"Whistleblower" hotlines show participant concerns
Institutions can receive reports, track investigations
When a human subjects protection program wants to ensure that participants have a confidential means of reporting concerns about studies, one alternative is a commercial "whistleblower" hotline service, which provides anonymity to callers.
Some institutions have gone further, employing a service that not only provides a phone and online reporting capability, but the ability to track what kinds of complaints the institution receives to look for trends and possible solutions.
Representatives of EthicsPoint, a Lake Oswego, OR- based company, say more than 200 colleges and universities use their service to log reports about everything from financial misconduct to NCAA violations. At many schools, they also are a conduit for participants and others involved in human subjects research to report serious concerns about studies.
Cornell University in Ithaca, NY, recently started putting out information to participants in informed consent documents about the availability of the EthicsPoint hotline, says Matthew Aldridge, senior IRB administrator for Cornell's Ithaca campus.
"If our office exists for the effort of maintaining the public trust in the research enterprise, then it behooves us to say we will take extra steps to make sure we have independent and anonymous (if wanted) reporting processes," Aldridge says. "People who have concerns can address them without feeling the risks of any sort of repercussion."
Aldridge says the university's Office of Research Integrity and Assurance already had planned to seek out an independent compliance reporting service when Cornell's Ithaca campus decided to use EthicsPoint for other reporting.
"So we bided our time until we could incorporate EthicsPoint into our various clients' programs, (which included the IRB, the institutional animal care and use committee and the institutional biosafety committee), he says. "Those are the three primary programs that have it available for reporting purposes through our offices."
Defining the questions
Tim Howard, senior account manager for EthicsPoint, says that when they first bring on an institution, a client services team works with representatives to set up a system that supports the institution's existing processes.
"Part of the goal is to sit down with the institution and define what are the questions we need to ask, what's the kind of data you would want to collect?" Howard says. The company also identifies various people within the institution who would serve as contacts for various types of reports as they are received.
People reporting concerns can call a hotline or can make a report online, either anonymously or providing a name.
EthicsPoint does not investigate the report, but rather passes the information to the designated person at the institution. Although their contract promises to deliver the report within 12 hours, the turnaround is more frequently less than two hours, says Bill Piwonka, senior director of marketing at EthicsPoint.
Because the person making the report is given a confidential login and password, the investigator can be in contact with that person, anonymously if necessary, for follow-up questions.
"We even have the capability for them to schedule an online anonymous chat if the investigator has a series of questions they want to direct to the reporter," Piwonka says.
The company provides case management capability as well, says Meg Carter, CCEP, senior analyst for investigations in the Office of the Senior Vice President for Ethics, Compliance and Audit Services at the University of California in Oakland.
EthicsPoint serves UC's far-flung and complex university system, and Carter says she uses an advanced version of EthicsPoint's case management system to manage the many reports that come in through the hotline, online and through other means, such as from managers and supervisors. All these reports, regardless of where they originate, are entered into the EthicsPoint system so that she can track them.
"You can make assignments, add people as primary investigators or reviewers on the case," Carter says. "You can indicate the names of people involved, implicated or witnesses. If there's an agency involved — funding or regulatory agencies — you can add their funding information or status."
Carter says keeping the information within the reporting system, as opposed to sending emails back and forth, maintains greater confidentiality.
Her institution also uses the information gathered from EthicsPoint to look at trends — where reports are coming from and what kinds of issues most commonly occur.
"It's extremely important to the president and to the regents of the university to know in detail what's going on," Carter says. "For example, are we having the same sorts of trouble in all the schools of engineering? Because that means we need to look at the policies and procedures in place in those areas. Or are we having lots of different types of problems in a certain department on a certain campus? Because that might mean some management issue is ongoing in that department."
She also can use the information for benchmarking purposes, comparing UC's statistics to those of EthicsPoint's academic customers as a whole.
Carter says there are relatively few reports related to human subjects protection issues, and so far, none have been reported via the EthicsPoint phone hotline or online reporting system. Aldridge says there have been no reports through EthicsPoint to his office since they started using the service at the beginning of the year.
Carter says the hotline is generally used by people who wish to remain anonymous, and people making reports about human subjects issues usually don't require that.
But both she and Aldridge say it's important to provide that choice to research participants.
"Really, most research participants and staff at the university know how to resolve the administrative things," Aldridge says. "But we want to be sure that anybody who has a substantive concern could report that. We wanted to be proactive in setting up a mechanism so that if, heaven forbid, there was something that did happen, we had something in place to address it effectively."
Carter says an institution that wants to use a service such as EthicsPoint should determine for itself exactly what information it wants to know.
"I think the most important thing is to thoroughly understand what kinds of issues and investigations you're currently dealing with," she says. "What do you want to be able to track? How do you want your staff to use the system?"
Aldridge says that when Cornell's IRB first signed on with EthicsPoint, there was concern that researchers' informed consent documents would all be out of compliance, because they didn't reference the hotline.
"So on every continuation, on institutional and administrative pre-review, we would automatically send people a form saying, 'By the way, everybody needs to update your consent forms.' And we created boilerplate language and modified our template online to include that language, because a lot of people simply cut and paste elements from that."
[Editor's note: For more information, access the EthicsPoint Web site at www.ethicspoint.com]
When a human subjects protection program wants to ensure that participants have a confidential means of reporting concerns about studies, one alternative is a commercial "whistleblower" hotline service, which provides anonymity to callers.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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