Editorial Policies
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Research ethics and consent
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All research published in Red Flower Publications must comply with international and local guidelines that ensure ethical research.
Research involving humans
All human research (individuals, samples, and data) must be carried out in accordance with the principles laid down in the Declaration of Helsinki. Before starting research, all protocols must obtain the approval of the local institution review board (IRB) and other appropriate ethics committees in order to ensure that research meets national and international guidelines for human research. The manuscript must include a statement confirming this, providing details of the name of the ethics committee and the reference/permit number where available.
For non-interventional research (such as surveys), where the ethical approval is not required (e.g. due to national law) or where the study has been granted exemption by an ethical committee, this should be stated in the manuscript, with full explanations. If a study is granted an exemption, the name of the ethics committee that provides the exemption should also be included. However, if the researcher is unsure, it is always necessary to seek advice from the relevant departments before conducting the study.
The language used must be non-stigmatizing and non-discriminatory, describing different groups in terms of race, ethnicity, age, disease, disability, religion, sex, gender, sexual orientation, etc. Human research categorized in such groups should include a description of definitions and categories, including whether any rules for human classification are required by the relevant funders.
All studies must be approved for ethics before research is conducted. The author must prepare to provide further information to the editorial office of the journal at the request.
Specific ethical considerations for study design
Prospective studies on humans
If the research involves an intervention (e.g., a clinical trial), participants must provide informed written consent for participation in the research. A statement confirming this must be included in the manuscript. The authors must submit signed copies and date to the editorial team at the time of request. In studies where oral informed consent has been obtained instead of written informed consent, this must be explained and indicated in the manuscript.
Clinical trials
In addition to the informed written consent required above, clinical trials protocols must be registered in a publicly accessible registry before recruitment of participants. Public registry must be open to all potential registrations and be managed by a non-profit organisation. We can accept trial registrations from WHO and ICMJE-approved registrations because they meet mandatory requirements, they are reliable, provide sufficient details, are accessible, and provide adequate version controls. A list of eligible registries can be found on the WHO International Clinical Trial Registry Platform (ICTRP). You can also register on Clinical Trials.gov or on the Clinical Trials Registry-India (CTRI).
The trial registration number and the date of registration must be included in the manuscript's abstract or method section, and any deviation from the original trial protocol must be explained. It is also recommended that the authors of clinical trials consult with Hrynaszkiewicz et al. for guidance on the preparation of basic clinical data for publication.
Clinical trials must be registered in advance, i.e. before the recruitment of participants. However, for clinical trials that have not yet been registered prospectively, Red Flower Publications journals require retrospective registration to ensure that all results of clinical trials are transparent and complete, which ultimately affect human health. Authors of the retrospectively registered tests must, at their request, provide additional information to the journal editor. Please note that some journals do not accept retrospectively registered trials, so authors are advised to consult with the publisher of the journal they want to submit.
Details of future and retrospective registration can be obtained from the AllTrials campaign, the National Institutes of Health and the ICMJE.
We follow the description of the clinical trial of the ICMJE as follows:
- Research studies that assess the impact on health outcomes of human participants or groups of human beings are subject to one or more health-related interventions.
- Health-related interventions include any intervention used to change biological and health-related results (e.g. drugs, surgical procedures, devices, behavioural therapies, food interventions and care process changes).
- Health outcomes include measures for biomedical or health related to patients and participants, including drugs and adverse reactions.
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Pure observational studies (the assignment of medical intervention is not at the discretion of the investigator) do not require registration.
Case reports/Case series/Clinical datasets
Organ or tissue transplants
Red Flower Publications supports the ethical guidelines described by the World Health Organization (WHO), the World Medical Association (WMA) and the Istanbul Declaration. In particular, all research involving human organ transplantation must be carried out with the ethical approval of an appropriate committee and must provide all sources of donor tissue in the submitted manuscript.
The author must ensure that the donated organs have been obtained with the full informed consent of the donor or parent or guardian of the donor (if the donor is a minor) or his/her family member (if the donor is a deceased person). Consent must be given freely and without any kind of coercion or bribery. The authors of research articles describing the use of donated organs must include a statement confirming the obtained informed consent. Authors must be particularly attentive to the risks of working with vulnerable people and are prepared to provide details of the process for obtaining informed consent. This applies to all studies involving donor or patients who have received organ or tissue transplants (including follow-up studies).
Red Flower Publications reserves the right to reject (pre-publication) or withdraw published articles that involve transplantation, if the author is unable to provide confirmed evidence of informed consent. The author must submit additional supporting information on their research (e.g. ethical approval and informed consent forms) to the publisher's office upon request.
Human embryos and human stem cells
Researchers reporting on the use of human embryos, human embryo stem cells (including clinical applications of stem cells) and related materials must include a statement in the manuscript confirming that all experiments have been carried out in accordance with all safety considerations, ethical guidelines and applicable regulations. The author must verify that all recipients and/or donors of stem cells or tissues (or their descendants if the donor is deceased) have provided full consent. Specifically, the authors must include in the manuscript a statement providing details of the name of the ethics committee (ethical committee) that has approved the study, including references/permit numbers if any, and a statement confirming that informed consent has been obtained.
Red Flower Publications supports the principles of ethical stem cell research described in the ISSCR Guidelines for stem cell research and clinical translation.
Human dignity
All people, living and dead, should be treated with dignity and respect in academic research. Ethical research practices require researchers to be careful to minimize the risks of their work and to avoid harm to participants. Particular attention should be paid to the protection of the dignity and well-being of vulnerable participants, including children, refugees, asylum seekers, migrants, vulnerable or institutionalized persons and those unable to give informed consent.
Research involving children and adolescents: the parent/guardian of participants who are not legally adults must obtain written consent, except in rare cases where the child can provide its own consent (e.g. emancipated minors). The legal adult age is determined by the country of origin of the study participant, typically 16-18 years old. In the best case scenario, researchers should also seek children's approval where possible. A statement confirming that informed consent has been obtained must be included in the manuscript.
If a verbal informed consent has been obtained, this must be explained and stated in the manuscript.
In accordance with the principles laid down in the Nuremberg Act and the Belmont Report, informed consent must be given free of will without any form of forced or bribery.
- Vulnerable groups: Authors should be familiar with the disciplinary, institutional and national/international guidelines for research on vulnerable groups. The Global Association of Human Trafficking Scholars and the Council for Economic and Social Research have developed research guidelines for these groups.
- Images: Researchers must ensure that participants fully understand the advantages and risks of including photographs and how they are used, stored and distributed.
- Derogatory and degrading languages: non-stigmatizing and discriminatory languages should be used when describing a group by race, ethnicity, age, disease, ability, religion, gender, sexual orientation or other identity categories. If the author of a particular study needs to incorporate a derogatory or offensive language (e.g. direct quotation, transcript, text, etc.), the author should clearly explain the scientific purpose of the terminology.
- Warnings of content: Authors should consider including warnings of content when articles contain particularly graphic or culturally sensitive content (e.g., surgical procedures, disease or illness, human remains).
The author is prepared to provide further information and documents on research methods and approvals to the journal's editorial offices upon request.
Journal editors and publishers reserve the right to reject articles that do not comply with the above-mentioned considerations.
Retrospective and database studies
Researchers must confirm that they have obtained ethical approval from an appropriate ethical review board for the study, and the dataset owner must approve the use of information in the database/repository for the purposes of the study. If the user does not require permission to use data from a database or repository (e.g., when it is available to the public and unrestricted reuse is allowed by an open license), an explanation must be included in the manuscript.
The data acquired must remain anonymous unless otherwise stated by the database content owner, and this statement should be included in the manuscript. When the details of the participants are not required to be anonymised, the authors must prove that each participant has obtained written informed consent, including permission to publish. A statement confirming this must be included in the manuscript.
Authors should not assume that a database study does not require an ethical review or approval, and authors must be prepared to provide details of the exemption for studies in which either an ethical review or approval has been cancelled or withdrawn. The exemption must be relevant and applicable to current studies submitted, and should also include a brief explanation of the exemption policy in the manuscript. The statement should include details of local, regional or institutional policies under which exemption was granted.
Survey studies
The researchers must ensure that they inform all participants why the research is carried out, whether anonymity is guaranteed or not, and how the collected data are stored. The right of participants to confidentiality should always be taken into account, and they should be fully informed of the purpose of the research and any risks associated with it. Their voluntary consent to participate should be recorded and all legal requirements concerning data protection must be fulfilled. Like all research studies, it is necessary to obtain the approval of the appropriate IRB/local ethics committee before conducting the research. A statement to confirm this must be included in the manuscript. In the context where ethics approval for survey research is not necessary, the author must include a statement explaining this in the manuscript.
Covert observational research
Covert observation research requires specific ethical and legal considerations, but is acceptable in rare cases and has a strong justification. Researchers should also consider the legal framework for the rights of privacy that are emerging around the world and are widely varied. Authors conducting secret research should consult relevant guidelines, such as the Ethical Practice Statement of the British Society.
All studies that involve concealed research must include the following:
- The manuscript includes a statement that fully explains the secret nature of the research and provides the name of the ethics committee that approved the research (including references/authorities where available).
- If a study is conducted on a social media platform (such as Facebook), the researcher should consult with the platform's code of conduct and/or terms of use to determine whether the platform is authorized to include user data in the study.
- The use of online aliases or individuals should be declared.
- Ideally, researchers should seek informed consent from the participants after the study has been completed.
Please note that journal editors and publishers reserve the right to consider hidden research inappropriate for consideration in journals.
“Helicopter” or “Parachute” Research
Research carried out abroad has particular ethical implications, particularly when researchers based in high-income countries carry out projects in resource-poor areas. In this regard, researchers are encouraged to obtain ethics approval from local institutions, to include local participants, researchers and communities in the research process and to include local collaborators/volunteers who meet the threshold of inclusion as authors (or to mention them in acknowledgment if they do not).
Researchers are also encouraged to include a statement describing how they take into account their impact on the environment/local population and why it is inevitable that they have to conduct research in this location. Further recommendations to be considered can be found in the Global Code of Ethics.
Research on indigenous communities
The authors should be aware of the specific research ethics approval procedures that must be followed in order to conduct research in communities where restrictions or special processes may exist. The authors should also be aware of cultural sensitivities or restrictions relating to any images contained in the manuscript. For example, in Australian Aboriginal culture, additional approvals may need to be obtained from community elders. The authors working with these communities are encouraged to consult AIATSIS's ethical publishing guidelines.
Social Media Research
Scholars who use social media platforms (such as Twitter, Facebook, etc.) to collect and publish such data must be aware of national laws and ethical guidelines.
When researchers interact with individuals or obtain private information, they should obtain ethical approval before conducting research. Researchers should also ensure appropriate anonymity and obtain informed consent from all potential identity users.
Please note that not all data can be collected as a fair use or copyright exception. Authors must check the user policies and services of the social media platform in the regions where the research has been conducted in order to determine whether permission from the platform is required.
The authors are advised to consult appropriate guidelines, such as the Social Data Science Lab's ethical declaration and framework, and the British Sociological Association's ethical guidelines for digital research.
Patient/participant privacy and informed consent
Red Flower Publications endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE), which emphasizes that patients and study participants have the right to privacy that should not be violated without informed consent. In accorance with the principles outlined in the Nuremberg Code and the Belmont Report informed consent must be voluntarily obtained from the participant who should be informed of the study including any of the benefits and risks involved.
Consent to participate
For all studies in which human participants participate, written consent to participate in the study must be obtained before the start of the study, and the statement must confirm this.
If no written consent has been obtained, a full explanation of why this consent has not been obtained in writing should be included, as well as the name of the IRB/local ethics committee that has approved verbal consent. In addition, a description of the way this document was recorded must also be included in the manuscript.
Patients or study participants who are not adults, or who are considered vulnerable or unable to provide informed consent, must obtain legal guardians or relatives, if the participant dies.
If the participant data has been anonymised, this should be clearly stated in the manuscript and a note must be made to ensure that such changes do not distorted the academic meaning.
Consent to publish identifiable information
Articles that may contain information that may identify a person (including the names, addresses, places of employment, dates of birth, telephone numbers, e-mail addresses, medical records or patient identification, account numbers, license numbers, IP addresses, complete or comparable photographic images or video) must confirm that they have obtained written informed consent to publish details of the person affected (or the person's parent or guardian, if he or she is not an adult or cannot provide informed consent; or his or her next of kin, if the Identification information includes (but is not limited to) written descriptions, photographs, videos, ancestors and rare diseases. The process of obtaining authorship includes sharing the article with individuals (or any authorized person) so that they are fully aware of the content before publication.
The Consent to Publish Declaration must confirm that details of images, videos, recordings, etc. can be published and show the content of the article that the person(s) who provide the consent is to be published. The author may use this consent form (provided by the Red Flower Publications, which must be completed, signed and stored securely.
A declaration to confirm that consent has been obtained to publish must be included in the manuscript. The authors must also indicate who granted permission for publication.
Consent to publishing is an obligation of the journal and cannot be exempted by the Ethics Committee. Authors must prepare, on request, to provide copies of signed consent forms to the editorial offices of the journal.
Research involving animals
Experiments in vertebrates and regulated invertebrates, field studies and other non-experimental animal research must be carried out in accordance with institutional, national or international guidelines and, where necessary, with the approval of an appropriate ethics committee.
If applicable, a statement of ethical approval or animal licences should be included in the manuscript. When a study is denied an exemption from the necessity for ethical approval, this must be specified as well as the name of the ethics committee providing the exemption and the reason for the exemption.
For non-human primate studies, it is necessary to prove that the work meets the standards set out in NC3R primate guidelines and that it follows best practice procedures. For experimental studies with animals owned by clients, the authors must also document informed consent of clients and owners and compliance with best veterinary practices.
Red Flower Publications supports the principles of ethical animal research set out in the Basel Declaration and the Ethics Guidelines of the International Laboratory Animal Science Council (ICLAS). Red Flower Publications advises all animal researchers to read the NC3Rs ARRIVE Guidelines. The guidelines set out the current accepted procedures for reporting on animal research and are available in a number of translations.
Research involving plants
Research into plants (cultivated or wild), including plant materials collection, must be carried out in accordance with the guidelines provided by the author's institution and national or international regulations. Field studies must comply with local laws, and manuscripts must include appropriate permissions and/or licences declarations.
Voucher specimens must be deposited in a public library or other public collection that provides access to the material deposited. Information on the voucher specimens and who identified them must be included in the manuscript.
Research on threatened/endangered species
Authors are advised to comply with the International Union for Conservation of Nature (IUCN) policies research involving species at risk of extinction (see Guidelines for appropriate uses of IUCN Red list data), the Convention on Biological Diversity and the Convention on the Trade in Endangered Species of Wild Fauna and Flora.
Biosafety, biosecurity and emerging biotechnology
Red Flower Publications will only consider research conducted in accordance with institutional biosafety and biosecurity policies, which in turn must be informed by national or international recommendations. Researchers should be aware of the dual use of research related to their work, which, according to the National Institutes of Health Science Policy Office, "can provide knowledge, information, products or technologies that can be reasonably expected to be directly misapplied and pose a major threat with significant consequences for public health and safety, agricultural crops, other plants, animals, the environment, materials or national security."
Researchers involved in research are advised to be aware of WHO recommendations for responsible life science research and to take measures to reduce the risks associated with such research.
If concerns about potential risks are raised, we may seek expert advice to assess them, so authors should prepare to provide further information requested by the journal editorial office.
Ethics FAQ for authors
Q: Do I need an ethical approval for retrospective patient data?
A: Yes. For all studies involving human subjects, medical records and human samples, the approval of a formal review committee (Institutional Review Committee or Ethics Committee) is required.
Q: Do I need the patient's consent to use the retrospective data?
A: Informed consent of the participants should always be sought. If this is not possible, the Institutional Review Board must decide whether it is ethically acceptable. Your manuscript's material and methodology section should contain a statement on the IRB's decision.
Q: Do I need an ethical approval for a review article?
A: No. This will be obtained by the original author.
Q: Do I need an ethical approval for the use of samples from commercial providers?
A: Yes. All studies involving individuals, medical records and human samples require approval from a formal review board (Institutional Review Board or Ethics Committee).
Q: If ethics approval is not required, what declaration should I include in the manuscript?
A: For investigators without formal ethical review committees, the principles outlined in the Helsinki Declaration should be observed. If the study is considered to be exempt, a statement from the Ethics Committee is required. The material and method section of your manuscript should contain a statement on the decision.
Q: Do I need ethical approval to report on veterinary clinical cases?
A: No. For studies with animals owned by clients, high standards (best practice) in veterinary care must be followed and an informed consent statement must be included in the Material and Methods section.
Q: Do I need ethical approval for studies with live animals?
A: Yes. In the Material and Methods section of the manuscript, you must specify the approval of the ethical review committee and the international, national or institutional guidelines for animal welfare.
Q: What if you need approval for cells from a certified commercial supplier?
A: However, if the cells have been gifted or sourced from a commercial supplier accredited, we require confirmation that the research has been approved by a designated institutional review committee or ethical committee.
Updated 09 December 2024