declaration of Helsinki (revised in 2013) [24], the Convention on the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention, 1997) [29], nor Directive 2001/20/EC of the European Parliament and Council for Clinical Research [30,31] mention the participation of pregnant women in research.
In global health, the most important statement on research ethics is the CIOMS International Ethical Guidelines for Health-Related Research Involving Humans [25]. The 2016 revision contains detailed and comprehensive international ethical guidelines for human research, including updated principles that specifically address research involving women of reproductive age and pregnant women.
The Publisher notes the following:
· Women who are capable of childbearing should be informed in advance of the potential risks to the fetus if they become pregnant while participating in the research [25].
· Research on pregnant women may be initiated only after careful consideration of the scientific sources available at that moment [25].
· The permission of another person shall never supersede the requirement for individual informed consent of the pregnant woman or lactating mother [32].
· The risks of research interventions or procedures that could potentially affect either the pregnant or lactating woman or her fetus or infant should be minimized and weighed against the prospect of potential individual benefits [25].
· Health research involving pregnant women with potential fetal harm should only be conducted where the women may be guaranteed access to a safe, timely, and legal abortion if the pregnancy becomes unwanted due to participation in the research [25].
· When conducting research involving lactating mothers, it may be necessary to consult the father. If the infant may be exposed to the study drug through the mother’s milk (or if it is not known whether the infant will be exposed thereto), ethical guidelines for research involving children and adolescents should be followed in the study [25].
Vulnerable populations: Clinical Research Involving Minors
Clinical trials in minors shall be conducted in accordance with the 2001 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E11(R1) Guidelines on Clinical Investigation of Medicinal Products in the Pediatric Population [30] ― most recently approved on September 1, 2017 by the European Medicines Agency’s Committee for Medicinal Products for Human Use. These guidelines define the main provisions for the development of drugs for children and highlights the main ethical issues that arise during the preparation and conduct of clinical trials in children―informed consent to participate in the study, risk assessment for the child participating in the study, reducing the risks, and minimizing distress and pain that arise during the study.
In the Decision of the Council of the Eurasian Economic Commission of November 3, 2016, No. 79, “On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union” [33], minors are also included in the group of vulnerable research subjects and may participate in research only with the consent of their legal representatives.
Thus, research involving children and adolescents must be conducted in accordance with current national legislation:
European Union (EU) Legislation:
EU Regulation No. 1901/2006 of the European Parliament and the Council of December 12, 2006, on Medicinal Products for Pediatric Use [34];
EU Regulation No. 1902/2006, an amending regulation in which changes to the original text were introduced to the decision procedures for the European Commission [35];
Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Pediatric Population [36].
United States Legislation:
· The Pediatric Research Equity Act of 2003 [37];
· The Best Pharmaceuticals for Children Act (BPCA) [38];
· Title V of The Food and Drug Administration Safety and Innovation Act (FDASIA) [39].
Legislation of the Russian Federation:
The general requirements/limitations to the inclusion of children in clinical trials are contained in:
The Federal Law of April 12, 2010, No. 61-FZ, “On Circulation of Medicines” [40], which defines all children as a vulnerable patient category and prohibits orphans and children without parental care from being considered as subjects of clinical trials;
The Federal Law of November 21, 2011, No. 323-FZ, “On the Fundamentals of Health Protection in the Russian Federation” [41].
In addition, in the industry standard, OST 42-511-99, “Rules for Conducting Qualitative Clinical Trials in the Russian Federation,” minors are categorized as vulnerable subjects [42].
In the national standard of the Russian Federation, GOST-R 52379-2005, “Good Clinical Practice” (ICH E6 GCP), minors are also classified as vulnerable research subjects [43].
Vulnerable populations: clinical research involving the elderly
The main ethical principles of conducting research involving older people include the basic principles for all studies: personal autonomy, informed consent, guarantee for minimizing risks, fair distribution of benefits and burdens of research, and scientific and social value of the outcomes obtained. Decision No. 79 of November 3, 2016, of the Council of the Eurasian Economic Commission “On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union” mentions “elderly persons” in the context of assigning them to a special group of patients―potentially vulnerable―to whom special attention should be paid when studying the safety of a drug [44]. In the context of the COVID-19 pandemic, elderly patients may also be referred to vulnerable categories as they are more susceptible to the disease and the severe course of coronavirus infection.
For elderly patients, including those with cognitive impairment, the research protocol may provide for the participation of a “caregiver.” The person acting as a caregiver must sign and date a specific, separate informed consent form before the elderly patient may be included in the study [45].
Vulnerable populations: research involving human subjects with mental, cognitive, and sensory disorders
All of the basic legal norms of international and Russian legislation apply to the participation in clinical trials of persons with mental disorders, including cognitive impairments. In addition to the general laws regulating the provision of medical care and the conduct of clinical trials, in Russia (as in several other countries), there is a special Federal law of the Russian Federation of July 2, 1992, No. 3185-1, “On Psychiatric Care and Guarantees of Citizens’ Rights During Its Provision” [46]. Further, Article 43 of the Federal Law of April 12, 2010, No. 61-FZ, “On the Circulation of Medicines” [40] establishes the rights of patients participating in a clinical trial of a medicinal product for medical use.
When conducting research involving people with sensory disorders, informed consent must be obtained. However, if the patient cannot read the text of the informed consent form himself, the researcher must read it in full in the presence of a disinterested witness, who shall also sign a special form of informed consent. If patients with severe forms of mental disorders―who have been declared incompetent by a court ― are included in the study, the consent of their legal representative (a guardian) shall be required [45].
Vulnerable populations: research involving patients who are in an emergency, are terminally ill, or unable to give informed consent
Ethical standards may permit an exemption from obtaining a patient’s informed consent only if the research entails minimal risk, or if the patient’s life is in danger and no alternative proven or generally recognized treatment is available that could be equally or more likely to save the subject’s life. In such cases, informed consent must be obtained from the legal representative [24].
In addition to the ethical standards, if conducting clinical research involving patients who are in an emergency, critical or unconscious condition, or unable to give informed consent, the research shall be based on the following legal acts:
· The WMA Declaration of Helsinki [24];
· The Constitution of the Russian Federation, Article 21 [47];
· Federal Law of November 21, 2011, No. 323-FZ, “On the Fundamentals of Health Protection in the Russian Federation” [41];
· Federal Law of April 12, 2010, No. 61-FZ, “On the Circulation of Medicines” [40];
· Industry standard OST 42-511-99, “Rules for Conducting Qualitative Clinical Trials in the Russian Federation” (approved by the Ministry of Health of the Russian Federation on December 29, 1998) [42];
· Russian national standard GOST-R 52379-2005, “Good Clinical Practice” (ICH E6 GCP) [43];
· Decision No. 79 of November 3, 2016 “On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union” [44].
Vulnerable populations: research involving minority ethnic groups
The following principles of biomedical ethics shall be implemented in research involving members of minority ethnic groups:
The well-being of all research subjects;
Fairness, accessibility, and autonomy of the individual;
Voluntary informed consent;
Confidentiality of personal data.
The legal basis for conducting biomedical research on minority ethnic populations is laid out in the WMA Declaration of Helsinki, which requires that “groups that are underrepresented in medical research should be provided appropriate access to participation in research” [24]. Meanwhile, according to the Good Clinical Practice Guidelines, ICH GCP E6(R1), ethnic minorities are classified as vulnerable subjects, to whom “special attention” should be paid [48]. The research must be conducted in accordance with the guidance from the International Council for Harmonization (ICH), “Ethnic Factors in the Acceptability of Foreign Clinical Data E5(R1)” [49].
Research conducted within the territory of the Russian Federation must comply with:
· Russia’s interstate treaties on human rights and the protection of the rights of national minorities;
· Russian legislation on guarantees of the rights of minorities, which is based on relevant norms of the Constitution of the Russian Federation [47];
· The Federal Law “On Guarantees of the Rights of Indigenous Minority Peoples of the Russian Federation” [50].
Biomedical research involving obtaining information on the genetic data of a research participant
When conducting any biomedical research involving obtaining information on the genetic data of a research participant, it shall be necessary to:
· Provide credible and convincing evidence to the Ethics Committee on the appropriateness of such research, its usefulness, or the potential benefit of the scientific data for the research participants or others;
· Obtain separate informed consent;
· Ensure all possible measures of confidentiality;
· Not use the genetic data obtained to cause discrimination in any way;
· Guarantee compliance with the requirements imposed by law on this procedure, as well as by the generally recognized principles and norms of international law.
For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, the physicians shall seek informed consent for their collection, storage, and/or reuse [24,51].
In this case, the research protocols must comply with:
· The Convention on Biological Diversity (UN, 1992) [52];
· The Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997) [53];
· The Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization (United Nations, 2002) [54];
· The International Declaration on Human Genetic Data (UNESCO, 2003) [55];
· The Universal Declaration on Bioethics and Human Rights (UNESCO, 2005) [56];
· The Guide for Research Ethics Committee Members (Council of Europe, 2010) [57];
· The WMA Declaration on Ethical Considerations Regarding Health Databases and Biobanks (WMA, 2016) [58];
· The WMA Declaration of Ethical Considerations Regarding the Use of Genetics in Health Care (WMA, 2019) [59];
· The Federal Law of June 23, 2016, No. 180-FZ, “On Biomedical Cell Products” [60];
· The Convention on the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine;
· The Convention on Human Rights and Biomedicine (Oviedo Convention, 1997) [29], The EC Guidelines on Good Clinical Practice Specific for Advanced Therapy Medicinal Products of October 10, 2019 [61], as well as other relevant international documents [62].
The patients shall be provided with all the relevant research information and their informed consent must be obtained [24].
Research involving stem cells, germ cells, or human embryos
If the research is conducted on human embryos, gametes, or stem cells, the Authors must confirm that they have complied with national and international regulations, such as the 2016 ISSCR Guidelines for Stem Cell Research and Clinical Translation [63].
The Authors must confirm that informed consent was obtained from all the donors. Copies of the documents may be requested by the Editorial Board.
Research involving medical devices
According to the Guidelines for Clinical Trials of Medical Devices, the rights, safety, and health of clinical research subjects should be protected in accordance with the ethical principles established in the Declaration of Helsinki [24], which are to be observed and applied at every stage of the clinical research. In the Russian Federation, research on medical devices is regulated by the Order of the Russian Ministry of Health of January 9, 2014, No. 2n, “Approval of the Conformity Assessment Procedure for Medical Devices in the Form of Technical Testing, Toxicological Studies, Clinical Trials for the Purpose of State Registration of Medical Devices” [64].
Ethics in Social Sciences and Humanities
The guidelines of this research should be based on norms recognized by the scientific community, in particular:
· Norms constituting good scientific practice associated with the pursuit of accurate, adequate, and up-to-date knowledge (academic freedom, originality, openness, reliability, etc.);
· Norms governing the research community (honesty, accountability, impartiality, criticism, etc.);
· Attitudes toward the people involved in the research (respect, human dignity, confidentiality, free and informed consent, etc.);
· Attitudes toward the rest of society (independence, conflicts of interest, social responsibility, dissemination of research findings, etc.).
Researchers should:
· Base their work on the fundamental principle of respect for human dignity. Respect for human dignity and personal integrity is formalized in several international human rights laws and conventions [65-70], including national constitutions [47];
· Respect the autonomy, integrity, freedom, and decision-making rights of the respondents. Legally, the protection of confidentiality is related to the processing of personal data. Therefore, research should be conducted in accordance with basic data protection principles, such as personal integrity, confidentiality, and the responsible use and storage of personal data, including compliance with personal data laws. If the research is conducted in the territory of the Russian Federation, the researchers must comply with the Russian Federal Law “On Personal Data” (No. 152-FZ) [38].
·
Provide
the respondents with adequate information on the research area and purpose:
— Who funded the project?
— Who will have access to the information?
— How are the results expected to be used?
— What are the consequences of participating in the research project?
Informed Consent
When a research project deals with personal data, the researchers should inform the respondents and obtain their informed consent. Consent should be given freely, informed, and explicitly [24].
In some studies, voluntary and informed consent is difficult to obtain. This can raise ethical concerns if the need for protection from harm or the need for freedom, self-determination, and privacy are seriously threatened. In such cases, researchers have a special responsibility to protect personal integrity. This may apply, for example, to research involving persons who either have limited capacity or no capacity to give free and informed consent.
The question of impaired capacity or lack thereof is usually raised in connection with research involving children, the mentally ill, persons with intellectual disabilities, those suffering from dementia, and those under the influence of alcohol. Individuals unable to give free and informed consent are usually included in research only if:
· It cannot be conducted on persons able to give consent; and
· There is good reason to believe that the research is of substantial benefit to the persons or groups being studied, whether indefinitely or in the distant future.
While free and informed consent is the general rule, exceptions may be made in situations where the research does not involve direct contact with the respondents, the data being processed are not particularly confidential, and the research benefits clearly exceed any inconvenience to the persons involved. An example is the use of existing registries where it is not possible to obtain the consent of all persons included in the registries. In such cases, the researchers have a special responsibility to inform the participants and the general public of the purpose and results of the project and explain in detail the potential benefits of the findings through newspapers, television, radio, etc.
Processing confidential data
As a general rule, researchers should process data obtained on personal matters in a manner that respects confidentiality.
Personal data should generally be anonymized.
Identifiable personal data collected for a specific research shall not automatically be used for other research.
Data relating to identifiable individuals must be stored responsibly.
Such data should not be kept longer than necessary to achieve the purpose for which it was collected.
Responsibility to research participants
Researchers are responsible for ensuring that the respondents do not experience serious physical or mental strain.
Moreover, researchers must consider and anticipate consequences for third parties who are not directly involved in the research.
Research involving children and adolescents
Children and adolescents who participate in the research have a special right to protection.
In general, minors who are at least 15 years old may consent to the collection and use of their personal data by the researchers. If the child is under 15, the researchers must obtain consent from his/her parents or guardians. An exception is the collection and use of confidential personal data, where only the parents may give the consent.
Aspects of privacy, family life, and values of research participants
Researchers should respect personal privacy and family life, while the respondents should be able to check whether their confidential information is available to others.
Researchers should not attribute irrational or unworthy motives to the respondents without providing convincing documentation and justification.
Researchers should be respectful of the respondents’ values and views, especially if they differ from those generally accepted in society as a whole.
Respect for Postmortem Reputation
Archives and documents left behind by deceased people may also contain confidential personal information, and researchers should handle information on the deceased and their descendants with care and respect.
Ethical principles of research involving historical and cultural monuments
Research on cultural and historical monuments must comply with the principles specified in the following documents:
· The Declaration of the Principles of International Cultural Cooperation, adopted by the UNESCO General Conference at its 14th session, Paris, November 4, 1966 [71];
· The UNESCO Universal Declaration on Cultural Diversity (2001) [72];
· The Budapest Declaration on World Heritage (2002) [73];
· The UNESCO Declaration Concerning the Intentional Destruction of Cultural Heritage (2003) [74];
· The Declaration on the Conservation of Historic Urban Landscapes [75];
· Multilateral international treaties concluded on specific subjects (binding on ratifying or acceding states);
· Protocols to the 1954 Convention on the Protection of Cultural Property in the Event of Armed Conflict [76];
· The UNESCO 1970 Convention on the Means of Prohibiting and Preventing the Illicit Import, Export, and Transfer of Ownership of Cultural Property [77];
· The 1972 Convention Concerning the Protection of the World Cultural and Natural Heritage (The World Heritage Convention) [78];
· The 2003 Convention on the Safeguarding of the Intangible Cultural Heritage [79];
· The 2005 Convention on the Protection and Promotion of the Diversity of Cultural Expressions [80];
· The Federal Law of June 25, 2002, No. 73-FZ, “On Objects of Cultural Heritage (Historical and Cultural Monuments) of the Peoples of the Russian Federation” [81].
In addition, UNESCO recommendations that formulate directive principles and norms for resolving any issues at the international level ― not subject to ratification and not binding; however, states are encouraged to apply thereto ― should be taken into account:
· Recommendations on International Principles Applicable to Archaeological Excavations (1956) [82];
· Recommendations Concerning the Safeguarding of the Beauty and Character of Landscapes and Sites (1962) [83];
· Recommendation concerning the Protection of Cultural Property Endangered by Public or Private Works (1968) [84];
· Recommendation Concerning the Protection, at a National Level, of the Cultural and Natural Heritage (adopted on November 16, 1972, at the 17th session of the General Conference of UNESCO) [85];
· Recommendation Concerning the Safeguarding and Contemporary Role of Historic Areas (1976) [86];
· Recommendation on the Historic Urban Landscape (2011) [87].
Charters formulating the general principles and objectives of any international agreements have considerable social and political content and are declarative and ethical in nature:
· International Charter for the Conservation and Restoration of Monuments and Sites (Venice Charter) [88];
· Charter for Cultural Tourism [89];
· Charter for the Protection of Historic Gardens (Florence Charter) [90];
· International Charter for the Protection of Historic Towns and Urban Areas (Washington Charter) [91];
· Charter for the Protection and Management of Archaeological Heritage [92];
· Nara Document on Authenticity (1994) [93];
· International Council on Monuments and Sites Principles for the Recording of Monuments, Groups of Buildings and Sites (1996) [94];
· Valletta Principles for the Safeguarding and Management of Historic Towns and Urban Areas (2011) [95];
· European Convention on Cultural Heritage [96];
· Convention on the Protection of the Architectural Heritage of Europe (The Grenada Convention) [97];
· European Convention on the Protection of the Archaeological Heritage (1969) [98];
· European Landscape Convention of the Council of Europe (Florence Convention, 2000) [99];
· Council of Europe Framework Convention on the Value of Cultural Heritage for Society (Faro Convention, 2005) [100];
· European Charter for the Protection of the Architectural Heritage (1975) [101].
The need to preserve places, monuments, artifacts, texts, archives, remains, and information on the past is based on the interest of present and future generations to know their own history and culture as well as the history and culture of others.
The value of the research must be weighed against the extent to which the material is disrupted or altered by the research. The research should be conducted in a way that will allow future generations of researchers to gain important information.
When researchers handle human remains from archaeological excavations, they must keep in mind the ethical issues involved in researching this type of material.
Researchers and research institutions should not engage in looting, theft, or questionable trafficking of protected artifacts. Respect for the origin of research materials requires special attention. Researchers, museums, and research institutions should exercise due diligence and not acquire (for themselves or for others) protected objects and cultural history source materials that have not been obtained in a transparent, honest, and verifiable manner for research purposes.
Moreover, caution should be exercised when researching materials with disputed origins. When researching such materials, research institutes and professionals have a special responsibility to be transparent about the origin.
Researching other cultures
When researching other cultures, it is important to consider the local traditions, traditional knowledge, and social issues. Whenever possible, researchers should engage in dialogs with the residents, representatives of the given culture, and local authorities. The interest in co-determination or local control may conflict with the research requirements for quality and impartiality. This imposes high demands on the initiation, planning, and implementation of research projects. When conducting research on other cultures, whether in other countries or among minorities, researchers should avoid using classifications or labels that allow for unwarranted generalizations. Researchers must avoid devaluing people from past cultures and historical periods. Here as elsewhere, humanities and social science researchers must make a clear distinction between documentation and assessment.
Limits of Cultural Recognition
Researchers must find a balance between acknowledging cultural differences and recognizing other fundamental values and general human rights.
Respecting and being loyal to the cultures in which the research is conducted does not mean accepting discrimination and cultural violence. In conducting normative analyses of such situations, the researcher must make a clear distinction between the descriptions of norms and practices in the studied culture and normative discussions of these factors related to particular values.
The researcher must be particularly careful when studying phenomena such as culturally motivated violations of life and health or violations of other human rights.
Research Compliance with International Regulations
Thus, sociological and legal research must conform to:
· the principles contained in the United Nations 1948 Universal Declaration of Human Rights [65];
· the 1966 International Covenant on Economic, Social and Cultural Rights;
· the 1966 International Covenant on Civil and Political Rights; the 1989 Declaration on the Rights of the Child [102];
· the 1960 Declaration on the Granting of Independence to Colonial Countries and Peoples [103]; the 1966 United Nations Declaration on the Elimination of All Forms of Racial Discrimination [104];
· the 1965 Declaration Concerning the Promotion among Youth of the Ideals of Peace, Mutual Respect, and Understanding between Peoples [105];
· and the 1979 Declaration on the Elimination of Discrimination Against Women [106];
· and in other UN treaties and resolutions [107].
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