Russ B Altman1†, Neal Benowitz2, David Gurwitz3, Jeantine Lunshof4, Mary Relling5, Jatinder Lamba5, Eric Wieben6, Sean Mooney7, Kathleen Giacomini2, Scott Weiss8, Julie A Johnson9, Howard McLeod10, David Flockhart7, Richard Weinshilboum6, Alan R Shuldiner11, Dan Roden12, Ronald M Krauss13 & Mark Ratain14 †Author for correspondence 1Stanford University, Department of Genetics and Bioengineering, Clark S172, Stanford, CA 94305-5444, USA E-mail: Russ.Altman@ stanford.edu 2University of California, San Francisco 3Tel-Aviv University 4VU University Medical Center 5St Jude Children’s Research Hospital 6Mayo Clinic 7Indiana University School of Medicine 8Harvard Medical School 9University of Florida 10University of North Carolina 11University of Maryland 12Vanderbilt School of Medicine 13Children’s Hospital Oakland Research Institute 14University of Chicago On 31st January 2007, the US Senate Health, Education, Labor and Pensions Committee approved the Genetic Information Nondiscrimination Act (GINA) by a vote of 19:2. It was unanimously approved by the US Congress Committee on Education and Labor 2 weeks later. This legislation, aimed at preventing genetic discrimination in employment and insurance [1], will be imperative for protecting altruistic individuals who volunteer for genetic research [2]. There is an emerging consensus among researchers that genetic data must be accessible to individual research participants upon their request [3], while not putting them at risk with respect to their employment, insurance and additional personal aspects [4]. The GINA balances individual freedoms and privacy rights with societal needs for affordable and more effective healthcare and helps to pave the way for more personalized medicine [5]. Indeed, genetic information can be used to improve healthcare, in particular with regard to reducing the alarming rates of adverse drug reactions, which led to 6.7% of all US hospital admissions during 2004–2005 [6], consistent with earlier studies in the UK [7]. Increased use of individual genetic information about drug-metabolizing and drug-target gene alleles as part of healthcare treatment decisions may substantially reduce such morbidity [8]. However, building up the required knowledge depends on the analysis of large individual genotype/phenotype data sets from patient cohorts and requires open data sharing so that large, meaningful and less biased data sets are available to researchers [9]. Lack of open data sharing, in particular between the private and public sectors, hinders our ability to assemble large aggregated data sets [9]. A key obstacle for data sharing is concern about depositing data sets from individual study participants into public databases; some researchers fear they will be held responsible in cases where the data are re-identified (using computational data-mining techniques) and subsequently used (by employers or insurers) to discriminate against study participants. We therefore believe that legislation that offers protection to individuals or groups who share genetic information – against both re-identification and discrimination – is essential for efforts to move genomic medicine into practice. Legislation barring discrimination or stigmatization based on genetic information has been proposed for years, but enactment has become particularly urgent in view of rapidly falling genotyping costs [10], the scope of ongoing genome-wide association studies [11] and the increasing availability of comprehensive personal data in the public domain [4]. We therefore strongly support the current efforts to establish a solid legal framework as a primary means to protect individuals against misuse of their genetic information and as an essential tool for allowing open data sharing in pharmacogenomics.