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New concept in informed consent aims to clear research hurdle for startups

on November 09, 2011

Companies working on new biomedical treatments or devices today spend about 18 months of their ramp-up capturing, organizing and analyzing data to validate their work, but a new protocol for gaining informed consent at the point of patient care could flatten that time curve significantly, according to the developers of the protocol.

John Wilbanks is leading a Kauffman Foundation team that is developing a new standard called “portable legal consent” with Sage Bionetworks. The goal is to have the standard ready to implement on Web sites by March 2012. The Dr. Susan Love Research Foundation's Army of Women has signed on as the first disease organization to test the process in real time.

During the Partnering for Cures meeting in New York City this week, Wilbanks emphasized the concept of standard, using hypertext markup language, or HTML, as an example. “One of the goals of standards is to disappear,” he said. “They’re things you don’t even notice anymore because they’ve disappeared into the infrastructure.”

The idea is for patients to give their consent for sharing their data from a variety of platforms with researchers. “It starts with the idea that patients are now sitting in the middle of an unparalleled capacity to collect data about themselves,” he said. The portable informed consent protocol focuses on four sources of that data:

  • Genome data, now available from a variety of providers, including family tree Internet sites
  • Electronic health records
  • Biosamples, such as medical laboratory test results
  • Smart phone data

The last item on that list is “not traditionally thought of as health data,” but Wilbanks said that it can be very telling about an individual’s health status. “It’s an enormous amount of post-marketing observation and day-to-day observation that can happen if a patient is giving permission to track and analyze their basic smart phone data,” he said.

While he acknowledged that some researchers already are using this information, the lack of network connectivity severely limits its use. Creating legal and technical standards for capturing and protecting this patient data provides the foundation for collecting this information into networks. “Then we can start querying those networks and finding out genotype-phenotype associations, drug response and other information so the researchers who hack our data don’t have to collect it all themselves,” he said.

The development team is working to streamline the click-through process for obtaining informed consent from individuals, Wilbanks said. The protocol would specifically ask individuals to grant the right to use the data for research and commercialization of products. “The data itself can’t be sold, but the point of this is to discover drugs, to make diagnostics and to come up with software applications,” Wilbanks said. “It’s important to enable commercial development at that level.”

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