The Health Improvement Institute’s (HII’s) Awards for Excellence in Human Research Protection recently honored two IRBs that streamlined and implemented new systems for efficiency and information-sharing to improve approval turnaround times and quality of human subjects protection in the areas of best practices and innovation.
The Harvard Longwood Medical Area (LMA) Office of Human Research Administration (OHRA) in Boston received the Best Practice award for 2014 for its One-Stop Shop Model of IRB review, in which investigators have one point of contact in the IRB for all ongoing reviews with study protocols.
The idea for the program began in 2007, when the current Harvard LMA School (OHRA) director came on board. The director had a quality improvement background and took a look at the current system in order to pursue AAHRPP accreditation, says Leslie Howes, CIP, director of the Office of Human Research Administration at Harvard Long. “There were a lot of kinks in the system and a lot of dissatisfaction; it was the age-old slow turnaround issue,” she says. “At the time, we had many unnecessary layers of review.”
Submitted protocols would go through one person for triage, then pass to another person to make sure the application was complete. Another person would make sure all criteria were complete, then one more IRB staff member would approve or send to the full board. “This was the impetus for simplifying the process,” Howes says.
Instead of having several people handle protocols, the IRB in 2008 instituted one direct point person for investigators, with IRB members handling the review process. Called review specialists, the points of contact have a higher level of education and IRB review experience, get their own portfolios of studies, and are assigned their own departments. There are five total research specialists at the Harvard LMA IRB office.
“The review specialists serve as the direct point of contact for the investigators in those departments,” Howes says. “Regardless of type or mode of submission, it’s always going to go to the same person to review it.”
If the study requires full board review, the review specialist prepares the protocol for the IRB meeting and conducts post-meeting follow-up with the investigator to deliver the determination. “The specialists also participate in the meetings because they have intimate knowledge of the protocols,” Howes says. The specialists can answer questions IRB members may have about the protocols.
The workloads of the five research specialists are adjusted as needed so no one person is given more than he or she can handle, Howes says. “Not all departments are created equal,” she says. “One investigator could have one protocol and another could have five. One could produce several amendments and have ongoing studies, while another may have just one. We try to balance it out between our five specialists as equally as we can.”
When the model was first implemented, it was only used at the Harvard T.H. Chan School of Public Health. But the success of the model has led to its implementation at the Harvard Faculty of Medicine, which includes the Harvard Medical and Dental Schools, in 2013, Howes says. “We demonstrated that we can replicate this model,” she says.
While the IRB has not evaluated the difference in turnaround times before and after implementation of the One-Stop Shop, staff have heard positive feedback from investigators and other institutional faculty. “From the get-go it was really an ‘a-ha’ moment that it was really clicking and working for the institution,” Howes says. “We hear from the faculty about the higher level of customer service and the decreased turnaround. There’s not any need for knowledge transfer — the same specialists are seeing these [protocols] at submission and continuing review year after year, so they’re intimately familiar with it and don’t need to get someone else caught up on what’s going on — I know the investigators greatly appreciate that.”
The Human Research Protection Office at Washington University in St. Louis was always open with sharing information on its website — except for one problem.
“People have always used the information off of our website, but haven’t always credited the information back to us,” says Sarah Fowler-Dixon, PhD, CIP, education specialist at the Washington University HRPO. Through discussions on how to solve the citation issue, the staff learned about the Digital Commons project at the university’s Becker Library. Digital Commons is an online repository for the university’s scholarly works that is available and searchable to anyone, without a need to sign up for an account. Through Digital Commons, the HRPO developed its Open Access Library in 2012.
The Open Access Library contains four categories of HRPO materials: Conferences, Human Research Protection Program Education, HRPO Podcasts, and HRPO Publications. All materials in the categories contain a creative commons copyright, and downloads of materials include instructions on how to do the attribution. “All we ask is that people attribute it [the information] back to Washington University when they cite it,” Fowler-Dixon says.
Information in the four collections dates back as far as 2002. The documents are also searchable in PubMed and Google. “We have a whole process for vetting the information [that is posted],” she says. “We try to put things out there that are relevant across the board and not just for WU — there are different structures that are set up across the country. We look at what we have done throughout the year and put out information that will be useful and that will be relevant for a longer period of time — not just something that we’re talking about today and can change. What we’re trying to do is increase the body of knowledge that is readily available — users don’t have to subscribe or sign up for anything.”
There are currently 113 items in the collections, Fowler-Dixon says. Of the 113 items, 111 have been downloaded from users in 53 countries. Items in the collections include the following:
• Conferences: This section contains PDFs of conference materials from sessions that were open to the public. For example, the Food and Drug Administration (FDA) recently gave a presentation about its new guidance on assays, Fowler-Dixon says. “That will be relevant to other organizations that work with assays and need to know who should be included or excluded,” she says. There are also materials from conferences on community-based research, the university’s annual ethics series, investigator-initiated research, and other topics specific to running an IRB.
- HRPP Education: This includes presentations on IRB ethics, navigating IRBs, consent challenges, education of researchers, confidentiality issues, etc.
- HRPO Podcasts: “Podcasts are done from an ethical standpoint, and anyone can listen to those,” Fowler-Dixon says. For the podcasts, a member of the IRB staff interviews an expert on ethical or regulatory issues. “For instance, there is a topic on social media, and one on inclusion of Native American and Alaska Native populations in studies. The people interviewed are recognizable names [to IRB professionals],” she says.
- HRPO Publications: Publications include training guides for IRB staff positions such as IRB analyst, expedited reviews specialist, and non-scientist IRB members. There is also an IRB meeting guide and a brochure for committee recruitment. Other IRBs may find the information useful for their offices, Fowler-Dixon says.
The HRPO plans to keep the information down to four topics and will add to them, Fowler-Dixon says. Materials will not be removed from the library. “Once the information is out there, it’s out there,” she says. “It also creates an archive of historical information.”
The HRPO won the 2014 innovation award for the Open Access Library. “I think the award recognizes the efforts people are putting forth to keep quality in the context of human subjects research,” she says. “It helps us all move forward and increase the professionalism of the field and the knowledge base of the field.”
HII’s Awards for Excellence in Human Research Protection are awarded annually to recognize excellence in the area of human subjects protections. For more information, visit www.hii.org.