Horizon scanning for new genomic tests.

PURPOSE: The development of health-related genomic tests is decentralized and dynamic, involving government, academic, and commercial entities. Consequently, it is not easy to determine which tests are in development, currently available, or discontinued. We developed and assessed the usefulness of a systematic approach to identifying new genomic tests on the Internet. METHODS: We devised targeted queries of Web pages, newspaper articles, and blogs (Google Alerts) to identify new genomic tests. We finalized search and review procedures during a pilot phase that ended in March 2010. Queries continue to run daily and are compiled weekly; selected data are indexed in an online database, the Genomic Applications in Practice and Prevention Finder. RESULTS: After the pilot phase, our scan detected approximately two to three new genomic tests per week. Nearly two thirds of all tests (122/188, 65%) were related to cancer; only 6% were related to hereditary disorders. Although 88 (47%) of the tests, including 2 marketed directly to consumers, were commercially available, only 12 (6%) claimed United States Food and Drug Administration licensure. CONCLUSION: Systematic surveillance of the Internet provides information about genomic tests that can be used in combination with other resources to evaluate genomic tests. The Genomic Applications in Practice and Prevention Finder makes this information accessible to a wide group of stakeholders.

Colorectal cancer screening, 1997-1999: role of income, insurance and policy.

BACKGROUND: Receipt of age-appropriate cancer screens can lead to reduced incidence and mortality. Yet, low-income and uninsured experience barriers to screening. This paper examines colorectal cancer rates by income, racial and insured groups 1997 and 1999. These years focus on changes pre/post a 1998 policy change for Medicare beneficiaries that reduced their out-of-pocket costs for colorectal screening. METHODS: The 1997 and 1999 Behavioral Risk Factor Surveillance System (BRFSS) survey is used to examine changes in age-appropriate fecal-occult blood testing (FOBT), flexible sigmoidoscopy screens. Differences in the odds that Medicare beneficiaries, relative to private insured, receive screens pre/post 1998 are examined using multivariate logit models. RESULTS: Average rates of sigmoidoscopy increased significantly during 1997-1999 but remain below desired levels. While Medicare beneficiaries are more likely than privately insured to be screened, gaps between low- versus high-income groups in both Medicare and non-Medicare populations remain. The 1998 Medicare policy change was associated with a significant increase in the odds of screening among low-income (<$25,000) Medicare beneficiaries. CONCLUSIONS: Policy makers should consider reasons for continued low colorectal screening rates among all insured groups. Barriers such as patient perceptions and physician advice should be considered along with the vulnerability that low income and lack of insurance imposes.

Human participants challenges in youth-focused research: perspectives and practices of IRB administrators.

The purpose of this research was to understand institutional review board (IRB) challenges regarding youth-focused research submissions and to present advice from administrators. Semistructured self-report questionnaires were sent via e-mail to administrators identified using published lists of universities and hospitals an Internet searches. Of 183 eligible institutions, 49 responded. One half indicated they never granted parental waivers. Among those considering waivers, decision factors included research risks, survey content, and feasibility. Smoking and substance abuse research among children was generally considered more than minimal risk. These findings are consistent with those from a study conducted by Mammel and Kaplan (1995), which investigated IRB practices concerning protocols involving adolescent participants. IRBs and investigators need to become aware of regulations' flexibility to ensure adequate participant protection. Investigators need to limit jargon and assumptions about participants' understanding of research objectives.