In some cases, achieving our strategic goals and objectives may be impeded by factors that are beyond the control of the Department of Health and Human Services (HHS). For example, national or local economic conditions can influence whether we are successful in helping families on welfare become economically independent. In some cases, there may b
According to the Treaty of Rome, under which the E.U. operates, the Member States thus have obligated themselves to bringing their national laws into conformance with the principles of the Directive within three years of adoption (i.e., by October 1998). In this "transposing" they can employ whatever instruments of law—statutes, regulations, dec
The Directive does not restrict the processing of data which are not personally identifiable. But for the processing of those that are, consent from the data-subject generally is required. Article 7 stipulates that "Member States shall provide that personal data may be processed only if:
On October 24, 1995, after five years of deliberation, the European Parliament and the Council of the European Union (E.U.) adopted a "Directive on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data" (hereafter, Directive). 80
External ethical oversight provides additional protection for research subjects. Prime examples in the U.S. are the Institutional Review Boards (IRBs) that supervise human-subjects research conducted under Federal jurisdiction, which is very broad. IRBs are carefully constituted boards that conduct independent oversight of research. 73
A universally endorsed ethical precept is that it is permissible to collect and use personally identifiable data, if the data-subject agrees to the conditions of data protection and use. The ideal is prior, informed, freely granted, specific consent . Researchers strive for this to varying degrees, and achieve it to varying degrees. 68,
A uniform "Federal Policy for the Protection of Human Subjects," often called the "Federal Common Rule," is promulgated by sixteen Federal agencies that conduct, support, or regulate research. It governs such matters as subject rights, informed consent, Institutional Review Boards, disclosure policy, recordkeeping, and a variety of other matters.
As every newspaper reader is aware, every aspect of health care now is being subjected to economic analysis—to size up the costs of illness and costs in specific episodes of care, evaluate cost-effectiveness of different interventions, see what effects various cost-related incentives have, and understand the component costs in healthcare systems
A prime example of innovation is the elaborate work of developing and improving the use of pharmaceuticals, medical devices, diagnostic instruments and tests, vaccines, and other "tools" of health care. 53 After much preliminary screening, an experimental entity or procedure is subjected to a long series of clinical trials , perhaps on tens of
All over the world, health and disease are monitored. Starting with prenatal observations and birth data, throughout life health-related measurements and observations accumulate. Analyses are made to portray the "natural history" of diseases and disabilities—how they start, progress in a person or spread to others, and run their courses. Also an
This study takes it as given that because members of society benefit greatly from health research, research— if it is for justifiable purposes, and is conducted with proper protection of subjects —must continue to be allowed controlled access to individuals' health data.
For the U.S., it will be very important over the next few years to engage in high-level, broadly based dialogue with European leaders over the implementation of the E.U. Directive and the Council of Europe Recommendation. Discussions will have to be held with national governments and with intergovernmental organizations. Health care and health res
In October 1995 the European Union (E.U.) adopted a "Directive on the Protection of Individuals with regard to the Processing of Personal Data and on the Free Movement of Such Data." By October 1998 all fifteen E.U. Member States must bring their national laws into congruence with the Directive. In February 1997 the Council of Europe adopted a "
The following principles are recommended for organizations that conduct, sponsor, or regulate health research involving personally identifiable data. They can be transposed into professional guidelines, standard operating principles, regulations, or laws. Criteria and procedures should be established that are specific to the context.
The Federal Common Rule and other laws and regulations require many protections for human subjects of research. The main social instruments are informed consent of the data- subject, and Institutional Review Board (IRB) supervision. Both of these mechanisms have served society well. But both now need to be renewed.
Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Drug Marketing Issues
Two market barriers related to drug marketing were identified. As previously described, the possibility of the pharmacotherapy being distributed through publicly-funded treatment centers rather than through physician offices was a concern of the pharmaceutical companies because of the companies' limited access to patients.
Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Industry Perception of Market Barriers
Some of the market barriers identified in the 1995 IOM report were confirmed through the interviews with private firms and case studies conducted for this effort. Figure 36 summarizes the market barriers that were confirmed (in full or in part) and not confirmed during this study. (As noted above, the number of interviews and case studies was limi