Research ethics and consent for all Dove Medical Press journals

     

All human and animal subjects, living and deceased, should be treated with dignity and respect in academic research. Ethical research practices require that researchers are vigilant in ensuring that their work minimizes risk and avoids harm. Researchers also have an ethical obligation to be transparent about their research methods in such a way that editors, peer reviewers, and readers may fairly and adequately evaluate their work.

Note that for interdisciplinary and mixed-methods research, researchers should decide which guidelines are relevant based on the type of research they are conducting.

 

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.

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.

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.

 

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 registry conforming to WHO standards.

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 and other primary registries in the WHO primary registries network.

 

The trial registration number must be included in the manuscript. Any deviation from the original trial protocol must be explained, especially changes concerning primary outcomes.

 

Clinical trials should be registered prospectively – i.e. before participant recruitment. However, for clinical trials that have not been registered prospectively, Dove Medical Press journals may consider clinical trials which have been registered at least prior to data analysis. This is to make sure 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 Editorial Office prior to or at submission. 

 

Details on prospective and retrospective registration are available from the AllTrials campaign and the ICMJE.

We follow the WHO and 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. This can be with or without concurrent comparison or control groups.
  • Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes, etc.). This includes all phases of the trial, starting from Phase 1.
  • 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.

Dove Medical Press reserve the right to reject submissions (pre-publication) or retract published articles involving clinical trials where authors have not been able to adequately address concerns regarding the registration status and/or conduct of the clinical trial. Authors must be prepared to provide further supporting information related to their clinical trial (e.g. original data) to the journal editorial office upon request.

 

Clinical Case reports and Case series

A clinical case report is a detailed clinical report on an individual patient. By comparison, a case series is considered a group of case reports involving patients who were all given similar treatments.

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 (provided by the Taylor & Francis group, parent company of Dove Medical Press), 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

Dove Medical Press 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 are expected to verify that donated organs were obtained with full informed consent from the donor, or donor’s parent/guardian (if the donor is a minor), 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 of any research articles reporting the use of donated organs must include a statement to confirm informed consent was obtained. Authors must be particularly attentive to the risks associated with working with vulnerable populations and should be prepared to provide details of the process by which informed consent was obtained.

 

These requirements apply for all studies (including follow-up studies) involving donors or patients who have received organ or tissue transplantation. Dove Medical Press journals reserve the right to reject submissions (pre-publication) or retract published articles involving transplantation, where the authors are unable to provide confirmed evidence of informed consent. Authors must be prepared to provide further supporting information related to their study (e.g. ethical approval and informed consent forms) to the journal editorial office upon request.

 

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.

Dove Medical Press endorses the principles on ethical stem cell research outlined in the ISSCR Guidelines for Stem Cell Research and Clinical Translation.

 

Specifically, authors must include a statement within the manuscript to provide details of the name of the ethics committee(s) which approved the study. They must also include the reference/permit numbers where available, and a statement to confirm informed consent was obtained.

 

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.

 

Authors should not assume a database study does not require ethics review or approval, and for studies where either ethics review or approval has been waived or exempted authors must be prepared to provide details of the exemption. The exemption must be relevant and applicable to the current study submitted and a statement should also be included in the manuscript providing brief details of the exemption policy. The statement should include details of the local, regional, or institutional policies under which the exemption was granted.

 

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.

Where required by national law or the researcher’s institution, ethical approval must be obtained prior to conducting the study. In settings where ethics approval for survey studies is not required, authors should include a statement to explain this within the manuscript.

 

  • 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
Covert observational research requires particular ethical and legal considerations but may be acceptable in rare cases with a strong justification. Researchers must also consider the emerging legal frameworks surrounding rights to privacy, which vary considerably across the globe. Authors conducting covert research should consult relevant guidelines, such as those outlined in the British Sociological Association’s Statement of Ethical Practice.

 

All studies that include covert research must include the following:  

  • A statement within the manuscript providing a full rationale for the covert nature of the research and the name of the ethics committee(s) that approved the study (and include the reference/permit numbers where available). 
  • If the study takes place on a social-media platform (such as Tinder), researchers should consult the platform’s code of conduct and/or terms of use to determine whether they need the platform’s permission to include user data in their research.
  • The use of aliases or online personas should be declared.
  • Ideally, researchers should seek informed consent from the study participants after completion of the study.

 

Please note that journal editors, scholarly societies and associations, and the publisher reserve the right to deem covert research unsuitable for consideration in their journal.

 

“Helicopter” research and ethics dumping

Research conducted abroad carries particular ethical implications. Particularly when researchers based in high-income countries, regions, areas, or institutions, undertake research projects in location/s with limited research ethics oversight or weaker socio-economic standing. This can lead to an inequity between the researchers and the local community. To this end, researchers are encouraged to:

  • Obtain ethics approval from local institutions/committees based on where the research is conducted
  • Include and partner with local participants, researchers, and communities throughout the research process
  • Involve local participants, researchers, and communities in the interpretation, analysis, and dissemination of research findings
  • Include local collaborators/volunteers who meet the threshold for inclusion as an author (or mention them in the acknowledgements if they do not)

Researchers are also encouraged to include a statement explaining how they considered their impact on the environment/local population. And, why it was essential that they had to perform the study in that location/community.

Researchers should also be mindful of ethics dumping. This is where researchers leading a study deliberately locate their study or establish research collaborations with the intention of circumventing international standards of research ethics and responsible research practices. In doing so, the safety and welfare of the public, of human research participants and/or experimental animals is not appropriately prioritized, and valid informed consent from research participants is lacking.

Researchers should be aware that the journal editorial team may ask questions about these considerations at any point in the submission or publication process. Dove Medical Press reserves the right to reject (pre-publication) or retract (post-publication) any submission where ethical concerns cannot be adequately addressed.

Further recommendations that can be considered are available at A Global Ethics Code.


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:

 

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., X (formerly Twitter), Facebook, etc.) should be aware of national laws and ethical guidance on the gathering of and publication of such information.

When researchers are interacting with individuals or obtaining private information, they should obtain ethical approval prior to conducting the study. Researchers should also ensure appropriate anonymization and obtain informed consent from anyone who could potentially be identified.

Please note that not all data can be collected as fair use or a copyright exception. Authors must check the social media platform’s user policy or terms of service in the region where the research was conducted to determine whether permission is required from the platform.

Authors are advised to consult appropriate guidance such as the ethics statement and framework from Social Data Science Lab the ethical guidelines for digital research from the British Sociological Association.

 

Human Dignity
Vulnerable populations: Authors should be familiar with disciplinary, institutional, and national/international guidelines regarding research on vulnerable populations. The European Commission, the Global Association of Human Trafficking Scholars and the Economic and Social Research Council have produced guidance for research involving these groups.

Images: Researchers must ensure that participants fully understand the benefits and risks of being included in photographs and how the photographs will be used, stored, and circulated.

Derogatory and Stigmatizing Language: Non-stigmatizing and non-discriminatory language should be used when describing groups by race, ethnicity, age, disease, ability, religion, gender, sexual orientation, or other identity category. Where a particular study may necessitate the inclusion of derogatory or offensive language (e.g., direct quotes, transcribed interviews, lyrics, etc.), authors should make clear the scholarly purpose for such terminology.

Content warnings: Authors should consider including content warnings when articles contain particularly graphic or culturally sensitive content (e.g., violence, sexual abuse, human remains).

 

Authors must be prepared to provide further information and documentation regarding research methods and approvals to the journal editorial office upon request.

 

Journal editors and the publisher reserve the right to reject articles that do not adhere to the above considerations.

 

Participant/patient privacy and informed consent

Dove Medical Press 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.

 

  • 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.

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.

 

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.

 

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.

Dove Medical Press 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:

 

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

Dove Medical Press 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.

 

Ethics FAQ for authors

Q: Do I need ethics approval for retrospective patient data?
A: Yes. Approval from a formally constituted review board (Institutional Review Board or ethics committee) is required for all studies involving people, medical records, and human samples.

Q: Do I need patient consent for the use of retrospective data?
A: Informed consent by participants should always be sought. If not possible, an Institutional Review Board must decide if this is ethically acceptable. A statement should be included in the Materials and Methods section of your manuscript, regarding the IRB decision.

Q: Do I need ethics approval for a review article?
A: No. This will have been obtained by the original authors.

Q: Do I need ethics approval for using samples sourced from commercial providers?
A: Yes. Approval from a formally constituted review board (Institutional Review Board or Ethics committee) is required for all studies involving people, medical records, and human samples.

Q: If ethics approval was not required, what statement should I include in my manuscript?
A: For those investigators who do not have access to formal ethics review committees, the principles outlined in the Declaration of Helsinki should be followed. If the study is judged exempt, a statement from the ethics committee is required. A statement should be included in the Materials and Methods section of your manuscript, regarding the decision.

Q: Do I need ethical approval when reporting on veterinary clinical cases?
A: No. For studies using client-owned animals, a high standard (best practice) of veterinary care must be followed and an informed client consent statement should be included in the Materials and Methods section.

Q: Do I need ethics approval for studies involving live animals?
A: Yes. You must specify in the Materials and Methods section of your manuscript, the ethical review committee approval, and the international, national, and/or institutional guidelines followed regarding the animal’s welfare.

Q: Do I need approval for cells that have been sourced from an accredited commercial provider?
A: No. However, if cells have been gifted, or not sourced from an accredited commercial provider, we require confirmation that the research has been approved by a named institutional review board or ethics committee.

Updated 10 July 2025