Ethical approval of research involving human participants
Our policy is to ensure that all articles published by General Practice in China 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 Ethics Committee of General Practice in China, 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.
