A survey of quality assurance practices in biomedical open source software projects. (33/96)

BACKGROUND: Open source (OS) software is continuously gaining recognition and use in the biomedical domain, for example, in health informatics and bioinformatics. OBJECTIVES: Given the mission critical nature of applications in this domain and their potential impact on patient safety, it is important to understand to what degree and how effectively biomedical OS developers perform standard quality assurance (QA) activities such as peer reviews and testing. This would allow the users of biomedical OS software to better understand the quality risks, if any, and the developers to identify process improvement opportunities to produce higher quality software. METHODS: A survey of developers working on biomedical OS projects was conducted to examine the QA activities that are performed. We took a descriptive approach to summarize the implementation of QA activities and then examined some of the factors that may be related to the implementation of such practices. RESULTS: Our descriptive results show that 63% (95% CI, 54-72) of projects did not include peer reviews in their development process, while 82% (95% CI, 75-89) did include testing. Approximately 74% (95% CI, 67-81) of developers did not have a background in computing, 80% (95% CI, 74-87) were paid for their contributions to the project, and 52% (95% CI, 43-60) had PhDs. A multivariate logistic regression model to predict the implementation of peer reviews was not significant (likelihood ratio test = 16.86, 9 df, P = .051) and neither was a model to predict the implementation of testing (likelihood ratio test = 3.34, 9 df, P = .95). CONCLUSIONS: Less attention is paid to peer review than testing. However, the former is a complementary, and necessary, QA practice rather than an alternative. Therefore, one can argue that there are quality risks, at least at this point in time, in transitioning biomedical OS software into any critical settings that may have operational, financial, or safety implications. Developers of biomedical OS applications should invest more effort in implementing systemic peer review practices throughout the development and maintenance processes.  (+info)

ECVAM's approach to intellectual property rights in the validation of alternative methods. (34/96)

In this article, we discuss how intellectual property rights affect the validation of alternative methods at ECVAM. We point out recent cases and summarise relevant EU and OECD documents. Finally, we discuss guidelines for dealing with intellectual property rights during the validation of alternative methods at ECVAM.  (+info)

Intellectual property policy in the pharmaceutical sciences: the effect of inappropriate patents and market exclusivity extensions on the health care system. (35/96)

Though patents are effective tools for promoting innovation and protecting intellectual property in the pharmaceutical sciences, there has been growing concern about 2 important ways that patents in this field can have a negative effect on patient care and the practice of medicine. First, inventors can seek and receive patents on pharmaceutical products or research tools that stretch the statutory requirements for patenting. Second, patent holders in the pharmaceutical market can use legal loopholes or aspects of the patent registration system to extend exclusivity for inventions beyond what was anticipated by the Patent Act or subsequent legislation. The monopoly control bestowed by such inappropriate patents or manipulation of the patent system can limit options available to patients, increase the cost of health care delivery, and make cooperative research more difficult. In response, several different government and market-based efforts have emerged to promote more equitable patent policy in health care that encourages dissemination of ideas while still supporting the development of innovative products.  (+info)

An introduction to foundation and industry-sponsored research: practical and ethical considerations. (36/96)

Investigators face formidable challenges in securing adequate support for their research efforts. Federal subsidies for biomedical research have not expanded in the past several years, while applications to the National Institutes of Health for investigator-initiated studies have increased substantially. Faced with stiffening competition, investigators, particularly those at the outset of their careers, may consider alternative sources of funding and support. Philanthropic foundations, private donors, and commercial industry provide a diverse array of funding opportunities. Strategies to identify and solicit funding from these alternative sources are addressed herein. Emphasis is given to the development and support of investigator-initiated clinical research. Ethical considerations that frame investigators' acceptance and utilization of research subsidies from for-profit entities, i.e., pharmaceutical or biotechnology companies, are reviewed. The importance of the protection of intellectual property and the preservation of academic integrity and autonomy, especially in the context of corporate sponsorship, also are highlighted.  (+info)

Indigenous ways of knowing: implications for participatory research and community. (37/96)

Researchers have a responsibility to cause no harm, but research has been a source of distress for indigenous people because of inappropriate methods and practices. The way researchers acquire knowledge in indigenous communities may be as critical for eliminating health disparities as the actual knowledge that is gained about a particular health problem. Researchers working with indigenous communities must continue to resolve conflict between the values of the academic setting and those of the community. It is important to consider the ways of knowing that exist in indigenous communities when developing research methods. Challenges to research partnerships include how to distribute the benefits of the research findings when academic or external needs contrast with the need to protect indigenous knowledge.  (+info)

Intellectual property in medical imaging and informatics: the independent inventor's perspective. (38/96)

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Bioprospecting the African Renaissance: the new value of muthi in South Africa. (39/96)

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Challenges to human embryonic stem cell patents. (40/96)

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