2. Research Ethics and Informed Consent
The editors reserve the right to reject a submission or to retract a published article on ethical grounds even when it has received formal ethical approval.
2.1 Research Involving Humans
Research involving human participants, human material or human data must be performed in accordance with 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 detailing this, including the name of the ethics committee and the reference number where appropriate, must appear in all manuscripts reporting such research.
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 committee or their research governance office before conducting the study.
Authors reporting the use of a new procedure or tool in a clinical setting, must give a clear justification in the manuscript for why the new procedure or tool was deemed more appropriate than usual clinical practice to meet the patient’s clinical need, and should obtain ethics approval and informed patient consent for participation in the study.
In case of clinical trials, which are defined 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", the trial registration number (TRN) and date of registration should be included in the last line of the manuscript abstract. Suitable publicly available registries are those listed on the ICMJE website and the WHO International Clinical Trials Registry Platform. For clinical trials that have not been registered prospectively, IMR Press encourages retrospective registration to ensure the complete publication of all results. In such cases, the TRN, date of registration and the words ‘retrospectively registered’ should be included in the manuscript.
2.2 Privacy and Confidentiality
IMR Press follows 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.
2.2.1 Consent to Participate
Research that is performed on humans should follow international and national regulations in accordance with the Declaration of Helsinki or any other relevant set of ethical principles. 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. In the case of articles describing human transplantation studies, authors must include a statement declaring that no organs/tissues were obtained from prisoners and must also name the institution(s)/clinic(s)/department(s) via which organs/tissues were obtained.
2.2.2 Consent for Publication
Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, date of birth or hospital numbers, images or statements should not be included in a manuscript unless the information is essential for scientific purposes and the patient (or parent or guardian) has provided written informed consent for publication. A statement must be included in the manuscript declaring that the patient, or parent, guardian or next of kin (in case of deceased patients) provided written informed consent for the publication of any associated data and accompanying images. The consent form that will be treated confidentially must be made available to the Editor if requested.
For case reports or other studies in which case details, personal information or images are included that may enable an individual to be identified, the participant (or parent or guardian), or next of kin must consent to its publication, and this consent should be declared in the manuscript. Authors should disclose to patients that personally identifiable material would be available via the Internet under the Creative Commons Attribution License 4.0 as well as in print after publication.
For data sets containing clinical data, authors have an ethical and legal responsibility to respect participants’ rights to privacy and to protect their identity. Ideally, authors should gain informed consent for publication of the dataset obtained from participants at the point of recruitment to the trial. If this is not possible, authors must demonstrate that publication of such data does not compromise anonymity or confidentiality or breach local data protection laws, for the dataset to be considered for publication. Authors must consider whether the dataset contains any direct or indirect identifiers and consult their local ethics committee or other appropriate body before submission if there is any possibility that participants will not be fully anonymous. Authors must state in their manuscript on submission whether informed consent was obtained for publication of patient data.
2.3 Research Involving Animals
Experimental research on vertebrates or any regulated invertebrates such as cephalopods must comply with institutional, national or international guidelines, and where available should have been approved by an appropriate research ethics committee (REC), often known as an Institutional Animal Care and Use Committee (IACUC). A statement detailing compliance with relevant guidelines (e.g., the revised Animals (Scientific Procedures) Act 1986 in the UK and Directive 2010/63/EU in Europe) and/or ethical approval (including the name of the ethics committee and the reference number where appropriate) must be included in the manuscript. This also applies to field studies and other non-experimental research on animals. If a study was granted an exemption from requiring ethics approval, this should also be detailed in the manuscript (including the name of the ethics committee that granted the exemption and the reasons for the exemption).
For experimental studies involving client-owned animals, authors must also document informed consent from the client or owner and adherence to a high standard (best practice) of veterinary care. If a study was granted an exemption from requiring ethics approval, this should also be detailed in the manuscript (including the name of the ethics committee that granted the exemption and the reasons for the exemption).
The Editor will take into consideration animal welfare issues and reserves the right to reject a manuscript, especially if the research involves protocols that are inconsistent with commonly accepted norms of animal research. When rodents are used as in vivo cancer models, the tumor burden should not exceed the recommendations of the University of Pennsylvania Institutional Animal Care and Use Committee guidelines.
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.
2.4 Research Involving Plants
Experimental research on plants (either cultivated or wild), including collection of plant material, must comply with institutional, national or international guidelines (e.g., IUCN Policy Statement on Research Involving Species at Risk of Extinction and the Convention on the Trade in Endangered Species of Wild Fauna and Flora). Field studies should be conducted in accordance with local legislation, and the manuscript should include a statement specifying the appropriate permissions 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.
An example of an Ethical Statement:
Torenia fournieri plants were used in this study. White-flowered Crown White (CrW) and violet-flowered Crown Violet (CrV) cultivars selected from ‘Crown Mix’ (XXX Company, City, Country) were kindly provided by Dr. XXX (XXX Institute, City, Country).
Arabidopis mutant lines (SALKxxxx, SAILxxxx,…) were kindly provided by Dr. XXX , institute, city, country).
2.5 Research Involving Cell Lines
If cell lines are used, authors are encouraged include the following information:
For de novo (new) cell lines (including those given to the researchers as a gift, authors must follow our policies for human subjects research or animal research, as appropriate):
(1) Provide the details of the institutional review board or ethics committee approval.
(2) If the line is of human origin, please provide written informed consent.
For established cell lines:
(1) Confirm that mycoplasma testing has been done for the cell lines used.
(2) Confirm that the cell lines used have been authenticated and state what method was used for the authentication.
(3) Provide the source, supplier and, if available, catalogue number of all the cell lines used in the study.
(4) Furthermore, information regarding misidentified or cross-contaminated cell lines must be provided and cross-checked with the International Cell Line Authentication Committee (ICLAC) and ExPASy Cellosaurus databases in order to exclude known contamination with other cell lines or their incorrect identification.
(5) And please note that if a cell line has previously been reported to be contaminated or misidentified, an STR profile of the cell line used in the study must be available for evaluation by the journal’s editor.
Examples:
The cells of the human cervical adenocarcinoma line (HeLa) were provided by the XXX. The human colorectal adenocarcinoma line DLD-1 CCL-221™ cells, human monocytic THP-1 TIB-202™ cells, and human promyeloblast cell line HL-60 CCL-240 were received from XXX. The HeLa cell line was cultured in XXX. All cell lines were maintained at 37 ℃ in a XXX atmosphere and were mycoplasma-free (XXXX Mycoplasma Detection Kit). The study was carried out in accordance with the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of XXX (Protocol No. xxxxxx). All cell lines were authenticated shortly before use by the XXXX technique, carried out by XXX.
2.6 Sex and Gender in Research
We encourage our authors to follow the ‘Sex and Gender Equity in Research – SAGER – guidelines’ and to include sex and gender considerations where relevant. Authors should use the terms sex (biological attribute) and gender (shaped by social and cultural circumstances) carefully in order to avoid confusing both terms. Article titles and/or abstracts should indicate clearly what sex(es) the study applies to. Authors should also describe in the background, whether sex and/or gender differences may be expected; report how sex and/or gender were accounted for in the design of the study; provide disaggregated data by sex and/or gender, where appropriate; and discuss respective results. If a sex and/or gender analysis was not conducted, the rationale should be given in the Discussion. We suggest that our authors consult the full guidelines before submission.