To improve institutional oversight of health professions education research projects and to aid the health professions education researcher at Duke University in study design and submission to the IRB, the Duke IRB has a research template specifically for health professions education research projects.
The goal of this template is to help researchers conduct a careful review of study plans and later to develop precise descriptions of research methodologies (both quantitative and qualitative), any risk to study subjects, and data management/security in their research summary documents. This will help the Duke IRB provide a complete and timely review of health professions education research proposals.
In iRIS, this Education Research Project Template is part of the application.
Education research projects include evaluation of teaching sessions, curricula, courses, programs, simulations and surveys that represent an important means by which Duke University and Duke University Hospital/Health System (DUHS) achieves its mission of training health professionals to provide effective and safe care for their patients, loved ones and each other. Education research projects range in scope from local efforts to improve the quality of teaching to larger trials of innovative methods designed for a more generalizable impact. Regardless of the project’s size, the education project leader(s) must determine whether the project meets the federal definition of research with humans. If it does, the leader(s) must then consider whether the research may qualify for exemption from further review by the DUHS Institutional Review Board, and if so, consider requesting such an exemption.
Research summary templates for DCRI coordinating centers and DCRI data/specimens repository protocol submissions have been posted on the IRB web site under (Forms/):
1) Coordinating Center Regular Study Application Research Summary Template for iRIS submission of a multi-site clinical research protocol, regular study application in which Duke is “engaged in research” and serves as a Coordinating Center (e.g., central clinical coordinating center, statistical coordinating center) or provides a central resource (e.g., Data Coordinating Center, Health Economics and Quality of Life (EQOL) coordinating center, Clinical Events Committee, Central Imaging, etc.) for the study.
2) Coordinating Center Request for Exemption Research Summary Template for iRIS submission of a multi-site Coordinating Center Study Application research protocol (e.g., central clinical coordinating center, statistical coordinating center, or a central resource such as Data Coordinating Center, Health Economics and Quality of Life (EQOL) coordinating center, Clinical Events Committee, Central Imaging, etc.) in which Duke may be considered “not engaged in human subjects research.”
3) Database and Specimens Repository Research Summary Template for iRIS submission of a data and/or specimens repository protocol from DCRI under which samples and/or private information are collected and stored for future research.
Note that to obtain an authoritative determination of whether an activity is exempt from further IRB review, the Faculty/Staff Member must request confirmation from the IRB that an activity does or does not constitute research with human subjects, and whether the project involving research with human subjects qualifies for exemption from further IRB review or meets the definition of “not engaged in research”. If you think your project may qualify for exemption, please submit the project to the IRB and choose the option ‘Application for exemption from IRB Review’ in iRIS.
The policy titled “Quality Improvement Activities in Health Care Versus Research” distinguishes between QI projects not requiring IRB review, and those projects that cross the regulatory line into the area of research involving human subjects, requiring IRB review. A checklist is provided at the end of the policy to assist clinicians and researchers planning to conduct QI projects, to help determine whether their proposed activity may require submission to the DUHS IRB.
A clinician/investigator or staff member may always request an authoritative determination from the IRB to confirm or assist with determining if an activity is a quality improvement project. To obtain this determination, the project should be submitted through iRIS using the new QI template summary, found on the “Forms” page of the IRB website.