Improving communication between researchers, IRBs
Recent IRB conference highlighted problem areas
If there was one thing that most people in the research industry can agree upon, it’s that communication channels between each part of the industry need to be improved.
IRB members, researchers, sponsors, and others attending the 2004 Annual IRB Conference, held Oct. 28-31 in San Diego, discussed how communication problems contribute to the problem of delayed clinical trials and misunderstandings among people who sometimes fail to remember that they’re working toward the same goals. The Boston-based Public Responsibility in Medicine and Research (PRIM&R) sponsored the conference.
"I think the bottom line in terms of sponsor relationships is communication," Philip Rubin, PhD, chief executive officer and vice president of Haskins Laboratories in New Haven, CT, told Clinical Trials Administrator. Rubin also is a professor adjunct in the department of surgery, otolaryngology at the Yale University School of Medicine in New Haven and a research affiliate in the department of psychology at Yale University.
"It’s important to have good communication in the process and to make sure that this communication is nonadversarial," he says. "I have been a researcher, so I know how because of delays and potential misunderstandings, people can get very frustrated and worked up about issues, and the situation can degenerate."
Investigators and clinical trials administrators may believe strongly in protecting their interests during the research process, but simultaneously fail to consider what’s most important to the others involved in the process, the experts say.
"Given the different priorities and reward systems in different institutions and companies, negotiators can, understandably, take strong positions on issues, such as confidentiality and data ownership, that get in the way of reaching a win-win agreement," says Ronald S. Newbower, PhD, senior vice president for research and technology at Massachusetts General Hospital and vice president for research management at Partners HealthCare System Inc. of Boston.
"The examples that come to mind of situations where communication slowed progress all involve the front-end work of reaching agreement on terms of sponsorship that both the commercial sponsor and the academic institution can live with," Newbower says. "And occasionally, the delays can simply exceed the window of opportunity for participation and enrollment."
Rubin, who had served as director of the Division of Behavioral and Cognitive Sciences at the National Science Foundation (NSF) from 2000 to 2003, has found that researchers often misunderstand the role of government sponsors.
"The first thing the researcher or institution needs to understand is that the role of the sponsor is often constrained because of policy set at the institutional level," he says.
"Say, for example, you’re having trouble with your IRB and someone calls the National Institutes of Health to intervene," Rubin says. "That’s not something NIH is allowed to do, although you might think NIH can."
Improving IRB relations
Researchers and clinical trials staff also need to make certain they understand the regulations and practices that are relevant to their studies, Rubin says.
It’s a good idea to use the university’s sponsored research office as a resource for information and guidance, he adds.
Another strategy for improving communication would be to provide formal training in negotiation skills to clinical trials staff, Newbower suggests. "This can be very helpful in preparing staff to see the issues of the other party and to develop creative solutions, or to recognize when they are simply negotiating with the wrong person and need to seek connections with someone more empowered to modify the terms of standard agreements," he says.
Clinical trials administrators and investigators also could improve the process through better communication with IRB staff and members and through a better understanding of what IRBs do, the experts say.
"The major burden of education falls to the IRB staff who have to do a lot of explaining to new investigators to help them understand what an IRB is in the first place and how to interact with the IRB," says Matthew Whalen, PhD, co-founder of Chesapeake Research Review Inc. of Columbia, MD.
"When it comes to communicating with IRBs, I think it helps to have a process where nothing ends up in a black hole — there should be some transparency of expectation," says Jeffrey Trunzo, RPh, MBA, CIP, vice president of Chesapeake Research Review.
"Too often IRBs don’t make their requirements clear, what materials they need to review, what the review process will look like, so folks don’t know what to expect and this sets up an uneven dynamic," he adds.
From a purely social standpoint, it’s important for clinical trials staff and investigators to make certain their interactions with the IRB are pleasant ones, Rubin notes.
"Try to frame them in a way that sounds conciliatory and brings entities together to see if they can solve a problem instead of just complaining about it," he says. "The ultimate goal is to do good research that protects participants in research."
Also, if there are unexplained delays during the IRB process and an investigator or clinical trials administrator wants to contact the sponsor, it helps to know the appropriate person to contact at the sponsoring agency, Rubin says.
"They’ll tell you whether or not there’s specific guidance addressing this issue," he adds.
However, the point, once again, is to frame the request in a problem-solving and conciliatory fashion, Rubin suggests.
"Instead of say, Wow, I have this problem and you guys have to do the following,’ which will never work, you should say, Here’s the situation, and is there anything we can do to make it better?’" he says.
Federal sponsors often have little flexibility for offering advice or assistance but occasionally there may be gray areas they can help interpret.
For instance, the NSF sometimes saw problems with informed consent among special populations, Rubin recalls.
"There is lot of latitude and flexibility in the Common Rule, but not everybody is aware of it," he says.
Communication also needs to be improved between clinical trials offices and research institutions and physician investigators.
"Research is not easy to conduct; you need a steady stream of investigators. And with them, you need study coordinators," Whalen says.
"The greater problem is turnover: At any given point in time, 60%-70% of all investigators do only one trial and don’t do a second one," he notes. "They do one trial and then say, I can’t do this — it negatively affects my practice,’ or, whatever the reason might be, the burden falls to clinical administrators."
Clinical trials offices could try to reduce this turnover rate by assisting in training new physician investigators that a clinical trial involves some different tasks and skills than their patient practice, Trunzo says.
For example, a clinical trial investigator needs to keep up with a considerable amount of paperwork and know research and human subjects regulations, as well as know basic details, such as what a case report form is and how to report data on serious adverse events, he explains.
"Often, these folks look at participating in a clinical trial as a way to supplement their income or reduce their reliance on insurance reimbursement, but they don’t realize you have to make an investment in your infrastructure to do it well," Trunzo adds. "You can’t just dive in and hope for the best."
Likewise, research coordinators often are overburdened and could use additional personnel help and training, he says.
One industrywide change that may have help improve training and communication is the new focus on credentials for clinical investigators, IRBs, and others, Trunzo adds.
Also, accreditation processes are contributing to better communication, he says.
"Accreditation of human research protection programs is a programmatic effort to make sure all parties understand what is going on in other areas and that they’re communicating effectively," Trunzo explains. "And through the accreditation process there will emerge best practices, which will be more widely shared than they have been in the past."
Besides accreditation, another strategy for improving communication and training is to hold educational meetings at which federal research staff are invited to speak, Rubin suggests.
These meetings could include all interested parties, including researchers, participants, IRB members, administrators, community leaders, and institution directors, he says.
Another communication problem area involves IRBs, which need to pay attention to the social impact of proposed new medications, devices, and vaccines, Whalen says.
"So if the clinical trials office and sponsor and IRB could share information along those lines, then that would help us fight the criticism of the me-too drug and device and, Why do we need it?’" Whalen says.
Clinical trials offices, along with researchers and IRBs, should make it a goal to improve public trust by discussing their work to the public and educating people about human subjects research protection whenever possible, the experts say.
"The whole purpose of the human research protection program is to improve communications throughout the research enterprise," Whalen says. "The whole notion is to enhance and systemize communications."