With the Human Genome Project complete for over a decade, the benefits of genomic data are now trickling into the business and practice of medicine. The passage of the Genetic Information Non-Discrimination Act in 2008 and the Affordable Care Act in 2010 have set the rules of the road, and made the critical investments necessary to lay the ground work for new advances in American genomics research. In the coming years, as the price of whole-genome scans come down and the medical community enters a new era of personalized medicine, we will have a new set of tools with which to study the origin of diseases affecting specific populations.

Genetics can reveal useful information about an individual’s health status, but they can also reveal unexpected information about group identity. The Latino community is both genetically and culturally diverse; and as gene-based medicine advances, Latinos will need to make sure that new medical technologies serve that diversity.

I believe that to capture the necessary genetic diversity to study the drivers of health disparities, America’s research agenda must include a broad swath of the Latino population. The National Institutes of Health (NIH) has so far committed $61 million to observe more than 16,000 Latinos over six years through the Hispanic Community Health Study, the nation’s largest longitudinal study of Latinos. Yet there is still so much more to be gained by incorporating the study of Latino populations into other research projects. But the research process does not end with research funding decisions. Clinical and biomedical research practices must also be more responsive to patients, who should be empowered to tell researchers and doctors what kinds of questions they want research to answer.

Every step of the biomedical research process — from genetic testing to clinical trials — can be made more inclusive, addressing the broad range of genetic and economic diversity in the U.S. The Latino community will need to work together with research institutions and private companies to overcome the barriers that exist with regards to inclusive biomedical research. These barriers range from economic inequalities and provider biases to lack of awareness, distrust, or cultural and linguistic differences.

Doctors can play a major role in making Latino patients more fully aware of clinical trials or genetic studies by communicating the possible risks and benefits. Doctors should also inform patients of the privacy protections afforded by laws like the Genetic Information Nondiscrimination Act and the Health Insurance Portability and Accountability Act in order to build trust and allay fears of discrimination in employment or insurance. This kind of communication will become a necessity in the future as medical research and clinical care become ever more closely intertwined.

The Department of Health and Human Services has already laid out recommendations for more inclusive research practices in a 2009 report. It recommends the building of a more diverse scientific and health care workforce; outreach to trusted community members who can promote the benefits of research; and the building of cultural awareness surrounding diet, work-life balance and access to resources. The report also elaborated on a research model known as “community-based participatory research,” which would involve the Latino community in the design and conduct of the research, creating a sense of community “ownership” over the results and a greater adherence to the outcomes.

These practices have the potential to create actionable, results-oriented research processes that incorporate the histories, lifestyles and values of Latino patients. The last thing we want is for the research establishment to become overly reliant on a single indicator, measurement or classification that does not account for the needs of individuals in the Latino community and other communities. Only by making sure that every community’s voice is heard, can we be sure that personalized genetic medicine will truly be personalized.

This op-ed is reposted from the Huffington Post. Michael Rugnetta is a former research assistant for Science Progress and author of the new report, “Addressing Race and Genetics: Health Disparities in the Era of Personalized Medicine” .

“You probably want to be sure they’re going to work so that your crab claws don’t turn into a complete exoskeleton,” he explained.

But in all seriousness, to design stem cell therapies that are effective and safe, scientists need to understand the full mechanics of the cell from its earliest developmental stages, and therefore must pursue many avenues of research. And that, as we have explained previously at Science Progress, will take time. Earlier this year, James M. Wilson, of the University of Pennsylvania underscored the importance of creating safe, responsible trials for stem cell therapies in an article in Science. Wilson understands first-hand the pitfalls of proceeding too quickly with a novel therapeutic technology, as he was the principal investigator in a gene therapy trial that resulted in the death of 18-year-old Jesse Gelsinger in 1999.

Collins also hit all the right notes in his explanation of personalized medicine, saying that it’s about “getting the right drug, at the right dose, for the right person.” It’s about “doing prevention in an individualized way instead of one-size-fits-all—taking advantage of the fact that we’re all different,” he said.

Just a few weeks ago Collins penned an article for Parade Magazine on the importance of pharmacogenomics and family history in treating cancer. It’s an important field of work, but the orchestra of federal agencies involved in the research and policy of personalized medicine is in need of a conductor, as Whitney Kramer and I explain in our recent report.

Here’s the full interview as Collins Reports to Colbert:

But the Centers for Medicare and Medicaid Services recently released their “Proposed Decision Memo for Pharmacogenomic Testing for Warfarin Response,” in which they write that genetic testing does not improve “health outcomes in Medicare beneficiaries” when trying to predict responsiveness to the anticoagulant.

However, CMS did decide to pursue a strategy known as “coverage with evidence development,” which is authorized under the Social Security Act. This means that CMS will cover the cost of genetic tests for warfarin responsiveness if they are a part of a “prospective, randomized, controlled clinical trial.” In short, CMS will cover more research on use of the genetic test, but not pay for it in clinical settings.

According to GenomeWeb, private insures such as Aetna have also chosen not to cover the tests and have not been moved by the CMS decision to cover them for clinical trials.

Overall, this is a sensible policy and CMS lays out clear reasoning for it. Out of the six professional societies that provided their positions on pharmacogenomic testing for warfarin dosing, only two, the American Association for Clinical Chemistry and the College of American Pathologists, felt that there was sufficient evidence of effectiveness to warrant coverage. CMS also incorporated five expert opinions into their decision, all of which attested that the evidence regarding real-world health outcomes was insufficient. Michael Brophy of the Department of Veterans Affairs Diagnostic Services wrote that the genetic factors influencing response to the drug did not make a practical difference in clinical situations: “It’s only one of many factors that determine the appropriate dose.”

This decision is likewise important because it answers questions raised at a Medicare Evidence Development and Coverage Advisory Committee meeting in February on diagnostic genetic testing, which tests for diseases or anticipates drug response in patients. Most of the committee members felt that diagnostic genetic testing should be held to similar standards and criteria as other forms of diagnostic testing. The committee also emphasized that in order to assess the impact of diagnostic genetic testing on patient-centered health outcomes, there need to be “methodologically rigorous” evidence gathered on direct patient-centered health outcomes such as “mortality, functional status, and adverse events.”

If anything, these evaluations all to point to the need for robust evidence gathering. Personalized medicine will further require a sophisticated infrastructure for collecting, analyzing, and coordinating clinical and research information, and that necessitates investment in health information technology and comparative effectiveness research to reduce costs and improve health care outcomes.