Licensing of the HIV-1 protease gene by the NIH Office of Technology Transfer (OTT) provides an example of the effective use of the principles of the NIH Research Tools Policy, which was designed to provide broad access to important biomedical technologies. The OTT licensing experience is presented in detail as it was applied to research reagents, diagnostics and drug development to thus enhance the overall development process for a wide variety of medical products.
A carefully negotiated clinical trial agreement will protect a biotechnology and medical device company in critical areas, including the management and control of data and confidential information, defining publication rights and the ownership of intellectual property. Properly constructed, the agreement can increase a company's value. This article will review the major provisions of a standard industry sponsored clinical trial agreement; the principle areas where there is likely to be differing views that need to be reconciled and interrelated ethical concerns. A form of clinical trial agreement designed for a single site therapeutic trial in the United States follows the article.
Dr. Urmila Thatte, Head of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Mumbai serves on several medical ethics committees. Viveka Roychowdhury interviews Dr. Thatte to get her views on the importance of ethics and adherence to Good Clinical Practice (GCP) standards.
Random audits of clinical trial sites in India are due to start any time now. These regulatory measures come at a very crucial time when India's relatively young clinical research industry is poised for exponential growth. Can the industry scale up fast enough? Viveka Roychowdhury spoke to a cross section of industry experts to get their views.
Patents may be refused in Europe on ethical grounds. Whereas in the past this issue has arisen only infrequently, recent developments in human embryonic stem cell research have given rise to conflicting opinions in Europe as to the approach that should be adopted in relation to patents. The United Kingdom Patent Office has adopted a positive policy towards inventions involving human embryonic stem cells, but the European Patent Office has to date refused to grant patent applications involving similar subject-matter. A series of legal questions on the role of ethics in granting European patents is now to be considered for clarification by the European Patent Office. The answers to these questions should eventually resolve the debate on the patenting of human embryonic stem cells throughout Europe.
The legal status of embryos in American law is changing. At present, most states do not afford embryos the same protections as a born person, but some states are attempting to change this standard. Granting embryos the same legal status as born human beings poses a significant problem for industries that work with embryos, especially fertility treatment facilities and scientists researching stem cell and gene therapy technologies. This paper describes the methods of defining embryos in American law, and discusses the implications of granting embryos the same rights as born persons for the reproductive technology and scientific research industries.
The purpose of this paper is to examine the past, present and future of financial conflict of interest regulation in biomedical human subject testing. Part I will briefly review the forces giving rise to the current controversy. Part II will examine the more influential ethical codes on human subject testing and argue that they are inconclusive on the subject of financial conflicts of interest. Part III will examine the various regulations now in place and identify their serious flaws. Part IV will critique the leading proposals for reform. The Conclusion will synthesize the best features of the various proposals for reform and suggest improvements left unaddressed by these proposals.
After over one year of consideration, the world's first face transplant has obtained research approval despite ethical and safety concerns.
NIH new ethics regulations limit its employees activities, investments, and receipt of awards of NIH employees.
California stem cell initiative faces legal challenges from groups opposing embryonic research and abortion opponents.
The "minimal" risk standard for protection of pediatric research subjects often fails due to unclear definitions and uneven IRB application, requiring an alternative standard to better assist pediatric research assessment.
Young, and mid size biotech companies can benefit hugely from the US National Institutes of Health (NIH), not least because of the agency's non-dilutive funding, guidance, and opportunities for collaboration. Increasingly, however, there is a fair bit of misunderstanding about what the NIH can and cannot do for a biotech entrepreneur.
The advent of the Human Genome Project signaled a new era in preventative care. However, this Project threatens to create a new form of employment discrimination, which legislation has yet to sufficiently address. Courts are attempting to utilize a variety of currently enacted laws to combat such discrimination but it is clear that this may be an inadequate deterrence. To combat this problem, a new set of laws and regulations will need to be enacted to ensure that the interests of employers are upheld while maintaining proper protection of employees from genetic discrimination. This paper focuses on genetic testing in the workplace and the need for Federal legislation.
HIPAA Privacy Rule significantly reduces the number of participants in research.
State funding and political support for embryonic stem cell research facilitate progress.
Protection of human subjects against medical research in prisons remains appropriate.
On November 2, 2004 California voters approved Proposition 71, the California Stem Cell Research and Cures Act ("Act"), a $3 billion bond measure to advance stem cell research over the next ten years. The Act also created the California Institute for Regenerative Medicine (CIRM) and the Independent Citizens Oversight Committee (ICOC) which will govern the Institute, and make grants and loans for stem cell research and research facilities. This article will cover the history of the "Act", its potential impact on NIH's current stem cell program, and what are other states doing to compete with California's revolutionary efforts. In addition, the article will discuss the criteria for California's grant applicants under the Act and the legal issues surrounding the new discoveries funded by the Act.
The medical examination has been an integral part of the immigration application process since the passing of the Immigration Act of 1891. Failing the medical examination can result in denial of the application. Over the years the medical examination has been expanded to include questioning about diseases that are scientifically shown to be rooted in an individual's genetic makeup. Recent advances in the fields of genomics and bioinformatics are making accurate and precise screening for these conditions a reality. Government policymakers will soon be faced with decisions regarding whether or not to sanction the use of these newly-developed genetic tests in the immigration application procedure. The terror threat currently facing the United States may ultimately bolster the argument in favor of genetic testing and/or DNA collection of applicants. However, the possibility of a government mandate requiring genetic testing raises a host of ethical issues; including the threat of eugenics and privacy concerns. Genetic testing has the ability to uncover a wealth of sensitive medical information about an individual and currently there are no medical information privacy protections afforded to immigration applicants. This article examines the potential for genetic testing in the immigration application process and the ethical issues surrounding this testing. In particular, this article explores the existing framework of privacy protections afforded to individuals living in the United States and how this and newly-erected standards like those released by the Health and Human Services (HHS) might apply to individuals seeking to immigrate to the United States.
The ban on the use of United States (U.S.) federal funds to support new embryonic stem cell research has had a chilling effect on such research in the U.S. In Canada, significant research opportunities are available for conducting stem cell research. The opportunities include using embryos that were originally produced for reproductive purposes, and using stem cells derived from adults and animals. Stem cell research in Canada is made even more attractive in view of the availability and quality of research facilities, the lower cost of conducting research in Canada than in the U.S., and the government tax credits.
