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U of M's 'DNA on a stick' project becomes platform for debate on genetic-research ethics

As a bid to connect science to the heartbeat of Minnesota's popular culture, the collection of DNA from hundreds of kids at this year's State Fair was a hit.

"DNA on a stick," said celebratory headlines in local newspapers and TV web sites. "Step right up and donate your DNA," proclaimed another report.

But was it ethical? Should kids be enticed to give over their individual genetic codes in exchange for tickets to fair rides — and, more central to the study, for the chance to further understanding of the relationship between genes and childhood growth and health?

Debate over that question is giving this study an unintended purpose. It has become a platform for exploring the latest ethical considerations about genetic research, considerations that can't be left to scientists alone.

Indeed, Logan Spector, the University of Minnesota pediatric cancer researcher who led this "Gopher Kids" study, said he welcomes this discussion.

"We are very committed to transparency and to building a relationship of trust with the Minnesota public and the fairgoers," Spector said in an interview with MinnPost. "I am happy to have this conversation."


What's the fuss about?
At its bare bones, this three-year pilot project is intended to determine, in part, whether the Minnesota State Fair — a popular family attraction with some 1.8 million visitors a year — could be a setting for efficiently conducting a large, long-range study of children. In addition to Spector, the project involves scientists from the U of M schools of health and nursing, College of Pharmacy and Department of Pediatrics.

Logan Spector
Logan Spector

A draft parental consent form [PDF] posted on the Gopher Kids website indicates that 500 children between the ages of 1 and 11 would be recruited at the fair.

The kids and their parents would be asked to donate cheek cells by spitting into a container or rubbing a soft brush inside the mouth. Optional choices were to donate a fingernail clipping or a blood spot from a prick of the finger.

Measures would be taken of each child's height, weight, waist and blood pressure. Parents would complete a survey initially and later fill out a 45-minute questionnaire. Finally, they would return to the fair in 2011 and 2012 for more study.

Records of the study would be kept private and no publication of the research would include information that could identify an individual.

In exchange, each kid was to get a fair souvenir, $5 worth of kids ride tickets and a promise that free tickets to the 2011 and 2012 fairs would be mailed to the family.

Ethical questions
During the fair, the international scientific journal Nature published an online article questioning the study's ethics on several grounds. I posed some of the same questions to bioethicists in Iowa and Wisconsin as well as to Minnesota scientists who are close to the research.

And I found broad disagreement — which, in itself, is telling. Debate over genetic research is evolving along with the science.

For years, we focused on issues related to individual privacy as scientists learned to associate certain genes with specific disorders. Would an insurance company deny medical coverage if it learned a woman had inherited a gene that placed her at high risk for breast cancer?

Such questions led to the Genetic Information Nondiscrimination Act of 2008.

But the uproar over this new Minnesota study shows we still have much to ponder and debate as scientists explore the chemical codes that could someday reveal which group of children will be at risk for diabetes, which will need to watch their cholesterol and which will have to worry about cancer.

Research near the midway?
One question posed in the Nature article was whether the State Fair is a setting where parents could give serious thought to the decision of donating DNA.

"It doesn't seem like an atmosphere that's conducive to really serious thinking about what you're being asked for," Marcy Darnovsky told Nature. She is associate executive director of the Center for Genetics and Society in Berkeley, Calif.

Marcy Darnovsky
Marcy Darnovsky

Dr. Norman Fost shares that concern. He directs a bioethics program at the University of Wisconsin Madison.

"Given the complexity of these issues, the fair seems like the worst place in the world for parents to sit down, discuss these things, have their questions answered and make thoughtful decisions about very complicated ethical issues," Fost said.

Spector said the strategy all along was to publicize the project in advance of the fair so that families could think about it and study the Gopher Kids website for answers to their questions.

He had plenty of help from news organizations. The story splashed across front pages, prime-time news and drive-time radio.

Spector acknowledged that some parents could have missed the coverage and signed consent forms on the spur of the moment. But they can back out of the study if they change their minds, he said, in which case the associated DNA and other data would be destroyed.

Further, the study would be housed in the U of M's exhibit, one of many educational centers at the Fair.

Spector disagreed with those who say that such exhibits are not fitting venues for serious matters.

"The fair is a place where people meet politicians, and politics involves serious decisions," Spector said. "The fair is a place where they have churches, and religion is serious. ... The critics who may not have visited the State Fair may not understand what the atmosphere actually is."

Consenting to what?
Another question is whether the four-page consent form gives parents enough information.

The document does not spell out specifically how the genetic information will be used in the future nor whether it will be shared with other researchers, Lee Black told Nature. He is a lawyer and professional associate at McGill University's Centre of Genomics and Policy in Montreal.

Here, in part, is what the form posted on the website says: "By studying the DNA, scientists can discover what genes might be involved in normal growth and development. We ask for a parent's DNA sample, although we are studying children, to tell which genes the children inherited. In this study we will be looking at millions of variations in the collected DNA sample."

Spector said consent forms are supposed to be written at a level that could be understood by an eighth-grader. They are not supposed to confuse non-scientists with technical detail. And parents who want more detail could go to the Gopher Kids website.

But Fost at the University of Wisconsin said the site itself also lacks essential detail.

"There is a remarkable lack of information anywhere," Fost said. "Nowhere does it say what genetic tests are being done. ... I have no idea what questions he is asking because it is just so vaguely worded."

Among other questions parents might consider is whether the study will duplicate other research such as a gigantic study at the National Institutes of Health into the relationship of genes to children's health.

"Is he doing anything different from them? I don't know because I can't tell what he is doing — and, therefore, neither can the parents that are being asked to consent to this," Fost said.

Spector said the study is deliberately open-ended to leave room for discovery in the vast array of genetic variations.

"Science moves very fast, and we don't know today what we are going to want to look at tomorrow," he said.

From single genes to vast arrays
This question of specificity speaks to the evolution of genetic research. For years, scientists laboriously sorted through the links between specific genes and diseases. Now they are scanning whole regions of DNA — even, whole genomes. In many cases, they don't know precisely what their statistical models will turn up.

"Ten years ago, we had to tell people exactly what we were looking for, but now we can look at such a large number and variety of genes ... we tend to cast a relatively broad net on a set of genes with the idea you don't want to miss the modifiers," said professor Brian Van Ness, who directs the Institute of Human Genetics at the University of Minnesota.

Van Ness is not a principal scientist on the Gopher Kids study, but he works closely with Spector and others involved in the research.

The pace of discovery has stepped up to the point where limiting research to a specific set of genes could be tantamount to ruling out potentially important information.

"We don't want to say we will only look at five genes when 5,000 may prove to be relevant," Van Ness said.

A ticket for your DNA
Yet another question is whether ethical lines were crossed by giving tickets for rides and future fairs in exchange for DNA.

"I think they should not be tempting kids and their parents with free tickets at a state fair and think they're going to get meaningful consent," Darnovsky from the Center for Genetics and Society told Nature.

Background is important here. It is routine for scientists to offer a small token to people who give their time to participate in a study, especially in research where there will be no direct medical benefit from participating. Indeed, review boards that oversee such research at universities and other institutions often will require it, said professor Christian Simon, a bioethicist at the University of Iowa.

Typically, the reward is something like a modest gift voucher or reimbursement for parking and time away from work. Gopher Kids' $5 ride ticket certainly falls within the range of appropriate value. If anything, it's on the low end.

But it is unusually enticing given the setting, Simon said.

"At a fair what kid is not going to be bouncing up and down saying "Yah, mommy, Yah! I've got to do it. I've got to get on that ride!'?" Simon said.

Fost at the University of Wisconsin agreed.

"There is a difference between an honorarium and an inducement," Fost said. "An inducement is something that you advertise and hope it will lead people to join the study who otherwise would not join the study. ... There is an element here that sounds more like an inducement."

The element of surprise
One of the trickiest ethical questions is whether the researchers have an obligation to inform a family if something turns up in the DNA that could directly impact the child's health — say, a genetic disposition to clog blood vessels with cholesterol at a dangerous rate.

The consent form is clear on this question. It says, "This information is for research purposes only and you will not be informed of your individual results."

What's more, the study is not designed to look at genes known to be associated with diseases.

But there is major debate in research circles over whether such limitations let scientists off the moral hook.

As researchers sift through millions of DNA variations, "the potential for these unanticipated findings is huge," said Simon at the University of Iowa.

A double shot in the dark
Such studies can be a double shot in the dark: Just as they don't know precisely what they will discover in the future, they also don't know what will be deemed significant in the future — precisely which genes will be telltales for Alzheimer's disease or breast cancer or any one of a number of other disorders.

Let's say the researchers do stumble across a decisive gene. Then the question becomes, does the researcher "have a moral obligation to share that discovery with the subject and potentially with the family," Simon said.

If there is such an obligation, you have more problems. This very general study likely would not meet the high standards for precise individual diagnostic genetic testing. And the researchers would have to think about bringing in genetic counselors and other experts to guide a family through any information that was revealed.

"I am not saying that they are off base with the position that they have taken," Simon said.

Instead of seeking individual findings, the Gopher Kids researchers have focused on the contribution they can make to the scientific knowledge of children's health. And families that choose to participate are "going to be no better or worse off than had they not participated," Simon said.

"Yet, this idea that a researcher could be sitting on information that is highly potentially valuable to the research subject and might have extraordinary consequences for their health," is troubling scientists across the country, he said.

Van Ness at the U of M said he struggles with the question too — not only for his own research but also on scientific panels at the university and the national levels.

No national consensus
"There is not a national consensus on how to handle this," Van Ness said. "I myself have been on the fence. ... I might have a legal way out in saying legally I am not responsible for giving out that information. But I might have a moral obligation too. And with that I am wrestling."

If anything, though, the Gopher Kids study might help define parameters that could eventually set the best ethical course, Van Ness said.

Meanwhile, the study's recruiting has finished for this year, so families considering participation have some time to think about it all.

Sharon Schmickle covers science, economics and other subjects. She can be reached at sschmickle [at] minnpost [dot] com.

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Comments (7)

For a five dollar ticket or a parking spot?

"There is a difference between an honorarium and an inducement."

The word 'bribe' comes to mind rather than the softer ring of "inducement".

Bribe is a cultural phenomena that hangs like a shadow lying dormant in too many initially ethical pursuits...who bribes can as easily be bribed; who knows?

Public interest enterprises for public or personal or private gain, however 'morally' intended, are filled with too many vagaries of future intent.

"We are committed to transparency"...like through a glass darkly?

"Scientists can discover what genes might be involved in normal growth and development"...and again I wonder, what determining factors are used to establish "normal growth and development"?

Too many privacy issues may be innocently abandoned or carelessly, for what-yet-to-be-explored purposes?

ARBEIT (DNA) MACHT FREI?

"Science moves very fast, and we don't know today what we are going to want to look at tomorrow..."

As I understand it, informed consent means that known risks are disclosed to the signer. The researcher can't disclose risks he doesn't know about, of course. But the risks, from the signer's point of view and IMO (don't know if this is legally correct), include risks not only from a procedure, but risks which might ensue from the USE of the information collected.

For example, the researcher today may plan to do thing A with the information, posing no risk to say, confidentiality. But in future, he decides he wants to do thing B and thing C with it, which might pose an unforeseen confidentiality risk - whether known to the researcher or no.

Here, the researchers are telling us they don't know to what use they will put the information in future, but they reserve the right to employ that use, whatever it may be.

How on earth can the signer be informed about the uses (and potential risks associated) if the researcher himself doesn't know what the uses will be?

I'm afraid this genie is long out of the bottle. The DNA of infants has been collected without permission of the parents for years in this country.

A quick disclaimer- I'm also a researcher, albeit far less along in my career, and I had Dr Spector as a professor once, so factor those things in how you will.

First- I'm sad to see that on these usually civil comment pages, a writer chooses to equate this type of research to Nazi Germany, with the infamous "Work makes you free" quote from Auschwitz. That's rather uncalled for.

Second, while one can (and many are) debate the merits of doing research in a state fair setting, and question whether the ride coupons are too enticing a gift than the usual token appreciation for a subject's time and energy, the underlying science is not all that contoversial.

Analyzing genomic data and correlating it to information gleaned from medical record review or interviews is becoming increasingly common, and the consent is by nature rather vague. Beyond saying that one is looking for correlations, it is hard to get more detailed. Listing the thousands of individual genes to be analyzed would not make any subject more knowledgeable, nor would it add to the risk/benefit equation. It would explode the consent form to such a preposterous length that no one would read it, as compared to the currently very manageable 4 pages that the story links to.

As to informed consent not being detailed enough, people need to recognize that informed consent does not truly cover every conceivable iteration of risk and benefit, whether in research or clinical medicine. Instead, a good informed consent covers the basics of what is done, what the risks are, and how more information can be obtained. It is also only a framework, and questions should be encouraged whenever there is uncertainty. I've seen studies where the consent forms are 25 pages long; including that level of detail merely increases the chances that the potential subject will just gloss over the material, or not read it at all.

Some benefits from enrolling subjects at a non-medical setting:
-If approached in a clinic, potential subjects may feel that to remain in the "good graces" of their provider, they should join this study that clearly s/he is involved with. Here there is no prior relationship to worry about jeapordizing.
-If enrolling in clinics, the sample represents only those who access care, whereas the state fair crowd may be more representative of the population as a whole, and thus include populations who are otherwise poorly represented in studies.
-Patients in medical settings are often sick, not the ideal time to ponder pros/cons of research, since again there may be a feeling that care will be sub-standard if the patient declines to participate.

I'm sure the Institutional Review Board hearings on this study were fascinating, and kudos to Dr Spector for discussing these issues with the media.

Should not all ideas be explored in all their historical or cultural variations? The good,the bad and the ugly are better known than unknown?

If science is not a god; and with its attendant handicaps...also vulnerable to errors, then it needs constant challenge in order to be a positive addition for whatever it pursues?

Gopher Kids researchers fail to gain respect for any professionalism with their use of a real-grabber audience at the State Fair. Seems like an inappropriate place and not a great to go...but that is my opinion. Others have the choice to think otherwise.

'Good intentions' and cotton candy...now there's a real extreme;"uncalled for" scenario...so it goes,eh?

correction:

fourth line from the bottom..."great way to go"

Consent at the State Fair, really what a joke. Is that really the appropriate atmosphere in which to obtain proper informed consent to clinical trials with children and parents? No distraction there (sarcasm). I wonder how that fits into subpart D. I can just hear it “Daddy, Daddy I want to go on this ride. Wait a second sweetheart I am trying to read this consent. But Daddy! OK I signed it now give me my tickets”
Really U of M IRB you approved this?