The theory behind a hospital-university research and IRB collaboration is that both organizations have different strengths, and together they can facilitate studies and research ethics review more efficiently. One such model is THRIVE, a new, inter-organizational partnership model.
Created by Northern Arizona Healthcare and Northern Arizona University, both of Flagstaff, the partnership includes a biomedical/genomics center and several Native American tribes that have a mission to address the responsible conduct of research.1
“The hospital and university have always worked in partnership on different types of research projects over time, but then it became apparent that we needed something more formulized,” says Paula McAllister, PhD, CIP, IRB specialist at Northern Arizona Healthcare. Information on THRIVE is available at http://nau.edu/Research/HRI/THRIVE/.
“For our IRB’s purposes, it means that we work cooperatively with the university IRB, get to know IRB members, have regular meetings with them,” McAllister says. “It’s really been helpful to sit down with people in the IRB office.”
THRIVE has led to studies that otherwise might not be launched, McAllister notes.
For example, a hospital nurse recently teamed with a psychologist who works at the university to conduct a study involving an LGBTQ (lesbian, gay, bisexual, transgender, queer) population. The study involves interviewing hospital patients who are from the LGBTQ community about their hospitalization experience and any issues that arise because of their LGBTQ status, McAllister says.
“The university has an LGBTQ student organization, and the researchers can work with that organization too,” she adds. “The LGBTQ community accesses both institutions.”
THRIVE benefits both institutions because the hospital has a wealth of medical history data and potential research participants, and the university has a wealth and depth of researchers, McAllister notes.
“Physicians don’t have time for research, and it is university people who need to do research for their jobs,” McAllister says. “What THRIVE provided was a formalized process where all these questions could be addressed through established processes and procedures.”
It saves IRB staff time by providing a roadmap, she adds.
“It gives us a way of working through all those initial questions and problems so we can get things up and running more quickly and more efficiently,” McAllister says. “It’s a very simple idea that just means we have an agreement to work together, and the goal is to collaborate on these population health initiatives.”
While some urban areas are already seeing this type of research/IRB partnership, THRIVE is a good model for more remote and rural areas, she adds.
Here are some of McAllister’s suggestions for how collaborations like THRIVE could work:
- Create agreement between stakeholders. THRIVE was initiated by university and hospital leaders, McAllister notes.
The stakeholders include representatives from the hospital, university, and biomedical center, as well as Native American leaders. THRIVE members conducted interviews, observations, and focus groups to determine cross-cultural differences in terms of beliefs and behaviors related to research integrity.1
The IRBs have aligned forms, processes, and procedures. They use an inter-agency authorization agreement (IAAA) that names one IRB as the main IRB of record. The other IRB allows the main IRB to take over management and oversight, she explains.
- Align the IRBs’ policies, practices. “We started scheduling a two-hour meeting every other week,” McAllister says. “We’d have a list of things we needed to tackle, like the IAAA.”
Other items discussed were application forms, informed consent forms, and specific projects.
“We agreed on CITI requirements,” she says. “Each institution had a different set of CITI courses they accepted, and we had to agree on which courses people needed.”
Another issue was that the university wasn’t listed as a covered entity under HIPAA from the hospital’s perspective, McAllister says.
“So if a university researcher was going to have access to hospital records, it takes de-identifying records and covering them under the IAAA,” she explains. “Those were the early issues we tackled, and now we tackle specific problems about studies.”
- Address regulatory issues and expand research projects. Prior to the collaboration, the university’s IRB did not address some HIPAA and Food and Drug Administration (FDA) requirements because it was focused on behavioral research and not clinical drug trials, McAllister says.
THRIVE has helped to bridge that gap. It’s also opened the door to new research.
“THRIVE has funds to give seed money for pilot projects, and so there are small grants that people at the university can apply for and use these to yield results that can be used for larger grants,” McAllister says.
An example of a THRIVE initiative includes a study working with a Native American community on the issue of diet and lifestyle changes. Its goal is to improve health and will involve researchers from the university’s anthropology department, as well as at the hospital, which has access to the population’s health data.
- Establish communication lines. When IRBs are part of a collaborative agreement like THRIVE, they need open lines of communication so they can understand how and why the other institution’s IRB does what it does, McAllister suggests.
“The larger institutional benefits are to improve healthcare provided to the community,” she explains. “But for our specific and immediate benefits in the IRB office, it’s about developing that relationship with the other institution and not operating in a bubble.”
- McAllister PG. THRIVE: an inter-organizational partnership model for fostering research integrity. Poster presented at PRIM&R’s 2014 Advancing Ethical Research Conference, held Dec. 5-7, 2014, in Baltimore, MD.