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By Melinda Young, Author
Research protocol submissions that are missing key information or are written vaguely are a common IRB problem. The new Common Rule focuses on creating a more efficient and streamlined IRB review process. This means the time is ripe for better education on how to submit a protocol.
One IRB improved its submission process through an open site for the IRB on the institution’s learning management system (LMS). This made it possible for information to be customized for student researchers, faculty researchers, and faculty sponsors.1
From September 2017 through March 2018, the IRB’s LMS received more than 21,000 visits and is gaining speed, says Megan Williams, MPA, director of research administration at Salem State University in Salem, MA.
Since creating the IRB’s site on the LMS, IRB application revision rates dropped from 66% to 25%. With multiple revision requests, it dropped from 23% to 3.8%.1
“The learning management system is an open website,” Williams says. “We needed to keep it open because we knew that some of our information needs to be transparent to outside constituents.”
Initially, the IRB considered using its website for providing more educational content. But there was a better idea: “The more we talked about it, the more we thought the learning management system would do more for us than the website could,” she says. “We tested the waters and started out with putting content out there and testing features.”
Students were comfortable with the LMS, which they can use on mobile and tablet devices as well as laptops. This helped with the rollout in the 2016-2017 academic year.
For faculty, the change was a little more difficult.
“Initially, the feedback from the faculty was very mixed,” Williams says. “They were not comfortable moving away from the traditional website. I think the main reason is that some of the faculty had some challenging experiences with the learning management tool itself — not with the IRB portion of it, but with using it in their classes.”
The faculty assumed they’d also have problems with the IRB portion of the system, she adds.
“The students are very accustomed to using it and are accustomed to the online environment. They love it, and the faculty is on board now, although it has taken them a while,” Williams says.
Through the LMS, the researchers, students, and the IRB can access documents, hold meetings, and link to other IRB sites, including an online submission site.
“We have online application tutorials and sample applications and exemplars up there with step-by-step instructions or best practices for completing an application,” Williams says. “We have created a lot more outreach and support documents.”
For example, there is a student IRB FAQ that is designed to tell students how to get their IRB application approved.
The FAQ provides thorough answers to questions about why IRB approval is necessary and what a student needs to do to get his or her IRB application approved smoothly and quickly. The following are a few sample points for getting through the application process:
• Be clear and precise in your writing, providing a clear rationale for your research.
• Do not ask participants to disclose other people’s personal information, including mental health status, general health status, substance use, or illegal behaviors.
• Anonymize participation by using an anonymous online survey. Include the actual survey instrument in your IRB application.
• Describe the risks of participation in detail.
Another tool is the list of questions for the IRB application. The following are some of the items researchers need to include in their application, according to the list of questions:
• CITI certificate uploaded to the applicant’s profile.
• Student researcher/principal investigator name, and additional researchers’ names and contact information.
• Will the research involve internet data collection?
• Will the research involve the use of transcriptions?
• Will the research involve the collection or study of existing data or documents, and are these identifiable or publicly available?
• Will participants be photographed?
• Are there any research incentives for participants? What are the incentives?
• How will research participants be recruited, and upload recruitment materials?
• Will any information be collected that identifies participants?
• Provide information on how confidentiality and/or anonymity of research participants and their data will be ensured.
When IRBs start new initiatives, it might be time to revise and improve existing procedures and tools, such as standard operating procedures (SOPs).
“We rewrote all of our SOPs,” Williams says. “It was a good opportunity to do it, so we also rewrote IRB policy, the procedural manual, and it is far more detailed than it was in the past.”
For example, the privacy and anonymity section was expanded.
“We pulled out a couple of pieces that we hadn’t before,” she explains.
There are many students who want to study physical activity and how exercise can enhance mood. The IRB did not have guidance on how to approach that type of research, and questions sometimes came up.
“We wrote guidance and best practices about screening for appropriate participation, safeguards during the intervention, minimizing risks, identifying minimal risk and greater than minimal risk, and risk to the institution,” Williams says.
The IRB’s new tutorial and educational information includes screen shots, revised consent templates, and more guidance than was previously available.
“It started as a small site and grew,” Williams says. “The more we started to use it, the more guidance we put up there.”
Using the learning management system facilitated a more holistic look at IRB support and education for student researchers and other new investigators.
“It allowed us to provide better support resources, and to expand the conversation and talk more about minimizing risks and why we have an IRB,” Williams says.
1. Williams M. Improving IRB application success through a learning management system. Poster presented at the Public Responsibility in Medicine and Research (PRIM&R) Advancing Ethical Research Conference, Nov. 5-8, 2017, in San Antonio. Abstract: 11.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher, Peer Reviewer Robert Vogel, MD, JD, and Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.