President’s Commission Addresses Informed Consent and Genomics, but Remains Silent on Core Concerns
Posted by Daniel Sharp February 7, 2012
Biopolitical Times
The President’s Commission for the Study of Bioethical Issues met last week at the University of California San Francisco. One hot topic on its plate was the relationship among whole-genome sequencing, privacy and informed consent.
These are sticky and challenging questions that need careful thought. Unfortunately, the meeting seemed to pass over a number of key points too quickly. With a few exceptions (most notably the excellent presentations by Pilar Ossorio and George Annas), the discussion fell into a number of the same-old pitfalls that so often surround discussions of genomics: over-emphasizing the urgency and imminence of genetic cure-alls, neglecting unique concerns surrounding privatized genomics, and recommending technological solutions to social problems.
The subtext of the commission’s discussion was the vast promises that are routinely made about the introduction of genomics into health care. Of course, there’s nothing wrong with emphasizing the potential benefits of genomics. What is problematic, however, is the creation of a false opposition between genetic privacy and scientific progress.
A remark by participant Daniel Masys is emblematic: “The genome will tell the book of humanity, and as it is, we only understand one third of the words,” he said. “My major concern is that privacy not materially inhibit the ability to decode that book and understand what that means.”
The idea here – that we may have to throw privacy concerns under the bus in a race to save humanity by sequencing as many genomes as fast as possible – is an unhelpful way to frame the discussion. It neglects the fact that there’s no compelling reason that maintaining privacy has to interfere with research. And it serves as an apologia for postponing the creation of real safeguards.
One set of privacy-related safeguards that clearly needs bolstering surrounds informed consent. This issue, of course, is not confined to genomics. As medical ethicist Harriet Washington pointed out in a recent article, the erosion of informed consent is taking place in a wide variety of contexts already.
Nonetheless, providing meaningful informed consent in the context of genomic data storage presents unique challenges, as discussed in the testimonies of Jane Kaye and John Willbanks. Kaye and Willbanks both criticized clunky and misleading consent forms and noted that stored genetic data is often used in a plethora of research projects, about which patients are often left in the dark.
Both Willbanks and Kaye focused on technical fixes, designed to provide a consent structure for individuals who opt to share their genetic information. Kaye proposed an ‘e-governance’ solution, based on “flexible governance software” that would notify patients how their data was being used as the research process progressed.
While such arrangements might be part of the solution, they are not by themselves sufficient. Software-solutions neglect the especially challenging concerns raised by for-profit genetic databases.
Currently, for-profit biobanks can shop out genetic information without the knowledge of the individuals who provided it. Do people who consent to having their genetic information stored have any idea that private companies are profiting off it? Do they know that corporations can sell the data to whomever they like?
Designing better genomics software is not enough to address these concerns. Robust regulation of commercial biobanks and personal genomics corporations is also necessary. But discussion of legislative solutions remained remarkably absent from the Commission’s discussion.
It’s a relief to see the President’s Commission beginning to address these issues. But it’s also time to deepen the discussion.
These are sticky and challenging questions that need careful thought. Unfortunately, the meeting seemed to pass over a number of key points too quickly. With a few exceptions (most notably the excellent presentations by Pilar Ossorio and George Annas), the discussion fell into a number of the same-old pitfalls that so often surround discussions of genomics: over-emphasizing the urgency and imminence of genetic cure-alls, neglecting unique concerns surrounding privatized genomics, and recommending technological solutions to social problems.
The subtext of the commission’s discussion was the vast promises that are routinely made about the introduction of genomics into health care. Of course, there’s nothing wrong with emphasizing the potential benefits of genomics. What is problematic, however, is the creation of a false opposition between genetic privacy and scientific progress.
A remark by participant Daniel Masys is emblematic: “The genome will tell the book of humanity, and as it is, we only understand one third of the words,” he said. “My major concern is that privacy not materially inhibit the ability to decode that book and understand what that means.”
The idea here – that we may have to throw privacy concerns under the bus in a race to save humanity by sequencing as many genomes as fast as possible – is an unhelpful way to frame the discussion. It neglects the fact that there’s no compelling reason that maintaining privacy has to interfere with research. And it serves as an apologia for postponing the creation of real safeguards.
One set of privacy-related safeguards that clearly needs bolstering surrounds informed consent. This issue, of course, is not confined to genomics. As medical ethicist Harriet Washington pointed out in a recent article, the erosion of informed consent is taking place in a wide variety of contexts already.
Nonetheless, providing meaningful informed consent in the context of genomic data storage presents unique challenges, as discussed in the testimonies of Jane Kaye and John Willbanks. Kaye and Willbanks both criticized clunky and misleading consent forms and noted that stored genetic data is often used in a plethora of research projects, about which patients are often left in the dark.
Both Willbanks and Kaye focused on technical fixes, designed to provide a consent structure for individuals who opt to share their genetic information. Kaye proposed an ‘e-governance’ solution, based on “flexible governance software” that would notify patients how their data was being used as the research process progressed.
While such arrangements might be part of the solution, they are not by themselves sufficient. Software-solutions neglect the especially challenging concerns raised by for-profit genetic databases.
Currently, for-profit biobanks can shop out genetic information without the knowledge of the individuals who provided it. Do people who consent to having their genetic information stored have any idea that private companies are profiting off it? Do they know that corporations can sell the data to whomever they like?
Designing better genomics software is not enough to address these concerns. Robust regulation of commercial biobanks and personal genomics corporations is also necessary. But discussion of legislative solutions remained remarkably absent from the Commission’s discussion.
It’s a relief to see the President’s Commission beginning to address these issues. But it’s also time to deepen the discussion.