How Are Human Subjects Protected In Biomedical and Behavioral Research Projects

Hybrid Medical Media: Reporting From Baylor College Of Medicine Houston, Texas

How Are Human Subjects Protected In Biomedical and Behavioral Research Projects

Gennxeix Biotech added Electronic Medical (EMR) Records to it products offering. With the release of EMR Gennxeix Biotech CEO Salene Flores says, We are now able to

comply and achieve higher safety standards for our breast cancer patients, that discover their cancer through genomics and evidence base medicine.

Gennxeix ability to sequence human genomes inexpensively raises complex issues concerning the rights and responsibilities of our scientists, health care providers, policymakers, and the public. Although the Health Insurance Portability and Accountability Act (HIPAA), the Americans with Disabilities Act (ADA), and the Genetic Information

Brought To You By gloStreamNondiscrimination Act (GINA) have addressed some of these issues, many issues remain unresolved. Their resolution will be critical to realizing the full benefit of genomic advances. Central to some of these issues is the boundary between research and clinical care, as defined in the Belmont Report produced by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the “Common Rule”

that governs much of federally funded biomedical research in the United States.2,3Clearly, further research is needed to identify which of the gene products and molecular mechanisms that are implicated by sequencing and genomewide association studies make good targets for experimental interventions. We have before us several thousand susceptibility variants, mainly identified by such studies. Although each of these variants typically has a small effect and thus is not helpful in predicting risk, the identification of such variants expands our understanding of the biology of human health and disease and implicates specific genes, loci, and pathways in disease susceptibility or progression. Although the translation of knowledge about genes associated with mendelian diseases to interventions has proved more difficult than many observers anticipated, there have been and continue to be many notable successes. These successes are founded on studies such as that described by MacKenzie4 in this issue of the Journal, which establishes an experimental approach to th e treatment of spinal muscular atrophy. The funding of similar research in the context of both rare and complex diseases is critical. Finally, health care providers who request, or are provided with, an analysis of the patient's whole-genome sequence face a nearly insurmountable informational challenge. Genomics education for most health care providers is inadequate, and because of the fast-moving nature of the field, there is a paucity of evidence-based guidelines and resources for the vast majority of genomic interventions. Current paradigms for providing genetic services, which were developed to handle rare chromosomal and monogenic conditions, break down in the setting of genomic approaches to more common and etiologically complex conditions.


There is a growing need for genetic counselors, physicians and other health care providers who are informed about genetics, and electronic support systems to provide accurate and current information about risk variants.Although patience is said to be a virtue, it is a commodity that many patients cannot afford, since there is much demand for an immediate clinical return on investment in genomics research. However, biology and health care systems are complex, and it is unrealistic to expect that the march of clinical progress will accelerate at the same rate as technological advances. That said, the advances described in the second Genomic Medicine review series show that genomics has made great strides toward improving human health.