Design and conduct of clinical research: Raising awareness of ethical aspects in biopharmaceutics for students of Biotechnology Engineering

One of the Biotechnology Engineering (BE) education pillars is to train students to be committed to protecting the quality, safety, and efficacy of bioproducts, promoting respect and professional responsibility. This leads us to the following questions: How to make students aware of the fundamental ethical aspects of clinical research? This project's main objective was to immerse students in a real-life scenario where they designed and submitted a clinical research protocol to an Institutional Review Board (IRB). We assessed the development of ethical sensitivity and technical knowledge through this experiential learning strategy compared to a conventional learning method. The didactic intervention was conducted in the fall semester of 2018 (PBD18) with senior BE students, and we compared the results with a conventional learning method on different groups. For PBD18, the activity included the following: a team project consisting of the design, IRB submission, execution of a basic clinical protocol, technical report, final presentation, and an individual essay. All groups were evaluated with an exam. The project presentation was graded and evaluated by faculty members. PBD18 students designed two randomized non-invasive clinical protocols that were IRB approved and recruited 60 healthy subjects. The IRB presentation was a formal, dynamic, and fulfilling experience. This activity prepared them to perform the presentation for faculty evaluators better than other groups (p<; 0.001). In terms of knowledge, groups' grades were significative different (p =0.039). By including research projects associated with experiential scenarios, students were sensitized on bioethical principles in clinical research. Students' interaction with the IRB allowed lifelong learning, making the assignment more challenging and meaningful.