By AMY HARMON

A settlement between 41 members of the Havasupai Indian tribe and Arizona State University highlights the risk researchers take when they fail to secure what is known as “informed consent,” fully informing research participants how their DNA may be used, legal experts and civil rights advocates said.

“It sows distrust,” said Hank Greely, a law professor and director of the Center for Law and the Biosciences at Stanford University. “And researchers cannot do their research unless people are willing to trust them.”

Citing the Havasupai dispute in recent years, other Indian tribes have refused to participate in genetic research. (Under the settlement, the Havasupai agreed to ask other Arizona tribes to repeal resolutions saying they would not cooperate with researchers at Arizona State University.)

Other cases have shown that people involved in medical trials and research want to be asked before their donated DNA is used for different purposes.

Parents in Texas sued the state health agency when they discovered that blood taken from their newborns, to be screened for genetic disorders, had been made available to scientists without the families’ authorization. Some samples, they later learned, had also been provided to federal law enforcement officials for research aimed at improving the interpretation of forensic DNA evidence.

“The nurses asked me if they could give my son a pacifier. They asked me if they could give him formula,” said Andrea Beleno, 34, of Austin, Tex. “No one asked me if his DNA could be stored in a state database.”

In the Texas case, and a similar one filed by parents in Minnesota, the states agreed to destroy the samples.

“It is a gesture of respect to say, ‘We told you we wanted to do one thing, and we’d really like to do something else,’ ” said S. Malia Fullerton, assistant professor of bioethics at the University of Washington in Seattle. Indian Tribe Wins Fight to Limit Research of Its DNA

By AMY HARMON
New York Times

SUPAI, Ariz. — Seven years ago, the Havasupai Indians, who live amid the turquoise waterfalls and red cliffs miles deep in the Grand Canyon, issued a “banishment order” to keep Arizona State University employees from setting foot on their reservation — an ancient punishment for what they regarded as a genetic-era betrayal.

Members of the tiny, isolated tribe had given DNA samples to university researchers starting in 1990, in the hope that they might provide genetic clues to the tribe’s devastating rate of diabetes. But they learned that their blood samples had been used to study many other things, including mental illness and theories of the tribe’s geographical origins that contradict their traditional stories.

The geneticist responsible for the research has said that she had obtained permission for wider-ranging genetic studies.

Acknowledging a desire to “remedy the wrong that was done,” the university’s Board of Regents on Tuesday agreed to pay $700,000 to 41 of the tribe’s members, return the blood samples and provide other forms of assistance to the impoverished Havasupai — a settlement that legal experts said was significant because it implied that the rights of research subjects can be violated when they are not fully informed about how their DNA might be used.

The case raised the question of whether scientists had taken advantage of a vulnerable population, and it created an image problem for a university eager to cast itself as a center for American Indian studies.

But genetics experts and civil rights advocates say it may also fuel a growing debate over researchers’ responsibility to communicate the range of personal information that can be gleaned from DNA at a time when it is being collected on an ever-greater scale for research and routine medical care.

“I’m not against scientific research,” said Carletta Tilousi, 39, a member of the Havasupai tribal council. “I just want it to be done right. They used our blood for all these studies, people got degrees and grants, and they never asked our permission.”

Researchers and institutions that receive federal funds are required to receive “informed consent” from subjects, ensuring that they understand the risks and benefits before they participate. But such protections were designed primarily for research that carried physical risks, like experimental drug trials or surgery. When it comes to mining DNA, the rules — and the risks — are murkier.

Is it necessary, for instance, to ask someone who has donated DNA for research on heart disease if that DNA can be used for Alzheimer’s or addiction research?

Many scientists say no, arguing that the potential benefit from unencumbered biomedical research trumps the value of individual control.

“Everyone wants to be open and transparent,” said Dr. David Karp, an associate professor of internal medicine at the University of Texas Southwestern Medical Center in Dallas, who has studied informed consent for DNA research. “The question is, how far do you have to go? Do you have to create some massive database of people’s wishes for their DNA specimens?”

The Havasupai settlement appears to be the first payment to individuals who said their DNA was misused, several legal experts said, and came after the university spent $1.7 million fighting lawsuits by tribe members.

Even as the Havasupai prepared to reclaim the 151 remaining blood samples from a university freezer this week, Therese Markow, the geneticist, defended her actions as ethical. Those judging her otherwise, she suggested, failed to understand the fundamental nature of genetic research, where progress often occurs from studies that do not appear to bear directly on a particular disease.

“I was doing good science,” Dr. Markow, now a professor at the University of California, San Diego, said in a telephone interview.

Edmond Tilousi, 56, a cousin of Carletta Tilousi and the tribe’s vice chairman, can climb the eight miles from his village on the floor of the western Grand Canyon to the rim in three hours, when he is in a rush. Horse or helicopter are the other ways out, and Mr. Tilousi is increasingly rare among the tribe’s members in his ability to make the hike. Beginning in the 1960s, an extraordinarily high incidence of Type 2 diabetes led to amputations, even among the younger members, and forced many to leave the canyon for dialysis.

In late 1989, Mr. Tilousi’s uncle Rex Tilousi approached John Martin, an Arizona State University anthropologist who had gained the tribe’s trust, to ask if he knew a doctor who could help. “I asked him, ‘How can we prevent this from spreading?’ ” the elder Mr. Tilousi recalled.

Professor Martin approached Dr. Markow. A link had recently been reported between a genetic variant and the high rate of diabetes among Pima Indians. If a similar link was found among the Havasupai, it might point to an important risk factor.

The two professors received money from the university to study diabetes in the tribe. Dr. Markow was interested in schizophrenia research as well, and in the summer of 1990, with a grant from the National Alliance for Research on Schizophrenia and Depression, she and her graduate students began collecting blood samples in Supai. Women here remember being happy to see her in those days, an athletic figure who talked to them about how to be more healthy. Working out of the health clinic in the center of the village, Dr. Markow recruited tribe members to ask others to give blood. To the Havasuapi, blood has deep spiritual meaning.

“I went and told people, if they have their blood taken, it would help them,” said Floranda Uqualla, 46, whose parents and grandparents suffered from diabetes. “And we might get a cure so that our people won’t have to leave our canyon.” Roughly 100 tribe members who gave blood from 1990 to 1994 signed a broad consent that said the research was to “study the causes of behavioral/medical disorders.”

The consent form was purposely simple, Dr. Markow said, given that English was a second language for many Havasupai, and few of the tribe’s 650 members had graduated from high school. They were always given the opportunity to ask questions, she said, and students were also instructed to explain the project and get written and verbal consent from donors.

Dr. Markow examined several genes that were thought to have medical relevance, including for schizophrenia, metabolic disorders and alcoholism, she said, but found little to pursue. The Havasupai did not, it turned out, share the gene variant linked to diabetes in the Pima.

But a few years later, a graduate student using new technology came up with a way to discern variations in the Havasupai DNA, which was stored in a university freezer, and he wrote a dissertation based on his research.

Carletta Tilousi, one of the few Havasupai to attend college, stopped by Professor Martin’s office one day in 2003, and he invited her to the student’s doctoral presentation.

Ms. Tilousi understood little of the technical aspect, but what she heard bore no resemblance to the diabetes research she had pictured when she had given her own blood sample years earlier.

“Did you have permission,” she asked during the question period, “to use Havasupai blood for your research?”

The presentation was halted. Dr. Markow and the other members of the doctoral committee asked the student to redact that chapter from his dissertation.

But months later, tribe members learned more about the research when a university investigation discovered two dozen published articles based on the blood samples that Dr. Markow had collected. One reported a high degree of inbreeding, a measure that can correspond with a higher susceptibility to disease.

Ms. Tilousi found that offensive. “We say if you do that, a close relative of yours will die,” she said.

Another article, suggesting that the tribe’s ancestors had crossed the frozen Bering Sea to arrive in North America, flew in the face of the tribe’s traditional stories that it had originated in the canyon and was assigned to be its guardian.

Listening to the investigators, Ms. Tilousi felt a surge of anger, she recalled. But in Supai, the initial reaction was more of hurt. Though some Havasupai knew already that their ancestors most likely came from Asia, “when people tell us, ‘No, this is not where you are from,’ and your own blood says so — it is confusing to us,” Rex Tilousi said. “It hurts the elders who have been telling these stories to our grandchildren.”

Others questioned whether they could have unwittingly contributed to research that could threaten the tribe’s rights to its land. “Our coming from the canyon, that is the basis of our sovereign rights,” said Edmond Tilousi, the tribe’s vice chairman.

Many members are still suffering from diabetes and say they were never told if researchers had learned anything that could help them. The classes on nutrition that Dr. Markow had sponsored with grant money have since petered out.

Ms. Uqualla, who had recruited blood donors, said she felt shamed by the news that it had been used for research that could potentially damage the tribe. “I let my people down,” she said.

The money from the settlement will be divided among the 41 tribe members. Ms. Uqualla, for one, hopes to buy a horse trailer.

But Stephen F. Hanlon, a lawyer who has represented the tribe members without charge, said the resources the university agreed to provide, including scholarships and assistance in obtaining federal funds for projects like a new health clinic, had the potential to transform the tribal village at the bottom of one of the world’s most famous natural wonders.

On Tuesday, Ms. Tilousi cried as a university official unlocked the freezer in the nondescript storage room in the Tempe campus where the blood samples had long been stored. Wearing protective glasses, gloves and a lab coat, she and a delegation of tribal members sang in Havasupai as they saw the blood that had been taken from them and from their relatives, now dead.

On the box inside the freezer was scrawled the name, “Markow.”

View Fox 7 News Report

On Monday the House Committee on Public Health held a five hour hearing on the state’s policy regarding blood screenings for newborn babies. The committee must make recommendations for how the state should obtain informed consent from parents for the screenings.

Andrea Beleno was the lead plaintiff in a lawsuit against the state of Texas after she and others found out that since 2002 the state has been taking babies’ blood samples, not just for screening against more than two dozen illnesses, but for research and bartering.

“Parents don’t get the ability or the information to give informed consent. It’s an opt-out program instead of an opt-in which is just not good enough,” says Beleno.

The group won the lawsuit which forced the state to destroy more than 5 million samples. Now the House Committee on Public Health must come up with recommendations for new legislation on the matter.

“We run the gamut of value for research vs. the need for privacy and informed consent, and I think somewhere we’ll have to find that balance,” said Lois Kolkhorst, Public Health Committee Chairwoman.

The issue at hand is how consent forms for parents should be worded and how thorough they should be.

“Are we truly informing parents that the blood of your child can be used in research in the future?” added Kolkhorst.

After blood samples are tested they are sometimes used for research to help maintain the quality of tests administered and new tests.

“To make sure we have better tests and we develop new tests because we have inherited disorders we don’t have test for,” says Dr. David Lakey, DSHS Commissioner.

It was revealed the samples were also being bartered for medical supplies and some samples were given to the Department of Defense for more research.

“We want it to be an opt-in not opt-out program. Right now they’ll take your babies blood and do what they want with it unless you opt-out,” says Wayne Krause, with the Texas Civil Rights Project.

That’s one recommendation made by Wayne Krause with the Texas Civil Rights Project, he addressed the committee on items to keep in mind when drafting a new law.

In the end it will be up to lawmakers to decide how to best inform parents. They will take up during the next legislative session.

Bartering your baby’s blood: State traded blood for goods and services

View KXAN News Report

AUSTIN (KXAN) – When Andrea Beleno gave birth to her son last year, she knew she’d do whatever it took to protect him. But she never dreamed she’d be taking on the State of Texas to safeguard her son’s most private information.

And now, revelations are surfacing that not only did the state store that blood without parents’ knowledge – but they also actually bartered it for goods and services to for-profit companies, without the knowledge of parents or of state lawmakers.

Beleno and several other Texas families sued the State Department of Health Services after they learned the agency had been storing and using newborn blood samples, or blood spots, that were leftover after testing for the Newborn Screening Program.

The families weren’t suing for money. They were suing for the right to decide what happens to their babies’ blood specimens – and the information contained in them. The suit prompted the Texas Legislature to step in and pass a new law giving parents the right to opt out of allowing the state to keep the samples leftover after screening.

In December 2009, the Texas Department of State Health Services settled the lawsuit with Beleno and the families. As part of the settlement terms , the state agreed to destroy the nearly 5 million blood samples it had retained without consent and disclose how the spots had been used.

The state posted the list of research projects using the blood spots on its website. The list gives a brief description of the 24 research projects that used just over 8,800 blood spots.

However, the number of research projects disclosed on its website didn’t match testimony by a DSHS official before the House Public Health Committee in March 2009.

Chairwoman Lois Kohlkorst asked DSHS lab director Susan Tanksley about the research and whether there had been any breakthroughs. Tanksley said that there hadn’t been many — only 4 projects had been completed.

Texas Rep. John Davis asked whether the spots had been used for any criminal investigation purposes. Tanksley denied any spots were used for that purpose.

But records obtained from DSHS show that’s not true. In 2003 and in 2007, the state provided samples collected under the Newborn Screening Program for a project sponsored by the Department of Justice and conducted by the Armed Forces Institute for Pathology .

The samples were to help expand the DNA database for law enforcement purposes. This was news that stunned parent Andrea Beleno.

“I think it’s a breach of public trust,” said Beleno. Parents were kept in the dark about how the leftover spots were used and so were lawmakers. During extensive hearings about the Newborn Screening Program, there was no mention of how the vast majority of spots were used.

It took several requests, but KXAN finally obtained records that show that the state has been using the spots to barter with for-profit corporations for lab supplies, test kits and maintenance contracts.

Among those deals was a five year agreement in which the State provided 228,000 blood spots in exchange for $456,000 worth of lab supplies and maintenance services.

In another deal, the state provided at least 3600 spots in exchange for HIV test kits. How much to charge and how to handle the billing was a source of internal discussions at DSHS.

We obtained one email sent by Barbara Kelly-King, who works in the Revenue Management Unit of DSHS. In February 2006, Kelly-King responded to staff questions about how to bill for spots being provided to bioMerieux.

She wrote: “Originally this was to be handled through a contract but the Health and Safety Code 12.0122 entitled Sale of Laboratory Services does not allow for a contract. The lab is now asking bioMerieux to issue a $2.00 credit for every dried blood spot sent.”

A month later, on March 6, 2006, Lab Director Susan Tanksley’s email to staff says:

“We do not have a contract with bioMerieux but essentially an understanding that we will provide DBS [Dried Blood Spots] to them and they will in turn provide HIV reagents. Originally, we wanted a contract for $2/specimen, but we cannot provide this ‘laboratory service’ to them as they are a for-profit organization. Our attorney’s opinion was that it was acceptable to receive reagents in return for the DBS.”

By October of 2008, DSHS decided it could skip the bartering and charge a fee for providing spots to for-profit corporations. It charged MP Biomedicals $1,600 for 400 spots. The same week, the State charged Avoiq $2,400 for 600 blood spots.

In another deal, a pending two-year contract with Avioq, DSHS agreed to provide a regular supply of blood spots at $4 each which would bring in $28,800 to the agency.

Carrie Williams, Acting Press Officer for the Texas Department Of State Health Services, said the charges were a nominal handling fee used to recoup taxpayer dollars.

Internal DSHS emails detail the process for billing. One dated August 26, 2008 asks how the income should be allocated: “What I’m looking for is this: which pot of money will it benefit us to book this under.”

In all, the State receives about 800,000 blood cards per year from babies born in Texas. By 2009, the number of stored spots had grown to about 5 million specimens.

When older spots were needed and were pulled from the A & M storage room supply, the university charged $15 for each specimen. All of those spots have since been destroyed as part of the settlement of the lawsuit filed by Andrea Beleno and the other parents.

Beleno said they were open to hearing options for preserving the spots for important research, but the state’s own actions have caused public distrust.

“I think the way they’ve behaved is unethical in the way that they’ve handled the disclosure of what they are actually doing,” said Beleno, “And I think it makes it really difficult for people to trust that they are in fact using those samples for public good rather than to make money.”

Williams says the agency is strengthening its process for reviewing and approving requests to use the spots. “The process will be more defined and will include more layers of review,” said Williams. She said the state was not selling the spots in any way shape or form. “Any benefit received from providing the bloodspots went directly back into the program or to the agency’s overall public health mission,” said Williams.

Jay Root, The Associated Press

AUSTIN — Texas health authorities will destroy more than 5 million blood samples taken from babies without parental consent and stored indefinitely for scientific research.

The Texas Department of State Health Services announced Tuesday it would destroy the samples after settling a federal lawsuit filed by the Texas Civil Rights Project. The project, acting on behalf of five plaintiffs, had sued the Texas Department of State Health Services and the Texas A&M University System.

The lawsuit alleged that the state’s failure to ask parents for permission to store and possibly use the blood — originally collected to screen for birth defects — violated constitutional protections against unlawful search and seizure. The plaintiffs cited fears their children’s private health data could be misused.

Under the settlement overseen by a San Antonio federal court, the blood samples collected without parental consent must be destroyed by early next year. It also requires the department to publish a list of all research projects that used the blood specimens.

State health services spokeswoman Allison Lowery said an estimated 5.3 million samples would be destroyed. About 4 million to 4.5 million are stored at the Texas A&M School of Rural Public Health, she said.

Andrea Beleno, 33, was one of the parents who sued the state. She said she was stunned to learn that blood samples taken from her son, born in Austin in November 2008, were being stored indefinitely for unspecified research projects.

News8 Austin: View Video

“You have to give permission for them to give your kid formula in the hospital,” Beleno said. “I don’t understand why you don’t have to give permission for the state to keep your kid’s DNA.”

Texas has been collecting blood samples for decades to screen for at least 27 different birth defects and other disorders. By law the blood could be taken without consent by hospitals, birthing centers and midwives.

The Department of State Health Services established a policy in 2002 in which it began setting aside the blood “spots” after the screenings are done and allowing some of it to be used for research. Before that, the blood was discarded after a certain interval.

This year the Texas Legislature tightened up the procedures, providing opt-out policies for parents, extending privacy guarantees and implementing controls over any scientific research that uses the samples. At issue in the lawsuit settlement are the millions of samples collected and stored before the law took effect in May.

“As a result of this settlement, DSHS will destroy all bloodspot cards received by the department before May 27, 2009,” the health services agency said in a written statement. “We will continue to be very sensitive to the privacy concerns of parents and the confidentiality of all medical information.”

Under current law, the department can still use the blood samples for quality control and disease research as long as parents don’t object. The department screens about 800,000 newborn blood specimens each year.

State agrees to destroy more than 5 million stored blood samples from newborns

By Mary Ann Roser, AMERICAN-STATESMAN STAFF

To settle a lawsuit, the state has agreed to destroy more than 5 million blood samples from newborns that it had stored indefinitely for possible research without parents’ consent, the two sides said Tuesday.

The Texas Civil Rights Project filed the lawsuit in U.S. District Court in San Antonio in March on behalf of four parents and a pregnant woman who dropped out later. It claimed that the state’s collection and storage of the samples amounted to “an unlawful search and seizure” and violated the privacy rights of the parents and their children. Under the settlement, the state will destroy 5.3 million samples it has collected between 2002, when the Department of State Health Services began storing the blood, and May 27, when a new state law restricting the practice was signed.

Federal Judge Fred Biery approved the settlement agreement Dec. 14 and gave the state 120 days — until April 13 — to finish destroying the samples, which are stored at Texas A&M University’s School of Rural Public Health.

This year, when stories in the American-Statesman brought the practice to light, the state health department and some medical researchers defended it, saying that collecting the blood spots on paper — done when newborns are screened for various health disorders — might one day provide valuable clues about childhood cancer and other diseases. They said that because the samples were coded and did not identify the babies by name, privacy rights were protected.

But the Texas Legislature approved a law in May requiring medical professionals to inform parents or guardians that the blood spots would be collected and stored indefinitely and could be used for research. Parents who objected could send a statement to the state health department, and their child’s samples would have to be destroyed within 60 days. If the parents didn’t do that, the child could upon reaching adulthood.

Between the time the law passed and Nov. 2, about 6,900 Texans have signed forms asking that the state destroy their child’s samples, out of 240,000 children born in that period, department spokeswoman Allison Lowery said. The department is getting 500 to 600 requests a week to destroy samples, she said.

A statement from the state health department said it “believes settling this lawsuit is in the best interest of this program’s core mission to screen all newborn babies in Texas for life-threatening disorders. Newborn screening saves children’s lives, and settling this lawsuit allows us to continue operating this critical program.”

Jim Harrington , director of the nonprofit civil rights group in Austin, said his organization was “very pleased with the way it worked out.”

KXAN News: View Video

Harrington said there were only two options to end the lawsuit: destroy the samples or try and go back to 2002 and get consent from all parents. About 400,000 babies a year are born in Texas.

Among the parents who sued was Austin lawyer Andrea Beleno, Harrington’s daughter-in-law. Her son Joaquin Harrington was born in November 2008, and Beleno said she had no idea “in the haze after giving birth” that any blood had been drawn and stored.

“To me, this whole thing was about consent,” she said. “If they had asked me … I probably would have consented. The fact that it was a secret program really made me so suspicious of the true motives, there’s no way I would consent now.”

Harrington said he will work with a legislative committee before the next regular session in 2011 to refine the new law.

He wants the state to divulge what research it is using the samples for and whether anyone is making money from it. He also wants to see how well the “opt out” provision is working.

Many other states do what Texas had been doing, and a consumer group in Minnesota has been fighting the practice there for several years.

“The State of Texas has taken first steps to restoring the genetic privacy rights of Texas children. This is a wonderful Christmas present for Texas citizens,” Twila Brase, president of the Citizens’ Council on Health Care in St. Paul/Minneapolis, said in a statement.

State to destroy 4 million newborn blood samples

By PEGGY FIKAC, Austin Bureau

AUSTIN — The state will destroy an estimated 5.3 million blood samples legally collected from newborns but kept without parental consent under a federal lawsuit settlement announced Tuesday.

The number of newborns involved is unclear because multiple samples are received from each by the Texas Department of State Health Services, department spokeswoman Allison Lowery said.

Typically, two samples are taken from each child, but there could be more, she said. The disputed samples cover a period of about seven years starting in 2002. The state conducts newborn screening to detect disorders or illnesses.

KEYE News: View Video

“This is about consent,” said lawyer Jim Harrington of the Texas Civil Rights Project. The group, after discovering the agency had been keeping the samples without permission, sued on behalf of parents in federal district court in San Antonio.

The Health Department said in a statement it would destroy the samples — retained as blood spot cards — that it received and stored before legislation took effect last May allowing their retention. The legislation allows parents, guardians or managing conservators to opt out of having the blood retained.

Lowery said the agency is seeking permission from fewer than 400 parents to preserve their babies’ samples because the children tested positive for rare disorders.

Collected before lawsuit

She said samples have been securely stored at the Texas A&M Health Science Center School of Rural Public Health.

That institution said in a statement that all the blood spots at the center were collected before the lawsuit and are subject to a joint resolution between the center and the agency to destroy them.

Andrea Beleno, an Austin mother who was one of the plaintiffs in the lawsuit, said she was pleased with the settlement.

“There’s no financial gain for any of the plaintiffs,” Beleno said. “Basically, what we wanted to do was to make sure that our children’s privacy was being protected and that the state is respecting our rights, because if we don’t stand up and make the government do that, nobody’s going to do it for us.”

Parents from San Antonio and Houston also were part of the lawsuit, which was filed against Commissioner David Lakey of the Department of State Health Services and Dr. Nancy Dickey, president of the Texas A&M Health Science Center and vice chancellor for health affairs of the Texas A&M System.

“The Texas A&M Health Science Center is glad that we have reached agreement in order to settle the lawsuit,” Dickey’s office said in a statement. “We are saddened, however, that a superb database has been lost. This database could have continued to shed light on causes of congenital birth defects and potentially led to preventive measures saving thousands of infants and their families the distress these defects cause.”

The parents’ lawsuit said there was no legal authority to keep the blood indefinitely without consent.

Harrington said his group became aware the blood samples were being stored after being called by a reporter from the Austin American-Statesman. Beleno said she first read about it in the newspaper.

Detailed conditions

Under the settlement, Harrington said, all blood specimens must be destroyed unless the state gets written permission to retain and use them. The destruction must occur within 120 days of the lawsuit being dismissed with the settlement, which occurred Dec. 14.

The agency also must post information on its newborn screening Web site, including a list of all research projects for which it has provided newborn-screening blood specimens.

In addition, the agency must inform the parents who sued how their children’s blood was used and any financial transactions involving the specimens, Harrington said.

Pledges compliance

The Texas Department of Health said in its statement that it is complying with the new law and “will continue to be very sensitive to the privacy concerns of parents and the confidentiality of all medical information.”

“If parents don’t object, the department saves the samples for uses allowed under the new legislation — primarily quality assurance and control purposes to ensure accuracy in lab testing and because the samples could provide an invaluable resource in researching new or more effective ways to prevent, diagnose and treat serious medical conditions that affect Texas children, including leukemia and birth defects,” the agency said in its statement.

U.S. District Judge Fred Biery of San Antonio has refused to dismiss the federal lawsuit filed in March by the Texas Civil Rights Project on behalf of five parents. He ruled against the efforts of state officials to dismiss the suit, filed in March.

Jim Harrington, TCRP Director and attorney who represents the Plaintiffs, called judge’s ruling “a great step that helps both scientific research but respects the privacy of people who do not wish to participate.”

The lawsuit sought to end the practice of the Texas Department of State Health Services from collecting and indefinitely storing blood samples from the blood screening done at childbirth without parental consent or disclosure to the parent — a secretive practice the health department has engaged in since 2002. Currently, about 4 million samples stored at Texas A&M, taken from every person born since 2002.

The suit resulted in new state legislation to protect the state’s access to people’s genetic information in the future, but questions remain about what to do with the four million blood samples the state has already collected and the Department of Health Service’s implementation of the new law. The judge’s order today means those issues will go to trial.

The new law, which TCRP helped negotiate, requires the department to present a detailed written disclosure form at time of birth, giving the parent the opportunity to opt out of the program, either at that time or within 60 days thereafter.

The new law also permits any adults to withdraw consent and have their sample destroyed, even if the parent had given consent. Nor may the department make any use of information or data taken from the sample, if destruction of the sample is requested.

The law puts into places rigorous privacy and confidentiality standards and assures that testing and research will be done consistent with accepted professional medical research methodologies.

Finally, it sets up an interim House of Representatives committee to study the application of the new law and make recommendations to the next session of the Legislature in 2011.

Press Release

The federal lawsuit filed in March by the Texas Civil Rights Project on behalf of five parents has resulted in new state legislation to protect the state’s access to people’s genetic information. The legislature sent the law to the governor this week for signature.

The lawsuit sought to end the practice of the Texas Department of State Health Services from collecting and indefinitely storing blood samples from the blood screening done at childbirth without parental consent or disclosure to the parent – a secretive practice the health department has engaged in since 2002. Currently, about 4 million samples are stored at Texas A&M, taken from every person born since 2002.

The new law, which TCRP helped negotiate, requires the department to present a detailed written disclosure form at time of birth, giving the parent the opportunity to opt out of the program, either at that time or within 60 days thereafter.

The new law also permits any adults to withdraw consent and have their sample destroyed, even if the parent had given consent. Nor may the department make any use of information or data taken from the sample, if destruction of the sample is requested.

The law puts into place rigorous privacy and confidentiality standards and assures that testing and research will be done consistent with accepted professional medical research methodologies.

Finally, it sets up an interim House of Representatives committee to study the application of the new law and make recommendations to the next session of the Legislature in 2011.

Jim Harrington, TCRP Director and attorney who represents the plaintiffs, called the new law “a great step that helps both scientific research but respects the privacy of people who do not wish to participate. It strikes an acceptable balance between medical science and individual liberty, and we are very pleased that the legislature responded so positively and so quickly to our lawsuit.”

According to Harrington, the only issue remaining in the lawsuit is what do with the 4 million blood samples collected without consent, which the plaintiffs claim violates the constitutional right to be free from unlawful search and seizure and fundamental privacy rights. Harrington said the plaintiffs are negotiating with the department at this time, but expects that the federal judge in the case ultimately will have to make the decision.

Suit Raises Concerns about Collecting Genetic and DNA Data

Five parents this week filed a federal lawsuit in San Antonio U.S. District Court against the Texas Department of State Health Services (TDSHS), Commissioner David Lakey, M.D., Texas A&M, and Texas A&M Vice Chancellor for Health Affairs Nancy Dickey, M.D., claiming they have unlawfully and deceptively collected blood samples from their children at time of birth and stored those samples indefinitely for undisclosed research purposes, without plaintiffs’ knowledge or consent.

The plaintiffs are Geoffrey Courtney of San Antonio, Andrea Beleno and Maryann Overath of Austin, and Keith Taylor of Houston. Also joining the suit is Nancy Pacheco of Austin, who is expecting a child in August.

Plaintiff Andrea Beleno and her son

The suit alleges that the agencies’ activities constitute unlawful search and seizure and violate fundamental privacy rights, contrary to federal and state law, because at the time newborn children have a blood test to screen them for disease or disorders, TDSHS secretly collects and stores their blood indefinitely for other purposes without telling parents what it is doing or why it is doing it. Law requires newborn screening, but there is no legal authority to “seize” the blood and keep it indefinitely, without consent.

The suit also claims that the agencies violate standard, mandatory medical research protocols of obtaining informed consent from subjects before they are studied, using a method that clearly explains to them all the privacy ramifications.

U.S. Department of Health and Human Services regulations set out protocols with regard to minor children and include providing: (1) a description of the research’s purpose and procedure; (2) disclosure of privacy implications of the research; (3) whom to call if questions arise about the research; (4) parental consent; and, (5) a statement of no reprisals for declining to participate in the research. The state agencies do not abide by a single one of these protocols.

Nor have the agency officials disclosed what financial interests or transactions are involved, such as taxpayer expense or whether the samples are sold.

Since 2002, agency officials have routinely collected blood samples from all babies in Texas at time of birth and stored those samples or “spots” indefinitely at the Texas A&M Health Science Center School of Rural Public Health for purposes of undisclosed research unrelated to the purposes for which the infants’ blood was originally drawn, without the knowledge or consent of the infants’ parents. And they continue to do so. So far, they have collected about 4.2 million samples, and collect about 375,000 each year.

The lawsuit asks the court to destroy all blood samples and spots, which defendants have gathered and stored indefinitely without informed parental consent, or obtain consent, within a period set by the judge.

Plaintiffs also want the judge to order the officials to advise them for what purposes the agencies have used the blood samples and spots of the children and disclose all financial transactions involved with the use of such samples and blood. And they want the agencies to stop collecting blood samples and spots from newborn infants and keeping them indefinitely without informed parental consent.

The Plaintiffs also seek to have the court establish a procedure by which the agencies re-acquire informed consent from those children whose parents give consent, when such child reaches the age of 18 and becomes an adult, or otherwise destroy such blood samples and spots.

The Plaintiffs do not object to the state’s mandated newborn screening program so long as safeguards are in place to destroy an infant’s samples within a reasonable period.

TCRP Director Jim Harrington, who is representing the parents, called the agencies’ actions “an amazingly brazen deception by the state and a stunning overreaching into the private lives of Texans.

“They draw blood for a good reason–newborn screening, but then they secretly collect and keep it indefinitely for their own purposes without telling anyone what they are doing or why they are doing it.

“The government can’t just go around collecting people’s blood with all its confidential genetic information and use it for its own purposes without consent or legal authority. In this case, there is neither. This violates our core, fundamental constitutional principles.

“And for what purposes are these agencies storing blood indefinitely, and why do they need to collect and store blood from every person in Texas? They claim they are doing some kind of ‘research,’ but to do research you don’t need to have the blood and genetic material from everyone in society. This raises the specter of a DNA data bank, which can too easily be matched with other personal information the government collects, such as social security numbers and fingerprints.

“There is something utterly incompetent about this – or utterly sinister – or both. This is ‘Big Brother’ in one of its worst incarnations.”

*****

State sued over babies’ blood:
Parents say storing samples without consent is illegal

By Mary Ann Roser
AMERICAN-STATESMAN STAFF

Four parents and a pregnant woman sued the state health department Thursday, claiming that its policy of storing infants’ blood indefinitely for possible medical research is unconstitutional.

The nonprofit Texas Civil Rights Project in Austin filed the suit on the parents’ behalf in U.S. District Court in San Antonio. The suit also names Texas A&M University, which stores the blood for the Department of State Health Services.

The suit claims the state is violating constitutional protections against unlawful searches and seizures as well as state privacy laws. It seeks to stop storage of blood samples without parental consent and asks that samples be destroyed unless the state gets parents’ consent.

Since 1965, the state health department has been tasked with screening newborns for birth defects and other disorders under a law that does not require parental consent. In 2002, the health department decided to store the blood samples, so they could be used for possible research and other purposes, such as calibrating lab equipment, department spokesman Doug McBride said.

The state has since amassed 4.2 million samples at the A&M School of Rural Public Health in Bryan.

After the American-Statesman wrote about the practice Feb. 22, some parents said they were angry that their child’s blood was now state property without their consent and wanted it returned or destroyed. They feared the blood spots might be used someday to discriminate against their child.

“The screening (for disorders) is fine,” said James Harrington, director of the Texas Civil Rights Project. “It’s what they’re doing afterwards.”

The state health department has said the samples could one day help scientists find causes or cures for diseases, adding that infant’s identities are not on the paper cards holding the blood spots.

Earlier this month, it said it would consider destroying samples from parents who sent letters, provided it could find a legal way to do so. Harrington called the response inadequate.

“If you want to talk about Big Brother, this is one of its worst incarnations,” Harrington said at a news conference while flanked by three of the plaintiffs.

McBride declined to comment on the suit, and officials at Texas A&M could not be reached for comment — although the school was experiencing power outages Thursday, according to a message on one official’s voice mail.

Andrea Beleno, 33, of Austin said when her son was born Nov. 4 at Seton Medical Center, she had no idea that blood was drawn, much less stored.

“I think the screening program is good. They test for things that can make babies really sick initially,” she said, holding her son.

“And if they’d asked me if I would consent for this blood to be used for specific medical research, … I would have probably said yes.”

But Beleno said she would have said no to storing his blood indefinitely, just as she would refuse to let her own be stored “forever and ever.”

By Mary Ann Roser
AMERICAN-STATESMAN STAFF

For almost seven years, the state has been indefinitely storing blood from nearly all newborns in Texas without their parents’ consent for possible use in medical research.

The blood is collected as part of a 44-year-old state-mandated newborn screening program in which hospitals, birthing centers and midwives draw blood from a baby’s heel — parental consent isn’t required for that, either — so the state can test for a host of birth defects. The state either discarded the blood after six months or, more recently, stored it for three years before destroying it.

But starting in 2002, the state health department began collecting and keeping blood indefinitely for current or future medical research, a practice that has been the subject of a legal challenge in Minnesota.

Jay Janner
AMERICAN-STATESMAN

Five dots of blood are collected on paper for the screening and then stored.

Under the health department’s policy, the samples can be used by the medical community for things like cancer research, birth defects studies and calibration of lab equipment, said Doug McBride, spokesman for the Department of State Health Services.

The law doesn’t require that parents be told how the blood might be used. But if parents are aware of the blood draws, Texas law lets them opt out only for religious reasons.

Parental consent isn’t obtained, McBride said, because “requiring permission might be more costly and could require more time of hospital staff. But our real concern would be for the babies with detectable disorders that weren’t detected because their parents declined the screening — babies who had no say in that decision.”

The blood spots are stored at Texas A&M University’s School of Rural Public Health, and each card bears a code number instead of a name, McBride said. The names matching those codes are kept at the state health department and are not released to researchers without parental consent, McBride said. The state considers the stored samples to be “de-identified.”

Since 1965, Texas law has required the screening of newborns for birth defects, and the state now checks for 27 different health conditions — ranging from a gene that can cause severe mental disability to sickle cell anemia.

In 2002, the state health department’s Birth Defects Epidemiology and Surveillance Branch asked that the blood be stored for research rather than discarded; the department’s leadership agreed.

It contracted with Texas A&M in 2006 to store the samples because the agency did not have room to keep them indefinitely, according to a Nov. 15, 2006, health department memo.

The agency says in the memo that it did not need to change state law to store the blood samples because “the agency’s position has been that health-related research that uses these bloodspots is consistent with this agency’s overall mission.”

The same memo says the department considers the blood samples to be “state records,” which state law allows agencies to store indefinitely.

Quinn Godfrey, a 32-year-old father of two from San Antonio, said he had no idea when his daughter was born three years ago that newborn blood was being collected or stored indefinitely.

“My concern is they might not be able to do much with it right now, but 10 years from now? They could do a lot with it the way technology is going,” Godfrey said.

When his second child was born Feb. 9, Godfrey said, he objected and asked to have an outside lab do it. But when he was told that wasn’t possible, he gave in, he said.

Researchers in Texas said they hope to allay any parental concerns by pointing to the good being done with the blood and the future benefits to society.

“I’m using it to extract genetic variations and causes of certain birth defects: cleft lip and cleft palate and club foot,” said Jacqueline Hecht, a professor of pediatrics and vice chairwoman for research at the University of Texas Medical School at Houston.

Jay Janner
AMERICAN-STATESMAN

Hecht gets selected blood samples of children known to have those defects from the state’s birth defects registry, but the names are excluded, McBride said.

By knowing the genetic fingerprints of disorders, researchers can suggest ways to prevent birth defects, Hecht and others said.

Without access to the blood samples, Hecht said, “we might miss the opportunity to make huge breakthroughs to help humanity. I’m using them to try and make life better.”

Hecht said she considers privacy concerns to be overblown because she and her colleagues have no idea to whom the blood belongs.

“There are a lot of hoops you have to jump through” to use samples, she said, such as getting approval from an institutional review board, which looks out for patients’ rights. “I don’t see what the issue is.”

But if the stored blood is so scientifically beneficial, “why isn’t it more publicized?” asked Godfrey, the San Antonio father. “It just seems like they’re being awfully sneaky about it.”

James Harrington, director of the Texas Civil Rights Project, said that although his three grown children were all born in Texas, he had no idea of the practice and was “stunned by the whole thing.”

Harrington said that he has no problems with screening newborns for birth defects but said he opposes storing samples without consent.

“I believe it’s a violation … of unlawful search and seizure,” he said. “We’re dealing with the most confidential information we have, and (for the government) to say, ‘Trust us,’ … I find it impossible to believe.”

McBride said, “There is nothing illicit, untoward or threatening going on. The purpose is to save lives, not to steal them.” He’s heard no complaints from anyone in Texas, he said.

“I would bet most parents aren’t aware in Texas,” said Twila Brase, a nurse who is president of the Citizens’ Council on Health Care in St. Paul, Minn. The nonprofit has advocated patient and physician relationship rights since 1998.

Her group is fighting the practice in Minnesota after learning about it six years ago, she said.

“Our greatest concern is that this blood is being stored unbeknownst to the parents, and genetic research is being conducted without the consent or knowledge of the parents,” Brase said. “And it’s available for whatever legislators would decide to do with it in the future. When parents here discovered that, they got absolutely steamed.”

What surprised Brase and others even more than not requiring parental consent was what they call the “warehousing” of the blood samples. Minnesota has stored more than 815,000 samples in the past 11 years, and as in Texas, no law authorizes that, Brase said.

Texas has stored 4.2 million samples since July 2002 — two per child, McBride said.

In Minnesota, Brase’s organization won a ruling from an administrative law judge ordering that the state get informed consent from parents to store the blood, and the group aims to start a national outcry against the policy. Already, Brase said, blood from 52,000 Minnesota children has been used for genetic research without their parents knowing.

Jay Janner
AMERICAN-STATESMAN

What if someday someone’s genetic information got out to insurers and employers and was used to discriminate against certain people, Brase asked. “This is my DNA; it’s not yours,” she said. “Ask me if you want to use me for some project.”

McBride said the state is bound by state and federal laws to protect the privacy rights of patients so it would not release the names to researchers or anyone else without parental consent.

Andrew Olshan, chairman of the epidemiology department at the University of North Carolina, said there is strong interest among researchers in creating a national database drawing on research from the samples to help solve the riddles of what causes autism, cancer and various birth defects. He said the potential benefits outweigh privacy concerns.

Art Caplan, a nationally known ethicist who directs the Center for Bioethics at the University of Pennsylvania, said he isn’t troubled by the lack of consent or the indefinite storage. He said he sees a “ton of benefits” to having the blood available for research but said Texans should be educated about it and a public commission should control the samples.

But a Texas medical ethicist said parental consent should be obtained at the time the blood is drawn.

“Even if something is a social good, there can be a social harm,” said Dr. Howard Brody, director of the Institute for the Medical Humanities at the UT Medical Branch at Galveston. “It’s important to have trust in the scientific community … and the more things that are done without consent, the more trust goes down.”

The argument that scientists have a right to the blood because what they are doing with it is good “runs roughshod” over the rights of others, Brody said.

At minimum, the issue deserves more public discussion and transparency, he said.

“This is exactly the kind of issue,” Brody said, “that is going to come back and bite us as a scientific community.”

FEDERAL COURT GRANTS A GIRL’S CHRISTMAS WISH:
HISTORIC BUILDING IS NOT EXEMPT FROM THE LAW

June 24, 2008 – Christmas came late in Wichita Falls, Texas to one little girl, but it brought a wonderful gift. Late yesterday, a federal judge ruled in favor of a local family that just wanted to take their daughter to see Santa Claus. By doing so, the court found that the defendant, the Wichita County Heritage Society, had been naughty, not nice.

“When it comes to the Americans with Disabilities Act, nobody is above the law,” said Wayne Krause, Legal Director of the Texas Civil Rights Project, who represented the Kennedy family. “This just shows how even one brave family can stand up for their rights and make a difference.” Testimony in the trial revealed that the Kell House regularly received calls from other people with disabilities who could not get in, either.

The court held that the WCHS had violated the ADA, stating, “The evidence establishes a studied indifference on the part of [the Kell House] to the requirements of the ADA….” A hearing was set July 21 to specifically determine what the judge will order Kell house to do, including “construction of a ramp to make the Kell House wheelchair accessible.”

Shamayn Kennedy, the girl’s mother, said, “Well, before a court got involved, we asked them so many times just to let our daughter enjoy the Christmas activities like all the other kids. We didn’t just ask to get in the building. We requested other options – a portable ramp, a temporary accessible location, and just to ask Santa to come out to offer greetings. We even offered to help out. They ignored us, strung us along.’ They even told me they had instituted a policy banning motorized wheelchairs in the Kell House.”

The ruling, by federal judge William F. Sanderson, is an historic one. It is the first time a federal court has ordered a registered historic building to eliminate architectural barriers to people who use wheelchairs. The decision sets a clear precedent for people who use wheelchairs — even historical buildings are not exempt from the ADA.

The family did not ask for damages and will not receive any money as a result of their victory. The father Mike Kennedy said, “We’ve run into plenty of problems over the years, but nobody has ever been mean like this. For three and a half years, they never did anything remotely helpful. We just want a chance for our daughter to experience the things other children do. We have a newborn son, and we don’t want to have to explain to him one day why he can see Santa and his sister can’t. And we hope this case will help other people with disabilities out there, too.”

The girl’s disability forces her to use a motorized wheelchair. The WCHS admitted it would have been dangerous to lift her chair into the Kell House. Because the girl must have a feeding tube constantly attached, she cannot be transferred to a different wheelchair. Transferring to and from other chairs or lifting wheelchairs are not viable options under the law, either, because they are dangerous and discourage independence.

Tim Hald, a CPA, and Tere O’Connell, a historical architect, also testified as experts for the family. Mr. Hald told the court WCHS had the financial ability to install a ramp. Ms. O’Connell designed ramps that have no negative effect on the historical nature of the Kell House.

The court also relied on testimony by Howard Morris, former WCHS board president, that “the cost of installing a wheelchair ramp has never been a major concern to the Society.” WCHS reported over $5 million dollars in assets on its tax returns.

The court also noted that renovations to accommodate disabilities were in keeping with the historic nature of the Kell House, since Mr. Kell himself had installed an elevator in the 1940′s to help him get up the stairs when he became disabled.

The lawsuit attempted to restore some Christmas cheer to the Kell House. In asking the court for help, it incorporated verse from popular Christmas poems and compared the WCHS to the Grinch and Ebenezer Scrooge. “When faced with mean-spirited exclusion like this, sometimes you have to laugh so you don’t cry,” said Krause. “We’re glad the court is putting an end to their Grinchy behavior.”

*****

From the Opinion by Magistrate Judge Wm F Sanderson, Jr on 6/23/08

Based upon the foregoing facts, the court finds that Plaintiffs have proved that removal of the architectural barriers, to wit: construction of a ramp to make the Kell House wheelchair accessible is readily achievable and that Plaintiffs on behalf of their minor daughter are entitled to appropriate injunctive relief . . .