Read more about BMJ Policies on:
- Ethical approval of research involving human participants
- Ethical approval of research involving animals
Ethical approval of research involving human participants
Our policy is to ensure that all articles published by BMJ report on work that is morally acceptable, and expects authors to follow the World Medical Association’s Declaration of Helsinki. To achieve this, we aim to appraise the ethical aspects of any submitted work that involves human participants, whatever descriptive label is given to that work including research, audit, and sometimes debate.
Our policy on these issues has been developed with the help and advice of the BMJ Ethics Committee and its key elements are explained here.
Statement of Ethics Approval
We require every research article submitted to include a statement that the study obtained ethics approval (or a statement that it was not required and why), including the name of the ethics committee(s) or institutional review board(s), the number/ID of the approval(s), and a statement that participants gave informed consent before taking part.
In addition we welcome detailed explanations of how investigators and authors have considered and justified the ethical and moral basis of their work. If such detail does not easily fit into the manuscript please provide it in the covering letter or upload it as a supplemental file when submitting the article. We will also be pleased to see copies of explanatory information given to participants. Even if we do not include such detailed information in a final published version, we may make it available to peer reviewers and editorial committees. We already ask peer reviewers to consider and comment on the ethics of submitted work.
Appraisal of Ethical Issues
Editorial appraisal of ethical issues goes beyond simply deciding whether participants in a study gave informed consent although this is, of course, one very important issue to consider. Editors should judge whether the overall design and conduct of each piece of work is morally justifiable, as summed up by the following questions:
- How much does this deviate from current normal (accepted, local) clinical practice?
- What is the (additional) burden imposed on the patients (or others)?
- What (additional) risks are posed to the patients (or others)?
- What benefit might accrue to the patients (or others)?
- What are the potential benefits to society (future patients)?
Even when a study has been approved by a research ethics committee or institutional review board, editors may be worried about the ethics of the work. Editors may then ask authors for more detailed information such as:
- how they justified the ethical and moral basis of the work
- to provide the contact details of the research ethics committee that reviewed the work, so that the journal can request further information and justification from that committee
- to explain what ethical issues they considered and how they justified their work, for studies that have not been reviewed by research ethics committees or institutional review boards
Editors may ask other editorial colleagues to evaluate the ethical aspects of an article, the authors’ comments, and the response of the relevant research ethics committee to the journal’s queries about ethics approval. This consultation may be informal, between the journal’s editors, or more formal, through seeking the advice of the BMJ Ethics Committee or the Committee on Publication Ethics (COPE). Problems referred to COPE or the BMJ Ethics Committee will be considered as anonymised summaries of the relevant articles, written by the editors concerned.
What happens when the journal considers a study to be unethical?
We believe that editors have a duty to take on issues of unethical audit or research, not to seek punishment for the authors, but to prevent unethical practice and to protect patients.
If the Editor, with or without the advice of its ethics committee and/or COPE, considers the work in a submitted article to be ethically unsound the editor may seek further advice or recommend investigation or action. The fact that the article would have been rejected anyway for other scientific or editorial reasons would not prevent the editor from taking such further action on serious ethics problems.
In the first instance the editor would usually contact the head of the department where the work was done to explain their concerns and recommend a local investigation. Secondly, the editor might write to the professional registration body of the paper’s guarantor or principal investigator. For a doctor in the UK, this body would be the General Medical Council.
In rare instances the journal might publish an article despite ethics problems in the work it reported. The usual reason would be that work done in one setting might not reach the ethical standard of work done in another setting, because of differing local resources and standards for health care and research. In deciding to publish such an article, we would consider carefully the context of the study and aim to balance the overall benefit to society against the possible harm to the research participants.
Ethical approval of research involving animals
All material published in BMJ journals which reports experiments performed using animals must adhere to high ethical standards concerning animal welfare.
Manuscripts will be considered for publication only if the work described:
- follows international, national and institutional guidelines for the humane treatment of animals and complies with relevant legislation;
- has been approved by the ethics review committee at the institution or practice at which the studies were conducted (where such a committee exists);
- for studies involving non-human primates, demonstrates that the standards meet those of the NC3Rs primates guidelines;
- for studies using client-owned animals, demonstrates a high standard (best practice) of veterinary care and involves informed client consent.
Before a manuscript can be accepted, authors must:
- confirm that legal and ethical requirements have been met with regards to the humane treatment of animals described in the study;
- specify in the Materials or Methods section the ethical review committee approval process and the international, national, and/or institutional guidelines followed.
Editors retain the right to reject manuscripts on the basis of ethical or animal welfare concerns. Papers may be rejected on ethical grounds if the study involves unnecessary pain, distress, suffering or lasting harm to animals, or if the severity of the experimental procedure does not appear to be justified by the value of the work presented. We ask that the work would be likely to gain approval in Europe under the European Directive 2010/63/EU (on the protection of animals used for scientific purposes).
See ‘What happens when the journal considers a study to be unethical?’ above for an outline of how ethical concerns will be dealt with
Manuscripts describing animal research must include a justification for the use of animals, and for the particular species used. They should also provide details of animal welfare, including information about housing, feeding and environmental enrichment, a description of steps taken to minimise suffering, humane endpoints and method of euthanasia. If the study has any implication for the 3Rs (replacement, reduction and refinement), these should be discussed in enough detail so that readers can implement the 3Rs in similar experiments.
This section was adapted from an article by Dr Trish Groves, BMJ’s Director of Academic Outreach.
Oral Diseases (2010) 16, 313-315.