Research ethics and consent - Author Services

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Research ethics

Taylor & Francis Editorial Policies

About this topic

All research published in Taylor & Francis journals must have been conducted according to international and local guidelines ensuring ethically conducted research.

Research involving humans

All research studies on humans (individuals, samples, or data) must have been performed in accordance with the principles stated in the Declaration of Helsinki.

Prior to starting the study, ethical approval must have been obtained for all protocols from the local institutional review board (IRB) or other appropriate ethics committee to confirm the study meets national and international guidelines for research on humans. A statement to confirm this must be included within the manuscript, which must provide details of the name of the ethics committee and reference/permit numbers where available.

For non-interventional studies (e.g. surveys), where ethical approval is not required (e.g. because of national laws) or where a study has been granted an exemption by an ethics committee, this should be stated within the manuscript with a full explanation. Where a study has been granted exemption, the name of the ethics committee which provided this should also be included. However, if the researcher is in doubt, they should always seek advice from the relevant department before conducting the study.

Non-stigmatizing and non-discriminatory language should be used when describing different groups by race, ethnicity, age, disease, disability, religion, sex, gender, sexual orientation, etc. Human studies categorized by such groupings should include an explanation of the definitions and categories, including whether any rules of human categorization were required by the relevant funding agencies.

Ethical approval for all studies must be obtained before the research is conducted. Authors must be prepared to provide further information to the journal editorial office upon request.

Ethical considerations for different human study designs

Prospective studies on humans

Especially where the research involves an intervention (e.g. a clinical trial), participants must provide informed written consent to be part of the study. A statement to confirm this must be included within the manuscript. Authors must be prepared to provide dated copies signed by the participants and author(s) to the journal editorial team if requested. In studies where verbal informed consent has been obtained rather than written informed consent, this must be explained and stated within the manuscript.

Clinical trials

In addition to the required informed written consent (as stated above), clinical trial protocols must also be registered in a publicly accessible registry prior to participant recruitment. The public registry must be open to all prospective registrants, and managed by a not-for-profit organization. A list of eligible registries can be found at the WHO International Clinical Trials Registry Platform (ICTRP). Trials can also be registered at Clinical Trials.gov or the EU Clinical Trials Register.

The trial registration number and registration date must be included in the Abstract and Methods section of the manuscript, and any deviation from the original trial protocol must be explained. Authors of clinical trials are also advised to consult Hrynaszkiewicz et al. for guidance on preparing raw clinical data for publication.

Clinical trials should be registered prospectively – i.e. before participant recruitment. However, for clinical trials that have not been registered prospectively, Taylor & Francis journals requires retrospective registration to ensure the transparent and complete dissemination of all clinical trial results which ultimately impact human health. Authors of retrospectively registered trials must be prepared to provide further information to the journal editorial office if requested. Please note, some journals may not accept retrospectively registered trials, and so authors are advised to consult with the Editor of the journal they wish to submit to.

Details on prospective and retrospective registration are available from the AllTrials campaign, the UK Public Accounts Committee, the UK Department of Health and the ICMJE.

We follow the ICMJE description of the clinical trial, which is described as:

  • Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
  • Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes).
  • Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.
  • Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration.

Clinical Case reports

A clinical case report is a detailed clinical report on an individual patient. As the level of details given in the manuscript can potentially identify the patient, explicit Consent to Publish is required for the publication of the case. Authors must obtain this from the patient (or their guardians if they are not adults or lack capacity to provide informed consent, or next of kin if deceased). This must be done even if the authors have removed direct identifiers. Authors are advised to adhere to CARE guidelines in order to ensure all key details about the case are reported.

Consent to publish is a journal requirement, and cannot be exempted by an ethics committee. Authors may use this Consent to Publish form, which should be completed, signed, and saved securely. Authors should be prepared to share this with the journal editorial office if requested. A statement to confirm consent to publish has been obtained must be included within the manuscript.

Organ or tissue transplants

Taylor & Francis endorses the ethics guidelines described by the World Health Organization (WHO) and the World Medical Association (WMA). Specifically, all studies involving transplantation of donated human organs should be conducted with ethical approval from an appropriate committee, and all sources of donor tissue must be provided in the submitted manuscript.

Authors must be able to verify that donated organs were obtained with full informed consent from the donor or their next of kin if the donor is deceased. Consent must have been given with free will, under no coercion or bribery of any kind. Authors must include a statement within the manuscript to specify the source of transplanted organs, and must include a statement to confirm informed consent was obtained.

This applies for all studies (including follow-up studies) involving donors, or patients who have received organ or tissue transplantation.

Human embryos and human stem cells

Authors of research reporting the use of human embryos, human embryonic stem cells (including clinical applications of stem cells) and related materials, must include a statement within the manuscript to confirm that all experiments were performed in accordance with all safety considerations, ethical guidelines and applicable regulations. Authors must be able to verify that all recipients and/or donors of stem cells or tissues (or their next of kin if the donor is deceased) provided full informed consent. Specifically, authors must include a statement within the manuscript to provide details of the name of the ethics committee(s) which approved the study and include the reference/permit numbers where available, and must include a statement to confirm informed consent was obtained.

Taylor & Francis endorses the principles on ethical stem cell research outlined in the ISSCR Guidelines for Stem Cell Research and Clinical Translation.

Consent for research involving children, adolescents, and vulnerable or incapacitated study participants

Written informed consent must be obtained from the parent or guardian of any participants who are not able to provide full informed consent themselves. Age of legal adulthood is determined by the country in which study participants are based, which is typically between ages 16-18. A statement to confirm informed consent has been obtained must be included within the manuscript.

In settings where verbal informed consent has been obtained rather than written informed consent, this must be explained and stated within the manuscript.

In accordance with the principles outlined in the Nuremberg Code and the Belmont Report, informed consent must have been given with free will, under no coercion or bribery of any kind.

Retrospective studies

Researchers must confirm they have obtained ethical approval to conduct the study, as well as permission from the dataset owner to use the information in databases/repositories for the purposes of the research they are conducting. Where permission to use information from a database/repository is not required (e.g. where it is publicly available and unrestricted re-use is permitted via an open license), a statement to explain this must be included within the manuscript.

Data acquired must be kept anonymized unless otherwise advised by the owners of the content in the database. Where participants’ details are not required to be anonymized, authors must be able to provide evidence that written informed consent, including consent to publish, was obtained from participants. A statement to confirm this must be included within the manuscript.

Survey studies

Researchers must ensure they have informed all participants why the research is being conducted, whether or not anonymity is assured, and how the data they are collecting is being stored. The participant’s right to confidentiality should always be considered and they should be fully informed about the aims of the research and if there are any risks associated. Their voluntary consent to participate should be recorded and any legal requirements on data protection should be adhered to.

As with all research studies, ethics approval from an appropriate IRB/local ethics committee must be obtained prior to conducting the study. A statement to confirm this must be included within the manuscript. In settings where ethics approval for survey studies is not required, authors must include a statement to explain this within the manuscript.

Covert observational research

As the nature of this type of research does not provide study participants the opportunity to opt-out or provide full informed consent, researchers must ensure they have considered the full rationale for the covert nature of their research and obtain ethical approval to conduct the study from an appropriate ethics committee. Ideally, researchers should seek informed consent from the study participants after the completion of the study. Authors must include a statement within the manuscript to provide the rationale for the covert nature of the research and the details of the name of the ethics committee(s) which approved the study and include the reference/permit numbers where available. Please note, the Editor reserves the right to deem research of this type not suitable for consideration in their journal.

Research on indigenous communities

Authors should be aware of any specific research ethics approval and informed consent procedures which need to be followed in order to conduct research in communities where special processes for permissions may exist. Authors should also be aware of cultural sensitivities or any restrictions associated with the publication of content, including images included in their manuscripts. In many indigenous communities, additional permissions may need to be sought from community leaders or an Elder.

Authors working with indigenous communities are advised to consult appropriate guidelines for ethical research and publishing (including requirements for authorship) such as the AIATSIS Guidelines for ethical publishing, the National Inuit Strategy on Research and Interviewing Elders: Guidelines from the National Aboriginal Health Organization. Authors conducting research using media tools are advised to consult appropriate guidelines such as the On Screen Protocols & Pathways: A Media Production Guide to Working With First Nations, Metis, and Inuit Communities, Cultures, Concepts & Stories.

Communication research

Scholars in the field of communication should be aware of any restrictions for using copyrighted content for their work. Authors are advised to consult appropriate guidance such as the Code of best Practices in Fair Use for Scholarly Research in Communication published by The International Communication Association.

Social media research

Scholars using data gathered from social media platforms (e.g. Twitter, Facebook, etc.) should be aware of the ethical guidance surrounding the gathering of and publication of such information. In particular, careful consideration should be made for any requirements for obtaining ethical approval of studies from appropriate institutional review boards or ethics committees prior to conducting the study, obtaining informed consent from anyone identified in the submitted work or ensuring appropriate anonymization. Authors are advised to consult appropriate guidance such as the ethics statement and framework from Social Data Science Lab and the ethical guidelines for digital research from the British Sociological Association.

Participant/patient privacy and informed consent

Taylor & Francis endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE), which emphasizes that patients and study participants have a right to privacy that should not be infringed without informed consent.

In accordance with the principles outlined in the Nuremberg Code, the Belmont Report and the American Anthropological Association, informed consent must be voluntarily obtained from the participant who should be fully informed of the study including any of the benefits and risks involved.

Consent to participate

For all studies involving human participants, informed written consent to take part in the research must have been obtained prior to the commencement of the study, and a statement to confirm this must be included in the manuscript.

If only verbal informed consent was obtained, a full explanation for why this was not obtained in written form should be included, along with the name of the IRB/local ethics committee which gave approval for verbal consent. A statement of how this was documented must also be included in the manuscript.

For patients or study participants who are not adults, or are considered to be vulnerable or unable to provide informed consent, this must then be obtained from their legal guardians, or next of kin if the participant is deceased.

Where participant data have been anonymized, this should be clearly stated within the manuscript with a note to confirm that such alterations have not distorted the scholarly meaning.

Consent to publish identifiable information

For any submissions including information which can potentially identify an individual (including by their online alias, social media handles etc.), authors must confirm that they have obtained written informed consent to publish the details from the affected individual (or their parents/guardians if the participant in not an adult or unable to give informed consent; or next of kin if the participant is deceased).

Identifying information includes (but is not limited to) written descriptions, photographs, illustrations, recordings, videos, pedigrees and rare diseases, physical traits or disorders. The process of obtaining consent to publish should include sharing the article with the individual (or whoever is consenting on their behalf), so that they are fully aware of the content of the article before it is published.

Consent to Publish statements must confirm that the details and any images, videos, recordings, etc. can be published, and that the person(s) providing consent have been shown the article contents to be published. Authors may use this Consent to Publish Form, which should be completed, signed, and saved securely.

A statement to confirm that Consent to Publish has been obtained must be included within the manuscript. Authors must also state who granted consent to publish.

Consent to Publish is a journal requirement and cannot be exempted by an ethics committee. Authors must be prepared to provide copies of signed consent forms to the journal editorial office if requested.

Research involving animals, plants, and heritage sites

Research involving animals

Studies involving vertebrates or regulated invertebrates (e.g. cephalopods), field studies and other non-experimental research on animals must have been carried out after obtaining approval from the relevant institutional ethics committee or the institutional animal use and care committee. Research procedures must be carried out in accordance with applicable national or international guidelines. In field studies authors must have also obtained any necessary permits for access to lands.

Authors must include a statement within the manuscript to provide details of the name of the ethics committee(s) which approved the study and include the permit or animal license numbers where available. Where a study has been granted an exemption from requiring ethical approval, this should be stated along with the name of the ethics committee which provided the exemption, and the reasons for exemption.

For experimental studies involving client-owned animals, authors must also document informed consent from the client or owner and adherence to best practices of veterinary care.

Authors conducting research on animals are advised to consult appropriate guidelines on care and handling of laboratory animals such as the Guide for the Care and Use of Laboratory Animals: Eighth Edition. (Washington, DC: The National Academies Press).

Specifically, submissions of research involving laboratory-based animals (vertebrates or regulated invertebrates) must include details on housing, husbandry and steps taken to reduce suffering. In submissions describing the sacrifice of experimental animals, details must be provided on humane endpoints. In particular, details about the planned behavioral observations or physiological measurements used to determine the humane endpoint must be described. Researchers conducting this type of research are advised to consult the NC3Rs guide on Humane Endpoints and the American Veterinary Medical Association Guidelines for the Humane Slaughter of Animals.

Any euthanasia or anesthesia methods must be described in detail, including information about the agents used. These procedures must be carried out in accordance with applicable veterinary guidelines, such as the American Veterinary Medical Association.

Taylor & Francis also endorses the principles on ethical animal research outlined in the Basel Declaration and the ethical guidelines by the International Council for Laboratory Animal Science (ICLAS).

Research involving plants

Research on plants (cultivated or wild), including the collection of plant material must be carried out in accordance with guidelines provided by the authors’ institution(s) and national or international regulations. Field studies should comply with local legislation, and the manuscript should include a statement of appropriate permissions granted and/or licenses.

Voucher specimens must be deposited in a public herbarium or other public collection providing access to deposited material. Information on the voucher specimen and who identified it must be included in the manuscript.

Research on threatened/endangered species

Authors are asked 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.

Research involving protected heritage sites

Researchers working on protected heritage sites must comply with all necessary ethical guidelines (including process of data collection, deposition and handling specimens) and obtain all necessary permits from relevant authorities for access to sites and/or specimens prior to conducting the work. Authors must include a statement within the manuscript to confirm that all necessary permits were obtained, and must include the name of the authority which provided it.

Research in paleontology and archaeology

Authors must ensure they have provided detailed information about the methods used for the research work and the analysis (including phylogenies). Detailed information must also be provided about the specimens (including numbers and repository information), museum name (if applicable) and geographic location.

If according to national or international regulations any permits are required for the research and/or the publication of the work, this must be obtained from the relevant authority. As required by local authorities, any discoveries from their sites must be reported to the relevant authorities prior to submission of the manuscript.

Authors reporting archaeological work involving human remains must comply with all necessary ethical guidelines (including observing best practice in data collection, recording and deposition) and obtain all necessary permits from relevant authorities for access to sites and handling of the human remains prior to conducting the work. Authors are advised to consult the Guidelines to the Standards for Recording Human Remains (Chartered Institute for Archaeologists).

Authors must include a statement within the manuscript to confirm that all necessary permits were obtained, and must include the name of the authority which provided it.

Biosafety, biosecurity, and emerging biotechnology

Taylor and Francis journals will only consider research which has been carried out in compliance with institutional biosafety and biosecurity policies, which in turn should be informed by national or international recommendations.

Researchers should be aware of Dual Use Research of Concern (DURC) related to their work, which according to the NIH Office of Science Policy “can be reasonably anticipated to provide knowledge, information, products or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security”.

Researchers of relevant work are advised to be aware of the WHO recommendations of responsible life sciences research, and should take steps to mitigate any risks contributed by their research.

Where concerns are raised about potential risk, we may seek expert advice to assess this, so authors should be prepared to provide any further information requested by the journal editorial office.

 

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