Biomedical Research Study on Conflicts of Interest Regulations-In Addition Discussing Human Subject Research and Intellectual Property Licensing

• Main Authors: Lee,Yu-Hua, 李毓華
• Other Authors: Chen,Chih-Hsiung
• Format: Others
• Language: zh-TW
• Published: 2013
• Online Access: http://ndltd.ncl.edu.tw/handle/26563009327390997023

碩士 === 國立交通大學 === 管理學院科技法律學程 === 101 === Conflicts of interest have an erosive effect on people’s trust in biotechnology research activities, damaging not only the attitude and trusts of the public toward scientists and their research studies, but also weakening scientist’s mutual trust on each other. Disclosure is recognized as the major methods for dealing with conflicts, but the approaches to managing and resolving conflicts must be improved. Furthermore, new ways of thinking on institutional conflicts of interest must be built. For the complete development of the biotechnology industry, the government should take the lead in proposing the best and innovative solutions on conflict of interest management. The government can begin first from government-funded research at biotechnology. The government must ensure the objectivity of providing the funds for biotech research activities and also make certain that the conflict of interest will not affect and reduce the objectivity of the study, as well as affecting people’s lives and health. Thus, U.S. Department of Health and Human Services (HHS) has also issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).The relevant regulations of these two parts state that those accepting the sponsorship from HHS and its partner institutions must comply with the above two amended monitoring rules. To take a broad view of the overall rule set by HHS, the concept of the risk management included in the project management is likely to be legislated. That is to say, the risk under the rule is the negative effect of the subjective research caused by the conflict of the interest. Risk management is a structured approach to managing institutional conflict of interest, through a sequence of activities including: the risk evaluation in three stages-before, within and after the assessment, and strategies development to manage it. Risk management also involves identifying, analyzing, and taking steps to reduce or eliminate the conflict of interest leading to negative effect of the research. The legislation of risk management utilizes many principal and flexible techniques, especially to manage conflict of interest encountered by the bio industry. The content of this article is intended to provide a general reference to the subject matter. The overall operational aspects of biotechnology (biomedical) research, each stage and level may be faced with the issue of conflict of interest. However this thesis selects one of the most important areas and will explore further in the thesis on the human subject research and the result of Biotechnology (Biomedical) licensing stage , this is because the test results of human subject research not only affect the level of the patient’s life, healthy right, but also have an impact on the majority of public health interests. Therefore there is the need for in-depth investigation for the issue of conflict of interest. In addition if biotech (biomedical) research involving financial assistance from national resources, then the research results must be fair, transparent, appropriately used. R &; D results must allow for a more comprehensive promotion and for the benefit of public health and welfare. Therefore it is very important to avoid the issue of conflicts of interest which caused the R&;D result authorization lack of fairness, justice and objectivity.