Research Ethics, COI, and Informed Consent

Conflict of interest, human and animal research ethics, and informed consent policies.

Competing interests

All financial or non-financial interests that are related to the research directly relevant to the content of the manuscript must be declared. Please use the author initials to refer to each author’s competing interests.

Example statements:
“Financial interests: [AA] and [BB] declare they have no financial interests. [CC] has received speaker and consultant honoraria from Company X. [CC] has received speaker honorarium and research funding from Company X and Company Y, respectively. [DD] has received travel support from Company Z.”
“Non-financial interests: [EE] has served on advisory boards for Company X. [FF] is an unpaid member of committee Z.”
If the authors do not have any competing interests, please state ” The author(s) declare(s) that there is no conflict of interest”.

Author contributions

The contribution of every author to the research and preparation of the manuscript should be specified. Please use author initials to refer to each author’s contribution.

Example statement:
“All authors contributed to the study conception and design. [AA], [BB] and [CC] performed material preparation, data collection and analysis. [AA] and [BB] analyzed and interpreted the data. The first draft of the manuscript was written by [AA], and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.”

In addition to the above, manuscripts that report the results of studies involving human and/or animal subjects should include the following declarations:

Ethics approval

Authors of research involving human or animal subjects should include a statement that confirms that the study was approved by the appropriate ethics committee (including the name of the ethics committee and approval number, if available). For research involving animals, authors should supply detailed information on the ethical treatment of their animals. These statements should be disclosed in the Declaration section, but not in Materials and Methods section. If a study was granted exemption or did not require ethics approval, this should be detailed.

“The protocol for this research project has been approved by the Ethics Committee of [X University] (Date …/Approval No. ….) and it conforms to the provisions of the Declaration of Helsinki.”
“This is an observational study. The [Y Research Ethics Committee] has confirmed that no ethical approval is required.”
“All procedures using animals were performed according to the ethical guidelines of Animal Research Committee of [X University] (Date …/ Approval No. ….)”.

For detailed information on relevant ethical standards and criteria, please refer to the sections on “Ethics Policies”.

For all research involving human subjects, informed consent to participate in the study must be obtained from the participants (or their parent or legal guardian in the case of children). All presentations of case reports must have consent for participation. A statement confirming that consent for participation has been received from all participants should appear in the section. If the study did not require it, please indicate “not applicable”.

Example statement:
“Informed consent was obtained from all individual participants included in the study.”
“Written informed consent was obtained from the parents of the patients.”

Please refer to the section on “Ethics Policies” for additional help.

Individuals may consent to participate in a study, but object to having their data published in a journal article. If your manuscript contains any individual person’s data in any form (including any individual details, images or videos), consent for publication must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent for publication. A statement confirming that consent for publication has been received from all participants should appear in the section. If the study did not require it, please indicate “not applicable”

The authors can use their institutional consent form, but do not have to send them on submission. The Editorial Bord may request to confirm the consent at any stages.

Example statement:
“The authors affirm that human research participants provided informed consent for publication.”

Please refer to the section on “Ethics Policies” for additional help.

5) Conflicting interests

Conflict of Interest must be considered to prevent ambiguity about financial and personal relationships that might bias the submitted work. All authors are requested to disclose any actual or potential conflict of interest including any financial, personal, or other relationships with other people or organizations for the past one year prior to submission that could inappropriately influence, or be perceived to influence, their work. This disclosure must be included in Declaration section of the manuscript.
For guidance on conflict of interest statements, please see the ICMJE recommendations.

2. Ethics Policies

Authors submitting manuscripts to PAIN Research are expected to conduct their research in strict accordance with the JASP Policies on Ethics.

PAIN Research recognizes its responsibility to ensure that questions of scientific misconduct or dishonesty in research are adequately pursued. Should scientific misconduct or dishonesty be suspected or alleged, PAIN Research follows the recommended procedures outlined by the Committee on Publication Ethics (COPE).

1) Publication ethics

PAIN Research takes issues of copyright infringement, plagiarism or other breaches of best practice in publication very seriously. We seek to protect the reputation of the journal against malpractice. Submitted articles may be checked using duplication-checking software. Where an article is found to have plagiarised other work or included third-party copyright material without permission or with insufficient acknowledgement, or where authorship of the article is contested, we reserve the right to take action including, but not limited to: publishing an erratum or corrigendum (correction); retracting the article (removing it from the journal); taking up the matter with the head of department or dean of the author’s institution and/or relevant academic bodies or societies; banning the author from publication in the journal, or appropriate legal action.

2) Human research

Authors must state that the protocol for the research project has been approved by a suitably constituted Ethics Committee of the institution within which the work was undertaken and that it conforms to the provisions of the Declaration of Helsinki (as revised in Fortaleza, Brazil, October 2013).
In general, submission of a study in which case are represented should be accompanied by the written consent of the subject (or parent/guardian) before publication. While the Editors recognize that it might not always be possible or appropriate to seek such consent, the onus will be on the authors to demonstrate that this exception applies in their case. The authors must state about the full name and the institution of the review committee with the approval number in the Declaration section of the manuscript as follows:
The protocol for this research project has been approved by the Ethics Committee of [X University] (Date …/Approval No. ….) and it conforms to the provisions of the Declaration of Helsinki. All informed consent was obtained from the subject(s) and/or guardian(s).

As shown in the Declaration of Helsinki, every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. Thus, any research project that assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome must be registered. Registration of retrospective studies is not required, but authors are encouraged to have official approval from an appropriate ethical committee at submission of the study. The authors must disclose the registry and the number of the registration in the Declaration section.

Clinical trials: Clinical trials are subject to all policies regarding human research. PAIN Research follows the World Health Organization’s (WHO) definition of a clinical trial: A clinical trial is 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. Interventions include but are not restricted to drugs, cells, and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.

All clinical trials must be registered at or before the time of first patient enrollment in any primary registry of the WHO International Clinical Trials Registry Platform (ICTRP). Authors must provide the registry name and registry number in the cover letter and methods section.

Papers on clinical trials must adhere to the CONSORT reporting guidelines appropriate to their trial design and provide a completed CONSORT checklist and flow diagram as a figure.

Our policies for clinical trial submissions are designed to promote transparency and reproducibility and ensure the integrity of the reporting of patient-centered trials. Editors and reviewers should carefully review trial protocols and registration details and assess manuscripts according to CONSORT.

3) Animal research

All manuscripts reporting animal studies must include the statement indicating that the protocol and procedures were ethically reviewed and approved, as well as the name of the body giving approval, in the Declaration section of the manuscript. Authors are required to adhere to animal research reporting standards, for example the ARRIVE guidelines for reporting study design and statistical analysis; experimental procedures; experimental animals and housing and husbandry. Descriptions of surgical procedures on animals should include the route of drug administration, drug name, and dose of anesthetic used. Authors must also state whether experiments were performed in accordance with relevant institutional and national guidelines for the care and use of laboratory animals.