05 May Response to "Aurora launches technology-driven biobank"
Editor’s note: The letter was submitted in response to an article, Aurora launches technology-driven biobank published April 29, 2009.
I would like to clarify Aurora Health Care’s mission behind the biorepository project.
Aurora is a not-for-profit health care provider, and the creation of the Open-Source Robotic Biorepository & Informatics Technology (ORBIT) is consistent with our values. We believe that every patient deserves the best care, in responsibly managing resources and in accountability, teamwork and respect.
Both the National Institutes of Health (NIH) and the President’s Council of Advisors in Science and Technology (PCAST) have advocated for the development of biorepositories as a strategy to improve the quality of health care and enhance safety by better understanding how genetic information can impact health outcomes.
Aurora’s leaders have taken every measure they can to ensure the safety and security of participants’ information. All the medical data is stripped of identifying information and no insurer, school, employer, company or researcher will be able to gain access to participants’ identities. The process for participation and consent is clearly explained to all patients, and they can completely withdraw from the biorepository at any time. Linking DNA back to the source would be extremely difficult to do, and Aurora has protocols in place to prevent this from happening.
Aurora’s biorepository is certified by NIH for confidentiality. The Health Insurance Portability and Accountability Act (HIPAA), known as the federal privacy rule, contains national standards for the safety and privacy of electronic health data, information and transactions. Incorporated into HIPAA provisions are federal privacy protections for individually identifiable health information. Also, the Genetic Information Nondiscrimination Act of 2008 protects against discrimination based on genetic information, allowing people to eventually take full advantage of the promise of personalized medicine without fear of the abuse of genetic information. In addition, an Institutional Review Board oversees this project, and its standards for Aurora’s biorepository exceed federal guidelines for research involving human beings. If there is a breach in privacy, the IRB has the authority to close the program.
We anticipate Aurora will be able to support a range of studies through the biorepository. There is an approval process in place, which includes the IRB, for screening requests. However, research in ethically challenging areas, such as abortion or the use of embryonic stem cells, will not be considered.
The Aurora patients who willingly consent to participate in the biorepository are helping advance responsible research that will move us toward safer, more effective personalized medical care. Better understanding how DNA impacts health is a critical part of discovering how to improve disease prevention so that we can offer patients better care in the future.
Sincerely,
Randall Lambrecht, Ph.D.
Vice President for Research
Aurora Health Care