AN INTEGRATED SYSTEM FOR SAFETY, HEALTH & COMPLIANCE OVERSIGHT FOR BIOMEDICAL RESEARCH IN NUS

Transcription

1 AN INTEGRATED SYSTEM FOR SAFETY, HEALTH & COMPLIANCE OVERSIGHT FOR BIOMEDICAL RESEARCH IN NUS Tessy Joseph, PhD, RBP Office of safety Health & Environment National University of Singapore The 2nd Asian Conference on Safety and Education in Laboratory (ASCEL) December, Universitas Indonesia, Depok, West Jawa, Indonesia

2 Outline Biomedical Research in NUS Regulatory Framework Roles of OSHE Roles of various committees Review and approval process

3 Biomedical Research 2 medical schools- Translational research Basic research (BSL-1 & BSl-2 labs) High containment lab Research Institutes Animal research- rodents, aquatic organisms, large animals etc Multidisciplinary research- bioengineering etc.

4 Emergence of infectious diseases Nipah virus (1999) SARS (2003) Avian Influenza ( ) (H5N1) and (H7N9) Dengue (2007) & Chikungunya (2008) Ebola haemorrhagic fever

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6 Live anthrax shipped accidentally to air base in S Korea and 51 labs in 17 states (US labs)

7 Need for the oversight Compliance to the relevant regulations Safe working atmosphere- prevent injury, LAI etc. Safety of public Safety Culture High-quality research The Office of Safety, Health & Environment (OSHE) OSHE- The corporate office in charge of occupational safety & health matters, environmental compliance and emergency management in NUS.

8 Regulatory framework International standards BMBL 5 th Ed WHO guidelines 3 rd Ed NIH guidelines OHSAS stds CWA std Guide for the Care and Use of Laboratory Animals, 8 th Ed Declaration of Helsinki by the World Medical Association (WMA) The Belmont Report by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Etc.

9 Regulatory framework National Biological Agents & toxins Act (BATA) by MOH GMAC guidelines for GM organisms Animals & Birds Act by Agri-veterinary Authority of Singapore (AVA) Human Biomedical Research Act 2015 by MOH NACLAR guidelines by AVA And all other relevant laws and regulations in Singapore Etc.

10 Institutional level programmes Safety Policy Biorisk manual Trainings Professional advisory Emergency response plan Audits & Inspections Guiding Principles Work with hazardous materials (biological, chemicals etc) pose potential risks The need to take necessary precautions to prevent undue exposure Avoid consequences leading to injuries, lab acquired infections etc.

11 NUS Safety & Health Organization President & Deputy Presidents & Vice Presidents Institutional Safety & Health Committees Office of Safety, Health & Environment Deans & Directors Faculty, Admin Office or Research Center Safety & Health Committee Safety & Health Officers Heads of Departments Departmental Safety & Health Committee Safety & Health coordinators Principal Investigators & Laboratory Supervisors Laboratory Safety & Health Group Safety & Health Leads OSHE is the secretariat for IBC, ILSC etc.

12 Roles of OSHE/Biomedical Group Safety & Health Division Biomedical Science (Physical) Science (Chemical) Etc. Review risk assessments for Biomedical research Review Animal research OSH (Occupational Safety and Health) issues and advice IACUC (Institutional Animal Care and Use Committee) Develop online trainings & conduct risk management trainings Audit & inspections Assist PIs with regulatory applications Provide professional advices Secretariat to IBC (Institutional Biosafety Committee)

13 Committees overseeing biomedical research compliances 1. Institutional Biosafety Committee (IBC) 2. Institutional Animal Care and Use Committee (IACUC) 3. Institutional Review Board (IRB)

14 Roles of IBC Formulate and review University Safety & Health Policy and Biosafety programmes Serve in an advisory capacity to Senior Management and OSHE Review and approve Risk assessments of research in the lab, in animals, GMOs, using human subjects Review high-impact accidents and incidents pertaining to biosafety and make recommendations Participate in audits & inspections Guided by BATA & GMAC Guidelines Appointed by NUS Provost Register with MOH

15 Composition of IBC Microbiologist Scientists A person with knowledge in the physical and biological sciences, and laboratory practices Member of the maintenance team A representative from the senior management Operator of the facility OSHE rep/biosafety professional IACUC member/rep Animal facility rep

16 Major Roles of IACUC & IRB IACUC Review and develop policies & programmes for animal care and use programme- health & safety of animals Review and approve animal Protocols IRB Reviews, approves and monitors the ethical aspects of all research projects that involve human subjects and human tissues/cells/data

17 Overlapping Roles by IBC, IACUC & IRB Examples: Committee (agency) GMOs In vitro studies In vivo testing (animal) Development of animal model Preclinical studies (in animals) Gene therapy & Xenografts IBC (BATA, GMAC IACUC (NACLAR) + (animals) IRB - + (human tissue)

18 Project Risk Assessment review & approval process PI s project with animal protocol Submission * IBC Approval OSHE/IACUC remind the PI regarding IRB approval during the review HOD IACUC Approval Review Approval OSHE PI start work *Joint office meeting before the IACUC meeting- IACUC office, OSHE & Animal facility

19 Online application submission by PI

20 Participation & Communication with other stakeholders IACUC IRB IBC/ OSHE PIs Animal facility OH Clinic

21 Biggest Challenges Scope of various committees oversight for research Shaping the committees to meet the needs of the institution, the faculty and the community

22 In Summary New technologies present new safety issues in the lab- in animals, in humans & to the environment IBC to evaluate biosafety & biosecurity (e.g. Dual use research, GM work etc) risk of every research projects IACUC and IBC will need to cooperate in oversight roles IRB should establish specific requirements for ethical use of human subjects All 3 need to work together - communication Oversight of Safety & Health & compliance is necessary to support highest quality of research

23 Thank you!