University explores transnational IRB
Bridging culture, compliance gaps is key
For about 30 years, the Indiana University School of Medicine in Indianapolis has had a research partnership with Moi University's Teaching and Referral Hospital in Eldoret, Kenya, including an exchange program for medical students. As the clinical collaboration grew, IU researchers partnered with researchers at Moi to conduct studies in Kenya and other parts of Africa.
But when researchers from either institution sought approval, they had to go through two processes: the IU IRB and the Moi University Institutional Research and Ethics Committee (IREC). The IU IRB might have changes that the Moi IREC didn't have, and vice versa. "Researchers were frustrated," says Shelley Bizila, MS, CIP, clinical research compliance officer for Indiana University. "We talk and communicate issues well with IREC, but for an investigator it's frustrating. The timelines would never match up."
In order to streamline the approval process, IU looked into forming a joint IRB with Moi University. IU received a federal research grant from September 2010-September 2011. "What we were hoping to do was create a joint IRB process," says Edye Taylor, JD, MA, CIP, senior compliance project manager with the IU Clinical Research Compliance Office. "Even if it didn't come to fruition, we would learn a lot to make the process better."
First, the IU grantees looked into whether such an international partnership would be possible from a regulatory standpoint. When searching the U.S. IRB regulations, Bizila and Taylor discovered there was nothing in the literature pertaining to international IRB partnerships of this nature.
"We looked at the regulations there were none prohibiting such a partnership, but there was nothing to govern how to do this," Taylor says. "It wasn't really on anyone's radar." They put forth the question to the U.S. regulatory and accrediting bodies as well as to the governing bodies in Kenya. "Once we determined there were no regulatory issues to prevent us going forward, we began the process."
The IU IRB members sat down to hash out the joint IRB process and make it more compatible with Moi University. They studied the IREC process at Moi and compared how each board handles things. They also had to determine when and how often to have meetings, what technology would need to be used, who would chair the meetings, etc. "We had to harmonize all the details," Taylor says.
One of the key things learned, Taylor says, is the value of interpersonal relationships and how they differ across cultures. "Anyone who has worked in any part of Africa knows that personal relationships have a very different role. In the U.S., we have very much become a society where we don't have as much face-to-face time," she says. "We would have to take a different approach there. The agencies also work a little differently in Kenya."
During planning, it was clear that the venture would be a strictly equal partnership, with no one side dominating or taking charge over the whole process, Taylor says. Each side also had to learn cultural and procedural differences, and find a middle ground. For example, she says, the Kenyan researchers at Moi tend to be more softspoken and less likely to interject with questions during discussions, and Americans are perceived as more dominant personalities. "We had to get the dynamics of the team right and get people who have no problem jumping into the conversation to ask more questions and press for more answers," she says.
There are also differences in how each institution approaches protocol review. "We are more systematic and process driven, while the Kenyan IREC has a more personal approach," Taylor says. "Their process in Kenya is far more formal in how they review each protocol they feel strongly that every board member should know every detail of what is being approved. Not that Indiana doesn't take the necessary steps for protocol review; it's just a different approach." In the end, Taylor says, "Moi found processes from us that they wanted to incorporate, and vice versa."
The IU grantees went to the Office of Human Research Protections (OHRP) with the proposal of an international IRB with staff consisting of equal parts IU and Moi members. "[OHRP] were supportive and in their eyes there were no barriers," Bizila says. "They were very excited to see us attempt [the partnership]."
In Kenya, nothing was found in the regulations to prevent the joint IRB from happening. However, the country's National Bioethics Commission was skeptical. "Kenya has been a research performance site in the past, and [the commission] felt that the Kenyan people had been taken advantage of in the past," Taylor says. "They were concerned that the time wasn't right, if was there a genuine need to flesh this out, and if it would create more work for the agencies there were a lot of great concerns in general."
So while the joint IRB plan is now on hold, the two universities are continuing the long-standing research partnership. There is also hope that the plan will someday be approved. "The politics are starting to change at the regulatory level in Kenya, and we're positive there will be renewed interest in the next couple of years," Taylor says. "At the institutional level, the folks at Moi thought it was a really good idea. They clearly understood how much this would mean for them and their Kenyan counterparts. On both sides, there was complete institutional buy-in."
While researchers still need to go through both institutions for research approval, the process of planning the joint IRB helped to smooth communication and make the dual review process a little easier. "Even though researchers have to do the dual review, it's more harmonized and the communication is better," Taylor says. "If there is a question about something that has already been approved, there's more of a group conversation that takes place."