with study design. Because of the costs involved, considerable attention should be given to avoiding poor study design, eliminating unintentional bias, and standardizing data collection.

These studies depend on the willing participation of the public and many researchers have noted a growing reluctance to participate, especially in studies that involve genetic testing and the collection of biological materials. Some of this reluctance has been attributed to fears that results of these tests could be misused by employers and by health and life insurance companies to discriminate against those with existing or potential problems.

With implementation of regulations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), other problems have emerged. The act was created for many reasons, among them to ensure the privacy and confidentiality of health information and make the transfer of health data more efficient. While the law was not intended to hinder research, it has changed the way health plans, clearinghouses, and providers handle personal health information and the way researchers share information.

The potential impact on research may prove far-reaching, especially on population-based research that requires broad and unbiased access to the medical records of health providers. The law also threatens the establishment of large databanks and makes it difficult to link data gathered in different institutions or to do studies that require long-term follow-up, which will be virtually impossible if all data have to be deidentified. While the Association of American Medical Colleges has established a network and database to monitor and document the impact of the law on research, uncertainty about the impact and interpretation of this very complex and lengthy law has already led to delays in research and has complicated the grant and contract process.

The concerns of committee members about the impact of this law, with its potential to impede efforts to improve the detection and diagnosis of breast cancer, led them to recommend that:

Professional societies should work together with women’s health organizations to identify barriers to participation in studies (especially those that require provision of biologic specimens) and ways in which those barriers might be overcome. (Recommendation C2)

  • A public education campaign should be undertaken to inform the public, particularly under-represented groups, of the merit of participation in research studies that require the involvement of healthy volunteers and the donation of biologic specimens for genetic analysis.

  • Advocacy groups and women’s health organizations should participate in design and execution of public education about clinical trials.



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