Honest brokers collaborate to preserve patient privacy

Network of brokers allows more sophisticated research

Honest broker systems — which process data and specimens for research by removing identifiers that otherwise would compromise patient privacy — have been touted as a smart way to encourage research while still protecting patient privacy as required by the Health Insurance Portability and Accountability Act (HIPAA).

Now the University of Pittsburgh has taken the honest broker approach to a more sophisticated level, creating a network of honest brokers at various institutional entities that can deidentify data from a variety of places, linking them in ways that allow for more meaningful research.

One important factor in the creation of this network was "an institutional IRB that was receptive to new ideas that were ethical and logical," says Rajiv Dhir, MD, chief of pathology at Shadyside Hospital, University of Pittsburgh Health Systems in Pittsburgh, PA.

"Essentially when the whole process was started, (the IRB) realized where we were coming from, what the purpose of the whole initiative was, and they participated very actively in the whole process of putting together the honest broker facility," Dhir says.

Under an honest broker system, researchers' requests for data or biological specimens go through a staffer who normally deals with patient data, but has had additional training and has been certified by the IRB to act as an honest broker. They strip the data or specimens of identifiers, and then package it in a usable form for the researcher.

Christopher Ryan, PhD, CIP, IRB director for the University of Pittsburgh, says a previous IRB director, Dennis Swanson, first saw the need for a way to deidentify records so that researchers could use them without compromising patient privacy.

"This was in the pre-HIPAA era," he says. "(Swanson) had many concerns about investigators going into medical records and poking around. And he thought (the honest broker approach) was a very clever way of protecting the integrity, the privacy of medical patients and maintaining the confidentiality of the records."

Preventing accidental exposure

Ryan says most studies involving data handled by an honest broker can be processed by the IRB using an exempt mechanism or a finding of no human subjects involvement under federal regulations. And he says it protects patients' confidential data from accidental exposure.

"We are not going to have situations that have happened elsewhere where identifiable medical record information has been left at Starbucks or on the bus or in a computer somewhere that gets stolen," he says.

However, there are challenges to using data and specimens that have been stripped of identifiers, since they cannot easily be linked to health care outcomes or other important annotating information from other sources.

"If you came to me and you needed, let's say 50 cases of breast cancer and you needed associated outcomes, etc.," Dhir says. "In the good old days what would happen is one entity would come up with the tissues, the biological specimens, and then you would have to approach somebody else to provide you with the information that is associated with that particular specimen."

"Investigators were going from one resource to another and it was a little uncomfortable with different entities interacting with each other when they didn't have any formal relationship and they were also handling information that could be considered critical or personal."

Dhir says requests at the University of Pittsburgh have become increasingly complex, requiring not just biological specimens, but more fully annotated tissues with clinical data, some of it difficult to access, such as post-therapy information.

So several entities, including the university system's health sciences tissue bank, cancer registry, outcomes group, oncology and informatics departments worked together to figure out a system for aggregating and disbursing data to researchers while maintaining patient privacy.

They created a network of individuals, all IRB-certified as honest brokers at different member entities. When a request comes to one of them, he or she can work through the network to find the various annotating data stored at the other entities and package it together – stripped of identifiers – to the researcher who made the request.

"If you come to me and say, 'I need tissue and I need these following pieces of information,' even if I don't have those data, I can approach the cancer registry or medical records or whoever might potentially have the information," Dhir says. " Since we're all part of the same system, we put together that information, we package it and we provide it to the investigator. It becomes like a one-stop shop."

The entire process has been approved by the University of Pittsburgh IRB, and brokers have the necessary business associate agreements to satisfy HIPAA regulations, he says.

Ryan says that different entities involved in the honest broker network often have slightly different ways of doing things.

"Some people handle only medical record information, some of the systems handle specimens, others handle both," he says. "Sometimes honest brokers who have control over information from different departments do their piece and somebody from another department does their piece and there's a third honest broker who puts it all together."

He says the various procedures used within the system all have been reviewed by his IRB. When brokers leave the system and new ones are certified, changes are brought to the IRB as well. The University of Pittsburgh Medical Center (UPMC) privacy officer also signs off on changes, Ryan says.

Institution must sign off

Ryan says an institution looking at putting a similar plan into place must decide who will handle the certification of new brokers – will it be the IRB, or some other entity? And the institution must provide for oversight of the honest broker system, a function that has fallen to the IRB at the University of Pittsburgh.

"The IRB and the IRB's compliance arm has started doing some audits and one of the first programs we audited was Dr. Dhir's because his program, from what we can tell, is the best run of the programs," Ryan says. "He handles a lot of information, he works with lots of different investigators, and they have put together a fairly detailed protocol that has been approved by the IRB."

Ryan says he'd like to see more centralization of the program at the university, and has been talking with UPMC officials about offering a centralized honest broker service that could be funded, possibly on a subscription basis, by charging individual departments or groups of investigators.

"There are costs associated with this, costs the institution incurs, and the institution has to figure out some way of charging them back to individual departments or investigators," he says. "I'm not sure it's an IRB issue, but it's an issue that anybody who wants to use an honest broker system really has to consider."

Dhir says that as the network developed, he's sought input from colleagues at other institutions and at the National Cancer Institute and International Society for Biological and Environmental Repositories. And in turn, other institutions have approached the University of Pittsburgh for input into how to set up similar structures themselves.

"We get about eight to 10 visitors a year from major institutions here or even internationally, so we've been working with folks from Singapore, folks from Australia," Dhir says. "It has been borrowed by other entities as they've developed their own initiatives."

Reference

  1. Dhir R, Patel AA, Winters S, et al. A Multidisciplinary Approach to Honest Broker Services for Tissue Banks and Other Data: A Pragmatic and Practical Model. Cancer 2008 Oct 1;113(7):1705-15.