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One small IRB has evolved in less than a decade from a board that had no full-time or part-time IRB professionals to having its own IRB administrator with part-time assistance.
“When I first started here about seven years ago, it was to primarily assist with some policy writing. The IRB didn’t have full-time or part-time support staff,” says Andrea Rossing McDowell, PhD, IRB administrator and business communication lecturer at Seattle University.
McDowell’s role grew with the IRB, but budget and staffing constraints remained.
“Limited staffing is the number one issue most small research programs face,” she says. “Our IRB chair gets a stipend, and I also have a graduate student worker with part-time hours. But a small IRB is compromised in how much bandwidth it can take on.”
McDowell describes the following challenges small human research protection programs (HRPPs) encounter and how they can overcome these:
• Focus on flexibility. “Our IRB chair and I attended national conferences and brought back ideas about streamlining policies in a way that’s beneficial for our researchers,” McDowell says. “We have a very small program in a small university that is almost exclusively social behavioral research, and it tends to be minimal risk. There are typically only two to four full board reviews a year.”
Most of the reviews are exempt, and there could be about 40 expedited reviews in a year, she adds.
“We’ve developed institutional policies that are appropriate for research conducted here, and it took some of the administrative burden off our office and off researchers,” McDowell explains.
The key to running the program well was to establish flexibility, making changes that now are encouraged with the updated Common Rule.
“We expanded on what we considered exempt studies, and we tried to cut down on unnecessary paperwork for us and researchers,” McDowell says. “We overhauled our website to make it more user friendly.”
• Create a website that can answer most questions. By reconfiguring the program’s website, the information is researcher-centered and easier to find.
“One of the main factors when you’re dealing with staffing limitations is to make sure your website and other communications are really effective,” McDowell notes. “Most researchers don’t care about regulatory language itself, but they want to know how they can get their study approved and what they need to do.”
User-friendly language is a positive change for everyone, she adds.
“Since we’ve revised the website, we’ve gotten tremendous feedback,” McDowell says. “But we’re trying to be intuitive for people filling out the applications. That cuts down on the number of phone calls.”
• Be proactive. The IRB provides pre-submission consultations for researchers.
“They can talk with me or a graduate student assistant about anything from, ‘Here’s an idea I have,’ to “I think my draft is finished, will you look over it?’” McDowell says.
“We don’t meddle with their methodology, but we ask how many identifiers they truly need,” she explains. “The number and nature of identifiers might reduce review level.”
Thanks to the consultations, the protocol submissions go through much more quickly, and researchers benefit from a more personal one-on-one with the IRB, she adds.
• Educate faculty and students about the IRB. McDowell meets with faculty and attends their classes, discussing the IRB.
“When I go to departments, often I will clarify that our goal is to help them do their research — not to be a hindrance or to prevent them from doing what they want to do,” McDowell says.
Since it is a small university, McDowell is able to build personal relationships and trust with many members of the research community.
“I answer questions about the process, different levels of review, and what kinds of services we provide, like pre-consultation,” she adds. “People feel it is a more personable office that is looking to help them.”
Discussions might take 10 minutes and cover issues like culture shifts and overapplication of regulations. McDowell also talks about the IRB’s new flexibility.
For instance, she will discuss how the old policy was to send any study involving minors to the full board, but that is no longer required.
“We changed it so that if a study involving minors is minimal risk, we can have it expedited,” McDowell says.
An example would be a study that collects biometrics with heart rates of high school students. It collects only de-identified information that cannot be tracked back to individuals, and the goal is to look at heart health. This could be an expedited review study, she explains.
• Play to the smaller IRB’s strengths. The biggest benefit of running an IRB in a smaller research institution is that there can be a flatter organizational structure, McDowell notes.
“We have more decisional authority,” she says. “For example, when the chair and I go to a conference, we hear amazing ideas and learn so much about different policies. We come home and bring these ideas to our board, and we get members’ feedback.”
Sometimes, the IRB can implement a change within weeks — or even days.
“At a huge institution with multiple IRBs, IRB chairs, and a far more hierarchal structure, you don’t have that flexibility to be responsive to policy changes,” she says.
One change the IRB enacted quickly involved broadening the definition of exempt studies.
“We developed a very brief, four-page exempt application,” McDowell says. “It gathers enough information, but doesn’t put a huge burden on researchers to create an entire protocol for something that doesn’t need to be read by the IRB.”
Once an investigator submits the exemption form, the IRB will make a quick determination.
“Rarely, we say we need more information,” McDowell says. “We can turn those exempts around quickly, within a week.”
Seattle University’s application for exemption from IRB review asks for investigators’ names and contact information, the project title, and anticipated study start and closure dates.
It also asks for a list of all funding agencies and non-monetary support, as well as the research location and research question or hypothesis. Other items include the following:
- Descriptions of procedures, psychological tests, educational tests, and experiments;
- Subject population and recruiting process;
- Anticipated maximum number of recruited participants;
- Minimum number of participants needed for study completion;
- Incentives participants will receive;
- Individual and societal benefits;
- Risks of participation;
- Direct or indirect identifiers;
- Informed consent process.
• Meet budget challenges. Small academic IRBs often are from small universities with budgets that fluctuate according to student enrollment, McDowell notes.
An IRB administrator will need to protect the IRB’s budget by tying its work to the institution’s mission and making sure institutional leaders know about regulatory mandates.
“This is not a program that someone would love to have, but can cut; it’s necessary,” McDowell says.
“When there are budget cuts, we need to clarify and make sure the administration understands we are tasked by the federal government, and we need to make sure studies are in compliance, following the Common Rule, and so forth,” she says. “This means that we might make do with a smaller budget, and we’ll rely on our good board members and try to be proactive.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSBioethics, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.