Article type
Year
Abstract
Background: conflict of interest (COI) refers to a conflict between an individual's private or personal interest and his or her duty, which could unduly influence their position in fulfilling their duty. It could directly affect objectivity either in clinical research or during the process of developing guidelines. The National Health Commission (NHC), China Food and Drug Administration (CFDA) and State Administration of Traditional Chinese Medicine (SATCM), along with medical research institutions and medical journals are also paying close attention to this field. This paper summarizes and reports China's current COI policies.
Objectives: to identify and evaluate the COI policies of the Chinese Government Health Departments, medical research institutions and medical journals.
Methods: we performed a manual and electronic search of relevant legal documents, provisions and guidelines related to health research in the China National Knowledge Infrastructure (CNKI) and PubMed platforms (4 April 2019), along with specific searches aimed at the websites of the Chinese top 10 medical schools, 3A hospitals (Class 3, Grade A) in Beijing and medical journals (23 April 2019). The search was specific to health provisions, so we excluded non-provision files. We searched a total of 210 medical journals from Chinese Medical Association (CMA), Chinese Association of Integrative Medicine (CAIM), China Association of Chinese Medicine (CACM).
Results: the study revealed that in China, Criterions for the Quality Control of Clinical Trial of Drugs (2003), Criterions for the Ethical Review of Traditional Chinese Medicine Clinical Research (2010), Guiding Principles For the Ethical Review of Clinical Trials of Drugs (2010), Measures for the Ethical Review of Biomedical Research Involving Humans (2016) have mentioned COI, but do not elaborate on it. These COI policies mainly focus on the composition and regulations of the ethical committee. The role of government departments as a supervisor is still unclear. Only one out of 10 medical schools, and two out of 10 hospitals had COI policies on their website. The 140 journals from CMA had a COI policy related to CMA’s provision, only 10 journals had a COI policy in another 70 journals.
Conclusions: the legislation and supervision of conflict of interest by Chinese Government Agencies are at a preliminary stage, which is far behind the sophisticated systems in other countries. In addition, although the regulations of research institutions and journals are not legally binding, they can play an important role in improving academic rigour and social credibility. Internationally it is recognized as an effective way to control conflict of interest by establishing a more transparent disclosure mechanism and social co-ordinated management.
Patient or healthcare consumer involvement: paying attention in managing conflict and interest could defend the legal right of patients and healthcare consumers.
Objectives: to identify and evaluate the COI policies of the Chinese Government Health Departments, medical research institutions and medical journals.
Methods: we performed a manual and electronic search of relevant legal documents, provisions and guidelines related to health research in the China National Knowledge Infrastructure (CNKI) and PubMed platforms (4 April 2019), along with specific searches aimed at the websites of the Chinese top 10 medical schools, 3A hospitals (Class 3, Grade A) in Beijing and medical journals (23 April 2019). The search was specific to health provisions, so we excluded non-provision files. We searched a total of 210 medical journals from Chinese Medical Association (CMA), Chinese Association of Integrative Medicine (CAIM), China Association of Chinese Medicine (CACM).
Results: the study revealed that in China, Criterions for the Quality Control of Clinical Trial of Drugs (2003), Criterions for the Ethical Review of Traditional Chinese Medicine Clinical Research (2010), Guiding Principles For the Ethical Review of Clinical Trials of Drugs (2010), Measures for the Ethical Review of Biomedical Research Involving Humans (2016) have mentioned COI, but do not elaborate on it. These COI policies mainly focus on the composition and regulations of the ethical committee. The role of government departments as a supervisor is still unclear. Only one out of 10 medical schools, and two out of 10 hospitals had COI policies on their website. The 140 journals from CMA had a COI policy related to CMA’s provision, only 10 journals had a COI policy in another 70 journals.
Conclusions: the legislation and supervision of conflict of interest by Chinese Government Agencies are at a preliminary stage, which is far behind the sophisticated systems in other countries. In addition, although the regulations of research institutions and journals are not legally binding, they can play an important role in improving academic rigour and social credibility. Internationally it is recognized as an effective way to control conflict of interest by establishing a more transparent disclosure mechanism and social co-ordinated management.
Patient or healthcare consumer involvement: paying attention in managing conflict and interest could defend the legal right of patients and healthcare consumers.