Biorisk Management Research Articles

Implementation of Active Learning Approach to Teach Biorisk Management and Dual-Use Research of Concern in Egypt.

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. 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 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. 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.

Development of a Biosecurity Checklist for Laboratory Assessment and Monitoring.

Introduction:Laboratory biosecurity is of continuously growing interest due to increasing concerns about deliberate misuse of biological materials and emerging biological risks. These risks continue to be magnified by globalization, the rapid pace of scientific development, and dual-use technologies. Worldwide laboratory capacities are expanding, which calls for concrete actions to improve laboratory biosafety and biosecurity practices to protect researchers and the community. Hence, laboratories require comprehensive biorisk management programs to minimize the risk of accidental and deliberate release of infectious biological materials.Objective:Malaysia has prioritized the concern of national biosecurity and aims to consolidate laboratory biosecurity performance to detect and prevent the deliberate release of biological agents.Methods:Two 3-day workshops were organized over the course of four months in which Malaysia collaborated with The Netherlands. This bilateral engagement aimed to integrate biosecurity practices in their national biorisk management programs, and resulted into a comprehensive biosecurity checklist for laboratory assessment and monitoring.Results:This biosecurity checklist is based on Malaysian and Dutch expert opinions and national and international guidelines and regulations. The biosecurity checklist is a survey-driven tool that consists of a set of concrete questions for each key biosecurity area, which are discussion points for assessment.Conclusion:We display a practical biosecurity checklist for laboratory assessment and monitoring. Although the presented checklist was the template for the specific Malaysia checklist, it could serve as a template for other countries.

Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia

Latar belakang: Laboratorium Badan Penelitian dan Pengembangan Kesehatan (Balitbangkes) ditunjuk sebagai laboratorium rujukan nasional dalam mendeteksi penyakit infeksi Emerging (EID) dan bertugas dalam mendeteksi pathogen infeksius serta berperan penting dalam sistem penanggulangan wabah. Laboratorium Balitbangkes harus menerapkan sistem manajemen biorisiko untuk mencegah terjadinya penyebaran penyakit yang bersumber dari laboratorium. Penerapan manajemen biorisk laboratorium yang terdiri dari biosafety dan biosecurity bertujuan untuk melindungi pekerja, lingkungan dan produk atau agen biologi. Penelitian ini bertujuan untuk menemukan kesenjangan terkait penerapan manajemen biorisk di Laboratorium Balitbangkes dengan standar.&#x0D; Metode: Studi dilakukan oleh Asesor professional pada tahun 2015 dengan mewawancara penanggung jawabLaboratorium BSL-3 (PJ BSL-3) dan Biosafety Officer (BSO) serta pemeriksaan dokumen. Pemilihan respondenberdasarkan jabatannya di laboratorium. Responden dipilih karena sebagai pelaksana teknis dan memilikiinformasi pelaksanaan biosafety dan biosecurity yang mendalam di laboratorium Balitbangkes. Pertanyaandiadopsi berdasarkan CWA 15793: 2011, berisi 160 pertanyaan dari 16 elemen. Analisis skor diinterpretasikanantara 0-2. Skor 0 memenuhi kesesuaian dengan standar dan skor 2 berarti tidak memenuhi standar.&#x0D; Hasil: Studi ini menunjukan 3 dari 16 elemen, memiliki kesesuaian penuh dengan standar yaitu teknik mikrobiologi yang baik, alat pelindung diri serta peralatan dan pemeliharaan alat laboratorium. Elemen yang memiliki kesenjangan paling tinggi adalah keamanan dengan skor 1.16. Tidak ada elemen yang dinilai tidak memenuhi kesesuaian standar atau skor2.&#x0D; Kesimpulan: Secara keseluruhan, Laboratorium Balitbangkes memiliki sistem manajemen biorisiko yang kuatdan sudah mapan disetiap elemen. Namun, tindakan perbaikan harus segera dilakukan di beberapa elemen untuk memenuhi standard CWA 15793:2011. (Health Science Journal of Indonesia 2018;9(2):70-5)&#x0D; Kata kunci: EID Laboratory, biorisk management, laboratory assessment, CWA15793&#x0D; Abstract&#x0D; Background: NIHRD laboratory was appointed as a national referral laboratory to perform laboratory detectionfor emerging infectious disease (EID). Because of its important role, NIHRD laboratory must implement bioriskmanagement system. A reliable high containment laboratory is crucial to perform laboratory diagnosis forEIDs and to avoid further spread of EIDs. The protection of laboratory workers, environment, and biologicalagents is achieved by addressing laboratory biorisk management consist of laboratory biosafety and biosecurity measures. This study aims to find gaps related the implementation of biorisk management with standard.&#x0D; Methods: This study was carried out by Professional Assessor in 2015 by conducting document checking andinterviewing BSL-3 Technical Managers and BSO who were considered to have in-depth information regardingbiosafety and biosecurity activities in NIHRD laboratory. Questionnaire developed based on CWA 15793:2011,which contain 160 questions provided from 16 elements of the standard. Analysis of the scores was interpretedbetween ranges of 0-2. Score 0 means full conformity and score 2 means doesn’t meet the required standard.&#x0D; Results: The study showed that only 3 out of 16 elements have full conformity with the standard. Theywere good microbiological technique, clothing and personal protective equipment, laboratory equipmentand maintenance. The highest gap was in security elements with the score: 1.16. No elements has a noncompliance with the standard or score 2.&#x0D; Conclusion: Overall the NIHRD laboratory has a strong biorisk management system already establishedwhich is working well in many areas. However, important action is needed in several elements in order tocomply with the standard. (Health Science Journal of Indonesia 2018;9(2):70-5)&#x0D; Keywords: EID Laboratory, biorisk management, laboratory assessment, CWA15793.

Biomedical Education: A Summary Report of the Biorisk Management Curriculum Development Workshop

<p style="text-align: justify;">Dear Editor,&nbsp; <p style="text-align: justify;">The safety in general and biological safety (biosafety) in particular is an important international issue. Member states of the United Nations (UN) have developed their national biosafety policies to address biosafety (and biosecurity) issues in line with the international agenda. The Biorisk Management (BRM) is a relatively new domain in biomedical sciences and biotechnology. It provides the strategic framework for action for the laboratory biosafety and biosecurity (along with bioethics).^1-2 In fact, BRM is very vital for the global safety and security. Therefore, the BRM curriculum should be developed and incorporated into biomedical sciences and biotechnology education programmes of every country to prepare next generations to meet the biosafety, biosecurity and bioethics challenges.<strong> Read more . . .&nbsp;</strong>

Progress Toward Poliovirus Containment Implementation - Worldwide, 2017-2018.

Substantial progress has been made since the World Health Assembly (WHA) resolved to eradicate poliomyelitis in 1988 (1). Among the three wild poliovirus (WPV) types, type 2 (WPV2) was declared eradicated in 2015, and type 3 (WPV3) has not been reported since 2012 (1). In 2017 and 2018, only Afghanistan and Pakistan have reported WPV type 1 (WPV1) transmission (1). When global eradication of poliomyelitis is achieved, facilities retaining poliovirus materials need to minimize the risk for reintroduction of poliovirus into communities and reestablishment of transmission. Poliovirus containment includes biorisk management requirements for laboratories, vaccine production sites, and other facilities that retain polioviruses after eradication; the initial milestones are for containment of type 2 polioviruses (PV2s). At the 71st WHA in 2018, World Health Organization (WHO) Member States adopted a resolution urging acceleration of poliovirus containment activities globally, including establishment by the end of 2018 of national authorities for containment (NACs) to oversee poliovirus containment (2). This report summarizes containment progress since the previous report (3) and outlines remaining challenges. As of August 2018, 29 countries had designated 81 facilities to retain PV2 materials; 22 of these countries had established NACs. Although there has been substantial progress, intensification of containment measures is needed.

Status, quality and specific needs of Ebola virus diagnostic capacity and capability in laboratories of the two European preparedness laboratory networks EMERGE and EVD-LabNet.

From December 2013 to March 2016, West Africa experienced the largest Ebola virus (EBOV) outbreak to date, leading to a European-wide activation of laboratory preparedness and response. At the end of the outbreak, laboratories associated with the two European preparedness networks of expert laboratories EMERGE JA and EVD-LabNet were invited to participate in an assessment of the response of European laboratories to the EBOV outbreak, to identify learning points and training needs to strengthen future outbreak responses. Response aspects assessed included diagnostics, biorisk management and quality assurance. The overall coverage of EBOV diagnostics in the European Union/European Economic Area (EU/EEA) was found to be adequate although some points for quality improvement were identified. These included the need for relevant International Organization for Standardization (ISO) accreditation, the provision of EBOV external quality assessments (EQA) in periods where there is no emergency, facilitating access to controls and knowledge, biorisk management without compromising biosafety and a rapid public health response, and the need for both sustained and contingency funding for preparedness and response activities.

Polio vaccines and biorisk management of polioviruses

Japan is the first country where inactivated polio vaccines derived from Sabin attenuated strains, which are used to manufacture oral polio vaccines, were introduced in routine immunization program. The Sabin-derived inactivated vaccine has been developed based on the fact that Sabin strains are less neurovirulent and manufactured at safer productionfacilities than wild polioviruses. It is also convincing that Sabin strains are more safely used for evaluating the efficacy of inactivated vaccines in rat immunogenicity tests. However, in the current situation where polioviruses are close to being eradicated, the facilities that manufacture vaccines and/or conduct quality control of them are needed to meet the biorisk management requirements established by WHO, which are based on the Polio Eradication & Endgame Strategic Plan 2013-2018. At present, type 2 polioviruses including Sabin 2 strain should be contained in the facilities which meet the WHO biorisk management requirements. The respective facilities are expected to give full consideration based on a careful risk assessment of viral transmission not only to personnel, but also to the environment and the community around the facilities, and the establishment of biorisk management will be needed. Thus, the facilities handling and storing infectious polioviruses must be certified as poliovirus-essential facilities following the WHO biorisk management requirements.

Prophylactic and immune modulatory influences of Nigella sativa Linn. in broilers exposed to biological challenge.

Background and Aim:Prophylaxis and disease prevention is an essential strategy among biorisk management in poultry farms that stimulate and maintain the birds’ immunity. The aim of this study was to investigate the prophylactic, and immune-stimulant influence of Nigella sativa Linn. in broilers under biological stress.Materials and Methods:A total of 250 1-day-old (ross) chicks were divided into 5 groups; four of which were supplemented with 1.4%, 2.8%, 4.2%, and 5.6% N. sativa Linn., respectively. The four supplemented groups were challenged with Escherichia coli O157:H7 1.5×108 at a 14th day old. A total of 1050 samples (150 serum, 150 swab, and 750 organ samples) were collected and examined.Results:A highly significant increase (p<0.01) in 5.6% N. sativa Linn. supplemented group in performance traits (body weight, weight gain, and performance index), biochemical parameters (proteinogram, liver enzymes, and creatinine), immunoglobulins concentration, and immune organs’ weight. Meanwile, liver showed improvement of histoarchitecture without fibrosis. Heart showed a mild pericarditis with a mild degree of hydropic degeneration. Bursa, thymus, and spleen showed lymphoid hyperplasia.Conclusion:A concentration of 5.6% N. sativa Linn. in broiler’s feed can improve the immune response and subsequent resistance of broilers against diseases.

Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues.

With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process.

Global Trends in Biorisk Management

This report recapitulates the diverse aspects of biological safety. Biological laboratory is a space that facilitates the handling and storage of microorganisms, their components or their derivatives. Laboratories that handle dangerous pathogens have to act in a responsible manner to manage the safety and security threats posed by these pathogens. This necessity was foreground in the December 2008 World at risk report, which specifically demanded bioscience laboratories that handle dangerous pathogens to implement a unified laboratory biorisk management framework to enhance their safety and security. The report also discusses the guidelines of biosafety regulations provided by World Health Organization (WHO) that are necessary to adequately and sustainably manage these biorisks and helps in better understanding of risk governance approaches for laboratories that handle dangerous pathogens to achieve the ultimate goal of minimizing or preventing the occurrence and consequences of human error within the laboratory environment: the biorisk management approach, composed of biosafety, laboratory biosecurity and ethical responsibility. It preferably provides an agreement between authorities, the public, and the scientific community establishing trust and societal safety and security, while enabling the continued progress of science. Biorisk management approach demonstrates that biorisks in all their potential forms are appropriately addressed, managed and minimized. Thus, biorisk management has become an important aspect of the development and sustainability of biological activities.

Progress Toward Containment of Poliovirus Type 2 - Worldwide, 2017.

The Global Polio Eradication Initiative (GPEI) continues to make progress toward the eradication target. Only one of the three serotypes, wild poliovirus (WPV) type 1 (WPV1), is still circulating, and the numbers of cases and countries with endemic transmission are at record lows. With the certification of wild poliovirus type 2 (WPV2) eradication in 2015 and the global replacement of trivalent oral poliovirus vaccine (tOPV) containing Sabin poliovirus types 1, 2, and 3 with bivalent OPV containing only Sabin poliovirus types 1 and 3 during April-May 2016, poliovirus type 2 (PV2) is now an eradicated pathogen. However, in eight countries (Cameroon, Chad, Democratic Republic of Congo, Mozambique, Niger, Nigeria, Pakistan, and Syria), monovalent type 2 OPV (mOPV2) was authorized for large-scale outbreak control after tOPV withdrawal (1). Poliovirus containment, an evolving area of work that affects every country, aims to ensure that all PV2 specimens are safely contained to minimize the risk for reintroducing the virus into communities. This report summarizes the current status of poliovirus containment and progress since the last report (2), and outlines remaining challenges. Within 30 countries, 86 facilities have been designated by the relevant national authorities (usually the Ministry of Health) to become poliovirus-essential facilities for the continued storage or handling of PV2 materials; each country is responsible for ensuring that these facilities meet all biorisk management requirements.

Molecular Characterization of HCV and Introduction of Biorisk Management CWA 15793-2008 at DHQ Divisional Headquarters Teaching Hospital &amp; MBBS Medical College, Chattar Parri, Mirpur District AJK

Molecular Characterization of HCV and Introduction of Biorisk Management CWA 15793-2008 at DHQ Divisional Headquarters Teaching Hospital &amp; MBBS Medical College, Chattar Parri, Mirpur District AJK

Poliovirus Studies during the Endgame of the Polio Eradication Program.

Since the beginning of Global Polio Eradication Initiative in 1988, poliomyelitis cases caused by wild poliovirus (PV) have been drastically reduced, with only 74 cases reported in 2 endemic countries in 2015. The current limited PV transmission suggests that we are in the endgame of the polio eradication program. However, specific challenges have emerged in the endgame, including tight budget, switching of the vaccines, and changes in biorisk management of PV. To overcome these challenges, several PV studies have been implemented in the eradication program. Some of the responses to the emerging challenges in the polio endgame might be valuable in other infectious diseases eradication programs. Here, I will review challenges that confront the polio eradication program and current research to address these challenges.

Biosafety Initiatives in BMENA Region: Identification of Gaps and Advances.

The objectives of this study were to identify and assess the impact of capacity-building biosafety initiatives and programs that have taken place in the broader Middle East and North Africa (BMENA) region between 2001 and 2013, to highlight gaps that require further development, and to suggest sustainable ways to build cooperative regional biosafety opportunities. A cross-sectional study was conducted with two aspects (1) thorough desktop review of literature for all biosafety/biosecurity-related activities in the study countries, such as seminars, conferences, workshops, policy documents, technology transfer, sustained scientific endeavors between countries, etc. and (2) an online survey of scientists in countries in the region to get first-hand information about biosafety and biosecurity initiatives and gaps in their country. A total of 1832 initiatives of biosafety/biosecurity were recorded from 97 web links; 70.68% (n = 1295) initiatives were focused on raising general awareness among the scientific community about biosafety/biosecurity/biocontainment. The most frequent areas of interest were biorisk management in biomedical and biotechnology laboratories 13% (n = 239), followed by living modified organisms (LMOs) 9.17% (n = 168). Hands-on training accounted for 2.67% (n = 49) of initiatives. Online survey results confirmed desktop review findings; however, the response rate was 11%.

An Overview of the NIH Biorisk Management Program

Biosafety and biorisk management are emerging areas of safety that are not well understood by the general public. With recent headlines questioning the safety practices and procedures at federal agencies, educating the public on what steps are taken to encourage a safe and transparent working environment in high-containment laboratories is important. This article describes for the ABSA International biosafety community, as well as for the general public, the biorisk program at the National Institutes of Health and discusses the steps taken to train researchers, report injuries, and encourage a culture of safety within the laboratories, rather than a culture of fear. It attempts to dispel the provocative headlines used by the media, through education on the process and procedures used to protect the researchers, as well as the public, when handling agents whose manipulation and propagation are restricted to high-containment laboratories. In doing so, the authors seek to better educate the public and help to create better awareness of the work that occurs in these facilities.

Strengthening Biosecurity in Iraq: Development of a National Biorisk Management System

Since 2004, the Republic of Iraq has undertaken a concerted effort to comply with all of its international obligations to prevent the proliferation and the use of chemical, biological, radiological, and nuclear (CBRN) weapons. A centerpiece of this effort is Iraq’s development of a National Biorisk Management System. The Iraqi National Monitoring Authority (INMA), which is responsible for CBRN security and non-proliferation in Iraq, has played a key role in establishing this system. This article provides an overview of Iraq’s international non-proliferation commitments, describes the legal and organizational steps it has taken to implement these commitments, and examines current initiatives to strengthen Iraq’s biosecurity.

Legislations on Biosecurity: Compliance Challenges for Malaysian Scientists

Abstract Malaysia is one of the State Parties to the Biological Toxins and Weapons Convention (BTWC), which was signed in 1972 and ratified in 1991. National legislation governing laboratory biosecurity is in progress. The Malaysian BTWC Bill, when implemented, will require all organizations working with infectious organisms to develop institutional biorisk policies and implement biorisk management programs to address laboratory biosafety and biosecurity at the workplace. Laboratory biosecurity is a relatively new and evolving paradigm for bioscience laboratories in Malaysia. Compliance with this legislation is a significant challenge and requires major change to organizational and workplace culture. Successful implementation would also require awareness training, resources, and a culture of responsibility among scientists.

CWA 15793: When the Biorisk Management is the Core of a Facility

CWA 15793: When the Biorisk Management is the Core of a Facility

Biosafety, Biosecurity, and Bioethics Governance in Synthetic Biology: The “7P” Approach

While recognizing the importance of synthetic biology as an emerging field within science and technology, as well as its potential benefits toward economic growth, public health, energy, and the environment, this article argues that the biorisks involved from a biosafety, biosecurity, and bioethics perspective need to be addressed. To do so, a comprehensive approach combining the two standard aspects of biorisk management—biosafety and biosecurity—and a third key aspect, bioethics, is proposed. Secondly, coming from a governance perspective, the challenge of “how best to govern” such risk is raised. As such the “7P” approach that defines seven key intervention points (Principal Investigator, Project, Premises, Provider, Purchaser, Public, and Publisher) among stakeholders to address the governance of synthetic biology is introduced. Within these intervention points, the opportunities at each stage for several key activities, including raising awareness, implementing education and training, establishing guidelines, and promoting codes of conduct in relation to national laws and regulations as well as international treaties, are highlighted.

Harmonization of European Laboratory Response Networks by Implementing CWA 15793: Use of a Gap Analysis and an “Insider” Exercise as Tools

Laboratory response networks (LRNs) have been established for security reasons in several countries including the Netherlands, France, and Sweden. LRNs function in these countries as a preparedness measure for a coordinated diagnostic response capability in case of a bioterrorism incident or other biocrimes. Generally, these LRNs are organized on a national level. The EU project AniBioThreat has identified the need for an integrated European LRN to strengthen preparedness against animal bioterrorism. One task of the AniBioThreat project is to suggest a plan to implement laboratory biorisk management CWA 15793:2011 (CWA 15793), a management system built on the principle of continual improvement through the Plan-Do-Check-Act (PDCA) cycle. The implementation of CWA 15793 can facilitate trust and credibility in a future European LRN and is an assurance that the work done at the laboratories is performed in a structured way with continuous improvements. As a first step, a gap analysis was performed to establish the current compliance status of biosafety and laboratory biosecurity management with CWA 15793 in 5 AniBioThreat partner institutes in France (ANSES), the Netherlands (CVI and RIVM), and Sweden (SMI and SVA). All 5 partners are national and/or international laboratory reference institutes in the field of public or animal health and possess high-containment laboratories and animal facilities. The gap analysis showed that the participating institutes already have robust biorisk management programs in place, but several gaps were identified that need to be addressed. Despite differences between the participating institutes in their compliance status, these variations are not significant. Biorisk management exercises also have been identified as a useful tool to control compliance status and thereby implementation of CWA 15793. An exercise concerning an insider threat and loss of a biological agent was performed at SVA in the AniBioThreat project to evaluate implementation of the contingency plans and as an activity in the implementation process of CWA 15793. The outcome of the exercise was perceived as very useful, and improvements to enhance biorisk preparedness were identified. Gap analyses and exercises are important, useful activities to facilitate implementation of CWA 15793. The PDCA cycle will enforce a structured way to work, with continual improvements concerning biorisk management activities. Based on the activities in the AniBioThreat project, the following requirements are suggested to promote implementation: support from the top management of the organizations, knowledge about CWA 15793, a compliance audit checklist and gap analysis, training and exercises, networking in LRNs and other networks, and interinstitutional audits. Implementation of CWA 15793 at each institute would strengthen the European animal bioterrorism response capabilities by establishing a well-prepared LRN.