Recruiting confidential: Finding subjects, protecting their identities
Technology lets patients choose privacy preferences
Trying to recruit people with medical conditions for research while maintaining their confidentiality can be a challenging task. Researchers are finding that the HIPAA Privacy Rule and its varying interpretations by IRBs at different institutions makes it very difficult to find people suffering from a particular ailment in order to recruit them for studies. Add to that the difficulty of finding people with less common genetic conditions that are geographically spread out, and you have a potentially significant obstacle to mounting serious research studies.
The Genetic Alliance, a network of more than 1,000 disease-specific advocacy organizations, already has in place a biorepository and clinical data registry aimed at solving this problem by gathering samples and information and making them available for research. Sharon Terry, Genetic Alliance's president and CEO, says her group is taking this effort further by partnering with a private technology company to devise a system in which individuals can sign up for a research registry while setting privacy preferences for being contacted by researchers, either anonymously or by name.
"The best analogy I can come up with is Facebook," Terry says. "It gives people a whole series of options around what sort of privacy preferences they have.
"Our hope, and the reason we're doing it at all is to accelerate recruitment of people who are interested in participating."
A father's goal
Genetic Alliance's partner in this effort is Private Access, an Irvine, CA-based company whose co-founder, Robert Shelton, is the father of a child with a chromosomal variation. Shelton's interest in the research registry was prompted by his experience as executive director of KS&A, an organization devoted to helping individuals who have extra X and/or Y chromosomes.
"We'd get calls all the time from researchers who say 'I've got an IRB-approved research study do you have any patients who meet these criteria and can I recruit them? Can I come to your national conference and set up a table?'" Shelton says. "I know the researchers and they're good people, but I truthfully, ethically don't have permission to give out people's names and identities."
Instead, he says, he would send e-mails to KS&A members suggesting that they contact the researchers, or call people he knew who he thought met the criteria.
"It was very inefficient, very time consuming," Shelton says. "And while I never had anybody complain about it, someone could have said, 'Why are you contacting me?'"
With Private Access, Shelton says his goal is to allow people to set their own limits for how accessible their data is to researchers who are looking for subjects.
People visiting the KS&A Web site, for example, can click on links regarding interest in participating in research. They can register, answer condition-specific questions about their health, and tailor security levels to their own preferences.
In this way, Terry says, the system can be used by people with varying comfort levels regarding divulging health information.
"One might say, 'I'm a very conservative person, I don't like my information shared,'" she says. "Another might say, 'I'm OK with sharing as long as it's information about psoriasis, because that's what I have, but nothing else.' "A third might say, 'I don't care about privacy at all, everyone can see all my data.'"
The existing trust relationship that people have with organizations such as KS&A have been vital to the success of this system, Shelton says.
"We've done market research studies of the people who have enrolled in this system," he says. "We've asked, 'Why do you trust it?' And something north of 95% trust the system because they trust the organization. Would some percentage trust the system if they just found it on the Internet? Probably. But it would probably be substantially less than 95%."
Currently, the system is up and running for KS&A, and Shelton is working with a number of other organizations. Terry says she predicts other disease communities within the Genetic Alliance will be rapidly enrolled into the system as they learn more about it.
She says people who previously have donated samples to the Genetic Alliance biobank will be included using a default privacy setting, unless individuals opt out.
And Shelton plans to expand the information accessible through the system to include not only answers to questionnaires and links to biological samples, but also links to other databases such as Google Health and Microsoft Health Vault accounts, if patients choose.
"There is no prohibition against you giving out your [health] information," he says. "As someone who's got a desire to be in touch with medical specialists, I have an ability to say to them, 'Here's information about me, and if I happen to be relevant to something now or in the future that you've got going on, I'd be interested in hearing about it.'"
IRB considerations
Shelton says that Private Access has considered engaging a nationwide IRB for the system, but currently relies on IRBs reviewing investigators' protocols. He says the process also relies on individual organizations such as KS&A choosing which researchers to represent to members as being trusted or vetted.
Genetic Alliance has its own independent IRB, which has seen an early version of the proposal, says IRB Chairwoman Patricia Murphy, PhD, also president and CEO of GeneWISE, a consulting firm in Slingerlands, NY.
Murphy says she did an expedited review of the proposal, with instructions that if anything changes, it would need to come back for a full board review. She says she was looking particularly at Private Access' security measures.
"I wanted to find out what they had in place. How did they prevent people from hacking into this Web site?" Murphy says. "This has to be 100% tight; you need to have as many layers as it takes to prevent any hacking."
She says that while this system employs new technology that IRBs will have to understand, the principles are the same ones they're accustomed to considering.
"Clearly, IRBs must use the regular routine rules that they have for everything, looking at it very carefully from the point of view of the patient," she says.
Terry says Genetic Alliance has discussed bringing this project up at meetings of Public Responsibility in Medicine and Research (PRIM&R) and other organizations to explain it and discuss potential human subjects protection issues raised by it.
For more information about Private Access, visit the company's Web site at www.privateaccess.info.
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