African AIDS: whose research rules?

Article Abstract:

Africa has a huge population of AIDS victims, and the rate of transmission of the disease is high. About half of the studies of AIDS in Africa involve collaboration with non-African researchers, and conflicts between Western research ethics and exploitation of African AIDS patients who have little access to good medical care are becoming an increasing problem. Many questions arise: Are the same ethical guidelines that were developed to protect subjects of biomedical research in industrial countries appropriate for research in the Third World? How can research be geared toward needs of the host country rather than the sponsoring country? Is it ethical to test experimental therapies or vaccines in countries that cannot afford to buy them when they reach the market? Another problem has been that some studies have involved so-called ''safari'' or ''helicopter research,'' in which foreign scientists gained access to a local African population, obtained samples, and then finished the study in the home laboratory without making results available to the supposed host investigators. This exploitation of African scientists and patients has led to drafting of new guidelines by the World Health Organization and the US Public Health Service in an effort to avoid these ethical impasses. Great emphasis is placed on close collaboration between indigenous and foreign researchers, from the initial concept through study implementation. Although in principle the study participants and community should have access to vaccines and other interventions resulting from studies, the guideline authors agree that in practice, the risks associated with some unproven therapies are acceptable when there is no other available treatment. Coercion of study subjects is another concern, and may exist even when payment is not an inducement, when a white person is asking a black African to participate in research. Informed consent is made difficult by cross-cultural, educational and other barriers, but again, participation by local communities and scientists and education of participants are steps by which this should be addressed. Although more complex than domestic studies, international collaboration will be essential in order to deal with the worldwide spread of AIDS. (Consumer Summary produced by Reliance Medical Information, Inc.)

Africa, AIDS (Disease), AIDS research

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NIH conflict-of-interest guidelines shot down

Article Abstract:

The National Institutes of Health (NIH) have proposed guidelines to prevent conflicts of interest in scientific research that is funded by the federal government. Conflicts of interest can arise from contacts between scientific researchers and private industry. The NIH guidelines, which have since been rejected and sent back for revision, specified that researchers must not have any financial interest in companies that could benefit from their findings. An example is a study of the effectiveness of a new medication; if the results show that the drug is valuable, the manufacturer will profit. The NIH guidelines aroused vehement protests from the scientific community and biotechnology companies alike. During the 90 days allowed for comment, NIH received 700 letters, the vast majority of which criticized the guidelines. Researchers complained that the detailed financial disclosures required would be take up excessive amounts of time and money. Some considered the guidelines too vague concerning which actions constitute a conflict of interest. Also, the guidelines prohibited scientists from accepting any money from firms whose products were being tested; this would be very problematic for research in which industry and the scientific community are cooperating to reach conclusions rapidly. Biotechnology companies objected to the guidelines on the grounds that the utilization of research findings by industry would be stifled. In response to the overwhelmingly negative reaction, Secretary of Health and Human Services Louis Sullivan told NIH to revise the guidelines and submit them again. (Consumer Summary produced by Reliance Medical Information, Inc.)

Laws, regulations and rules, Pharmaceutical industry, Clinical trials

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NIH urged to be a smart shopper

Article Abstract:

A change in the way the National Institutes of Health awards research grants is being considered. Scientific and technical merit are the criteria upon which funding decisions are currently made. However, the number of grants that are acceptable based on these principles is much greater than the available monies could possibly fund. There are two type of costs in research. The first are direct costs, including supplies and salaries. The second type is indirect costs that the institution where the scientist is working charges for infrastructure and overhead. These indirect costs vary at different institutions. A congressional committee has suggested that the funding process should favor grants from low-cost institutions. This would increase the number of new grants that are being awarded from 4,600 to 6,000 each year. However, many individuals and associations are opposed to this suggestion, saying that the decision about whether a grant is funded should not be based upon costs, but upon the merit of the proposed research. (Consumer Summary produced by Reliance Medical Information, Inc.)

Management, Economic aspects, Federal aid to research, Government aid to research

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