A Learning Activity to Introduce Undergraduate Students to Bioethics in Human Clinical Research

Abstract

We developed a pharmacology practicum assignment to introduce students to the research ethics and steps involved in a clinical trial. The assignment included literature review, critical analysis of bioethical situations, writing a study protocol and presenting it before a simulated ethics committee, a practice interview with a faculty member to obtain informed consent, and a student reflective assessment and self-evaluation. Students were assessed at various steps in the practicum; the learning efficiency of the activity was evaluated using an independent survey as well as students' reflective feedback. Most of the domains of Bloom's and Fink's taxonomies of learning were itemized and covered in the practicum. Students highly valued the translatability of theoretical concepts into practice as well as the approach to mimic professional practice. This activity was within a pharmacy program, but may be easily transferable to other medical or health sciences courses.

Using IRB Protocols to Teach Ethical Principles for Research and Everyday Life

“…The data demonstrate that a modified IRB protocol experience within a CURE is associated with increased understanding of the three BREPs and how to apply them to everyday-life experiences. This result is consistent with previous findings showing that such experiences were associated with greater appreciation of ethical research principles (Kallgren & Tauber, 1996) and issues of informed consent and participant risks (Segarra & Gomez, 2014). The current investigation demonstrated that a mentored IRB-like activity was related to increased knowledge of ethical research issues as proposed by Hubbard and Ritchie (1995) as well as Olszewski (2019).…”

“…Increasingly, undergraduate research is being highlighted as an important opportunity for learning through an HIP (Kuh, 2008) by engaging students in faculty-led research and encouraging students to develop their own research projects in independent studies and senior capstone projects. This HIP can also involve introducing research into existing course instruction through course-based undergraduate research experiences (CUREs; Brownell & Kloser, 2015;Corwin, Graham, & Dolan, 2015;Segarra & Gomez, 2014;Teixeira-Poit, Cameron, & Schulman, 2011). Research on undergraduate research and CUREs has shown that students benefit from this mentored experience through increased knowledge and skill acquisition (Adedokun et al, 2014;John & Creighton, 2011;Stanford, Rocheleau, Smith, & Mohan, 2017), feelings of achievement in project ownership and selfefficacy (Adedokun et al, 2014;John & Creighton, 2011;Sandquist, Cervato, & Ogilvie, 2019), higher retention and graduation rates (Stanford et al, 2017), and greater commitment to the profession (Adedokun et al, 2014 ;Helm, & Bailey, 2013).…”

“…More instructors have been turning to these hands-on experiences, including writing and defending IRB-like protocols, when teaching research ethics (e.g., Danowitz, Brown, Jones, Diegelman-Parente, & Taylor, 2016;Diaz-Martinez, et al, 2019;Kallgren & Tabuer, 1996;Olimpo, Diaz-Martinez, Bhatt, & D'Arcy, 2017;Olszewski, 2019;Segarra & Gomez, 2014). The few existing studies on the benefits of using IRB-like procedures have shown that students reported an appreciation for ethical issues (Kallgren & Tabuer, 1996) and were more likely to address issues of informed consent and risks to participants in study design (Segarra & Gomez, 2014). Interestingly, Mabrouk (2016) found students who were involved in undergraduate research activities may tend to understand ethical concepts but not necessarily be able to apply them to their own research.…”

Moral dilemmas involving anthropological and ethical dimensions in healthcare curriculum

“…33 This is consistent with the outlook in professional decision making and validated in preliminary studies. 24 The initial theoretical reflection on moral concepts and the coherence with which the dilemmas are raised in both General Anthropology and Ethics-Bioethics facilitates critical evaluation of the ethical questions in a larger perspective. 34…”

“…23 These cases offer the students real-like situations and scenarios in routine practice and require reflection and implementation of the most basic professional qualities, fundamentally prudence. 13,24…”