In a consensus article titled, “Managing incidental findings and research results in genomic research involving biobanks and archived data sets” published in Genetics in Medicine and discussed in Nature and Science, Professor Susan Wolf of the University of Minnesota and 25 esteemed colleagues from across the U.S. and Canada, including Coriell’s President and CEO, Dr. Michael Christman (pictured left), offers the first recommendations on whether and how to offer individual research results and incidental findings to people who contribute their specimens and data to genomic research using biobanks and archived data sets.
“This article offers consensus recommendations on how to handle a huge problem in large-scale genomic research—what to do with findings about individual research participants when those findings have high health importance,” says Wolf. “Indeed, some of these findings can make a life-or-death difference.”
Biobank collections increasingly power genomic research around the world by collecting tissue samples and associated clinical data for research use. A remarkable example is Coriell’s Biobank, a significant and diverse research resource relied upon by biomedical researchers worldwide. Since the first repository was established at Coriell in the 1960s, hundreds of thousands of cell lines and DNA samples representing numerous diseases have been distributed to researchers in 65 countries. Coriell’s biobank collections provided support to the Human Genome Project, the renowned worldwide program to map the entire human genome.
Wolf and her co-authors write that biobanks should play an important part in setting up a system to handle incidental findings. They urge that biobanks capable of reidentifying consenting contributors should generally offer individuals results and findings that reveal an established and substantial risk of a serious health condition when the findings will allow action to alter the course or improve the treatment of the condition.
Coriell’s project – the Coriell Personalized Medicine Collaborative (CPMC) follows this very principle. It’s a research study designed to understand the usefulness of genetic information in clinical use. By providing study participants with personalized risk reports informing them of their risk of complex disease, including heart disease, prostate cancer, and diabetes, the study seeks to understand how people and healthcare providers use this genetic information to manage health. The innovative contenting process utilized by the CPMC study is a model that accommodates future follow-up; as genetic associations with disease risk are made, new personalized risk reports are provided to all study participants. Learn more about this pioneering study at www.cpmc.coriell.org.
The consensus article was funded by a 2-year grant from the National Human Genome Research Institute (NHGRI) at the National Institutes of Health (NIH).