Abstract
Introduction:
Frequent reports of laboratory- and hospital-acquired infection in Egypt suggested a deficiency in handling hazardous samples and microorganisms among different researchers and professionals. The most common cause of laboratory incidents and potential exposure is often identified as a lack of biosafety training.
Methods:
In this study, we designed and implemented an effective laboratory biorisk management (BRM) training. Two workshops were delivered to 42 faculty members working in laboratories handling biological material in Egypt. The workshop modules were based on the global biorisk management curriculum developed by Sandia National Laboratories, with some modifications. The content was delivered to actively engaging participants in the learning process that included group work, case studies and scenarios, short presentations, demonstrations, hands-on activities, and questions and answers that created analytical thinking situations. These workshops introduced the concept of biorisk management, which combines risk assessment, risk mitigation, and performance systems and dual-use research of concern.
Results:
Results of pre-tests/post-tests revealed significant (P < .001) improvement in knowledge acquisition among participants. Course evaluation surveys indicate that most participants felt that these teaching methods met their needs and that their personal laboratory practices would change as a result of the training course.
Conclusion:
We conclude that using varied hands-on strategies in teaching biorisk management provided the participants with the skills, tools, and confidence to guide their laboratory staff and colleagues on sustainable biorisk management to reduce the risks associated with infectious disease research in a laboratory setting.
Keywords: biorisk management, active learning, continuing education, global biorisk management curriculum (GBRMC), dual-use research of concern (DURC)
Ensuring that advances in biotechnology are properly used in life science research is crucial.1 Many developing countries lack national regulations for managing biorisks.2 Over the past years, national and international initiatives and programs have been launched to promote and provide a variety of trainings, conferences, workshops, and seminars in the broader Middle East and North Africa (BMENA).3 These initiatives aimed to raise awareness among the scientific community about different biorisk management (BRM) topics in the BMENA region to comply with international biosafety and biosecurity policies.3 In Egypt, most BRM courses have not been effectively delivered to researchers working in biomedical science–related fields, as most are delivered either using a traditional passive learning approach or through different reading materials and written polices and guidelines. Due to the wide range in the scope of the life science field, biosafety and biosecurity are not considered as fixed concepts with a single correct way of achieving the end goal.4 Although guidelines are well defined and concepts established to implement biosafety and biosecurity, these guidelines rely heavily on proper risk assessment.5 Consequently, traditional passive teaching methods may not improve laboratory practices and attitude toward biosafety and biosecurity.6,7 Individuals working in laboratories need to understand the basic concepts of risk management to implement and adapt them to their always evolving environment. Adult education often requires a more interactive approach to be successful, by allowing a direct correlation with their current work environment. This fosters participants’ engagement on issues related to the responsible conduct of science (RCS). One recognized educational method for working professionals is to implement active-learning pedagogical methods in the classroom. Developing human resources for biosafety management was achieved by formulating and implementing a series of training workshops to raise the awareness and knowledge of the biosafety and biosecurity rules among life science researchers and hospital employees working with hazardous microorganisms, samples, and genetically modified organisms. These workshops actively engage participants in the learning process, using group discussions, problem solving, case studies, role-playing, and structured learning groups. This enables all participants to promote the integration of new knowledge and best practices into their theoretical and conceptual frameworks as they learn together.
Our goal in teaching BRM by a “learner-centered” approach is to apply an active learning environment to supply participants with the knowledge of a broad range of biosafety topics applicable to biomedical research facilities. The goal is to boost critical thinking and problem-solving skills vital to potential hazard recognition, accident prevention, and BRM.
Methods
Target Audience
A total of 42 different faculty members from 7 different faculties at Mansoura University, Egypt, were trained in BRM (22 participants in the first workshop and 20 participants in the second workshop). The represented faculties were from Veterinary Medicine, Science, Agriculture, Nursing, Pharmacy, Medicine, and Dentistry. Applicants are holders of master’s or PhD degrees working in biomedical and biotechnology laboratories. All participants represented researchers working in laboratories containing different types of biohazards. Following the deadline for submission of the workshop application form, a total of 88 applications were screened by the workshop evaluation committee, and participants were selected based on research merits and a personal statement to clarify the reasons for attending the workshop. All applicants were notified regarding the status of their applications within 1 month of the application deadline. Participants’ distribution among the different faculties was also taken into consideration. Each workshop lasted for 3 days, and all participants were actively engaged in different activities during the mornings and afternoons (∼20 hours total). In each workshop, a total of 4 working groups consisting of 5 to 6 participants were assigned. All participants signed the informed written consent to participate in this study. Local ethics committee ruled that no formal ethics approval was required in this particular case.
Curriculum Development and Delivery
This curriculum was designed in accordance with the Global Biorisk Management Curriculum (GBRMC) for use in the Cooperative Biological Engagement Program. The program, funded by the US Defense Threat Reduction Agency, is implemented by Sandia National Laboratories (http://biosecurity.sandia.gov/gbrmc/). The Egyptian curriculum contains some pedagogic modifications to actively engage participants in the learning process and to extend the cognitive learning outcomes previously designed by Bloom et al8 and Paul and Elder.9 The CEN Workshop Agreement (CWA) 15793 (European Committee for Standardization) version of 2011 (both Arabic and English versions) was also used as a reference manual during the training. Presentations were used as reference material as well as to direct the different activities and discussions. The backward design model was used to align both formative and summative assessments with the learning goals and objectives.10 Tables 1 and 2 summarize the learning objectives and the teaching activities used in each module.
Table 1.
Learning Objectives of the Biorisk Management Modules.
Course Module | Learning Objectives |
---|---|
Introduction to Biorisk Management |
|
Biorisk Assessment |
|
Biorisk Mitigation |
|
Biorisk Performance |
|
Dual-Use Research of Concern |
|
Abbreviations: AMP, assessment, mitigation, and performance; PPE, personal protective equipment.
Table 2.
Teaching Activities Used in the Biorisk Management Modules.
Course Module | Description of the Teaching Activity |
---|---|
Introduction to Biorisk Management (day 1) |
|
Biorisk Assessment (day 1) |
|
Biorisk Mitigation (day 2) |
|
Biorisk Performance (day 3) |
|
Dual-Use Research of Concern (day 3) |
|
Abbreviations: AMP, assessment, mitigation, and performance; FMD, foot and mouth disease; PPE, personal protective equipment; SARS, severe acute respiratory syndrome.
The first module was an introductory session that provided an opportunity for participants to understand biorisk management as a concept, to identify the 3 key components of biorisk management (assessment, mitigation, and performance [AMP] model), and to learn about the CWA 15793 standard. Using case studies and group exercises, participants worked together to identify the differences among biorisk, biosafety, and biosecurity and to apply AMP. Activities performed in this module included discussing cases that might prove challenging in distinguishing biosafety and biosecurity situation components. One example considered the leakage of the effluent system in the Pirbright Institute for Animal Health, United Kingdom, that led to an outbreak of foot and mouth disease (FMD). Two intersecting circles (1 representing biosafety and 1 representing biosecurity) were then drawn on a flipchart and participants in groups were asked to add biosafety and biosecurity measures via sticky notes. In another example, a case study was presented to participants who were asked to extract the sections where aspects of the study were addressed in CWA 15793.
Sample Case Study: Cataract University Scenario
Amil works in a biosafety level 2 research lab at Cataract University studying anthrax vaccines. He recently visited the emergency room with a serious skin infection on his neck. Doctors determined this infection was caused by Bacillus anthracis and started treating him with antibiotics. He is expected to make a full recovery. Amil was surprised to learn of this diagnosis because he works in the lab only with the Sterne strain of B anthracis, a nonlethal strain used to vaccinate animals. Although the high-containment lab in the adjacent building works with the fully virulent strain, Amil never enters there.
Upon learning about the infection through the news, the lab director asked for a study to determine what went wrong and whether or not Amil contracted the agent in the lab. Amil reported that he had been working with Huda 2 weeks prior to grow cultures of the nonlethal, live vaccine strain. Huda was working in the biological safety cabinet (BSC) to prevent contamination.
After transferring a small amount of broth culture to a microcentrifuge tube, Huda sealed the tube and wiped it down with alcohol before transferring the tube to Amil, who placed the tube in a labeled container and walked it down the hallway to put it in a common use refrigerator. Amil was not wearing gloves during the process. As he explained, “I was not directly handling the agent and Huda was wiping it down with alcohol so I did not think there was anything to worry about.” Neither researcher was aware of the fact that alcohol has little effect on Bacillus spores.
The lab director suggested that the cultures in the lab be tested to determine whether or not the strains were indeed the vaccine version or the fully virulent strain. However, the samples turned up missing after a search of the common refrigerator where they had been stored. No one is sure what happened to them. The custodian cleaned out the refrigerator the week before and may have inadvertently tossed them in the trash, but he does not remember. Fortunately, Huda saved some of the stock solution and upon testing was surprised to find that it was the fully virulent strain of B anthracis and matched the strain that was cultured from Amil’s lesion. Huda had ordered the vaccine strain from Acme Labs several months ago.
When questioned about the possibility of sending the wrong strain to Cataract University, a manager at Acme Labs reported that this was very unlikely because it ships the virulent strains only to labs that are registered with Acme, and Cataract was not registered. However, the manager did concede that the shipping supervisor happened to be on vacation when the shipment was sent to Cataract, so some of the records were not kept during that period.
In the second module, Risk Assessment, participants were involved in examples of learner-centric training activities, including a group poster design highlighting the hazards at their own laboratory or its procedures, as well as group discussions on risk-ranking based on the risk assessment matrix. After 10 minutes, the facilitators led a discussion about the hazards the BRM teams have identified and overlooked. In addition, each team designed a poster highlighting a complete risk assessment for working in Brucella in the laboratory, including analyzing the hazard(s) and their likelihood and consequences, as well as highlighting a summary of risk levels (high, medium, low, and why). These activities specifically addressed the learning objectives by focusing on risk assessment factors and practicing the basics of risk assessment.
In the third module, Biorisk Mitigation, different class activities included proper procedures and sequence for donning and doffing personal protective equipment (PPE) and using and maintaining BSCs. Following training, participants donned disposable gloves that were then “contaminated” using a commercial fluorescent material (Rit Dye color remover powder). Participants then doffed their gloves, and facilitators using an LED UV flashlight demonstrated residues on participants’ hands to reinforce how contamination can spread due to improper doffing. Participants also viewed an incident response video to document and identify improper practices and procedures. The activities used in this module specifically addressed the learning objectives by allowing the participants to select appropriate risk mitigation measures and address needs and uses of key controls—engineering, administrative, practices and procedures, and PPE.
In the fourth module, Biorisk Performance, an open discussion among all groups was performed to highlight the meaning of different terms, including validation, verification, compliance, accreditation, certification, audit, and inspection. Next, different groups were assigned to respond to different questions reflecting the implementation of audit programs at their institutes (Table 2).
The fifth module focused on defining dual-use research of concern (DURC) and discussing aspects of dual-use research. A case regarding extending the host range of Listeria monocytogenes by rational protein design11 was used provided to participants. They were asked to determine if the research could be classified as dual use. The 7 categories of experiments that are classified as DURC, developed by the National Science Advisory Board for Biosecurity,12 were presented to participants. In a group activity, participants designed a poster to depict a scenario of potential dual-use research, allowing participants to apply their knowledge to identify different aspects of dual-use research.
The final module included examples of the modifications made to the global biorisk management curriculum that were implemented in these workshops. Modifications in the DURC module were based on success stories from the Egyptian institutes teaching dual-use sessions and the responsible conduct of research. This was fostered by a US National Academy of Sciences meeting held in 2015 to develop a network of faculty members in Egypt who could teach about research with dual-use potential based on elements of responsible science while using active-learning pedagogical techniques (https://www.nap.edu/resource/18356/responsible_science/egyptprograms.html).
Assessment of the Workshops’ Effectiveness
Anonymous pre- and post-summative assessments of BRM knowledge were used to evaluate the effectiveness of the course. The questions were the same in both tests, thus allowing the course instructors to assess an increase in participants’ knowledge in different topics of the course. This type of assessment also allows the participants to engage in self-realization of their own knowledge of the topics covered. The assessments included 20 multiple-choice questions (MCQs). Table 3 provides the questions used in the pre-test and post-test modules. Statistical analyses were performed using MEDCALC software. Data for each question were coded as follows: 1 for correct answers and 0 for incorrect ones, and then a total score for each category was calculated based on the number of correct answers for each question in the pre-test/post-test. Finally, percentages of participants with 100% correct answers for each category in the pre-test/post-test were compared using the χ2 test. Results were considered significant with P ≤ .001.
Table 3.
Questions Used on Pre-tests and Post-tests (N = 20) to Assess Perception of Competencies of Participants in the Course.a
Course Module | Questions in the Pre-tests/Post-tests |
---|---|
Introduction to Biorisk Management |
|
Biorisk Assessment |
|
Biorisk Mitigation |
|
Biorisk Performance |
|
Dual-Use Research of Concern |
|
Abbreviations: BSC, biological safety cabinet; WHO, World Health Organization.
Represents the order of the questions in the exam.
Assessment of Participants’ Feedback
Evaluation of the quality of training delivered during the workshop, including the lectures, curricula structure, logistics, and facilitation process, was assessed by the participants using anonymous evaluation sheets. Evaluation questions were formatted into different responses: outstanding/very high (score = 5), high (score = 4), fair (score = 3), low (score = 2), and unsatisfactory/very low (score = 1). Statistical analyses were performed using GraphPad InStat (GraphPad Software, San Diego, CA, USA).
Results
Workshops’ Effectiveness
The age of participants ranged from 24 to 40 years. Nearly equal sex distribution was also considered in the workshops (23 women and 19 men). The ratio of students to trainers was 42/2. Most of the participants were PhD holders (20; 47.6%), followed by master’s degree holders (12; 28.6%) and bachelor’s degree holders (10; 23.8%). Most of the participants (37; 88.1%) reported in the participants’ feedback survey that they previously attended BRM workshops delivered using “instructor-centered” approach. None (0%) of the participants reported in the participants’ feedback survey that they previously attended any BRM workshops delivered using “learner-centered” approach.
Comparison of answers from pre-tests and corresponding post-tests revealed significant (P < .001) improvement in participants’ knowledge in both overall and all individual content areas measured. Overall knowledge of participants in each category represented by correct responses was a mean (SD) of 26.19% (0.87%) to 50% (0.99%) on the pre-test and 78.57% (2.03%) to 92.85% (0.452%) on the post-test (Figure 1, Suppl. Table S1).
Figure 1.
Results of pre-tests and post-tests for participants’ perception of biorisk management and dual use potential activities.
The lowest pre-test scores were obtained in the research with dual-use category, where a mean (SD) of 26.19% (0.87%) of the participants answered those questions correctly on the pre-test with an increase to 92.85% (0.452%, P < .0001) correct responses on the post-test. The highest scores were obtained in the introduction category, where a mean (SD) of 50% (0.99%) of participants answered those questions correctly on the pre-test with an increase to 92.85% (0.452%, P < .001) correct responses on the post-test.
The comparison of the performance of participants in each pre- and postassessment question used in the course is shown in Figure 2 and Supplemental Table S2. In the pre-test, the overall lowest score was obtained for the research with dual-use question (question 18), where 26.19% of the participants answered the question correctly, with a significant increase after the course to 97.61% of the participants answering correctly (71.42% improvement, P < .0001). The risk mitigation questions (questions 13 and 17) showed very low scoring, with only 33.33% of the participants answering those questions correctly. A significant improvement in risk mitigation knowledge was observed. The number of participants answering correctly in the post-test was 97.6% and 95.23%, respectively (representing a 64.28% and 61.9%, improvement, P < .0001).
Figure 2.
Performance of Participants (N = 42) in pre- and post-assessment questions (N = 20) used in the course.
Workshop Evaluation Survey
The feedback survey administered to each participant at the completion of each workshop was analyzed to assess learner satisfaction about the course and trainers. The results of the course/workshop evaluation showed that the overall percentage of outstanding satisfaction (with a score of 5) was 90.5%, and 9.5% of participants expressed high satisfaction (with a score of 4). With the pedagogical methods used in the course, 97.6% of participants agreed that the course was very exciting and engaging (by giving a score of 5 to that question).
Discussion
The most common cause of laboratory incidents and potential exposure is often identified as a lack of safety training.13 Standardization of techniques used by microbiologists and pathologists to isolate, manipulate, and propagate different pathogenic agents should align with standard laboratory safety work and procedures planned to mitigate the potential hazards to the environment and humans.14 To meet these needs, an efficient active-learning BRM curriculum was developed and delivered to faculty members at Mansoura University. This curriculum employed group discussions, problem solving, case studies, role-plays, and structured learning groups. In this way, all participants integrate new knowledge and best practices into their theoretical and conceptual frameworks as they learn together.
A lack of training for faculty members at Mansoura University is demonstrated by preassessment scores of 26.19% to 50% of correct answers. Comparison of pre- and postassessment scores shows the improvement in BRM-related knowledge in a majority of participants to averages of 78.57% to 92.85% of correct answers. In addition, the participants reported positive feedback in the postworkshop feedback survey. In this survey, participants stressed the importance of increasing awareness on BRM-related topics through the dissemination of such trainings to different institutions.
Trainees also reported that their laboratory practices and procedures will be changed based on the information received and knowledge gained from the training. This study suggests that implementing an active BRM learning model boosts the learning outcomes of trainees and empowers them to change their laboratory practices and teach coworkers BRM by example. To our knowledge, no studies in Egypt or in the Middle East reported the efficacy of active-learning pedagogies in teaching BRM to adult learners. Nonetheless, a limitation in this study is the lack of comparison of trainees’ BRM-related knowledge following active-learning modules with the knowledge acquisition of a different group of participants who received the BRM content using traditional teaching methods. This active-learning model would be beneficial in teaching different aspects related to the responsible conduct of science (RCS). Indeed, this effort to integrate the active-learning pedagogical methods in teaching aspects related to RCS was applied by the National Academies in the Middle East and North Africa and Southeast Asia regions.15
Critical factors were identified during the implementation of these workshops, including the limited number of staff experience in both BRM content and active-learning pedagogies. Additional trainers would have been beneficial to help in the delivery and facilitation of these workshops based on the ratio of students/trainers. As these workshops were based on different class activities and discussions, examples used in the case studies were more relevant to some specialties than to others. Addressing the difference in background and field of scientific expertise of the participants will allow a more tailored presentation of material. To increase the number of BRM trainers who could deliver these workshops, we designed a “Train the Trainer” (TOT) course. That curriculum provides an outline of the content of the training and includes 3 modules: a biorisk management module, an active-learning pedagogy module, and a project management module. Implementation of the curriculum would be carried out in 2 direct contact phases and 2 online phases mentored by distance facilitators. This curriculum would provide the trainers with the skills and pedagogical knowledge needed to deliver focused BRM workshops within their institutes themselves.
Conclusions
In this study, implementing active learning in teaching biorisk management provided the participants with the skills, tools, and confidence to guide their laboratory staff and colleagues on sustainable biorisk management to reduce the risks associated with infectious disease research in a laboratory setting. Based on these results, a TOT biorisk curriculum has been developed to increase the number of trainers who could deliver these workshops at their own institutions across Egypt, with the goal of increasing the safety of laboratories across the country.
Acknowledgments
The authors thank Dr. Robert A. Heckert (Robert Heckert Consulting) for his excellent advices during the workshops. The authors would like to thank Dr. Eman Abo Elfadl at Faculty of Veterinary Medicine, Mansoura University for her help with statistical analysis. The authors also thank Sandia National Laboratories (William Pinard, Halley Smith, and Eric Cook) for proving all the assistance needed for designing the BRM curriculum and for their help reviewing the TOT curriculum. The work was partially presented at MENA Round V Twinning Project Meeting, August 9-12, 2016, at Kuala Lumpur, Malaysia, and Kota Kinabalu, Malaysia, February 26-28, 2017.
Ethical Statement
Local ethics committee ruled that no formal ethics approval was required in this particular study.
Statement of Human Rights
Not applicable.
Statement of Informed Consent
All participants signed the informed written consent to participate in this study.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by a grant funded by CRDF Global (agreement number GTR3-16-62685-0) awarded to Dr. Mohamed Elhadidy.
Supplemental Material
Supplemental material for this article is available online.
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