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Since the “Joint Statement of Establishing a Chinese Clinical Trial Registration and Publishing System” was published five years ago (1), more and more people in medical fields in China have learned of the term “clinical trial transparency.” The number of registered clinical trials in China has correspondingly risen over time. Now that clinical trial transparency has become an international medical research ethics convention and a part of international biomedical journal publication ethics, a new challenge has arisen for Chinese biomedical journals. A conference on this new standard and practice was held on May 6, 2011, and included delegates from the member agencies of Chinese Clinical Registration and Publication Collaboration (ChiCTRPC), namely the PLA Medical Publishing House; School of Chinese Medicine of Hong Kong Baptist University; Medical Faculty, University of Hong Kong; West China Journals Agency of Sichuan University; Journal of Chinese Integrative Medicine; Medical Ethics Society of Sichuan Medical Society; Hong Kong University Medical School; Chinese Clinical Trials Registry; Chinese Ethics Committee of Registering Clinical Trials; and Chinese Evidence-Based Medicine Centre. We hereby on behalf of all attendees publish this joint statement to promote development and improvement of publication and editing ethics of biomedical journals in China.

Medical journals bear a very important social responsibility, including disseminating new knowledge from medical research and practice and reflecting global and national medical research in order to improve the quality of medical service and promote the improvement of medical enterprise.

Ethics is an integrated system of action rules and moral principles. The action and development of an enterprise or a business must run according to its special rules and moral principles, which in turn must comply with the public interests of the whole society and global recognized moral principles. Publication ethics principles include publisher ethics, editing ethics, and reporting ethics for authors. There are some commonalties between medical and other types of journals in terms of editing and publication practices and social values, but other characteristics of medical journals are particular to this field.

From the beginning, the establishment and dissemination of a global publication and editing ethics system for medical journals was based on the lofty goals of developing world medical enterprise in order to improve the health of all human beings. In the 1990s, basic medical service for everyone was seen as a lofty ideal representing social justice, and the proper objective of all human beings. High quality, efficiency, and making the best use of limited medical resources are key means for achieving this objective. While clinical epidemiology and evidence-based medicine have been the cornerstones of producing high quality clinical research evidence and providing high quality medical service through reformed medical enterprise, idealistic scholars and journal editors have established several global organizations of biomedical journals or editors to construct and disseminate publication and editing ethics principles and standards for medical journals worldwide. These documents have become the standards of thousands biomedical journals, such as:

World Association of Medical Editors, WAME: Publication Ethics Policies for Medical Journals (2, 3).

International Committee of Medical Journal Editors, ICMJE: Uniform Requirements for Manuscripts Submitted to Biomedical Journals (4).

Committee on Publication Ethics, COPE:

  • 1
    Code of Conduct and Best Practice Guidelines for Journal Editors;
  • 2
    Code of Conduct for Journal Publishers;
  • 3
    Ethical Editing Newsletter
  • 4
    Guidelines for retracting articles;
  • 5
    A Short Guide to Ethical Editing for New Editors;
  • 6
    How to handle authorship disputes: a guide for new researchers (5)

CONSORT Group and EQUATOR Network: CONSORT family (6)

Clinical trial transparency has become a very important tool for promoting improvement in the quality of clinical trials in the global medical field. The term “clinical trial transparency” includes clinical trial registration, transparency of the study process, and good reporting of results. Ensuring the transparency of clinical trials is the ethical obligation and responsibility of medical researchers (7, 8).

In 2004 the ICMJE published a milestone document, “the Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors.” In 2007 the organization published “Update on Trials Registration: Clinical Trial Registration: Looking Back and Moving Ahead,” in which the ICMJE stated that its member journals would accept registration in any of the primary registers that participate in the WHO ICTRP (9, 10). This policy has been the strongest one of mandatory registration of clinical trials.

In July 2005 the WAME published a statement of support for the development of registries in which it aimed to articulate a consensus on requirements for registry contents, responsibility, assessment, search ability, and comprehensiveness. The statement also encouraged medical editors to publish pre-registered trials in their journals (11).

In October 2008 two new items, 19 and 30, appeared in the updated Declaration of Helsinki requiring clinical trials to be registered in a public registry before enrollment of the first participant. The new items also stated that editors and publishers all have ethical obligations with regard to publishing reports of research results in detail, making research results publicly available and ensuring their completeness and accuracy, and declaring funding sources, author institutions, and conflicts of interest (12).

In March 2010 the updated CONSORT 2010 required authors to provide the registration number of randomized controlled clinical trials in their reports (13).

Basically, the institutional building in the biomedical journals publication field is keep to process under the leader of their owners in China, and some editing standards and regulations have been made which have contributed to the development of publication and editing ethics at Chinese biomedical journals. Some journals published in China published a statement of intent to follow ICMJE's Uniform Requirements for Manuscripts Submitted to Biomedical Journals (14), while others have joined the World Association of Medical Editors (15) and the Committee on Publication Ethics (16). However, we should point out that most of these participating journals are owned by international publishing groups, while most Chinese-owned journals did not appear in these lists; some instead formed editing standards and regulations that were used for internal exchange between journals and for voluntary but not mandatory practice. The main reasons for this lack of participation include the present lack of an adequate biomedical research ethics review system, a gap in awareness of the principles of and need for ethical review, the need for stronger methodology and report writing skills among clinical practitioners, and the fact that many employees of medical journals in China are not aware of the internationally accepted publication and editing standards and ethics. All of these factors have made it very difficult for international publication ethics to permeate among medical journals in China.

The question is whether to wait for this problem to resolve itself, or to push for faster adoption of international ethics standards.

The term waiting, means give the guidance function of promoting the development of medical enterprise by medical journals up, but negatively waiting for the ambient environment going to be maturity and perfection.

Pushing would mean taking actions similar to those of the ICMJE and WAME—that is, actively becoming a special engine and guide for medical journals rather than passively waiting.

There is no shirking the responsibility and obligation of building up publication ethics and internationalizing the research and education standards of medical journals in China, and therefore this means of promoting the development of the medical enterprise has been put on our shoulders. We appeal to our colleagues at Chinese medical journals to join us in taking responsibility for completing this historic mission of developing and perfecting medical journal publication and editing ethics. The process of devising standard publication ethics will be completely transparent, which we hope will smooth their acceptance by most medical journals and their editors. We have therefore decided:

  • 1
    To establish a public open access website for medical journal publication ethics collaboration (http://www.mjpe.net), which will be a public platform for sharing ideas and information among interested medical editors. We will publish relevant manuscripts to call for comments and discussion.
  • 2
    A membership block will be established on the website to allow contributors to sign consensus documents;
  • 3
    The use of our formally published recommendations on publication ethics for Chinese medical editors will be voluntarily. We plan to develop a series of documents based on internationally accepted publication regulations and guidelines, considered in light of China's particular circumstances.

We sincerely welcome your contributions.

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