Category Archives: Human Research

The Thin Red Line of Predictive Genetic Testing in the Military

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Bryan Helwig

By Bryan Helwig, PhD

A military segregated by genetics? The possibility is more reality than science fiction and an issue I encountered while leading a research team for the Department of Defense.  Recent advances in science and technology have produced genetic tests that are low cost, easily performed and able to produce significant amounts of genetic information about individuals. Once confined only to scientific experiments, the general public now has options to trace their family origins from a cheek swab, detect genetic abnormalities prior to birth from a sample of the mother’s blood, and determine their genetic profile using saliva.

Since the mid-1990s the Department of Defense has required that all new recruits provide a DNA sample that can be used for identification purposes. Now, advances in genetic technology are helping to identify genes profiles associated with a predisposition to post-traumatic stress disorder (PTSD) or suicide. The use of genetic testing in this manner is considered predictive genetic testing.

Proponents of predictive genetic testing in the military note the invaluable role testing provides in keeping armed forces safe. Critics contend that mandatory genetic testing is an invasion of privacy and a violation of civil liberties. These individuals contend that the Genetic Information Nondiscrimination Act (GINA) of 2008, which protects civilians from job-related discrimination based on genetic test results, should also apply to military personnel.  Specifically, §202 and §203 prohibit employment discrimination practices based on genetic information. With few exceptions, §203 reads “it shall be an unlawful employment practice for an employer to request, require, or purchase genetic information with respect to an employee or a family member of the employee . . . “ However, the military is a unique environment in which the needs of the unit are a higher priority than those of the individual, complicating the application of civilian policies such as GINA to members of the armed forces.

Military duty is characterized by physical demands and exposure to environments that are unpredictable and often extreme. As a result, work in military environments can result in manifestation of genetic abnormalities that would remain unknown without diagnostic genetic testing in which screening occurs for specific genes that are diagnostic for a condition.

During the last five years, the expansion of genetic testing has been proposed. An advisory panel of independent scientists produced the JASON report in 2010 recommending “The DoD should establish policies that result in the collection of genotype and phenotype data, the application of bioinformatics tools to support the health and effectiveness of military personnel, and the resolution of ethical and social issues that arise from these activities.” The idea is robust and one I frequently encountered during my career directing a Biomedical Research Laboratory for the Department of Defense.

The focus of my team’s work was to better understand how and why the human body responds in extreme environments. For instance, the expression of a subset of genes allows for adaptation to high altitude, low-oxygen environments such as the mountains. Although not as well established, a similar set of genes also may be advantageous to prolonged work in hot and cold environments. Thus, predictive genetic screening in the military could be used to identity individuals that would have advantageous or disadvantageous physiological responses to hot, cold or high-altitude environments. In addition, the JASON report proposes the use of predictive genetic testing to identify service members at increased risk of blood coagulation abnormalities, bone fracture risk, tolerance to sleep deprivation and over two hundred other health-related phenotypes of interest to the military.

Although not widely recognized, each of us undergoes a diagnostic genetic test at birth for phenylketonuria, more commonly known as PKU, an inborn error of protein metabolism that can have profound negative affects on development if not identified early in life. In comparison, the use of predictive genetic screening is in its infancy. Genetic tests are highly accurate in quantifying gene expression, however use of the results in a predictive capacity is less accurate and often over-exaggerated by the media.

For instance, a genetic profile that affords natural protection in a hot environment is likely to be comprised of up and down regulation of hundreds or even thousands of genes. Some genes may be affected by health status, nutrition, sleep, etc. Thus, the use of predictive genetic testing requires identification of stable gene profiles that serve as accurate predictors of health status and only change expression in the environment being studied. Additionally, many scientists cite a two-fold change in gene expression as significant.  However, a two-fold change is arbitrary and not always indicative of a significant physiological impact. Despite rapid expansion of genomic technology, the reliability of predictive gene profiling remains nascent.

Despite the scientific gaps, legal and ethical issues need to be addressed before genetic testing achieves an accuracy allowing its use en masse. Initial efforts should focus on privacy, including modification of GINA to protect privacy of military members in a way that is similar to the general public. Secondly, if GINA cannot be modified, discussions regarding new policies associated with predictive genomic testing that address the intersection of military personnel privacy and mission readiness should be encouraged. Instrumental will be deciding how broadly predictive genetic testing should be used by the Department of Defense. Conversations must also include updated policies regarding the handling or even destruction of DNA samples and specimens after military service ends and related rules for governing the almost fifty million samples in the Department of Defense Serum Repository (DoDSR). Such policy decisions should be balanced with the knowledge that the DoDSR is the largest repository of samples in the world and its use in understanding disease has been substantial.

Some service members refused to provide DNA for inclusion in the DoDSR and the punishment was harsh, including court martial, a reduction in rank and loss of pay. The Hawaii District Court held that requiring DNA samples from service members does not violate the Fourth Amendment right to be free from unreasonable searches [Mayfield v. Dalton, 901 F. Supp. 300 (D. Haw. 1995), vacated as moot, 109 F. 3d 1423 (9th Cir. 1997)]. Objection to inclusion may become more common if predictive genetic testing is used without privacy protection. The military must revisit the thin red line between privacy and military needs; a line that currently favors minimizing individual needs.

Standard informed consent required whenever biological samples are obtained must also be re-evaluated to better reflect the current practices. Informed consent forms should be re-written, allowing the service member to give different levels of permission regarding future use of their DNA beyond the required baseline diagnostic screening and identification purposes. Importantly, this option must be revocable at any time, during or after their military career. The military should also consider the alternative of an external third party to perform predictive genetic screening, the results remaining private, and released only as required by strict criteria. Regardless of the results, policies must be in place to prevent discriminatory practices related to genetic results in military and post-military career advancement.

The military benefit to the Warfighter from genetic testing is significant and, if used responsibly, can help protect a soldier’s health. However, many ethical and legal hurdles exist that must be resolved before predictive genetic testing becomes mainstream.  Conversations addressing such issues need to occur now; the issues are central to protecting the privacy of those who keep us safe.

Bryan Helwig, PhD is a first-year law student at Chicago-Kent College of Law (Class of 2017) with an interest in the intersection of intellectual property, genetics and privacy. During the five years preceding law school he directed a Biomedical Research Lab for the Department of Defense.

A White House Invitation to Launch Precision Medicine

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By Lori Andrews

President Obama at the launch of the Initiative

Last Friday, I was a guest at the White House for President Obama’s launch of the Precision Medicine Initiative.  The goal of the Initiative is to sequence people’s genomes and read the nuances of their genes to determine how to prevent disease or more precisely treat it. The President illustrated how this would work by introducing Bill Elder, a 27 year old with cystic fibrosis. Bill has a rare mutation in his cystic fibrosis gene and a drug was fast-tracked at the FDA to target that mutation.  “And one night in 2012, Bill tried it for the first time,” explained President Obama. “Just a few hours later he woke up, knowing something was different, and finally he realized what it was:  He had never been able to breathe out of his nose before.  Think about that.”

When Bill was born, continued the President, “27 was the median age of survival for a cystic fibrosis patient.  Today, Bill is in his third year of medical school.”  Bill expects to live to see his grandchildren.

The Precision Medicine Initiative will involve sequencing the genomes of a million Americans.  Such a project would have been unimaginable if we hadn’t won the Supreme Court case challenging gene patents.  Prior to that victory, genetic sequencing cost up to $2,000 per gene due to patent royalties.  Now it will cost less than ten cents per gene.

Bill Elder at the White House event

The people who volunteer as research subjects for the project may expect cures for their own diseases.  But, even when genetic mutations are discovered, cures are a long way off.   “Medical breakthroughs take time, and this area of precision medicine will be no different,” said President Obama. And despite the fanfare surrounding genetics, researchers often find that environmental factors play a huge role in illness. At the same time the White House was preparing for the launch of the Precision Medicine Initiative, Stanford researchers and their colleagues across the globe were publishing a study in the January 15 issue of the prestigious journal Cell challenging the value of sequencing research.  Their study, “Variation in the Human Immune System is Largely Driven by Non-Heritable Influences,” tested sets of twins’ immune system markers.  The result: Nearly 60% of the immune system differences were based on the environment rather than genes.

Capturing environmental information about the million volunteers will involve invasions of their privacy as their health and behavior is categorized and quantified from every perspective.  Their genetic data will be combined with medical record data, environmental and lifestyle data, and personal device and sensor data.  If not handled properly, this data could be used to stigmatize the research participants or discriminate against them.  Will they be properly informed of the risks in advance?  Will sufficient protections be in place for their device and sensor data, which is often not covered by medical privacy laws such as HIPAA?

At the White House last Friday, President Obama said, “We’re going to make sure that protecting patient privacy is built into our efforts from day one. It’s not going to be an afterthought.” He promised that patient rights advocates “will help us design this initiative from the ground up, making sure that we harness new technologies and opportunities in a responsible way.”

Professor Andrews with Henrietta Lacks’ descendants at the White House

President Obama underscored that commitment by inviting members of Henrietta Lacks’ family to last Friday’s event. In 1951, Henrietta Lacks was dying of cervical cancer.  A researcher at Johns Hopkins University undertook research on her cells without her knowledge or consent (or that of her family).  Her immortalized human cell lines provided the basis for generations of research in the biological sciences, as well as research by commercial companies.  When her husband learned about it years later, he said, “As far as them selling my wife’s cells without my knowledge and making a profit—I don’t like it at all.”

A former Constitutional Law professor, President Obama is aware of the importance of people’s rights.  Let’s hope that his aspiration of an Initiative that guards research subjects’ autonomy and privacy will be honored by the scientists who will actually operationalize the $215 million project.

Clinical Trials: Not as Independent As You’d Expect (or Hope)

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JenAckerby Jen Acker

Before a new pharmaceutical makes it to market, it undergoes years of clinical trials to test and prove its efficacy and safety.  Data safety monitoring boards (DSMBs) are small committees of individuals tasked with ensuring that throughout the three phases of the clinical trials process, the researchers running the study remain uncertain as to whether the trial drug or the control drug is more effective, and whether participant patients are being harmed by the trial drug.  A recent editorial, however, suggests that DSMBs might not be acting objectively because of undue influence by interested parties:  namely, the pharmaceutical company that manufactured the trial drug.

Drug trials are often conducted double-blind, where neither the doctors and researchers nor patient participants know whether the control drug or the trial drug is being administered.  Trials must not put human subjects at unnecessary risk, a determination made by DSMBs at regular intervals during the course of the trial.  If, at any point, one drug poses a risk of harm, the DSMB decides whether the study should proceed.  If the control drug is shown to be more effective mid-trial, the DSMB might stop the study, and the trial drug will not be approved.  Likewise, if the trial drug is shown to be much more effective than the control, it might be approved for widespread patient use before the study is completed (this is rare).

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From Nude Photos to Naked Genomes: Berkeley Gets Poor Marks on Frosh Gene Tests

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Lori Andrews by Lori Andrews

What do George W. Bush, Hilary Clinton, Meryl Streep and Wendy Wasserstein have in common?  As incoming freshman to Ivy League universities, they were required to pose nude for photographs.  The goal of the project was to correct students’ posture—and to correlate posture with later life achievement.  From the Ivy League, the practice spread across the country until a female freshman at the University of Washington in Seattle challenged it.  In 1968, the program was abandoned, under criticism it was eugenic.

I attended Yale after the demise of the notorious photo program.  But when I read about U. Cal Berkeley’s recent plans for its incoming freshman, I realized Berkeley officials hadn’t learned the lesson of the posture program.  Rather than requiring nude photos of their students, Berkeley officials were planning to peer at students’ DNA.  Indeed, they were opening the door for sensitive genetic information to be made available about our future leaders–their current students.

The Scope of the Berkeley Program

Last summer, 5,000 incoming students at University of California, Berkeley received a surprise along with the packet of information about their freshman year.  Their admissions packet contained an item that looked like a Q tip and an invitation to swab the inside of their cheeks for genetic testing.  The targeted genes were involved in breaking down lactose, metabolizing alcohol and absorbing folic acid.

The program came under criticism from lawmakers, bioethicists and even the California Department of Public Health.  Now Berkeley has significantly cut back the program.  What lessons should Berkeley officials learn from this experience? 

Lessons to be Learned

1.    In the quest to be avant garde, don’t forget the basics

Berkeley officials seem to have been caught up in the novelty of the program.  “Science is moving so fast right now,” said Alix Schwartz, director of academic planning for the college’s undergraduate division. “If we assigned them a book, it would be out-of-date by the time they read it.”

Think hard about that comment.  Parents are spending up to $40,000 a year to send their children to Berkeley.  In most of their courses, students will be assigned books to read.  It would not be unreasonable for parents to ask, is it really worth $160,000 for my child to get an obsolete education?  Why don’t I just get a quickie genetic profile done on my child an put him or her in a job best on the genotype?

2.    Take responsibility for the well-being of your students

Years ago, psychology professors routinely required their students to be subjects in experiments as part of their course requirements.  Now the Code of Ethics for psychologists forbids this sort of coercion of students.  But Berkeley’s “offer” to students, although presented as voluntary, was itself coercive.  “The consent form for the project is pure marketing,” Jeremy Gruber, the president of the Council for Responsible Genetics told California lawmakers at the August 2010 hearing on the program.  The form listed speculative, unproven benefits of the testing, but none of the risks.

The genetic testing program was replacing the “one book” program to give students a common experience to discuss.  A student entering Berkeley might feel compelled to swab rather than risk ridicule by others or marginalization by not participating.  Or worse yet, by saying “My parents wouldn’t let me send in my DNA.”

And what happens when the students started discussing the results of their tests?  Would those who were poor metabolizers of alcohol be left behind when others went to the local bar?  And, as Boston University public health professor George Annas asked, would those who had genes related to alcohol tolerance feel they could drink to excess? 

3.    Look closely at conflicts of interest

According to the consent form for the project, the students DNA sample would “become the property of the University” until its destruction and the university would “save the data for future teaching purposes and for possible publication of the aggregated data and its analysis.”  Such an approach makes one wonder if the project is being undertaken for the students’ benefit or for that of university researchers.  Indeed, the professor behind the program had formed his own genetic testing company last year.

There was also to be a writing contest where the winning students would have a chance to win further genetic testing from 23andMe, a private company that offers DNA profiling.  But should a public university be endorsing a private company?  “The FDA and Congress are currently investigating this type of testing, described as ‘snake oil’ by a member of the House Energy and Commerce Committee at a recent hearing, also described as ‘not ready for prime time’ by the Centers for Disease Control,” Gruber said at the California hearings.

4.     Check the legality of what you are doing

Berkeley planned to do the genetic testing in one of its university labs and provide the individual results to the students.  But its labs had not complied with state and federal requirements, such as the Clinical Laboratory Improvement Act, which cover any lab that provides a medical result back to a consumer.  These laws are designed to ensure the accuracy of the test results.  The university argued that it was not providing medical information and thus was not covered by the laws.  But that argument was just not credible, given the university’s position that this information could be useful to students in planning preventive measures.

Ultimately, Berkeley backed off of its program when the California Department of Public Health warned that the plan to have students’ DNA samples analyzed at an uncertified lab would violate state law.  Now, instead of offering individual test results to students, it will only post aggregate results.

Berkeley’s Poor Marks

The Berkeley administration deserves poor marks on how they handled the program.  In fact, they seemed to have flunked psychology (with a coercive program), law (not complying with statutes), biology (by not acknowledging the limits of predict
ive value in the tests they were offering), ethics (creating a potential conflict of interest) and history (not applying what had been learned from posture photos debacle).   Perhaps now they’ve learned the lesson that the use of genetic tests needs to be analyzed and contextualized–which, after all, are the hallmarks of any great college education.

One Judge Puts a Halt to Human Embryonic Stem Cell Research

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Jake Meyer by Jake Meyer

Before the cells in your body become skin cells, muscle cells, or nerve cells, they are first stem cells.  Human embryonic stem cells are pluripotent – they can become any of the approximately 200 types of cells in the human body – which makes them particularly valuable for treatment and research.  Human embryonic stem cells could conceivably be used to treat patients, by transplanting them into damaged or diseased tissue.  They can be used to study disease mechanisms that cannot be studied within the body and to develop non-stem cell based therapies for conditions.  Among the many promising developments in stem cell research, researchers have created: dopamine-producing nerve cells that could be a promising treatment for Parkinson's disease, insulin-producing islet cells that control the insulin levels in mice with diabetes, and liver cells that could be used for treatment of liver diseases.  But a recent case decision casts into doubt the legality of all federal funding of stem cell research.

Chief Judge Royce Lamberth of the District Court for the District of Columbia granted a preliminary injunction preventing the National Institutes of Health from implementing federal guidelines that allow for the federal funding of research on human embryonic stem cells.  For researchers like Dr. George Q. Daley, director of the stem cell transplantation program at Children’s Hospital Boston, "[t]his ruling means an immediate disruption of dozens of labs doing this."

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Rebecca Skloot’s Journey into the Life of Henrietta Lacks

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Lori Andrews by Lori Andrews

In 1890 a man sold the rights to his body after death to the Royal Caroline Institute in Sweden for research purposes.  Later, he tried to return the money and cancel the contract.  In the subsequent lawsuit, the court held that he must turn his body over to the Institute and also ordered him to pay damages for diminishing the worth of his body by having two teeth removed.

Photo of Lori Andrews and Rebecca Skloot

Lori and Rebecca Skloot

Today, it would be an anathema for a person’s body to be used against his wishes or for a research subject not to be allowed to withdraw from a study.  In fact, the Uniform Anatomical Gift Act allows people to change their minds and withdraw a previous agreement to donate organs and tissue after their death and the Federal research regulations allow people to withdraw from studies without penalty or loss of benefits.  Yet the law is murky regarding research on a person’s tissue outside of his body and some modern doctors and researchers emulate the Royal Carolina Institute and stake their claims on materials from people’s bodies.

In 1951, a 31-year-old African-American woman, Henrietta Lacks, died of ovarian cancer.  Without the knowledge or consent of Lacks or her family, her tissue was taken and made into a cell line that has been extremely valuable for research and is still sold today.  In an interview in 1994, her husband said, “As far as them selling my wife’s cells without my knowledge and making a profit — I do not like that at all.  They are exploiting both of us.”
Body Bazaar Cover Image
Dorothy Nelkin and I wrote about Henrietta in our 2000 book, Body Bazaar: The Market for Human Tissue in the Biotechnology Age.  Over the past decade, journalist Rebecca Skloot probed more deeply.  In The Immortal Life of Henrietta Lacks, Skloot tells a moving story of how the unauthorized use of Henrietta’s cells (known to scientists as HeLa cells) provided the foundation for most modern medical discoveries.  I caught up with Rebecca Skloot on her whirlwind book tour when she spoke at the Northwestern Medical School.

Skloot-Book-CoverShe described how Henrietta’s cells formed the basis for much of the scientific enterprise across the world in the decades since her death.  Virtually every high school biology student, every medical student, and every vaccine maker has manipulated her cells.  While fortunes have been made on the foundation of the HeLa cells, her own children lacked access to education and basic health care.  In fact, when her children were contacted decades after her death by researchers wanting their tissue, they completely misunderstood what scientists meant by research on their mother’s cells.  They visualized their mother as still alive, in a cell, being researched upon.

But they are not the only people kept in the dark about tissue research.  How many people realize that their tissue is being used today without their knowledge and consent?  Over 282 million archived and identifiable pathological specimens from more than 176 million individuals are being stored in United States repositories.  Some specimens are anonymized or coded and not identified with specific individuals; others carry patient names or codes that allow personal identification.  Virtually everyone has his or her tissue “on file.”

Expanding markets have increased the value of this tissue, and institutions — hospitals, research laboratories, and the state and federal repositories that store tissue samples — find they possess a capital resource.  Medical centers have deals in place with biotech companies to do genetic research on their hospital patients’ tissue without the patients’ permission.

This lackadaisical approach to consent has recently been called in question.  A Native American group, the Havasupai, gave tissue to a scientist for research on diabetes.  Instead, the scientist undertook research about schizophrenia and in-breeding, which stigmatized the Havasupai, and research about geographical origins, which conflicted with the Havasupai’s religious beliefs.

When the researcher was challenged in federal court, the judge found that the Havasupai had asserted valid claims for intentional infliction of emotional distress, negligent infliction of emotional distress, civil rights violations, negligence and gross negligence.  In April 2010, the researcher’s university settled with the Havasupai, paying $700,000 to 41 members of the tribe for using their tissue without appropriate informed consent.

The attention being paid to Skloot’s excellent book and the good news of a settlement in the Havasupai case are spurring societal discussion about the use of tissue samples.  Clear laws and regulations are needed to assure that no one’s tissue is used without specific informed consent.

The specifics of Henrietta Lacks saga will soon be made into a movie, with Oprah as an executive producer.  But her story affects us all.  Hospitals, universities, research centers, and private depositories retain pathology samples and genetic data collected in the course of surgical procedures or research projects — a fact unknown to most patients.  New laws are needed to make sure we are not a nation of guinea pigs.

Should We Clone Neanderthals?

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Lori Andrews by Lori Andrews

In 1856, workers in a limestone mine in the Neander Valley in Germany made a startling discovery.  They came across an assortment of bones — a skull cap, a rib cage and certain leg and arm bones — that they initially believed came from a bear.  But when the bones were examined by anatomist Hermann Schaaffhauesen, the field of paleoanthropology was born.  The bones belonged to a distant relative of humans — a Neanderthal.

Now, a century and a half later, the Neanderthals are again in the news.  A group of scientists have completed the rough draft of the genetic sequence of the Neanderthal and compared it to the genetic sequence of modern humans.  The scientists are asking now asking the question:  What legal and ethical issues would be raised by cloning a Neanderthal?

Neanderthals are the closest relatives of humans and lived from at least 350,000 years ago until about 30,000 years ago.   They survived for about 15,000 years after modern humans appeared.  They lived in Europe, where fossils have been discovered from Spain to Southern Siberia.

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Another One Bites the Dust–Second Conspirator Found Guilty in Sale of Body Parts from UCLA

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JulieBergerBy Julie Burger

On May 14, 2009, a jury convicted Ernest Nelson of conspiring to commit grand theft, embezzlement and tax evasion for selling body parts that had been donated to UCLA's medical school to private medical research companies and pharmaceutical companies.  Nelson's alleged co-conspirator in the case, Henry Reid, the former director of UCLA's willed-body program, is currently serving four years after pleading guilty to conspiring to commit the theft. 

According to allegations, Reid provided portions of cadavers to Nelson who then sold them to companies for research.  But it wasn't the mere exchange of money for body parts that was the problem.  Prosecutors stated in 2009 that the defendants' plan unraveled because they had failed to properly fill out paperwork showing that the bodily tissue had been tested and was disease free, raising the suspicions of a state health investigator.  They stated that the companies that provided $1.5 million for the body parts over the course of four years had "legally paid" for the tissue.  Nelson's defense was that UCLA had authorized the sales, but that Henry Reid, the director, had not forwarded the money to the university. 

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Biobanks: Let’s Regulate At Least One Banking Industry

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Jake Meyer by Jake Meyer

Large repositories of biological samples (biobanks) are being collected for medical and scientific research.  Some biobanks are publicly funded, like the UK Biobank, a government plan to create a database of DNA samples of 500,000 volunteers aged 40-69 in order to improve prevention, diagnosis, and treatment of life-threatening illnesses.  Some biobanks are held by private companies, like Genizon Biosciences which contains samples from 47,000 patients who are direct descendants of the original French founders of Quebec (a relatively homogenous population useful for genetics research).  Other biobanks are public-private partnerships, such as the biobank operated by deCODE Genetics, in which the government of Iceland granted deCODE an exclusive license to Iceland's genealogical and medical records.

Scientists think that significant advances in medicine science might be achieved through the study of normal genomic variations across whole populations.  These studies must analyze the whole genome, in contrast to using traditional methods to analyze a single gene.  In order to perform studies of normal genomic variations, large-scale collections of samples are required.  One way to get the large number of samples required for this type of research on the whole human genome is through international collaboration and networking among biobanks.  Commentators Barth Maria Knoppers, Ma'n H. Abdul-Rahman, and Karine Bédard, have suggested that achieving international collaboration and networking among biobanks will require the establishment of international frameworks, standards, and norms. 

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Wheels of Justice Grind Slowly for Havasupai Tribe

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JulieBergerBy Julie Burger

In a remote section of the Grand Canyon about 450 members of the Havasupai Tribe live on tribal lands where they have lived for hundreds of years.  Another 200 members of the Tribe live away from Supai, the village area.  In March of 1990, researchers from Arizona State University (“ASU”) (Drs. Theresa Markow and John Martin) presented the Havasupai Tribal Council with a proposed diabetes study, saying that they would like to collect and use tribe members’ blood for diabetes studies.  The researchers met several times with the Tribal Council, but according to allegations, never revealed they intended to perform research other than diabetes research.  With the Council’s approval, blood samples were collected from members of the Tribe, including children and vulnerable people.  Researchers additionally took handprints from members.  English is not the tribal members’ primary language and many members do not even speak English as a second language.

The researchers did not stop at diabetes research.  They also performed additional research on the samples for schizophrenia, inbreeding, and population migration, and shared the samples with researchers at other institutions.  After discovering the additional research, the Havasupai filed state court complaints on behalf of individual Tribal members and on behalf of the Tribe against ASU and the researchers in 2004.  The Havasupai maintain that the schizophrenia and inbreeding research was stigmatizing and that they would not have consented to the migration research because it conflicts with their religious origin theory.  A member of the Tribe points out that “[the researchers] challenged our identity and our origins with our own blood and without telling us what they were doing.”

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