IRB puts its imprint on recruitment registry

Confidentiality of collected information is key

Thanks to a volunteer recruitment registry at Vanderbilt University, potential research subjects — even those not currently being treated at the university's medical center or by affiliated doctors — can make their names and health information available for future use.

Though the project doesn't sign potential subjects up for a particular protocol, the IRB had a strong hand in ensuring that the registry advertised itself appropriately and kept registrants' personal medical information confidential, says Denise Roe, LPN, CCRP, CIP, director of the IRB at the Nashville-based institution.

"It's sort of that first step of recruitment," Roe says. And that's why they decided to run it through the IRB. "The real issue for us was separating it out — to actually make it a true recruitment protocol, so it's not tied to any specific treatment protocol."

The project was begun in an effort to create a simple tool that could direct potential research volunteers to the researchers who might want to enlist them in their studies. Often, unsolicited volunteers would call Vanderbilt telephone operators, who would have a hard time deciding where to route calls.

Developers from the biomedical informatics department created web-based software that allows volunteers to submit their own health information. A volunteer filling out the web questionnaire is asked about demographic information, tobacco use, and to list any diseases or conditions he or she has.

The information is stored in a secured database available only to researchers with IRB approval for studies. Researchers can use the software to pull out potential volunteers with health histories that meet their needs, and then solicit them directly for a study.

It's different from Vanderbilt's clinical trials center web site, which lists available active studies at the university.

Roe says the volunteer registry has been successful in drawing people from both inside and outside the university community. (To access Vanderbilt University's Clinical Research Volunteer Registry, visit the web site at https://www.volunteer.mc.vanderbilt.edu/.)

Confidentiality concerns

The project first went before the IRB in 2002 in a fairly simple form, which prompted volunteers for less health information than the current version does. At that time, the board's chief concern was the security of the information, says Dena Johnson, CCRP, CIP, a protocol analyst at Vanderbilt.

"[IRB members] have always wanted to make sure that participants who volunteered for this would not be at risk for any of this information being disclosed," Johnson says. "That was a lot of the reason they kept it at a full committee review for several years. They wanted to see what types of things might need to be reported at the time of continuing review."

Roe says that at the time, the IRB had several tech-savvy members who questioned the developers closely about how the software would work. Some members even went to the trouble of registering, so they could test the process themselves.

Over time, Johnson says, no one came forward with concerns related to security breaches.

In 2004, the IRB, satisfied that the security of the system was working, decided to allow continuing review to be expedited, Johnson says. The IRB reviewed the project in full again last year, when more direct questions about volunteers' health were added to the online form.

Johnson says the developers had wanted to ask volunteers to allow researchers to access their medical records prior to a formal consent process, but the IRB had reservations about the idea, and the developers withdrew it.

Roe and Johnson say there are other issues the IRB looked at in reviewing the volunteer registry proposal:

Advertising. Ads promoting the registry in the local newspaper and elsewhere had to adhere to the same strict standards Vanderbilt requires of all study advertising, even though the registry doesn't solicit for a particular study. The advertising includes a toll-free telephone number people can call if they don't have Internet access and want to submit information to the registry.

Explaining privacy protections. Johnson says a statement in the online form explains exactly who may access the volunteer's information and for what reason. Some of the language in that section was taken directly from the university's HIPAA template language.

The notice explains that the information will be kept indefinitely unless the volunteer requests deletions or wishes to withdraw his or her name entirely. Roe says a volunteer can unsubscribe online, in the same way that he or she registered, or by phone or mail.

Excluded groups. Roe says certain groups are not included in the registry, including vulnerable groups such as pediatric patients and dementia patients who are unable to fill out the form themselves.

Oncology patients use a registry system through Vanderbilt's cancer center, a distinction Roe says is deliberate. The cancer center has its own toll-free number for research volunteers, answered by the center's staff.

"I think they very much wanted to have that human contact, she says. "Because they don't do just research, they arrange for treatment — doing intake forms and facilitating appointments."

Working with IT

Roe says that for a project like this to be successful, there needs to be a partnership between those on the information technology side and human subjects protection experts who can ensure volunteers are being protected.

"Oftentimes, what you see happening is really great developers going off and developing something and they've never once taken the time to get the input from the content experts," she says.

She credits Paul Harris, PhD, a research associate professor of biomedical informatics who spearheaded the project, with working closely with the IRB members and staff throughout the development of the registry.

"Dr. Harris was very open in the beginning to hearing the committee's concerns," says Roe. "That's why they collected so little information, until they felt certain that they had enough checks and balances in place to really provide the confidentiality and privacy they felt was necessary. I think that's the way to make it successful."

She says IRBs will increasingly be asked to review more of these non-traditional types of projects.

"I think we're going to receive more proposals that require us to think outside the box," Roe says. "But if you do due diligence, it can work. You follow the regulations, you ask good questions and you make sure that investigators doing this type of research understand what the committee's concerns are. "I think that was just instrumental in this proposal."