Research Ethics: Human Participants and Animals

Journal of Science and Technology (JST) · e-ISSN 2456-5660 · published by Longman Publishers

JST publishes research involving people, human material or data, or animals only where it was conducted ethically, with the approvals and consents this policy describes. The policy applies to every manuscript submitted to the journal. It follows the Declaration of Helsinki, the ICMJE Recommendations, the ARRIVE guidelines for animal research and the guidance of the Committee on Publication Ethics (COPE). Where this policy and a national law or institutional rule differ, the stricter one applies.

1. Research involving human participants

For any study involving human participants — including surveys, interviews, questionnaires, observations, experiments, clinical studies and studies using identifiable personal data — the manuscript must state, in its Declarations section and where appropriate in the Methods:

  • that the study was conducted in accordance with the ethical principles of the Declaration of Helsinki;
  • that it was approved by an institutional review board (IRB), institutional ethics committee or equivalent independent body before the research began, giving the name of the body and the approval reference number and date;
  • that informed consent was obtained from every participant, or from a parent or legal guardian for minors and for adults unable to consent, and in what form (written, oral and recorded, electronic); where consent was waived, the body that granted the waiver and its reasons;
  • how participants' privacy and confidentiality were protected, and that data were handled in accordance with the data-protection law that applies to them.

Studies of publicly available, fully anonymised data, and research the authors' institution has formally classed as exempt from review, must still say so in the manuscript, naming the exemption or the body that confirmed it.

2. Consent for publication

Where a manuscript contains details, images, video or recordings that could identify a person — a case report, a photograph, a facial image, a distinctive scan, a personal history — the authors must have obtained written consent for publication from that person (or a parent or guardian) and must say so in the manuscript. The consent form is kept by the authors and shown to the journal on request. Removing a name is not enough to make a person unidentifiable; the editors judge identifiability and may ask for the material to be altered or removed.

3. Clinical studies and trials

A manuscript reporting a clinical trial must give the trial's registration number and the registry (for example CTRI, ClinicalTrials.gov or another WHO ICTRP primary registry) in the abstract and the Methods; trials should have been registered before enrolment of the first participant, and the authors must explain any late registration. Reports of clinical studies follow the relevant reporting guideline (CONSORT for randomised trials, STROBE for observational studies, PRISMA for systematic reviews, CARE for case reports); the completed checklist is submitted with the manuscript.

4. Human material and data

Research using human tissue, cells, blood or other biological material, or using medical records or other personal data, requires the same ethics-committee approval and, unless the committee waived it, consent for the use of the material or data for research. The source of any cell line is stated; commercially obtained or established lines are named with their supplier or catalogue reference.

5. Research involving animals

For any study involving live vertebrates or higher invertebrates, the manuscript must state:

  • that the work followed the institutional, national and international guidelines that apply to it (in India the CPCSEA guidelines; elsewhere the equivalent) and was approved by an institutional animal care and use committee (IACUC) or an equivalent ethics body, giving the name of the body and the approval reference;
  • the species, strain, sex, age or weight, number of animals, source, housing and husbandry, and the methods used to minimise pain, suffering and distress, including anaesthesia, analgesia and the method of euthanasia;
  • that the number of animals was the minimum needed for a valid result, and how the principles of replacement, reduction and refinement (the 3Rs) were applied.

Animal studies are reported in line with the ARRIVE guidelines. Field studies on wild animals also state the permits or licences under which animals were observed, captured, sampled or collected, and confirm compliance with the law protecting endangered species.

6. Plants, field collections and biosafety

Research on plants, fungi or microorganisms, and any field collection, must comply with the relevant institutional, national and international guidelines and legislation, and the manuscript must state the permits obtained — for collection, for access to protected areas, for work with endangered or protected species, and for the transfer of material across borders (including compliance with the Convention on Biological Diversity and the Nagoya Protocol where they apply). Voucher specimens are deposited in a recognised collection and cited. Work with genetically modified organisms, pathogens or other hazardous biological material states the biosafety approval and containment level.

7. Hazards and dual-use research

Where the work involves chemicals, procedures or equipment with unusual hazards, the authors identify them clearly in the manuscript. Where the results could plausibly be misused to cause serious harm to public health, safety or the environment, the authors say so at submission; the editors may seek specialist advice and may decline to publish details that would enable such harm.

8. What to write in the manuscript

Every manuscript carries a Declarations section (see the Writing Rules) with an "Ethics approval and consent" statement. Three examples of acceptable statements:

  • "This study was approved by the Institutional Ethics Committee of [institution] (approval no. [number], [date]) and conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants."
  • "All animal procedures were approved by the Institutional Animal Ethics Committee of [institution] (approval no. [number]) and carried out in accordance with CPCSEA guidelines and the ARRIVE guidelines."
  • "Not applicable — this study involved no human participants, human material or data, or animals."

A statement that only says "ethical approval was obtained" is not enough: the body, the reference and the consent must be named.

9. What the editors do

Manuscripts that involve people, human material or animals and do not carry the required statements are returned to the authors before peer review. Editors and reviewers may ask to see the approval letter, the consent form or the permit at any stage, and the authors must be able to provide them. A published article found to report research conducted without the required approval or consent is handled under the Publication Ethics and Malpractice Statement, following COPE guidance, and may be retracted as the Crossmark Policy describes; the authors' institution may be informed.

10. Contact

Authors unsure whether their study needs approval, or how to describe an exemption, should ask the editorial office before submitting: editor@jst.org.in.