Ethics approval of research

The BMJ aims to ensure that all articles published in The 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. This policy also applies on the very rare occasions that we publish work done with animal participants.

Many people consider that studies referred to as audit do not need any consideration of ethics, whereas all research must be approved by a formally constituted research ethics committee or, in the USA, an institutional review board. But the distinction between audit and research is unclear, and the assumption that audit or analysing previously collected data is never unethical may not be justified. Furthermore, review by an ethics committee cannot necessarily guarantee that work is morally sound.

For these reasons journals have a duty to consider the ethical aspects of both submitted and published work. The BMJ’s policy on these issues has been developed with the help and advice of the BMJ ethics committee , and its key elements are explained here.

Editorial appraisal of a study’s ethics is not always easy because the standard format for presenting original papers does not emphasise the reporting of ethical aspects of research.

We require every research article submitted to The BMJ to include a statement that the study obtained ethics approval (or a statement that it was not required), 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.

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 and ask them how they justified the ethical and moral basis of the work. Editors may also ask authors 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. For studies that have not been reviewed by research ethics committees or institutional review boards editors may ask authors to explain what ethical issues they considered and how they justified their work.

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 BMJ’s queries about ethics approval. This consultation may be informal, between The BMJ’s editors, or more formal, through seeking the advice of The BMJ’s ethics committee or the Committee on Publication Ethics (COPE). Problems referred to COPE or The BMJ's ethics committee will be considered as anonymised summaries of the relevant articles, written by the editors concerned.

What happens when The BMJ 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 BMJ, 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 The BMJ’s 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 BMJ 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.