Team-Based Design in Biomedical Engineering Education (R25)

This Notice of Funding Opportunity (NOFO), issued by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), encourages applications from institutions that propose to establish new or to enhance existing team-based design courses in undergraduate Biomedical Engineering departments or programs. This NOFO targets undergraduate students. Courses that address innovative and/or ground-breaking development, multidisciplinary/interdisciplinary training and clinical immersion are especially encouraged.

With this program, NIBIB supports courses focused on team-based biomedical design projects that prepare future engineers who can address NIBIB’s mission of leading the development and accelerating the translation of biomedical technologies to improve health. NIBIB encourages applications from institutions that propose to establish new or to enhance existing team-based design courses in Biomedical Engineering departments or programs. This funding opportunity targets undergraduate students. Courses that address innovative and/or ground-breaking development, multidisciplinary/interdisciplinary training, and diversity recruitment are especially encouraged. Also encouraged are courses that offer a clinical immersion period or emphasize the specific issues related to the translation and commercialization of developed products. Programs that involve students in the needs assessment and project identification/selection rather than assign them to predetermined projects will be given priority.

For the purposes of this program, clinical immersion is defined as a 6- to 10-week program, where students engage full-time in the hospital or other clinical environment becoming familiar with the language, issues, and problems that can benefit from an engineering approach. The clinical immersion period which is expected to be carried out under the supervision of (a) clinical mentor(s), will typically involve rotations at various departments of the hospital. Although students may be involved in solving some clinical problems during this time, the main purpose of the clinical immersion period is to observe the clinical activities, acquire communication skills necessary to interact with clinicians, and identify unmet needs that can subsequently be addressed in biomedical design projects.

Direct costs of up to $20,000 per year may be requested for parts and supplies, machine shop or prototyping costs, speaker fees, technical support, travel and other project- or course-related expenses. Faculty salary for the academic year may not be requested. Up to $5,000 may be requested as summer salary for PD/PI(s) that engage in activities that are not a part of their regular academic duties, such as coordinating a clinical immersion program or conducting workshops to discuss clinical immersion observations for needs identification and project development. Whether funds are requested for a single PD/PI or multiple PD/PIs, the total faculty salary request for the program cannot exceed $5,000 annually. Up to $5,000 may also be requested for a) technical staff who directly support students in their design projects and/or b) administrators who directly support a given aspect of the design or implementation of the course such as the restructuring of an existing course to enable interdisciplinary participation in the course, or working with clinical departments to establish and run a clinical immersion program. Total salary costs requested may not exceed $10,000 ($5,000 for faculty summer salary and $5,000 for the technical staff and/or administrators) annually.

Programs that include a full-time clinical immersion program outside the academic year (typically in the summer) may additionally request up to $20,000 in student salaries (at no more than $12 per hour, with $4,000 max per student). Participant costs other than these summer salaries are not allowed. Travel costs may only be requested for PD(s)/PI(s) or mentor(s) of the program to attend scientific meetings specifically to present activities and outcomes of the course/program supported by the NOFO , and not for students. In summary, a direct cost maximum of $40,000 per year can only be requested if a qualifying clinical immersion period is proposed in the application; if no clinical immersion period is proposed, the direct cost may not exceed $20,000 per year. Program durations of up to 5 years may be supported.

Projects supported by this NOFO may involve human subjects research (HSR). Applicants are encouraged to discuss the following two cases with their IRB to determine whether proposed interactions would be characterized as HSR:

1. Students as human subjects in an educational environment
   • Use of surveys or other tools to assess student learning is considered to be HSR and requires IRB review. As one of the goals of this NOFO is to evaluate the effectiveness of educational practices, it is anticipated that most projects submitted to this NOFO will include this type of HSR.
   • Educational HSR may qualify for an exemption. Your IRB would make that determination.
2. Human subject testing of devices/techniques developed by the students
   • Any testing performed on human subjects, regardless of whether the human is the student designer(s) themselves or another individual and regardless of risk to the participant, would be HSR. There are two common cases:
     1. If the design of the experiments and number of participants are known at the time of the application, applicants must provide full details of the HSR in the application
     2. If the design of the experiments is not known due to projects being selected by students after enrollment in the class, applicants may indicate “Delayed Onset” in their application. Prior to performing any experiments on humans, grantees must get NIBIB approval by sending a detailed human subjects section and IRB approval.

Programs must respond “Yes” to the Human Subjects question in the R25 application if either or both type(s) of HSR are included, even if exempt. Applicants need to follow all instructions in PAR-22-000. If both types of HSR are included in the program, each study must be clearly described under a separate heading.

Applicants are strongly encouraged to contact Dr. Dave Gutekunst before submitting an application.