Editorial Policies and Guidelines 

IJM Ethics Committee

The IJM has an ethics committee that meets quarterly and communicates regularly by email. Collectively, the members have broad expertise including clinical medicine, research, journalism, bioethics, law, and medical editing.

The committee has five main roles:

1. Clarifying, reviewing and developing editorial policies on issues such as:

• consent to publication of material arising from the doctor patient relationship
•  competing interests for authors, reviewers, editors, and ethics committee members
• prior disclosure of results to research participants
• editors' duty of confidentiality to authors

2. Formulating new editorial policies3. Advising editors on ethics questions that arise during routine editorial work. This includes scrutinising papers referred by editors or peer reviewers worried about some aspect of the conception, design, conduct, presentation, authorship, or peer review of the work described in those papers.4. Advising editors on their moral duties and responsibilities to patients, research participants, authors, reviewers, publishers, other editors and readers.5. Helping editors to enhance the coverage of bioethics in the IJM6. Keeping editors informed of developments in research and publication ethics.

The committee's role is advisory. The editor can ignore its advice, but must justify his action to the chairperson in writing: the editor's and chairperson's comments will be published. The chairperson can appeal to the journal committee of the IJM in the event of a dispute.

Decisions made by the committee, the minutes of its meetings, and its annual report are posted on www.ijmjournal.org.uk . Any papers discussed by the committee and mentioned in these reports are anonymised first. The committee is recruited through open advertisement in the lay press and the IJM, and we welcome applications from both within and outside the UK.

Useful links

Research Ethics

American Association of Medical Colleges (AAMC) - http://www.aamc.org/research/dbr/compliance/models.htm

Canadian guidelines on Ethical Conduct for Research Involving Humans - http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm

Central Office for Research Ethics Committees (UK) - http://www.corec.org.uk/

Indian Council of Medical Research? Ethical Guidelines for Biomedical Research on Human Subjects - http://www.icmr.nic.in/ethical.pdf

Office of Research Integrity (US) - http://ori.dhhs.gov/html/policies/introduction.asp

World Medical Association Declaration of Helsinki - http://www.wma.net/e/policy/b3.htm

Publication Ethics

International Committee of Medical Journal Editors - http://www.icmje.org/index.html

Committee on Publication Ethics (COPE) - http://www.publicationethics.org.uk

World Association of Medical Editors (WAME) - http://www.wame.org

Ethics Resources on the Web

Applied Ethics Resources on the web - http://www.ethicsweb.ca/resources/

Journal of Medical Ethics online link resource - http://jme.bmjjournals.com/misc/links.shtml

National Institutes of Health Bioethics Resources on the web - http://www.nih.gov/sigs/bioethics/

Editors' Duty of Confidentiality to Authors

IJM editors treat all submitted manuscripts as confidential documents, which means they will not divulge information about a manuscript to anyone without the authors' permission. During the process of manuscript review the following people may also have access to manuscripts:

• editors and editorial staff at the IJM, including medical students on placement and occasional overseas visitors - usually doctors or editors from other journals
• external reviewers, including statisticians and experts in trial methods
• members of the journal's various editorial "hanging" committees - the final stage in our peer review process for original papers and other unsolicited manuscripts
•  the only occasion when details about a manuscript might be passed to a third party without the authors’ permission is if the editor suspects serious research misconduct—see below.

What we do if we suspect research or professional misconduct

• if an editor has concerns that a submitted paper describes something that might be considered to constitute research or professional misconduct, the case may be discussed with the IJM Ethics Committee.
• The IJM’s Ethics Committee - The committee scrutinises a small proportion of papers which are referred to them by IJM editors or reviewers. Authors of these papers are informed of such referral beforehand and given feedback from the committee after the meeting. The committee's decisions are posted in an anonymised form on bmj.com (please see the separate section on the IJM ethics committee and two editorials: An Ethics committee for the IJM and The IJM's ethics committee is open for business)
• if the case cannot be resolved by discussion with the author(s), and the editor still has concerns, s/he may report the case to the appropriate authorities. If, during the course of reviewing a paper, an editor is alerted to possible problems (for example, fraudulent data) in another publication, the IJM editor may contact the journal in which the previous publication appeared to raise the concern • the IJM is a member of the Committee on Publication Ethics (COPE). Cases of research or publication misconduct may also be referred to COPE in an anonymised format.

Patient Confidentiality and Consent to Publication

Please read the IJM ethics committee’s detailed guidelines on patient consent to publication:Revised consent to publication guidelines 2003

The main points of this policy are:

1. Publication of any personal information about a patient will normally require the signed consent of the patient. We expect authors to use the IJM's consent form. You may remove a patient’s identifying details from a IJM article, although consent will still be required. Do not change the personal details of patients to try to disguise them: this is bad scientific practice. In addition, black bands across the eyes are wholly ineffective in disguising a patient’s identity in a photograph: we will not publish these.
2. Personal information about a patient will not be published over the patient’s refusal, except in the most exceptional circumstance of overriding importance to public health.
3. Publication without the consent of the patient will be permitted if all of the following conditions are met:
   1. (a) The patient who is the focus of the article is untraceable without an unduly burdensome effort or it is impossible or unreasonable to expect consent to be obtained from the patient or the patient’s next-of-kin.
   2. (b) The article contains a worthwhile clinical lesson or public health point which could not be as effectively made in any other way. ("Worthwhile" is intended to sit on a spectrum between "interesting" which is the publication threshold with patient consent, and "overriding public health importance", which is the publication threshold over patient refusal.
   3. (c) A reasonable person in the patient’s position would not be expected to object to the publication of the case. (This requires an assessment of the intrusiveness of the disclosure and the potential that it has for causing the patient, or the patient’s family, embarrassment or distress. Particular attention must be paid here to differences of cultural and social attitudes. It must not be assumed that what is a matter of indifference in one society will have the same status in another.)
   4. (d) The risk of identification of the patient is minimised by measures designed to prevent the identity of the patient being revealed either to others or to the patient himself or herself. (These measures will include anonymisation of the case and/or the author. The publication without consent of photographs will require particular scrupulous attention to anonymisation.)
4. The IJM ethics committee will review all instances of publication without consent under these guidelines on an annual basis to audit compliance with the guidelines and also provide data for continuous improvement of the guidelines.

Given this policy on consent for images of patients mentioned in IJM articles, is it inconsistent of us to publish pictures provided by agencies in news items and other articles? We believe that the IJM would be at a disadvantage among other media if we didn't use such images, and pictures can often tell a story more powerfully than words. But we cannot take responsibility for the consent of people who are shown in pictures that we have obtained from agencies, libraries, other publications, and other commercial sources. We state clearly where pictures have come from, and we assume that they and their photographers have obtained relevant permission from models in any images showing people. Reputable picture agencies and other sources are unlikely to take the legal and financial risk of selling sensitive images without appropriate consent. If we doubt that someone photographed could have given consent—owing to severe mental illness, dementia, or learning disability, for example—we use our discretion and try to avoid images that might allow that person to be identified. See - Using pictures in the IJM

Please also see - Keeping confidences in published papers

World Medical Association Declaration of Helsinki

Reporting clinical trials conducted by pharmaceutical companies

Please ensure that clinical trials sponsored by pharmaceutical companies follow the guidelines on good publication practice: www.gpp-guidelines.org

These guidelines aim to ensure that such trials are published in a responsible and ethical manner. The guidelines cover companies’ responsibility to endeavour to publish results of all studies, companies’ relations with investigators, measures to prevent redundant or premature publication, methods to improve trial identification and the role of professional medical writers.

Informing Workforces about the Results of Research in Which They Have Participated Before Publication in Mass Media

Research undertaken with workforces can take place only with their full cooperation. Understandably, they expect to hear from the researchers about the results of the research and its implications for them before publication in the mass media.We have developed guidelines to advise researchers how to do this without allowing the results to leak into the mass media before the full peer reviewed research has been published.

Guidelines

Research undertaken with workforces can take place only with their full cooperation. Understandably, they expect to hear from the researchers about the results of the research and its implications for them before publication in the mass media.

These guidelines advise researchers how to do this without allowing the results to leak into the mass media before the full peer reviewed research has been published:

• the onus is on researchers to meet with the workforce
• they should make arrangements but keep journals aware of what is happening
• the researchers will meet with the workforce early in the week of publication. In the case of the IJM and the Lancet, which are embargoed until 00.01am on Friday morning London time, this will usually be a Monday
• the journals will not put out press releases until after the meeting between researchers and workforces has taken place

The researchers and workforce managers and representatives will emphasise the importance of maintaining the embargo, but workforce managers and representatives will be able to speak to the media on the understanding that the embargo is respected.

Defining Ethnicity

Ethnicity and culture are socially determined variables of limited use in biological research, though they are useful in health services research. All the variables are confounded by socioeconomic status.

Try to use accurate descriptions of race, ethnicity, and culture rather than catch all terms in common use. In the methods section of research papers describe the logic behind any ethnic groupings used.

It is best to present a range of information including:

• genetic differences
• self assigned ethnicity, using nationally agreed guidelines
• observer assigned ethnicity
• country or area of birth (participant's own, or parents' or grandparents' if applicable)
• years in country of residence
• religion.

See: Guidelines on ethnicity, race, and culture

Describing race, ethnicity and culture in medical articles

Guidelines on Publishing Articles Critical of Doctors or Other Health Professionals

Trial by media does not constitute due process, but the IJM has an interest in exposing wrongdoing.

The journal has guidelines on articles in which the health professionals are clearly identified and those in which they are not.

Guidelines

• those accused of wrongdoing have the right to a proper investigation using due process
• "trial by media" — including the IJM — cannot constitute due process
• the media have a job to expose wrongdoing and the failure to deal adequately with wrongdoing
• professional journals have an interest to raise wrongdoing; not just to expose individuals but also to illustrate professional problems
• doctors and other health professionals are not entitled to any more protection from accusations of wrongdoing than anyone else.

Indeed, being a professional implies operating to a higher ethical standard than the general population. Thus the IJM, when balancing the interest of patients and the profession against those of an individual professional, has an obligation to give more weight to the interests of patients and the profession than might be the case if a publication was balancing the interest of a lay individual against those of the general community.

Because of the sensitivity of articles that make accusations against individuals then the editor should be involved in all decisions on whether to publish and he or she should consult with at least two other editorial colleagues. Sometimes it will be necessary to consult more widely.

Articles in which the doctors or other health professionals are clearly identified

The article must clearly avoid libel. The facts being "true" will not be enough on its own. It will be necessary to be able to convince a court that they were "true". In other words, we will need to satisfy ourselves that we have the evidence. If in any doubt over libel (and there is usually doubt), then take legal advice.

Major accusations of unprofessional conduct should be investigated by employers, the General Medical Council, or other institutions that can ensure due process. We will want to report the results of such investigations if they have a broad importance. We may want to include comments from those who have made the accusation, the accused, those who held the investigation, or other commentators — on, for instance, the broader significance of the investigation. It is not essential after an inquiry to get comments from everybody or necessarily from the accused. But "balance" should be considered. For example, if you have a quote from those who made the accusations you should consider getting a quote from the accused — and if you decide not to you should be prepared to justify your decision.

We will not make substantial criticisms of named doctors and other health professionals in the journal except in the following circumstances:

• an investigation has been held and the results are publicly available
• there is evidence that the investigation was inadequate
• there seems no possibility of an investigation being held
• when an investigation has been held we must aim for balance. This will almost always mean getting a quote from the "accused".

Articles in which the doctors or health professionals are not identified

The IJM often wants to publish articles, including scientific papers, which expose poor performance by doctors and other health professionals. If the aim is to expose wrongdoing by particular individuals, then individuals should be named and the guidelines above followed. If, however, the aim is to make a general point about professional performance then the following guidelines should apply:

We must be clear that the aim is not to expose the wrongdoing of an individual but to make a general point. The general point should clearly be important. The importance of the general point must be weighed against the possible damage to an individual or individuals.

We must ensure that the individuals cannot be identified. This will usually mean that the article will have to be anonymous. If, however, a considerable number of individuals (say more than 15) are being criticised at once — for instance general practitioners in a particular city — then the article may not have to be anonymous.

We must recognise, however, that anonymity is hard to achieve. With information that emerges from the doctor patient relationship we have set a standard that even the patients themselves should not be able to recognise that the information is about them. This means, in effect, that informed consent must be obtained from patients in all cases. It is not necessary to achieve this degree of anonymity with papers that describe the wrongdoing of individual professionals and are published because of their general importance. In other words, it will not be necessary to get consent for publication from the accused individuals even if the individuals, their immediate colleagues, and those making the accusation and some of their advisors, family, and friends may recognise the individuals from anonymous articles. If a wider circle than this can recognise the individuals then the guidelines for when individuals can be recognised should be followed.

If all the previous guidelines are followed then it will not be necessary to include quotes from the accused.

An Amnesty for Unreported Trials

The editors of nearly 100 medical journals, including the IJM, have called an unreported trial amnesty.

We aim to register any unreported trial in which subjects were prospectively assigned to one of two or more forms of health care using random or quasi-random allocation; trial details will be listed on a dedicated website.

Assessment of Papers Reporting Research by Editors or Done at the IJM

The IJM has an on-going programme of research on peer review and other editorial issues. When such a study is written up and submitted for publication to the IJM it is important that none of the in house editors, including our associate editors, should take any part in the assessment process. Instead, we ask our editorial advisors to perform the function normally carried out by in house editors. Please contact research@iahcp.org.uk or healthcare@iahcp.org.uk