DMU operates under high ethical standards to earn and sustain the trust and respect of the public, research participants and the research community. Its Institutional Review Board (IRB) is a committee that is mandated by federal law to review and approve all research that involves human subjects. The IRB’s purpose is to protect human subjects’ rights and welfare and support the institution’s research mission. By requiring local review, the federal government requires local responsibility that is both institutional and individual at the level of the investigator.
Recently, Lisa Grant, a third-year podiatric medical student, and R. Tim Yoho, D.P.M., FACFAS, dean of DMU’s College of Podiatric Medicine and Surgery, submitted an IRB application requesting approval to research his project, “Dissimilarity in Charcot Ankles versus Charcot Midfoot.” Its goal was to identify current bone quality in patients with Charcot, a serious condition that causes weakening of the bones in the foot, by using biomarkers and DEXA scans. With their results, these researchers hope to be able to characterize Charcot types. Also included in the project was a plan to collect blood samples for serum Vitamin D to further evaluate subjects’ bone status.
In reviewing the application, the DMU Office of Research noted the high quality in which this application was put together. Key components that made it stand out included well-developed, specific goals, a clear and concise informed consent document for the participants, and a thorough explanation of the whole project in both scientific and layperson’s terms, each of which are required for the IRB process.
“The application really had an excellent balance of strong science and attention to patient protection,” says Jeffrey Gray, Ph.D., DMU’s vice president for research.
Both Grant and Yoho reported they felt the research process was fairly easy and straightforward. Their first step, as is recommended for all investigators, is to seek funding for the project. Their team sought funding from DMU’s internal funding source and submitted a Research and Grants (R&G) grant application to support that. This application went through a peer review process by the R&G committee. Once that process was under way, the team started on the IRB application.
Grant and Yoho found that the IRB application required much of the same information that was developed for the R&G application. On the components they had questions about, they contacted the Office of Research Compliance Manager Diane Ament, who guides DMU researchers throughout the process whenever needed.
“All our questions were answered adequately, and the turnaround time was impressive,” Yoho says.
One area that can be difficult for scientists is to summarize the project in layperson’s terms; this is needed so that all patients completely understand the project.
“The proposal should be written so that your neighbor can understand the language,” Ament notes.
She praises Yoho’s application for IRB approval. “It’s one of the best I’ve seen since joining DMU,” she says. “All of the questions were thoroughly and carefully addressed, it was easy to understand the progression of the study from recruitment of volunteers to the final steps of data analysis, and all of the necessary attachments – such as the informed consent document and advertisements – were included.”
In working on their informed consent document, Yoho and Grant found collaboration with other faculty members who had completed this process to be especially helpful. They reviewed sample documents to learn what had been used in approved protocols. Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether to participate.
When putting together all of their information to create their IRB proposal, Yoho and his colleagues on the Charcot project kept in mind their potential to gain external funding.
“Building a strong foundation within our internal applications, both the IRB and R&G, was what we needed to start down the path of applying for external grant opportunities,” Yoho says.
Grant says completing required training also was helpful in submitting a high-quality proposal. To be eligible to conduct research on DMU’s campus, investigators must complete some training modules relating to the type of research each project entails
“Taking the training gave me much needed guidance I would not have gained elsewhere,” she says.
DMU’s Office of Research is ready to help all University faculty and students in preparing research proposals. Faculty can use Pulse to find forms needed for the application process and also guidance for completing the necessary documents.
The Office of Research is located in Ryan Hall, Room 209; phone, 515-271-1445.