Re: State agency swaps babies’ blood for supplies

This is a response to the recent article in the Austin American Statesman: State agency swaps babies’ blood for supplies

Institutional Review Boards (IRBs) are NO LONGER the best solution – or even an adequate solution – for state problems (or for research) when informed consent is needed for the use of individual health information, tissue, or bloodspots. There are now effective, affordable technology solutions that enable individual families to make their own informed choices.

The state of Texas was sued because families could not individually decide how their spots were handled – whether they should be kept and how they could be used. Technology offers great solutions for those sensitive problems.

Governance of bio-banks like the NBS Program is critical as Dr. Callan points out, BUT governance cannot replace individuals’ existing rights to privacy and informed consent.

And there is no longer a need to use IRBs (typically stacked with members who have conflicts of interest) to replace individual families’ rights to make decisions about their child’s newborn bloodspots, now that technology offers much better solutions where each family can set their own preferences and be contacted for use/sale of their spots.

IRBs and privacy boards were needed in the past when the time and cost of contacting hundreds and thousands of people to ask consent for the use of their records was prohibitive, but that is no longer true thanks to technology. Millions can be contacted by email or text mail on cell phones instantly, at virtually no cost. And their responses can be addressed automatically via technology—think of online response cards when you donate money, you get an email confirming what you did. Technology can enable each family to make their own informed decisions.

There are many problems with using IRBs to replace individual informed consents. IRBs tend to be dominated by researchers and data users — people who want to use patient records or bio-specimens, rather than consumers and privacy advocates. IRBs have not focused on protecting medical record privacy — the focus has been on clinical research on the use and effectiveness of new drugs and devices that can directly harm people’s minds bodies weighing the safety of the study vs. the risk of side-effects and even death. IRBs were designed to protect people who participate in research from harm and death. So IRBs view research in patients’ records and bio-specimens as safe—as if no serious harms or risks result from these kinds of research. But research using bio-specimens or sensitive personal health information poses great risks to privacy. Personal health information, from prescriptions to DNA, are very valuable commodities that are sold and used to discriminate against patients and their children and grandchildren. Bio-specimens contain genetic information, which can be re-identified, and put families at risk for generations of discrimination.

In addition, the public does not agree that researchers should have unfettered access to their medical records. Open access to the nation’s sensitive health information is not seen as a desired public good. In fact Alan Westin’s survey for the Institute of Medicine on this subject showed that only 1% of Americans would agree to let researchers freely use their health records for any purpose. See: http://patientprivacyrights.org/media/WestinIOMSrvyRept.pdf?docID=2501

Also, the story did not highlight how deceptive ‘opt-out’ consents are. ‘Opt-out’ consent has been utterly rejected in the UK as the method of consent for transferring people’s health records to the NHS—the program had to be stopped when the public found out. ‘Opt-out’ consent was perceived by the public as deceptive, unfair, difficult to understand and enact. See: http://patientprivacyrights.org/2010/04/controversial-medical-records-database-suspended/

The proposal to ‘Save the Spots’ team including Patient Privacy Rights, the Genetic alliance, the UT LBJ School, and innovative technology corporations would have offered an online consent tool where Texas families could choose to:

  • Destroy the spot
  • store and do nothing
  • store and allow use for research, etc.
  • store and contact us for each use
  • send a copy of the test results to us for use with our doctor and our health planning

The story missed the key point about how technology can improve the informed consent process and create trust. Think about this example: you can set your preferences for how your bank pays your bills. Online banking allows you to set preferences for how something of yours ($ instead of spots or information)) is shared with whom, for what purpose. You can set up the bank to pay some bills automatically every month, others are one-time occurrences– ALL at your direction. And you can change your preferences at any time. We need dynamic, real-time patient-centric technology like that in the health care system—technology has NOT been used to assure patients rights, expectations, or convenience. I just saw a system for consent Friday where you can receive requests to use your health information on your cell phone, with the doctor’s name, and how long access is needed.

ALSO—the details about what we offered were not correct in the story—naturally we did not have the funding in hand when we went to the state. How would that be possible? We formally asked the state to agree with the plaintiffs for a delay for 90 days (easy to get from the judge, when both parties agree) so that we could seek the funding from federal and other state and national funders. Funders would not even look at our proposal UNLESS the state had agreed to work with us; ie, without the state’s agreement we could NOT DO IT. The state would not agree.

We could not have come to the state with funds for our proposal in hand—that’s why we needed the state’s formal agreement to the delay and approval to let us seek the funds to execute our proposal.

Unfortunately the story also did not explain why electronic consents can solve seemingly difficult problems, or why IRBs should no longer be used to replace individuals’ rights of consent when technology enables individuals to make their own informed choices about research.

The issue of what kind of consents we will have for the state of Texas as we move toward requiring and exchanging electronic health information is VERY CRITICAL—it is critical for lawmakers and the public to realize that innovative consent and privacy-enhancing technologies can be used to protect their rights in electronic health systems, not destroy them.

Again, you can see the Article referenced here at this link: http://patientprivacyrights.org/2010/05/state-agency-swaps-babies-blood-for-supplies/

State agency swaps babies’ blood for supplies

When a California company asked Texas for blood samples from newborns in 2008, the state charged $1,600 for 400 blood spots. A North Carolina company swapped 16 HIV testing kits for 5,400 blood spots from the Department of State Health Services in 2006 and 2007. And another company has a five-year contract to get 3,800 blood spots a month in exchange for $456,000 worth of lab supplies.

Blood taken from Texas newborns in a state-mandated program to screen for defects and potentially deadly disorders has proved to be a valuable commodity — not just for researchers who might discover causes and treatments for diseases, but for companies developing, manufacturing and selling lab tests around the world. The blood samples — which were stored indefinitely starting in July 2002 without parents’ knowledge until recently — help companies evaluate and bring disease screening tests to market. In exchange, the health department gets needed supplies to conduct lab tests on newborns and other patients…

…In March 2009, the Texas Civil Rights Project sued the state over the storage program, claiming the state was violating constitutional protections against unlawful searches and seizures as well as state privacy laws. It wanted the state to stop storing blood without parental consent — state law doesn’t require consent — and asked that samples be destroyed unless consent was obtained.

The issue struck a chord nationally as parents learned other states had similar programs and feared the potential for misusing private genetic information.

“Newborn screening programs are under attack nationally, and they hope this will just go away, but it won’t,” said Dr. Deborah Peel, founder and chairwoman of Patient Privacy Rights, a national organization that advocates for patient privacy. “The public is terrified of the state owning their DNA.”

The Texas suit was settled in December when the state agreed to destroy 5.3 million blood spots stored since 2002, despite last-minute efforts led by Peel and others to try to save the spots by creating an informed consent process. New state laws passed last year put controls on the samples, and now the department must inform parents of possible uses and allow them to opt out of having their baby’s blood stored for up to 25 years.

Ethics Debate Over Blood From Newborn Safety Tests

After those tiny blood spots are tested for a list of devastating diseases, some states are storing them for years. Scientists consider the leftover samples a treasure, both to improve newborn screening and to study bigger questions, like which environmental toxins can harm a fetus’ developing heart or which genes trigger childhood cancers.

But seldom are parents asked to consent to such research — most probably do not know it occurs — raising privacy concerns that are shaking up one of public health’s most successful programs. Texas is poised to throw away blood samples from more than 5 million babies to settle a lawsuit from parents angry at what they call secret DNA warehousing. A judge recently dismissed a similar lawsuit in Minnesota.