Consent process for BioVU participation updatedJan. 29, 2015, 8:42 AM
As of last week, Vanderbilt has updated the process used to facilitate patient participation in BioVU, the Medical Center’s DNA repository.
The change came in response to new National Institutes of Health (NIH) regulations designed to protect human data while promoting genomic data sharing.
BioVU broadly supports research into the genetic basis of disease and drug response. The program collects blood left over from clinical tests that would otherwise be thrown away. The collected samples are de-identified and then linked to de-identified electronic health records. Formerly, all patients arriving at Vanderbilt Medical Group clinics received a brief form allowing them to opt out of the program.
Now, instead of an opt-out form, patients are presented with a research consent form with more information about the program, including use of BioVU data outside of Vanderbilt.
As with the former form, patients receive the consent form during clinic check-in, along with standard clinic intake forms.
“BioVU has been so successful in leveraging the clinic registration process, and we didn’t want to disrupt this. Patients will notice a new form, with more information about BioVU, but the clinic process will remain the same,” said Erica Bowton, Ph.D., research assistant professor of Medical Education and Administration and program manager for BioVU.
The switch was accompanied by clinic posters, brochures and a brief online tutorial for patient services representatives (clinic receptionists).
At last count, BioVU included DNA samples from more than 193,000 patients, including 169,659 adults and 23,516 children. It is by far the largest bio-repository in the NIH-funded eMERGE Network (Electronic Medical Records and Genomics Network).
For more information, patients can call 866-436-4710 or visit the BioVU website. Staff and faculty can address questions to firstname.lastname@example.org.
The new NIH genome data sharing policy (effective Jan. 25) applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as use of these data for subsequent research. Investigators can find additional information, including an FAQ, on the Vanderbilt Office of Sponsored Programs website.