557238
research-article2014
JREXXX10.1177/1556264614557238Journal of Empirical Research on Human Research EthicsSegarra and Gomez
Research Ethics Education
A Learning Activity to Introduce Undergraduate Students to Bioethics in Human Clinical Research: A Case Study
Journal of Empirical Research on Human Research Ethics 2014, Vol. 9(5) 56–63 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1556264614557238 jre.sagepub.com
Ignacio Segarra1 and Manuel Gomez2
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. Keywords clinical trials, bioethics, research ethics, human subjects, pharmacology, medical education, Fink’s taxonomy, Bloom’s taxonomy Over the past decade, student learning has gradually shifted from teacher-centered to learner-centered and from a structured space and classroom setting to a dispersed environment (Blouin et al., 2009). In addition, students gather information efficiently from a variety of sources, and not exclusively from lectures or conferences in a defined setting like classrooms or laboratories. These features, together with the availability of standardized, cost affordable, and easy to use information technology devices, have displaced learning focused on information transmission to information compilation (Goodyear & Ellis, 2008). Nowadays, genuine learning may take place within a social, diverse, and fragmented environment where experiential events take priority (Clayton, Brinthaupt, & Draude, 2008). In this “scenario of learning,” it becomes necessary to identify appropriate and optimal tools that simulate and mimic real world scenarios to ensure that students acquire sufficient knowledge and competences for their professional practice (Stuart, 2007). New technologies have made possible innovative teaching tools with a variety of teaching and learning applications in health sciences (Khogali et al., 2011; Mpotos, De Wever, Valcke, & Monsieurs, 2012; Vyas, Wombwell, Russell, & Caligiuri, 2010) as well as continuing professional development and practice (Bridges, Davidson, Odegard, Maki, & Tomkowiak, 2011; van de Wiel, Van den Bossche, Janssen, & Jossberger, 2011). In this context, the application of
non-traditional active learning requires a clear understanding of the learning goals and key elements that configure the learning process. This integrative approach to activity/ curriculum design is crucial to ensure lasting, effective, and efficient learning (Goodyear & Ellis, 2008; Koole et al., 2011; O’Neill & Murphy, 2010). In the bachelor of pharmacy degree at San Jorge University (Zaragoza, Spain), students progress along a 5-year course of 300 European Credit Transfer System (ECTS) to acquire practice competences. During the first 2 years of the program, the students take mostly basic science modules (e.g., human biology, physical chemistry, statistics, etc), laboratory instruction, and are gradually introduced to pharmaceutical care (the correct use of medicines). In Years 3 and 4, the students progress toward clinically driven subjects (pharmacokinetics, clinical pharmacy, toxicology, etc) and pharmaceutical technology and development-related modules. During the last year, the students would undergo hospital and community 1
University of Barcelona, Barcelona, Spain San Jorge University, Zaragoza, Spain
2
Corresponding Author: Ignacio Segarra, Faculty of Pharmacy, Department of Pharmaceutical Technology, Clinical Pharmacy and Pharmacotherapy Unit, University of Barcelona, C/Sant Albert 4, 08197 Valldoreix, Barcelona, Spain. Email: [email protected]
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Segarra and Gomez
Activity Design
Table 1. Levels of Learning. Bloom’s taxonomy of learning (hierarchical)
Fink’s taxonomy of significant learning (non-hierarchical)
Evaluation (highest level) Synthesis Analysis Application Comprehension Knowledge (lowest level)
Foundational knowledge Application Integration Human Dimension Caring Learning how to learn
pharmacy clerkships, carry out a research project, and take modules related to research ethics (Universidad San Jorge, 2012). However, students are first introduced to clinical research ethics during the third year in two main subjects: a 12-ECTS module on biopharmacy and pharmacokinetics, and a 6-ECTS module on general pharmacology. Both modules include theory and practical work and develop the basis to understand drug behavior in the body, the main mechanisms of action, and its therapeutic potential through clinical trials. It is in relation to this last part that students are introduced to the basic concepts of bioethics involved in clinical research. Assessment is specific for each module and may include class tests, individual course work, group course work, practicum assignments, and a final exam. The weight of each assessment toward the final board mark would vary for each module (Universidad San Jorge, 2012). To introduce the students to basic clinical research ethics, we designed a set of activities taking into account the two most relevant taxonomies of learning (Table 1): Bloom’s taxonomy of educational objectives and Fink’s taxonomy of significant learning. Both taxonomies aim to align learning goals and assessment methods based on the learning scope (O’Neill, 2010). Bloom’s taxonomy focuses on a hierarchical approach to content-based learning, where the student progresses toward higher order cognitive skills. Differently, Fink’s taxonomy of significant learning puts emphasis on skills acquisition and their relational aspects with other domains of learning. Thus, it is not hierarchical but interactive (Fallahi, 2011; Fink, 2003). The aim of this practical assignment is to familiarize the students with the basic ethical concepts involved in the execution of a clinical trial. The overall practicum was designed to encourage students to identify, discuss, and evaluate ethical approaches to human research (Anderson et al., 2012; Plemmons & Kalichman, 2013). In keeping with this goal, we also aimed to gather information about the students’ learning process to update our curriculum. This case study of the practicum activities identifies the strengths and weaknesses of this approach, to guide further teaching improvement.
Students were given the following assignment: to evaluate the ethical issues that arise during the development of a clinical trial to compare the pharmacokinetics of a drug in two different populations. The students were allowed to enter freely in nine groups of three to four students each, and asked to identify the steps involved in a clinical trial including the preparation of a study protocol. A flowchart of the practicum with the requested output of each activity and approximate time distribution is shown in Figure 1. Each activity of the practicum was designed to target specific cognitive competences described in Bloom’s and Fink’s taxonomies of learning (Table 2).
Review and Analysis of Fundamental Bioethics Concepts The first activity of the practicum focused on the basic ethical principles of research on human subjects. The students were asked to perform a thorough review and critical analysis of four main documents that address ethics in human experimentation: the Hippocratic Oath (ca. 400 bc), the Nuremberg Code (1947) the Declaration of Helsinki (1964), and the UN Declaration of Bioethics (2006). On completion of the review, and with these concepts in mind, the students identified, evaluated, and discussed the bioethical issues portrayed in the commercial film “Extreme Measures” (Apted, 1996), which portrays different ethical positions toward the enrolment of patients in research and their vulnerability. Following the film, an open discussion forum was started to facilitate critical analysis and peer review within the group of students (Plemmons & Kalichman, 2013). Last, each group of students submitted a synthesis of the documents and a short essay developing their critical analysis of the research ethics positions portrayed in the film. These assignments were assessed and contributed toward the general pharmacology module.
Preparation of an Experimental Protocol The next step in the practicum was the preparation of an experimental protocol for a simulated clinical trial. The main learning objective of this task was to identify the different parts that comprise a clinical study protocol. To attain this goal, the students were asked to write a clinical protocol for a study proposal with the information available in the literature. Each group also prepared an addendum to the protocol including a model interview and a ready-to-sign informed consent form. We aimed to maximize the learning scope and experience of the practicum by requiring the students to present the experimental protocol before a simulated ethics committee composed of staff of the School of Pharmacy and
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Journal of Empirical Research on Human Research Ethics 9(5)
Output - Hippocratic Oath - Declaration of Helsinki - Nuremberg Code - Declaration on Bioethics
Review & Analysis
- Critical synthesis - Short essay
Schedule 1h Workshop1
- Video "Extreme Measures"
Debate
- Goals and Objectives - Literature Review
Study Design
- Short essay
3h
- Study Protocol 2h - Informed consent form Workshop2
Simulated Ethics Committee
Volunteer Interview
- Observation
1h
- Volunteer recruitment - Volunteer feedback
1h
Review Session
Workshop3 - On-line Lecture
Evaluation
- Performance essay
2h
Figure 1. Flowchart of the practicum: Sequence of the activities and tasks during the practicum assignment, the output of each activity, as well as the approximate time allocation needed for the activity. Table 2. Competences Map of the Activities: Integrated Mapping of Expected Outcomes, Cognitive Competences, and Tasks Executed by the Students Correlated With Bloom’s Taxonomy of Learning and Fink’s Taxonomy of Significant Learning. Assignment
Expected outcome
Activity
Review of selected documentation Viewing a medical ethics related film Literature review
Knowledge of the relationship between researchers and subject-volunteers. Identification of ethical positions
Study protocol
Identify the essential parts Identification of failures
Stepwise protocol
Ability to select and recruit subjects Identification of study deficiencies
Subject interview Informed consent Visualization Summary essay
Ethics review Subject recruitment Viewing of a lecture on clinical trials
Evaluation of previous studies
Cognitive competences
Bloom’s taxonomy
Fink’s taxonomy
Active reading Critical essay Group discussion
Critical analysis
Knowledge Comprehension
Fundamental knowledge
Visualization Summary essay Guided debate Summary of previous studies
Critical analysis Relational analysis
Comprehension Analysis
Fundamental knowledge
Critical review Synthesis of information Structuring of information Effective communication Effective communication Self-appraisal
Synthesis
Integration
Synthesis Application Evaluation
Integration
Brief presentation
Application Evaluation
Learning how to learn Human Dimension Application Learning how to learn
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Segarra and Gomez Health Sciences: a pharmacokinetics expert, a practicing nurse, a scientist, a laboratory technician, and three students randomly selected. Last, each group submitted their protocol proposal for assessment.
Subject Recruitment, Data Collection, and Analysis The next activity of the practicum focused on the concept of informed consent. Students were required to interview and obtain informed consent for their simulated study. It was necessary for the students to schedule an appointment with a volunteer (a faculty or staff member of the School of Pharmacy) for an informative interview and a follow-up meeting to collect the signed informed consent form. This step was assessed based on feedback provided by the “volunteers” about the performance of the students in the interview, the depth of the explanation, the relevance of the information provided, the possibility to ask questions, and overall communication skills.
Reflective Assessment and Self-Evaluation Self-assessment and an individual reflective essay were required after the study. This was augmented with a lecture conference on the design of clinical trials (Flaherty, 2007). The main purpose of this post-study activity was to encourage self-appraisal and evaluation of their learning in view of the standards proposed in the conference (Plemmons & Kalichman, 2013). Each student summarized the main aspects of the conference and wrote a short critical report addressing the differences between the model clinical trial presented in the conference and their study proposal (Koole et al., 2011).
Results and Discussion The teaching of bioethics and clinical ethics at an undergraduate level has been traditionally based on the reading of principles and regulations to ensure that the process complies with the law (Fox, Arnold, & Brody, 1995). Changes in student learning habits and teaching methodologies encourage active learning activities that simulate and mimic working scenarios. For this, simulation tools have been developed with virtual environments for a variety of learning purposes including simulated clinical situations, simulated patients, or combination of both to integrate conceptual learning and competency (Duvivier et al., 2011). We aimed to develop a practicum composed of a set of structured activities in a step-wise sequence to avoid fragmentation of the learning experience. The design was carefully sequenced to allow learning in each step based on the competences and concepts acquired in previous ones according to the comprehensive map of the cognitive and learning goals shown in Table 2.
Preliminary Review of Fundamental Concepts The initial task, to review and discuss the foundations of medical ethics, was attractive for the students as it shifted their role from passive receivers to active learners. During the review of the four selected documents, the students identified the gradual steps incorporated in each declaration and how the essence of each document revolves around the respect of the patient (or subject-volunteer) as a person with full rights and dignity to be protected. In particular, they were encouraged to identify features regarding vulnerability and factors affecting informed consent. In this context, an interesting observation was that some students viewed the Nuremberg Code as a more subject-volunteer oriented document versus the Declaration of Helsinki, which was portrayed as more method-oriented to ensure validity and quality of the results (Bertholf, 2001). After their essay was submitted, students watched the film “Extreme Measures” (Apted, 1996) and participated in a guided debate focused on the learning goals. In the debate, the students identified various scenes that had bioethical relevance. In the first scene of the movie, the physician (and main character of the film) in charge at the emergency room is confronted with the decision to choose between first treating a robber who has been shot by a policeman and the policeman himself whom the robber shot. The medical condition is critical in both patients although it is not at the level of immediate fatal development. There are other circumstantial factors that may weigh on the decision. The students raised different points of view regarding whether the physician took an ethics-based decision when he chose one patient and not the other and the influence of the other factors in the decision. The second point of debate was about the statement “what would you do to walk again?” delivered by a scientist to justify his intended research. In this scene, the physician finds himself in a hospital bed and paralyzed from neck down, the same situation for which the research scientist is seeking an experimental cure using homeless subjects. The physician’s answer, “Anything,” changes the perspective of this question toward a more general one of “what would you do to ensure your quality of life?” It also illustrates a change of attitude produced in the physician on experiencing his own full paralysis. In the discussion that ensued, the students concluded that there are some human rights that cannot be denied to the individual for the greater good of others, even if the subject would decide to do so. Some students based this decision mostly on the Hippocratic Oath (also brought into the movie in a later scene) as well as the various declarations protecting vulnerable subjects (Bertholf, 2001). Furthermore, the change of attitude of the physician was deemed to be unrelated and not coherent with the requirement to protect the dignity of vulnerable subjects, as opposed to furthering a scientific gain.
60 In the last scene of the film, the wife of the scientist gives the physician laboratory records and data that were generated via the unethical research approach that the scientist was defending. The students were required to consider whether data collected in unethical ways should be used. The students discussed this question looking at the different ethical approaches portrayed in the film: Kantian ethics, utilitarianism, consequentialism, and principlism ethics. The debate following the film showed the ability of the students to identify, understand, and contextualize the key elements that underlie general medical ethics decision criteria. It also allowed them to apply the concepts retrieved from the main documents to the simulated situations of the film. This allowed them to build their own skills of critical thinking and analysis starting from the source documents (Table 2).
Student Level of Learning An attempt into “translational bioethics” was made in this practicum: Each group of students wrote a study protocol and presented it before a simulated ethics committee. For this, we mimicked the functions and roles of an Institutional Review Board (IRB) to evaluate the protocol. The simulated IRB focused attention on the protection of vulnerable subjects through a variety of questions. In this exercise, we found an unexpected learning opportunity: Students noticed the operational differences among the proposals presented. This enhanced the importance of the technical review for each clinical study. The simulated IRB provided feedback to them. The analysis of the written protocol sent by each group of students reveals some interesting features. Overall, the identification of the researchers, the description and rationale of the experiment (study objectives), the inclusion and exclusion criteria, and data collection procedures (reporting data sheet, code-key to ensure the confidentiality of the volunteer information) were included in all protocols. However, some protocols lacked essential information such as the informed consent form, the patient data sheet, or the drug administration procedure. A total of 17 different items comprised the protocol, and these were sorted in three main groups (Table 3): the introduction and general description (Items 1 to 6), the clinical study methodology and procedures (Items 7 to 11), and the volunteer recruitment process (Items 12 to 15). Our findings indicate that the items related to methodology were included in all protocols with the exception of one. This seems consistent with the students’ expected level of competence and training in the pharmacology and clinical pharmacy modules and the previous activities of the practicum. However, we observed diverse levels of response in the other two categories: Research concepts such as conflict of interest (Item 1), study keywords (Item 3), research question (Item 4), formulation of a hypothesis (Item 6), and a description of the limitations of the study (Item 16) were
Journal of Empirical Research on Human Research Ethics 9(5) absent across the groups. This observation suggests some insights into their training and learning process: •• It shows some knowledge fragmentation that prevents the students from linking individual aspects (conflict of interest) with the driven force of a study (to verify a hypothesis). •• It may point out a preference for the analytical dimensions of the study versus the integration of the different components. An explanation of this finding may relate to the emphasis to acquire technical skills during the first 2 years of the pharmacy curriculum, which may not include formal training in research methodology. Therefore, “synthesis” and “integration” domains (Bloom’s and Fink’s taxonomies, respectively) may have not been acquired yet. This feature stresses even more the need to develop learning activities that facilitate integration of learning under a learning goal (Blouin et al., 2009). •• Absent in most groups were also the definition of a clear target population for the study (Item 7), a model interview (Item 13), the risks related to the study (Item 15), the limitations of the study (Item 16), and the budget to carry on the study (Item 17). Some of these aspects are related to the direct execution of a clinical trial and learned during work exposure (van de Wiel et al., 2011). This also suggests the need to integrate these concepts in the curriculum to ensure the learning outcomes and competences expected from pharmacists, even when these competences may not be directly related to clinical practice (e.g., management, finance skills, etc). Communication skills and information presentation were also evaluated. Each subject-volunteer submitted an assessment of the informative interview with the students and their performance. The volunteers assessed six aspects of the interview: confidentiality and privacy, the clarity of the explanation of the study, the possibility to ask questions, the scheduling of the interview, time planning of the simulated study, and, finally, their motivation. Each item was scored following this scale: 0—if that item was absent or not done, 1—if their performance was worse than expected, 2—if their performance was in accordance with the expectations, and 3—if their performance exceeded expectations. It is important to note that these results can only be evaluated from a general, qualitative point of view because it is a very small sample (only nine groups) and the assessment method is not free of subjectivity. Overall, exceeding expectations scores were achieved in items “study planning” and “motivation,” and meeting expectations (Score 2) was found in most questions. These results, although limited, may reflect the interest shown by the students in this kind of activity (Duvivier et al., 2011).
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Segarra and Gomez Table 3. Students’ Performance in the Preparation of the Study Protocol.
Protocol Section Introduction Conflict of interests Researchers ID Key words Research question Objectives Hypothesis Methodology Target population Inclusion criteria Exclusion criteria Administration procedure Data collection procedure Recruitment Informed consent form Model interview Patient data sheet Risks Others Limitations of the study Budget Performance level (% or total score)
Student Group
Item ID
1
1 2 3 4 5 6
+ + + + + +
7 8 9 10 11 12 13 14 15
2
3
4
5
+
+
+
+ +
+
+
+ + + + +
+ + + +
+ + + +
+ + + +
+ +
+
+
+
+
+
+ +
+ +
+
9 53
+ + 12 71
16 17 13 82
+
6
7
8
9
+ +
+
+
+
+ +
+
+
+
+ + + + +
+ + + +
+ + + +
+ + + + +
+ + +
+ + + +
+ + + +
9 53
10 58
11 65
+ + + +
7 41
5 29
12 71
Score 2 (22%) 7 (78%) 1 (11%) 3 (33%) 9 (100%) 1 (11%) 3 (33%) 9 (100%) 9 (100%) 8 (89%) 9 (100%) 8 (89%) 3 (33%) 8 (89%) 5 (56%) 2 (22%) 1 (11%)
Note. The students identified 17 items to form part of a protocol but there were different levels of performance across the groups. (+) means that the group included that item in their protocol proposal.
Student Reflective Feedback The last task in this practicum was to watch the lecture “Drug studies: Who, what, when, where and why” (Flaherty, 2007). The main goal of this task was to foster self-reflection on their own performance, and to motivate self-directed learning (Duvivier et al., 2011; Plemmons & Kalichman, 2013). The students identified the differences between their own study design and the study design proposed in the lecture. Students found the most relevant difference in the design and methodology, which would limit the significance of their study versus a randomized, double blind, controlled study. Additional features of their self-reflection were the failure to clearly define the target population, the concern about procedures to avoid conflict of interests, and how to ensure that the volunteer had understood everything.
Facilitating Learning This step-wise activity around a clinical trial creates an optimal scenario to achieve the learning outcomes. Based on Bloom’s and Fink’s taxonomies of learning (Table 1), we could align most of these activities with the learning domains (Table 2). Comparing both taxonomies of learning,
we observed that Bloom’s taxonomy describes this set of activities better than Fink’s taxonomy. This difference may reflect how the construction of the domains of each taxonomy differs in the evaluation of activities. Bloom’s taxonomy of learning is more conceptual than Fink’s taxonomy (Fallahi, 2011; O’Neill & Murphy, 2010). In addition, there are some aspects included in Fink’s taxonomy (human dimension and caring), which are difficult to translate unless a more real scenario is implemented. However, in an indirect manner, these concepts were present in the appreciation for subject vulnerability and autonomy during the interview process. However, no explicit assessment for “caring” and “human dimension” domains was considered during the interview as the students interacted in a predefined context. From a strict perspective, the activity failed to meet two key domains proposed in Fink’s taxonomy of significant learning. A modification of the interview assessment may create the opportunity to introduce them to these dimensions of professionalism. This is a limitation of our activity design as described here. Students’ independent feedback of the pharmacokinetics and pharmacology courses was collected by the Quality Assessment Department of the university using a standardized survey. Students evaluate in a 0 to 10 range scale aspects
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Journal of Empirical Research on Human Research Ethics 9(5)
Table 4. Representative Student Feedback. Commentaries From the Different Feedback Collected From the Students. The Feedback Was Collected Anonymously. •• “We have appreciated how complex it is to carry them out [human studies] and how exhaustive study and long-term follow-up are needed to reach a correct and robust conclusion. Moreover, with this experience we are more conscious and deeply acknowledge that thanks to the large efforts and work of so many researchers, we have excellent sources available to continue working.” •• “This practical has been a really good learning experience . . . it has mimicked closely the overall processes involved in the professional scenario. It has allowed us to learn and to navigate the different steps involved in a clinical study as well as to solve and overcome limitations which we may face along other projects.” •• “The practical of the pharmacokinetic study was very interesting and the scope was fitting. It allowed us to learn how to develop a protocol.” •• “I have been able to appreciate the application of theoretical concepts which facilitated its understanding and draw very positive conclusions.” •• “The practical has helped me much to understand the theoretical concepts as they were fully correlated with each other.”
such as the laboratory facilities, content delivery, and a variety of items related to teaching and learning activities. It evaluates the whole module (e.g., biopharmacy and pharmacokinetics, general pharmacology) separately and it is not possible to isolate a score for each specific practicum assignment. However, the students have the possibility to include anonymous comments and suggestions for improvement, or aspects they may dislike. Their comments and feedback seemed to indicate that the students highly valued the intertwining of the theoretical concepts (lectures) with their practical translatability (Table 4). These findings seem consistent with other reports indicating that blending experiential methods with deliberate practice in ad hoc scenarios is effective for the acquisition of professional skills (Plemmons & Kalichman, 2013; van de Wiel et al., 2011).
Final Remarks The need to deeply understand the foundations of ethical behavior in clinical research is increasingly becoming more important due to the transnational scope of clinical research (Aultman, 2013; Francer et al., 2014). This goal not only includes the scientists developing the research projects, but it also involves other support staff, technicians, and the volunteers and the social community where the research is developed (Anderson et al., 2012; Gonzalvo-Cirac, Roqué, Fuertes, Pacheco, & Segarra, 2013). The introduction of bioethics education programs in health sciences studies (e.g., pharmacy, nursing, dentistry, etc) should be encouraged to train health professionals on responsible research ethics (Bauchner & Fontanarosa, 2013; Bertholf, 2001). We find it necessary to encourage the gradual and systematic introduction of bioethics. The set of activities described here provides a starting point toward the design of a more comprehensive practicum/curriculum able to assess all the domains of both taxonomies of learning. Our student-centered approach met most of those domain criteria but failed to meet some domains described in Fink’s taxonomy of significant learning. Therefore, a further research
agenda to meet these goals will need to develop specific designs, including controlled studies, additional learning tools, and deeper analysis of the learning process to clearly differentiate both approaches and to measure the level of acquired skills to ensure an efficient learning of ethical issues in clinical trials (Bridges et al., 2011; Francer et al., 2014). Acknowledgments The authors thank the faculty and the staff of the School of Pharmacy (San Jorge University) for their participation as simulated volunteers. The authors are thankful to Ms. C. Suarez for technical assistance.
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References Anderson, E. E., Solomon, S., Heitman, E., DuBois, J. M., Fisher, C. B., Kost, R. G., . . .Ross, L. F. (2012). Research ethics education for community-engaged research: A review and research agenda. Journal of Empirical Research on Human Research Ethics, 7(2), 3-19. Apted, M. (1996). Extreme Measures. Retrieved from http://www. imdb.com/title/tt0116259 Aultman, J. M. (2013). Abuses and apologies: Irresponsible conduct of human subjects research in Latin America. The Journal of Law, Medicine & Ethics, 41, 353-368. Bauchner, H., & Fontanarosa, P. B. (2013). Restoring confidence in the pharmaceutical industry. Journal of the American Medical Association, 309, 607-609. Bertholf, R. L. (2001). Protecting human research subjects. Annals of Clinical & Laboratory Science, 31, 119-127. Blouin, R. A., Riffee, W. H., Robinson, E. T., Beck, D. E., Green, C., Joyner, P. U., . . . Pollack, G. M. (2009). Roles of innovation
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Segarra and Gomez in education delivery. American Journal of Pharmaceutical Education, 73(8), Article 154. Bridges, D. R., Davidson, R. A., Odegard, P. S., Maki, I. V., & Tomkowiak, J. (2011). Interprofessional collaboration: Three best practice models of interprofessional education. Medical Education Online, 16, Article 6035. Clayton, M. A., Brinthaupt, T. M., & Draude, B. J. (2008). Serving students by helping faculty: Encouraging instructional technology integration. Academic Leader, 24(3), 5-6. Duvivier, R. J., van Dalen, J., Muijtjens, A. M., Moulaert, V. R. M. P., van der Vleuten, C. P. M., & Scherpbier, A. J. J. A. (2011). The role of deliberate practice in the acquisition of clinical skills. BMC Medical Education, 11, Article 101. Fallahi, C. (2011). Using Fink’s taxonomy in course design. Observer, 24(7). Retrieved from http://www.psychologicalscience.org/index.php/publications/observer/2011/september-11/using-finks-taxonomy-in-course-design.html Fink, L. D. (2003). What is “significant learning?” Retrieved from.pdf http://www.wcu.edu/WebFiles/PDFs/facultycenter_SignificantLearning Flaherty, J. (2007). Drug studies: Who, what, when, where and why. Retrieved from http://www.youtube.com/watch?v=JdK1sAlsjM&feature=youtube_gdata_player Francer, J., Izquierdo, J. Z., Music, T., Narsai, K., Nikidis, C., Simmonds, H., & Woods, P. (2014). Ethical pharmaceutical promotion and communications worldwide: Codes and regulations. Philosophy, Ethics, and Humanities in Medicine, 9, Article 7. Fox, E., Arnold, R. M., & Brody, B. (1995). Medical ethics education: past, present, and future. Academic Medicine, 70(9), 761-769. Gonzalvo-Cirac, M., Roqué, M. V., Fuertes, F., Pacheco, M., & Segarra, I. (2013). Is the precautionary principle adaptable to emergency scenarios to speed up research, risking the individual informed consent? American Journal of Bioethics, 13(9), 17-19. Goodyear, P., & Ellis, R. A. (2008). University students’ approaches to learning: Rethinking the place of technology. Distance Education, 29, 141-152. Khogali, S. E. O., Davies, D. A., Donnan, P. T., Gray, A., Harden, R. M., McDonald, J., . . . Yu, N. (2011). Integration of elearning resources into a medical school curriculum. Medical Teacher, 33, 311-318.
Koole, S., Dornan, T., Aper, L., Scherpbier, A., Valcke, M., Cohen-Schotanus, J., & Derese, A. (2011). Factors confounding the assessment of reflection: A critical review. BMC Medical Education, 11, Article 104. Mpotos, N., De Wever, B., Valcke, M. A., & Monsieurs, K. G. (2012). Assessing basic life support skills without an instructor: Is it possible? BMC Medical Education, 12, Article 58. O’Neill, G., & Murphy, F. (2010). Guide to taxonomies of learning. Retrieved from http://www.ucd.ie/t4cms/ UCDTLA0034.pdf Plemmons, D. K., & Kalichman, M. W. (2013). Reported goals of instructors of responsible conduct of research for teaching of skills. Journal of Empirical Research on Human Research Ethics, 8(2), 95-103. Stuart, M. (2007). Introduction: The industrial relations of learning and training: A new consensus or a new politics? European Journal of Industrial Relations, 13, 269-280. Universidad San Jorge. (2012). Bachelor of Pharmacy Degree. Retrieved from http://internationalstudents.usj.es/en/studies/ graduate/pharmacy Van de Wiel, M. W. J., Van den Bossche, P., Janssen, S., & Jossberger, H. (2011). Exploring deliberate practice in medicine: How do physicians learn in the workplace? Advances in Health Sciences Education, 16, 81-95. Vyas, D., Wombwell, E., Russell, E., & Caligiuri, F. (2010). High-fidelity patient simulation series to supplement introductory pharmacy practice experiences. American Journal of Pharmaceutical Education, 74(9), Article 169.
Author Biographies Ignacio Segarra is a member of the Clinical Pharmacy and Pharmacotherapy Research Group of the Faculty of Pharmacy of the University of Barcelona, Spain. His research interests are clinical pharmacokinetics, bioethics, and medical education. He was responsible for the design, execution, data analysis and interpretation, and the manuscript writing. Manuel Gomez is professor of statistics and pharmacoeconomics at the School of Health Sciences of the San Jorge University (Zaragoza, Spain) where he is the associate dean of the Pharmacy Degree. His research interests include pharmaceutical care, pharmacoeconomics, and medical education. He has collaborated on data analysis and interpretation and reviewed the article.
research-article2014
JREXXX10.1177/1556264614557238Journal of Empirical Research on Human Research EthicsSegarra and Gomez
Research Ethics Education
A Learning Activity to Introduce Undergraduate Students to Bioethics in Human Clinical Research: A Case Study
Journal of Empirical Research on Human Research Ethics 2014, Vol. 9(5) 56–63 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1556264614557238 jre.sagepub.com
Ignacio Segarra1 and Manuel Gomez2
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. Keywords clinical trials, bioethics, research ethics, human subjects, pharmacology, medical education, Fink’s taxonomy, Bloom’s taxonomy Over the past decade, student learning has gradually shifted from teacher-centered to learner-centered and from a structured space and classroom setting to a dispersed environment (Blouin et al., 2009). In addition, students gather information efficiently from a variety of sources, and not exclusively from lectures or conferences in a defined setting like classrooms or laboratories. These features, together with the availability of standardized, cost affordable, and easy to use information technology devices, have displaced learning focused on information transmission to information compilation (Goodyear & Ellis, 2008). Nowadays, genuine learning may take place within a social, diverse, and fragmented environment where experiential events take priority (Clayton, Brinthaupt, & Draude, 2008). In this “scenario of learning,” it becomes necessary to identify appropriate and optimal tools that simulate and mimic real world scenarios to ensure that students acquire sufficient knowledge and competences for their professional practice (Stuart, 2007). New technologies have made possible innovative teaching tools with a variety of teaching and learning applications in health sciences (Khogali et al., 2011; Mpotos, De Wever, Valcke, & Monsieurs, 2012; Vyas, Wombwell, Russell, & Caligiuri, 2010) as well as continuing professional development and practice (Bridges, Davidson, Odegard, Maki, & Tomkowiak, 2011; van de Wiel, Van den Bossche, Janssen, & Jossberger, 2011). In this context, the application of
non-traditional active learning requires a clear understanding of the learning goals and key elements that configure the learning process. This integrative approach to activity/ curriculum design is crucial to ensure lasting, effective, and efficient learning (Goodyear & Ellis, 2008; Koole et al., 2011; O’Neill & Murphy, 2010). In the bachelor of pharmacy degree at San Jorge University (Zaragoza, Spain), students progress along a 5-year course of 300 European Credit Transfer System (ECTS) to acquire practice competences. During the first 2 years of the program, the students take mostly basic science modules (e.g., human biology, physical chemistry, statistics, etc), laboratory instruction, and are gradually introduced to pharmaceutical care (the correct use of medicines). In Years 3 and 4, the students progress toward clinically driven subjects (pharmacokinetics, clinical pharmacy, toxicology, etc) and pharmaceutical technology and development-related modules. During the last year, the students would undergo hospital and community 1
University of Barcelona, Barcelona, Spain San Jorge University, Zaragoza, Spain
2
Corresponding Author: Ignacio Segarra, Faculty of Pharmacy, Department of Pharmaceutical Technology, Clinical Pharmacy and Pharmacotherapy Unit, University of Barcelona, C/Sant Albert 4, 08197 Valldoreix, Barcelona, Spain. Email: [email protected]
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Segarra and Gomez
Activity Design
Table 1. Levels of Learning. Bloom’s taxonomy of learning (hierarchical)
Fink’s taxonomy of significant learning (non-hierarchical)
Evaluation (highest level) Synthesis Analysis Application Comprehension Knowledge (lowest level)
Foundational knowledge Application Integration Human Dimension Caring Learning how to learn
pharmacy clerkships, carry out a research project, and take modules related to research ethics (Universidad San Jorge, 2012). However, students are first introduced to clinical research ethics during the third year in two main subjects: a 12-ECTS module on biopharmacy and pharmacokinetics, and a 6-ECTS module on general pharmacology. Both modules include theory and practical work and develop the basis to understand drug behavior in the body, the main mechanisms of action, and its therapeutic potential through clinical trials. It is in relation to this last part that students are introduced to the basic concepts of bioethics involved in clinical research. Assessment is specific for each module and may include class tests, individual course work, group course work, practicum assignments, and a final exam. The weight of each assessment toward the final board mark would vary for each module (Universidad San Jorge, 2012). To introduce the students to basic clinical research ethics, we designed a set of activities taking into account the two most relevant taxonomies of learning (Table 1): Bloom’s taxonomy of educational objectives and Fink’s taxonomy of significant learning. Both taxonomies aim to align learning goals and assessment methods based on the learning scope (O’Neill, 2010). Bloom’s taxonomy focuses on a hierarchical approach to content-based learning, where the student progresses toward higher order cognitive skills. Differently, Fink’s taxonomy of significant learning puts emphasis on skills acquisition and their relational aspects with other domains of learning. Thus, it is not hierarchical but interactive (Fallahi, 2011; Fink, 2003). The aim of this practical assignment is to familiarize the students with the basic ethical concepts involved in the execution of a clinical trial. The overall practicum was designed to encourage students to identify, discuss, and evaluate ethical approaches to human research (Anderson et al., 2012; Plemmons & Kalichman, 2013). In keeping with this goal, we also aimed to gather information about the students’ learning process to update our curriculum. This case study of the practicum activities identifies the strengths and weaknesses of this approach, to guide further teaching improvement.
Students were given the following assignment: to evaluate the ethical issues that arise during the development of a clinical trial to compare the pharmacokinetics of a drug in two different populations. The students were allowed to enter freely in nine groups of three to four students each, and asked to identify the steps involved in a clinical trial including the preparation of a study protocol. A flowchart of the practicum with the requested output of each activity and approximate time distribution is shown in Figure 1. Each activity of the practicum was designed to target specific cognitive competences described in Bloom’s and Fink’s taxonomies of learning (Table 2).
Review and Analysis of Fundamental Bioethics Concepts The first activity of the practicum focused on the basic ethical principles of research on human subjects. The students were asked to perform a thorough review and critical analysis of four main documents that address ethics in human experimentation: the Hippocratic Oath (ca. 400 bc), the Nuremberg Code (1947) the Declaration of Helsinki (1964), and the UN Declaration of Bioethics (2006). On completion of the review, and with these concepts in mind, the students identified, evaluated, and discussed the bioethical issues portrayed in the commercial film “Extreme Measures” (Apted, 1996), which portrays different ethical positions toward the enrolment of patients in research and their vulnerability. Following the film, an open discussion forum was started to facilitate critical analysis and peer review within the group of students (Plemmons & Kalichman, 2013). Last, each group of students submitted a synthesis of the documents and a short essay developing their critical analysis of the research ethics positions portrayed in the film. These assignments were assessed and contributed toward the general pharmacology module.
Preparation of an Experimental Protocol The next step in the practicum was the preparation of an experimental protocol for a simulated clinical trial. The main learning objective of this task was to identify the different parts that comprise a clinical study protocol. To attain this goal, the students were asked to write a clinical protocol for a study proposal with the information available in the literature. Each group also prepared an addendum to the protocol including a model interview and a ready-to-sign informed consent form. We aimed to maximize the learning scope and experience of the practicum by requiring the students to present the experimental protocol before a simulated ethics committee composed of staff of the School of Pharmacy and
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Journal of Empirical Research on Human Research Ethics 9(5)
Output - Hippocratic Oath - Declaration of Helsinki - Nuremberg Code - Declaration on Bioethics
Review & Analysis
- Critical synthesis - Short essay
Schedule 1h Workshop1
- Video "Extreme Measures"
Debate
- Goals and Objectives - Literature Review
Study Design
- Short essay
3h
- Study Protocol 2h - Informed consent form Workshop2
Simulated Ethics Committee
Volunteer Interview
- Observation
1h
- Volunteer recruitment - Volunteer feedback
1h
Review Session
Workshop3 - On-line Lecture
Evaluation
- Performance essay
2h
Figure 1. Flowchart of the practicum: Sequence of the activities and tasks during the practicum assignment, the output of each activity, as well as the approximate time allocation needed for the activity. Table 2. Competences Map of the Activities: Integrated Mapping of Expected Outcomes, Cognitive Competences, and Tasks Executed by the Students Correlated With Bloom’s Taxonomy of Learning and Fink’s Taxonomy of Significant Learning. Assignment
Expected outcome
Activity
Review of selected documentation Viewing a medical ethics related film Literature review
Knowledge of the relationship between researchers and subject-volunteers. Identification of ethical positions
Study protocol
Identify the essential parts Identification of failures
Stepwise protocol
Ability to select and recruit subjects Identification of study deficiencies
Subject interview Informed consent Visualization Summary essay
Ethics review Subject recruitment Viewing of a lecture on clinical trials
Evaluation of previous studies
Cognitive competences
Bloom’s taxonomy
Fink’s taxonomy
Active reading Critical essay Group discussion
Critical analysis
Knowledge Comprehension
Fundamental knowledge
Visualization Summary essay Guided debate Summary of previous studies
Critical analysis Relational analysis
Comprehension Analysis
Fundamental knowledge
Critical review Synthesis of information Structuring of information Effective communication Effective communication Self-appraisal
Synthesis
Integration
Synthesis Application Evaluation
Integration
Brief presentation
Application Evaluation
Learning how to learn Human Dimension Application Learning how to learn
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Segarra and Gomez Health Sciences: a pharmacokinetics expert, a practicing nurse, a scientist, a laboratory technician, and three students randomly selected. Last, each group submitted their protocol proposal for assessment.
Subject Recruitment, Data Collection, and Analysis The next activity of the practicum focused on the concept of informed consent. Students were required to interview and obtain informed consent for their simulated study. It was necessary for the students to schedule an appointment with a volunteer (a faculty or staff member of the School of Pharmacy) for an informative interview and a follow-up meeting to collect the signed informed consent form. This step was assessed based on feedback provided by the “volunteers” about the performance of the students in the interview, the depth of the explanation, the relevance of the information provided, the possibility to ask questions, and overall communication skills.
Reflective Assessment and Self-Evaluation Self-assessment and an individual reflective essay were required after the study. This was augmented with a lecture conference on the design of clinical trials (Flaherty, 2007). The main purpose of this post-study activity was to encourage self-appraisal and evaluation of their learning in view of the standards proposed in the conference (Plemmons & Kalichman, 2013). Each student summarized the main aspects of the conference and wrote a short critical report addressing the differences between the model clinical trial presented in the conference and their study proposal (Koole et al., 2011).
Results and Discussion The teaching of bioethics and clinical ethics at an undergraduate level has been traditionally based on the reading of principles and regulations to ensure that the process complies with the law (Fox, Arnold, & Brody, 1995). Changes in student learning habits and teaching methodologies encourage active learning activities that simulate and mimic working scenarios. For this, simulation tools have been developed with virtual environments for a variety of learning purposes including simulated clinical situations, simulated patients, or combination of both to integrate conceptual learning and competency (Duvivier et al., 2011). We aimed to develop a practicum composed of a set of structured activities in a step-wise sequence to avoid fragmentation of the learning experience. The design was carefully sequenced to allow learning in each step based on the competences and concepts acquired in previous ones according to the comprehensive map of the cognitive and learning goals shown in Table 2.
Preliminary Review of Fundamental Concepts The initial task, to review and discuss the foundations of medical ethics, was attractive for the students as it shifted their role from passive receivers to active learners. During the review of the four selected documents, the students identified the gradual steps incorporated in each declaration and how the essence of each document revolves around the respect of the patient (or subject-volunteer) as a person with full rights and dignity to be protected. In particular, they were encouraged to identify features regarding vulnerability and factors affecting informed consent. In this context, an interesting observation was that some students viewed the Nuremberg Code as a more subject-volunteer oriented document versus the Declaration of Helsinki, which was portrayed as more method-oriented to ensure validity and quality of the results (Bertholf, 2001). After their essay was submitted, students watched the film “Extreme Measures” (Apted, 1996) and participated in a guided debate focused on the learning goals. In the debate, the students identified various scenes that had bioethical relevance. In the first scene of the movie, the physician (and main character of the film) in charge at the emergency room is confronted with the decision to choose between first treating a robber who has been shot by a policeman and the policeman himself whom the robber shot. The medical condition is critical in both patients although it is not at the level of immediate fatal development. There are other circumstantial factors that may weigh on the decision. The students raised different points of view regarding whether the physician took an ethics-based decision when he chose one patient and not the other and the influence of the other factors in the decision. The second point of debate was about the statement “what would you do to walk again?” delivered by a scientist to justify his intended research. In this scene, the physician finds himself in a hospital bed and paralyzed from neck down, the same situation for which the research scientist is seeking an experimental cure using homeless subjects. The physician’s answer, “Anything,” changes the perspective of this question toward a more general one of “what would you do to ensure your quality of life?” It also illustrates a change of attitude produced in the physician on experiencing his own full paralysis. In the discussion that ensued, the students concluded that there are some human rights that cannot be denied to the individual for the greater good of others, even if the subject would decide to do so. Some students based this decision mostly on the Hippocratic Oath (also brought into the movie in a later scene) as well as the various declarations protecting vulnerable subjects (Bertholf, 2001). Furthermore, the change of attitude of the physician was deemed to be unrelated and not coherent with the requirement to protect the dignity of vulnerable subjects, as opposed to furthering a scientific gain.
60 In the last scene of the film, the wife of the scientist gives the physician laboratory records and data that were generated via the unethical research approach that the scientist was defending. The students were required to consider whether data collected in unethical ways should be used. The students discussed this question looking at the different ethical approaches portrayed in the film: Kantian ethics, utilitarianism, consequentialism, and principlism ethics. The debate following the film showed the ability of the students to identify, understand, and contextualize the key elements that underlie general medical ethics decision criteria. It also allowed them to apply the concepts retrieved from the main documents to the simulated situations of the film. This allowed them to build their own skills of critical thinking and analysis starting from the source documents (Table 2).
Student Level of Learning An attempt into “translational bioethics” was made in this practicum: Each group of students wrote a study protocol and presented it before a simulated ethics committee. For this, we mimicked the functions and roles of an Institutional Review Board (IRB) to evaluate the protocol. The simulated IRB focused attention on the protection of vulnerable subjects through a variety of questions. In this exercise, we found an unexpected learning opportunity: Students noticed the operational differences among the proposals presented. This enhanced the importance of the technical review for each clinical study. The simulated IRB provided feedback to them. The analysis of the written protocol sent by each group of students reveals some interesting features. Overall, the identification of the researchers, the description and rationale of the experiment (study objectives), the inclusion and exclusion criteria, and data collection procedures (reporting data sheet, code-key to ensure the confidentiality of the volunteer information) were included in all protocols. However, some protocols lacked essential information such as the informed consent form, the patient data sheet, or the drug administration procedure. A total of 17 different items comprised the protocol, and these were sorted in three main groups (Table 3): the introduction and general description (Items 1 to 6), the clinical study methodology and procedures (Items 7 to 11), and the volunteer recruitment process (Items 12 to 15). Our findings indicate that the items related to methodology were included in all protocols with the exception of one. This seems consistent with the students’ expected level of competence and training in the pharmacology and clinical pharmacy modules and the previous activities of the practicum. However, we observed diverse levels of response in the other two categories: Research concepts such as conflict of interest (Item 1), study keywords (Item 3), research question (Item 4), formulation of a hypothesis (Item 6), and a description of the limitations of the study (Item 16) were
Journal of Empirical Research on Human Research Ethics 9(5) absent across the groups. This observation suggests some insights into their training and learning process: •• It shows some knowledge fragmentation that prevents the students from linking individual aspects (conflict of interest) with the driven force of a study (to verify a hypothesis). •• It may point out a preference for the analytical dimensions of the study versus the integration of the different components. An explanation of this finding may relate to the emphasis to acquire technical skills during the first 2 years of the pharmacy curriculum, which may not include formal training in research methodology. Therefore, “synthesis” and “integration” domains (Bloom’s and Fink’s taxonomies, respectively) may have not been acquired yet. This feature stresses even more the need to develop learning activities that facilitate integration of learning under a learning goal (Blouin et al., 2009). •• Absent in most groups were also the definition of a clear target population for the study (Item 7), a model interview (Item 13), the risks related to the study (Item 15), the limitations of the study (Item 16), and the budget to carry on the study (Item 17). Some of these aspects are related to the direct execution of a clinical trial and learned during work exposure (van de Wiel et al., 2011). This also suggests the need to integrate these concepts in the curriculum to ensure the learning outcomes and competences expected from pharmacists, even when these competences may not be directly related to clinical practice (e.g., management, finance skills, etc). Communication skills and information presentation were also evaluated. Each subject-volunteer submitted an assessment of the informative interview with the students and their performance. The volunteers assessed six aspects of the interview: confidentiality and privacy, the clarity of the explanation of the study, the possibility to ask questions, the scheduling of the interview, time planning of the simulated study, and, finally, their motivation. Each item was scored following this scale: 0—if that item was absent or not done, 1—if their performance was worse than expected, 2—if their performance was in accordance with the expectations, and 3—if their performance exceeded expectations. It is important to note that these results can only be evaluated from a general, qualitative point of view because it is a very small sample (only nine groups) and the assessment method is not free of subjectivity. Overall, exceeding expectations scores were achieved in items “study planning” and “motivation,” and meeting expectations (Score 2) was found in most questions. These results, although limited, may reflect the interest shown by the students in this kind of activity (Duvivier et al., 2011).
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Segarra and Gomez Table 3. Students’ Performance in the Preparation of the Study Protocol.
Protocol Section Introduction Conflict of interests Researchers ID Key words Research question Objectives Hypothesis Methodology Target population Inclusion criteria Exclusion criteria Administration procedure Data collection procedure Recruitment Informed consent form Model interview Patient data sheet Risks Others Limitations of the study Budget Performance level (% or total score)
Student Group
Item ID
1
1 2 3 4 5 6
+ + + + + +
7 8 9 10 11 12 13 14 15
2
3
4
5
+
+
+
+ +
+
+
+ + + + +
+ + + +
+ + + +
+ + + +
+ +
+
+
+
+
+
+ +
+ +
+
9 53
+ + 12 71
16 17 13 82
+
6
7
8
9
+ +
+
+
+
+ +
+
+
+
+ + + + +
+ + + +
+ + + +
+ + + + +
+ + +
+ + + +
+ + + +
9 53
10 58
11 65
+ + + +
7 41
5 29
12 71
Score 2 (22%) 7 (78%) 1 (11%) 3 (33%) 9 (100%) 1 (11%) 3 (33%) 9 (100%) 9 (100%) 8 (89%) 9 (100%) 8 (89%) 3 (33%) 8 (89%) 5 (56%) 2 (22%) 1 (11%)
Note. The students identified 17 items to form part of a protocol but there were different levels of performance across the groups. (+) means that the group included that item in their protocol proposal.
Student Reflective Feedback The last task in this practicum was to watch the lecture “Drug studies: Who, what, when, where and why” (Flaherty, 2007). The main goal of this task was to foster self-reflection on their own performance, and to motivate self-directed learning (Duvivier et al., 2011; Plemmons & Kalichman, 2013). The students identified the differences between their own study design and the study design proposed in the lecture. Students found the most relevant difference in the design and methodology, which would limit the significance of their study versus a randomized, double blind, controlled study. Additional features of their self-reflection were the failure to clearly define the target population, the concern about procedures to avoid conflict of interests, and how to ensure that the volunteer had understood everything.
Facilitating Learning This step-wise activity around a clinical trial creates an optimal scenario to achieve the learning outcomes. Based on Bloom’s and Fink’s taxonomies of learning (Table 1), we could align most of these activities with the learning domains (Table 2). Comparing both taxonomies of learning,
we observed that Bloom’s taxonomy describes this set of activities better than Fink’s taxonomy. This difference may reflect how the construction of the domains of each taxonomy differs in the evaluation of activities. Bloom’s taxonomy of learning is more conceptual than Fink’s taxonomy (Fallahi, 2011; O’Neill & Murphy, 2010). In addition, there are some aspects included in Fink’s taxonomy (human dimension and caring), which are difficult to translate unless a more real scenario is implemented. However, in an indirect manner, these concepts were present in the appreciation for subject vulnerability and autonomy during the interview process. However, no explicit assessment for “caring” and “human dimension” domains was considered during the interview as the students interacted in a predefined context. From a strict perspective, the activity failed to meet two key domains proposed in Fink’s taxonomy of significant learning. A modification of the interview assessment may create the opportunity to introduce them to these dimensions of professionalism. This is a limitation of our activity design as described here. Students’ independent feedback of the pharmacokinetics and pharmacology courses was collected by the Quality Assessment Department of the university using a standardized survey. Students evaluate in a 0 to 10 range scale aspects
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Journal of Empirical Research on Human Research Ethics 9(5)
Table 4. Representative Student Feedback. Commentaries From the Different Feedback Collected From the Students. The Feedback Was Collected Anonymously. •• “We have appreciated how complex it is to carry them out [human studies] and how exhaustive study and long-term follow-up are needed to reach a correct and robust conclusion. Moreover, with this experience we are more conscious and deeply acknowledge that thanks to the large efforts and work of so many researchers, we have excellent sources available to continue working.” •• “This practical has been a really good learning experience . . . it has mimicked closely the overall processes involved in the professional scenario. It has allowed us to learn and to navigate the different steps involved in a clinical study as well as to solve and overcome limitations which we may face along other projects.” •• “The practical of the pharmacokinetic study was very interesting and the scope was fitting. It allowed us to learn how to develop a protocol.” •• “I have been able to appreciate the application of theoretical concepts which facilitated its understanding and draw very positive conclusions.” •• “The practical has helped me much to understand the theoretical concepts as they were fully correlated with each other.”
such as the laboratory facilities, content delivery, and a variety of items related to teaching and learning activities. It evaluates the whole module (e.g., biopharmacy and pharmacokinetics, general pharmacology) separately and it is not possible to isolate a score for each specific practicum assignment. However, the students have the possibility to include anonymous comments and suggestions for improvement, or aspects they may dislike. Their comments and feedback seemed to indicate that the students highly valued the intertwining of the theoretical concepts (lectures) with their practical translatability (Table 4). These findings seem consistent with other reports indicating that blending experiential methods with deliberate practice in ad hoc scenarios is effective for the acquisition of professional skills (Plemmons & Kalichman, 2013; van de Wiel et al., 2011).
Final Remarks The need to deeply understand the foundations of ethical behavior in clinical research is increasingly becoming more important due to the transnational scope of clinical research (Aultman, 2013; Francer et al., 2014). This goal not only includes the scientists developing the research projects, but it also involves other support staff, technicians, and the volunteers and the social community where the research is developed (Anderson et al., 2012; Gonzalvo-Cirac, Roqué, Fuertes, Pacheco, & Segarra, 2013). The introduction of bioethics education programs in health sciences studies (e.g., pharmacy, nursing, dentistry, etc) should be encouraged to train health professionals on responsible research ethics (Bauchner & Fontanarosa, 2013; Bertholf, 2001). We find it necessary to encourage the gradual and systematic introduction of bioethics. The set of activities described here provides a starting point toward the design of a more comprehensive practicum/curriculum able to assess all the domains of both taxonomies of learning. Our student-centered approach met most of those domain criteria but failed to meet some domains described in Fink’s taxonomy of significant learning. Therefore, a further research
agenda to meet these goals will need to develop specific designs, including controlled studies, additional learning tools, and deeper analysis of the learning process to clearly differentiate both approaches and to measure the level of acquired skills to ensure an efficient learning of ethical issues in clinical trials (Bridges et al., 2011; Francer et al., 2014). Acknowledgments The authors thank the faculty and the staff of the School of Pharmacy (San Jorge University) for their participation as simulated volunteers. The authors are thankful to Ms. C. Suarez for technical assistance.
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References Anderson, E. E., Solomon, S., Heitman, E., DuBois, J. M., Fisher, C. B., Kost, R. G., . . .Ross, L. F. (2012). Research ethics education for community-engaged research: A review and research agenda. Journal of Empirical Research on Human Research Ethics, 7(2), 3-19. Apted, M. (1996). Extreme Measures. Retrieved from http://www. imdb.com/title/tt0116259 Aultman, J. M. (2013). Abuses and apologies: Irresponsible conduct of human subjects research in Latin America. The Journal of Law, Medicine & Ethics, 41, 353-368. Bauchner, H., & Fontanarosa, P. B. (2013). Restoring confidence in the pharmaceutical industry. Journal of the American Medical Association, 309, 607-609. Bertholf, R. L. (2001). Protecting human research subjects. Annals of Clinical & Laboratory Science, 31, 119-127. Blouin, R. A., Riffee, W. H., Robinson, E. T., Beck, D. E., Green, C., Joyner, P. U., . . . Pollack, G. M. (2009). Roles of innovation
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Segarra and Gomez in education delivery. American Journal of Pharmaceutical Education, 73(8), Article 154. Bridges, D. R., Davidson, R. A., Odegard, P. S., Maki, I. V., & Tomkowiak, J. (2011). Interprofessional collaboration: Three best practice models of interprofessional education. Medical Education Online, 16, Article 6035. Clayton, M. A., Brinthaupt, T. M., & Draude, B. J. (2008). Serving students by helping faculty: Encouraging instructional technology integration. Academic Leader, 24(3), 5-6. Duvivier, R. J., van Dalen, J., Muijtjens, A. M., Moulaert, V. R. M. P., van der Vleuten, C. P. M., & Scherpbier, A. J. J. A. (2011). The role of deliberate practice in the acquisition of clinical skills. BMC Medical Education, 11, Article 101. Fallahi, C. (2011). Using Fink’s taxonomy in course design. Observer, 24(7). Retrieved from http://www.psychologicalscience.org/index.php/publications/observer/2011/september-11/using-finks-taxonomy-in-course-design.html Fink, L. D. (2003). What is “significant learning?” Retrieved from.pdf http://www.wcu.edu/WebFiles/PDFs/facultycenter_SignificantLearning Flaherty, J. (2007). Drug studies: Who, what, when, where and why. Retrieved from http://www.youtube.com/watch?v=JdK1sAlsjM&feature=youtube_gdata_player Francer, J., Izquierdo, J. Z., Music, T., Narsai, K., Nikidis, C., Simmonds, H., & Woods, P. (2014). Ethical pharmaceutical promotion and communications worldwide: Codes and regulations. Philosophy, Ethics, and Humanities in Medicine, 9, Article 7. Fox, E., Arnold, R. M., & Brody, B. (1995). Medical ethics education: past, present, and future. Academic Medicine, 70(9), 761-769. Gonzalvo-Cirac, M., Roqué, M. V., Fuertes, F., Pacheco, M., & Segarra, I. (2013). Is the precautionary principle adaptable to emergency scenarios to speed up research, risking the individual informed consent? American Journal of Bioethics, 13(9), 17-19. Goodyear, P., & Ellis, R. A. (2008). University students’ approaches to learning: Rethinking the place of technology. Distance Education, 29, 141-152. Khogali, S. E. O., Davies, D. A., Donnan, P. T., Gray, A., Harden, R. M., McDonald, J., . . . Yu, N. (2011). Integration of elearning resources into a medical school curriculum. Medical Teacher, 33, 311-318.
Koole, S., Dornan, T., Aper, L., Scherpbier, A., Valcke, M., Cohen-Schotanus, J., & Derese, A. (2011). Factors confounding the assessment of reflection: A critical review. BMC Medical Education, 11, Article 104. Mpotos, N., De Wever, B., Valcke, M. A., & Monsieurs, K. G. (2012). Assessing basic life support skills without an instructor: Is it possible? BMC Medical Education, 12, Article 58. O’Neill, G., & Murphy, F. (2010). Guide to taxonomies of learning. Retrieved from http://www.ucd.ie/t4cms/ UCDTLA0034.pdf Plemmons, D. K., & Kalichman, M. W. (2013). Reported goals of instructors of responsible conduct of research for teaching of skills. Journal of Empirical Research on Human Research Ethics, 8(2), 95-103. Stuart, M. (2007). Introduction: The industrial relations of learning and training: A new consensus or a new politics? European Journal of Industrial Relations, 13, 269-280. Universidad San Jorge. (2012). Bachelor of Pharmacy Degree. Retrieved from http://internationalstudents.usj.es/en/studies/ graduate/pharmacy Van de Wiel, M. W. J., Van den Bossche, P., Janssen, S., & Jossberger, H. (2011). Exploring deliberate practice in medicine: How do physicians learn in the workplace? Advances in Health Sciences Education, 16, 81-95. Vyas, D., Wombwell, E., Russell, E., & Caligiuri, F. (2010). High-fidelity patient simulation series to supplement introductory pharmacy practice experiences. American Journal of Pharmaceutical Education, 74(9), Article 169.
Author Biographies Ignacio Segarra is a member of the Clinical Pharmacy and Pharmacotherapy Research Group of the Faculty of Pharmacy of the University of Barcelona, Spain. His research interests are clinical pharmacokinetics, bioethics, and medical education. He was responsible for the design, execution, data analysis and interpretation, and the manuscript writing. Manuel Gomez is professor of statistics and pharmacoeconomics at the School of Health Sciences of the San Jorge University (Zaragoza, Spain) where he is the associate dean of the Pharmacy Degree. His research interests include pharmaceutical care, pharmacoeconomics, and medical education. He has collaborated on data analysis and interpretation and reviewed the article.
