Research ethics and consent

      

All research published in Dove Medical Press 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.

Ethics 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.

 

Study design specific ethics considerations

Prospective studies on humans

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 signed and dated copies 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 either the Abstract or 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, Dove Medical Press journals require 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, 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, National Institutes 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.

Case reports/Case series/Clinical datasets

Given the specificity of details provided in a case report, case series or clinical dataset authors are required to obtain consent from patients (or their guardians if they are not adults or lack capacity to provide informed consent, or next of kin if deceased) for the publication of the case(s). This must be done even if the authors have removed direct identifiers and 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 Patient Consent Form (provided by the Taylor & Francis group, of which Dove Medical Press is part of) which should be completed, signed, and saved securely. Authors should be prepared to share this with the journal editorial office if requested. A statement confirming consent to publish has been obtained must be included within the manuscript.

Dove Medical Press considers a case report to be the diagnosis, treatment and post-treatment follow-up of a single patient. By comparison, a case series is considered a group of case reports involving patients who were all given similar treatments. A clinical dataset is a list of well-defined variables collected during ongoing patient care or as part of a clinical trial program. It includes electronic health records, administrative data, patient registries, and clinical trial data.

In some instances, a case report or case series containing information on less than three patients may not require IRB approval. This is because a case series of less than three subjects may not be considered generalized knowledge or research. However, this requirement is dependent on the institution, country or region implementing it and authors must ensure they have followed the correct regulatory requirements of their respective institution or country. A statement explaining this requirement must be included within the manuscript.

Organ or tissue transplants

Dove Medical Press endorses the ethics guidelines described by the World Health Organisation (WHO), the World Medical Association (WMA) and the Declaration of Istanbul. 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.

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

Consent from 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.

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 licence), a statement to explain this must be included within the manuscript. Data acquired must be kept anonymised unless otherwise advised by the owners of the content in the database. Where participants details are not required to be anonymised, 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 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.

Research on indigenous communities

Authors should be aware of any specific research ethics approval procedures which need to be followed in order to conduct research in communities where restrictions or special processes may exist. Authors should also be aware of cultural sensitivities or restrictions associated with any images included in their manuscripts. In the Aboriginal Australian culture for example, additional approval may need to be sought from a community elder. Authors working with these communities are advised to consult the AIATSIS Guidelines for ethical publishing.

 

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 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 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 anonymised, 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 articles including information which could potentially identify an individual (including but not limited to an individual’s name, address, place of employment, date of birth, telephone number, email address, medical records or patient ID, account numbers, license number, IP address and full or comparable photographic image or video) 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, videos, pedigrees and rare diseases. 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 (provided by the Taylor & Francis group, of which Dove Medical Press is part of), 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

Experiments involving vertebrates or regulated invertebrates, field studies and other non-experimental research on animals must have been carried out in accordance with institutional, national or international guidelines, and with approval of an appropriate ethics committee where available.

Where applicable, a statement of ethics approval, or animal licenses should be included within the manuscript. 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 the exemption.

For non-human primate studies, it must be demonstrated the work meets the standards set out in the NC3Rs primate’s guidelines and follows best practice procedures. 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.

Dove Medical Press 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). Dove Medical Press advises all authors conducting animal research to read NC3Rs ARRIVE guidelines. The guidelines set out the currently accepted procedures for the reporting of research using animals and are available in a number of translations.

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 licences.

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 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

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 28 May 2020