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Making Sure Informed Consent is Truly Informed: Research in the Digital Age


Guinea pigs no more. The power dynamic is shifting between clinical-research participants and investigators.

Today’s study volunteers often want to be notified with results so they can learn how their involvement contributed to finding a cure for diabetes or a new treatment for depression. More than ever before, they want assurances that investigators will protect their privacy and de-identify their samples. 

But, even with the old-school, experimenter-subject relationship bowing to a more active and engaged partnership, is it possible for volunteers to really understand what they’re signing up for when they consent to being part of a study? How can participants be properly educated before their biospecimens are stored—or biobanked—when it’s impossible to know exactly how they’ll be used or by whom? 

The topic couldn’t be timelier. The National Institutes of Health Precision Medicine Initiative (PMI), first announced by President Obama during his 2015 State of the Union Address, is set to begin recruiting a cohort of one million or more volunteers in early 2016. 

“To realize the full potential of precision medicine, we need research, and we all need to participate on some level,” said Leslie Wolf, J.D., M.P.H., a public health law and ethics expert at Georgia State University, during a University of Utah-sponsored panel discussion that explored the ethics of consent in human research. 

In PMI’s all-hands-on-deck approach, volunteers who broadly reflect the U.S. population will be asked to share electronic health records and fill out health surveys. They’ll undergo an exam and provide a blood sample. For years to come, scientists will be able to tap into these resources. 

The program is unprecedented and could pave the way to breakthroughs, but challenges are emerging. Wolf provided the real-life example of the Havasupai Indians’ case against Arizona State University. Hoping to learn why tribe members have higher rates of diabetes, the Havasupai, who live among the waterfalls inside the Grand Canyon, gave blood samples to university researchers. The tribe later learned that their samples had been used for research beyond diabetes, including studies about schizophrenia, inbreeding and migration. Researchers found that their ancestors first came to the area across the Bering Strait, which offended tribe members because it contradicts the tribe’s traditional origin stories. 

“I’m not against scientific research,” Havasupai tribal council member Carletta Tilousi told The New York Times. “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.” 

In 2010, Arizona State apologized, returned the samples and agreed to pay $700,000 to tribe members. It’s a unique case, but Rothwell, who studies state and federal laws in search of strengths and gaps in the protection of human subjects, said these kinds of issues and legal disputes may begin to pop up more frequently if research volunteers discover that their DNA or health information isn’t being used how they intended. 

So, what’s the answer? Will asking study participants to sign lengthy consent forms that cover all the potential uses of their specimens solve the problem? 

As the University of Utah’s Erin Rothwell, Ph.D., pointed out during the panel discussion, that’s not exactly fair to volunteers. The College of Nursing associate professor and bioethics expert asked the audience: How many of us skip the fine print and quickly hit “agree” when our iPhones ask if we’re OK with the terms and conditions? 

Many of us even do the same thing at the doctor’s office when we’re handed a clipboard of 15 sheets of paper containing thousands of words in size-10 font. 

“The consent process is seriously flawed,” said Rothwell, who strongly believes we need to improve the “informing” part of informed consent especially when we’re talking about donors giving what is referred to as “broad consent for future unlimited research.” 

Carrie Wolinetz, Ph.D., NIH associate director for science policy, suggested that high walls need to be built around PMI data so only researchers who comply with privacy policies have access. In addition, she said we need steep penalties for researchers who don’t honor the anonymity of donors — “So, if you tried to re-identify, you would get hit with a hammer,” she said.   

Rothwell suggested that researchers should be required to pledge an oath that they will engage in honorable behaviors before conducting a project. Such oaths could be hung publicly in places like hospitals. Or, she said, perhaps researchers should be required to record online video oaths—with their identity on display—in which they vow to protect the identities of study participants. 

“If we’re going to move this forward, the researchers have to consent just like [the study participants],” she said. 

Said Wolinetz, it all comes down to finding a way to balance the benefits of broad access to health information with the risks posed to the individuals who trustfully stepped forward to do their part to advance medicine.  

By: Natalie Dicou

Natalie Dicou is a Communications Specialist for University of Utah Health.