Medical Data Use Broadened by Human Genome

Posted September 8, 2014 at 5:09pm

The completion of the Human Genome Project in 2003 did more than unlock many of the secrets of man’s DNA. It also fundamentally broadened the collaborative use of medical data, according to a top National Institutes of Health researcher.

“One of the critical contributions of the genome project was a cultural shift to sharing data,” where once such research material had been more closely guarded, said Eric Green, the director of the National Human Genome Research Institute, in a recent interview.

The continuing payoff from that change in attitude was clear in late August, as Green announced a sweeping new policy of sharing genetic information collected for research projects.

Starting with applications submitted on Jan. 25, 2015, the NIH will push researchers to obtain the informed consent of study participants for the potential future use of their genetic data for broad sharing among researchers. Scientists working with large packets of human genetic data should plan to make sure this information is stripped of key identifying details and submitted to NIH-approved repositories. In constructing these rules, the NIH hewed to federal privacy regulations known as HIPAA rules, due to their origin as part of the 1996 Health Insurance Portability and Accountability Act (PL 104-191).

Some people, including members of Native American tribes, raised concerns about misuse of the data or reprisals for those researchers who might not want to share the genetic information that they have gathered. Members of a tribe may be willing to work with scientists who share their background in tackling diabetes and obesity, which plague Native American communities, but not wish to see their information more widely used, wrote researchers Linda Burhansstipanov and Lynne Bemis in a comment on the draft policy.

“If they do not want to share with anyone who knows little about local tribal cultural issues, they are not likely to be viewed as competitive for NIH funding,” they said.

Many commenters, though, were openly enthusiastic about the NIH proposal. Green sees increased enthusiasm among the public for sharing their medical data among researchers, and said he is intent on preserving it.

“If we can keep their trust and put in place the proper protections, such as those aligned with the genomic data sharing policy, I think we can use their energy and harness it and really propel science forward,” he said.