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Committee on Publication Ethics (COPE)

GUIDELINES ON GOOD PUBLICATION PRACTICE

Why the guidelines were developed
COPE was founded in 1997 to address breaches of research and publication ethics. A voluntary body providing a discussion forum and advice for scientific editors, it aims to find practical ways of dealing with the issues, and to develop good practice. We thought it essential to attempt to define best practice in the ethics of scientific publishing. These guidelines should be useful for authors, editors, editorial board members, readers, owners of journals, and publishers. Intellectual honesty should be actively encouraged in all medical and scientific courses of study, and used to inform publication ethics and prevent misconduct. It is with that in mind that these guidelines have been produced. Details of other guidelines on the ethics of research and published codes of conduct are listed in the Appendix.
How the guidelines were developed
The guidelines were developed from a preliminary version drafted by individual members of the committee, which was then submitted to extensive consultation. They address: study design and ethical approval, data analysis, authorship, conflict of interests, the peer review process, redundant publication, plagiarism, duties of editors, media relations, advertising, and how to deal with misconduct.
What they aim to do
These guidelines are intended to be advisory rather than prescriptive, and to evolve over time. We hope that they will be disseminated widely, endorsed by editors, and refined by those who use them.

1 Study design and ethical approval

Definition
Good research should be well justified, well planned, appropriately designed, and ethically approved.To conduct research to a lower standard may constitute misconduct.
Action
(1)
Laboratory and clinical research should be driven by protocol; pilot studies should have a written rationale.
(2)
Research protocols should seek to answer specific questions, rather than just collect data.
(3)
Protocols must be carefully agreed by all contributors and collaborators, including, if appropriate, the participants.
(4)
The final protocol should form part of the research record.
(5)
Early agreement on the precise roles of the contributors and collaborators, and on matters of authorship and publication, is advised.
(6)
Statistical issues should be considered early in study design, including power calculations, to ensure there are neither too few nor too many participants.
(7)
Formal and documented ethical approval from an appropriately constituted research ethics committee is required for all studies involving people, medical records, and anonymised human tissues.
(8)
Use of human tissues in research should conform to the highest ethical standards, such as those recommended by the Nuffield Council on Bioethics.
(9)
Fully informed consent should always be sought. It may not always be possible, however, and in such circumstances, an appropriately constituted research ethics committee should decide if this is ethically acceptable.
(10)
When participants are unable to give fully informed consent, research should follow international guidelines, such as those of the Council for International Organizations of Medical Sciences (CIOMS).
(11)
Animal experiments require full compliance with local, national, ethical, and regulatory principles, and local licensing arrangements. International standards vary.
(12)
Formal supervision, usually the responsibility of the principal investigator, should be provided for all research projects: this must include quality control, and the frequent review and long term retention (may be up to 15 years) of all records and primary outputs.
Appendix
The Association of the British Pharmaceutical Industry. Facilities for non-patient volunteer studies. London:APBI, 1989. The Association of the British Pharmaceutical Industry. Guidelines for medical experiments in non-patient human volunteers. London:ABPI, 1990.
ABPI fact sheets and guidance notes:
 
Clinical trials and compensation guidelines, January 1991. Guidelines for phase IV clinical trials, September 1993. Guidelines on the conduct of investigator site audits, January 1994. Relationship between the medical profession and the pharmaceutical industry, June 1994. Good clinical trial practice,November 1995. Patient information and consents for clinical trials, May 1997. Guidelines on the structure of a formal agreement to conduct sponsored clinical research, July 1998. Good clinical research practice, July 1998.
Council for International Organizations of Medical Sciences (CIOMS). International Guidelines for Ethical Review of Epidemiological Studies. Geneva: WHO, 1991. General Medical Council. Good medical practice guidelines series:
 
Consent, February 1999.
Confidentiality, October 1995.
Transplantation of organs from live donors, November 1992.
International Committee of Medical Journal Editors (ICMJE). Uniform requirements for manuscripts submitted to biomedical journals. JAMA 1997;277:927-34.
Medical Research Council. Policy and procedure for inquiring into allegations of scientific misconduct. London: MRC, 1997.
Medical Research Council. The ethical conduct of research on the mentally incapacitated. London: MRC, 1991.
Medical Research Council. The ethical conduct of research on children. London:MRC, 1991.
Medical Research Council. Responsibility in the use of animals in medical research. London:MRC, 1993.
Medical Research Council. Responsibility in the use of personal medical information for research. Principles and guidelines to practice. London:MRC, 1985.
Medical Research Council. MRC Guidelines for good clinical practice in clinical trials. London:MRC, 1998.
Medical Research Council. Principles in the assessment and conduct of medical research and publicising results. London:MRC, 1995.
Nuffield Council on Bioethics. Human tissue: Ethical and legal issues. London: Nuffield Council on Bioethics, 1995.
Royal College of Physicians. Research involving patients. London: RCP, 1990.
Acknowledgement
The following are gratefully acknowledged for their contribution to the drafting of these guidelines:
Philip Fulford (Coordinator)
Professor Michael Doherty
Ms Jane Smith
Dr Richard Smith
Dr Fiona Godlee
Dr Peter Wilmshurst
Dr Richard Horton
Professor Michael Farthing
Other members of COPE
Delegates to the Meeting on April 27 1999
Other corresponding editors