A research institution has found that a model way to improve collaboration between research protection staff and research staff is through a study initiation program (SIP).
Collaboration between an IRB and research team works better when the research group is well-educated to the IRB’s process and human subjects research protections. Trust also enhances collaboration. Both of these aims can be achieved through a study initiation program.
“We’re looking at not only what the IRB approves, but how we can support best practices with their study,” says Martha Jones, MA, CIP, executive director of the human research protection office at Washington University School of Medicine in St. Louis.
The study initiation program resulted in 30 SIPs last year and very positive responses from research staff, she says. A survey that asked if investigators or research coordinators would recommend the SIP to peers showed that 92% said they would make the recommendation.
Also, more than 90% said they agreed or strongly agreed that the human research protection and human research quality assurance staff had answered all questions effectively and with constructive advice, she says. Most researchers and coordinators also agreed that they had learned more as a result of the SIP, according to survey answers.
The IRB uses the SIP to provide helpful tools to research staff and to guide them in beginning the research process, Jones says.
“With a research study and waiting for approval, they could work on detailed procedures about how to conduct activities and how things change,” she says. “This process allows us to make a personal connection that, hopefully, will help them feel comfortable contacting [the IRB] for help if they run into problems.”
Once trust exists, research staff will call with questions before problems arise. For instance, research staff often calls to learn more about data management and recordkeeping, says Mickey Clarke, director of human research quality assurance at Washington University.
IRB staff can help research staff with writing protocols and improving flaws.
“People might say they’ll do individual consent for a study at some gathering, but then they arrive and there’s no place to speak with people privately, so they’ll do a mass consent that wasn’t approved by the IRB,” Clarke explains. “They have difficulty because they haven’t thought through how they would provide informed consent and get it approved.”
Another example involves clinical trials with inclusion/exclusion criteria. Investigators might have the criteria written into the application, but they haven’t gone through and shown how they might document each criterion to ensure the person is eligible for the study, Jones says.
The SIP helps researchers think about logistics and other obstacles to a successful study.
“We might ask, ‘Do you really think the subject can tolerate nine different tests in one day, and could you really get that many scheduled?’” Clarke says. “Changing the protocol might lengthen their timeline for accomplishing things, but that’s better than having people drop out or withdraw, and we want people to think through those logistics in advance.”
The SIP starts with an email as the protocol is being reviewed. The email notifies a research team that the study has been selected for the study initiation program, which is explained in detail. It also asks the team to schedule about an hour for the meeting with a member of the human research protection office and someone with the human research quality assurance program.
Research staff receive a packet of materials, including a report that walks them through their application, giving examples of best practices and templates.
“We also provide a small gift — a little box of mints — for everyone,” Jones says. “It has contact cards in it so they know who to contact after the visit.”
Next, SIP reviewers meet with research staff.
“We almost always go to their site because Martha’s staff and my staff are a mile apart, so it’s best to meet in the middle and it’s always courteous to go to the faculty,” Clarke says.
“Then the teams spend a lot of time reading the review,” Clarke adds. “We’ve developed a template that covers X points, and they read the submission before discussing it.”
Questions the SIP reviewer might ask include the following:
- How are you going to recruit and consent subjects?
- How will you carry out your procedures?
- How will you minimize risk?
“We go through key parts and regulatory issues first, and then look at execution and best practices,” Jones says. “We look at how to document and how to run a study effectively, including having good communication between study team members and the investigator.”
Researchers have been receptive to the program to the point that some call Clarke’s office to request a study initiation program visit.
After the meeting, research staff receive a follow-up survey to gauge satisfaction.
“One of the most important things is we’re actually forming relationships with researchers,” Clarke says.
New investigators welcome the help with their protocol submissions, and as a result, they are less likely to see the IRB as an adversary, Clarke notes. “By intervening early on with someone in their career here, we give them a totally different impression of how we mean to be helpful and can help them navigate the system; it’s very positive.”
Researchers can learn from IRB and human subjects protection classes, but it’s much more helpful if they learn while working on a specific research study, Jones notes.
“They can modify their studies and the minor changes go through our system very quickly,” Clarke says.
“A lot of what we do is about logistics and execution, rather than regulatory determination,” Clarke adds. “From my perspective, we do a lot of monitoring and review of open studies, where we’ve seen all kinds of issues and activities.”
One goal is to get research staff to think about which parts of their plan are feasible and to consider things that might go wrong. It takes someone with experience to shed light on these issues, Clarke says. “People are willing to engage you around those questions because they’re talking with two people from my staff who have a lot of experience.”
Another goal is to address special regulatory requirements.
“The staff familiar with those additional requirements can walk through them with the research team to make sure they understand those requirements,” Jones says.