Resources For Conducting Safe Research LABORATORY BIOSAFETY FOCUS FORUM (LBFF) Resources For Conducting Safe Research

Office of Regulatory Affairs & Research Compliance Immunology & Infectious Diseases Delia Wolf Stanley Estime Alexis Fagan Noman Siddiqi Environmental Health Occupational Health, EH, Epidemiology Alice Bedugnis Marshall Katler Thomas Donaghey Jennifer Ford Genetics and complex diseases Jane Lee Brian Frederick EHS-Safety and Biosafety Nadya Yun Shawna Marquis Marissa Cardwell Jackie Kerr

Typical issues considered and discussed Lab safety issues Lab practices Training requirements Safety deficiency Compliance issues Knowledge gaps Awareness drive Sustainability Lab operational issues Program reviews

Schools and Departments Regulatory Committees Laboratory Safety Biosafety Operations Researchers and Staff Green Team Schools and Departments Regulatory Committees Lab safety issues Lab practices Training requirements Safety deficiency Compliance issues Knowledge gaps Sustainability Lab operational issues Program reviews Awareness drive

Our Partners are LBFF EHS Sustainability Operations ORARC

Institutional Oversight Committees Harvard has established the Committee on Microbiological Safety (COMS), a standing faculty committee that reviews all research involving recombinant DNA as well as work involving biohazards at Harvard and its affiliated institutions. The Institutional Animal Care and Use Committee (IACUC) requires researchers to obtain Harvard COMS approval for the use of microbiological agents, human materials and viral vectors in animals before an animal protocol will be approved. Any use of human subjects in research must be registered with the Institutional Review Board (IRB). COMS IRB IACUC

Roles and Responsibility

Principal Investigator ESCO Environmental Safety Compliance Officer Principal Investigator Lab Manager

Principal Investigators (PIs) PIs have the responsibility for the implementation, management and enforcement of a safe and compliant environment within their lab. Harvard University EH&S Policy “The PI has primary responsibility for chemical hygiene and EH&S compliance in his or her laboratory.” Harvard University Chemical Hygiene Plan “Faculty members and others with supervisory responsibilities are expected to promote safe and environmentally responsible practices… Individuals with overall responsibility for teaching and research laboratories must take additional special steps to implement safety and environmental programs in their laboratories.” FAS Grey Book “The PI is the person principally responsible for EH&S compliance in the laboratory.” Harvard Longwood Campus EH&S Compliance Management Plan “Principal Investigators ultimately have the responsibility for safety in their laboratories” SEAS Lab Safety Program

How Can Principal Investigators ensure that their responsibilities are met? Under the authority delegated by the Deans and Senior University Administration, the ESCO for each school is responsible for promoting and maintaining a safe, healthful and environmentally responsible workplace. PIs play an essential role with ensuring compliance through interactions with EH&S, Operations and ORARC. Summary of Roles and Responsibilities from Harvard University Environmental Health & Safety (EH&S) Policy

Lab Safety Representative (Coordinator/Officer) Delegated by PI to: Serve as liaison between safety committees/EH&S and lab Communicate with lab members and PI Get support from EH&S, ORARC and safety committees Attend safety meetings Assist in EH&S lab inspections Inspect hazardous chemical waste Satellite Accumulation Areas Communicate information to lab staff Assist in other tasks assigned by PI

Available Resources Office of Regulatory Affairs & Research Compliance (ORARC) Environmental Health & Safety (EH&S) Operations

ORARC develops and implements policies and procedures to ensure regulatory compliance in the areas of human/animal research and laboratory & biosafety 13

Office of Regulatory Affairs and Research Compliance, HSPH Associate Dean, Regulatory Affairs & Regulatory Compliance Delia Wolf ORARC Coordinator Alexis Fagan Office of Human Research Administration Harvard Longwood Medical Area Managing Director Leslie Howes Assistant Directors Alyssa Speier (Regulatory Affairs & Research Compliance) Stanley Estime (Bio and Laboratory Safety) Assistant Director Kim Serpico Sr. IRB Review Specialist Keren-Nicole Insalaco Sr. QA/QI Specialists Lisa Gabel QA/QI Specialists Scott Meyers IRB Review Specialists Jada Dixon Grace Bullock Alma Castro TBD

Office of Regulatory Affairs and Research Compliance, HSPH Associate Dean, Regulatory Affairs & Regulatory Compliance Delia Wolf EH&S Directors Greg Brady Marissa Cardwell Shawna Marquis ORARC Coordinator Alexis Fagan Assistant Director Stanley Estime (Bio and Laboratory Safety) EH&S Safety Advisors Jackie Kerr (Lab Safety Advisor) Nadya Yun (Biosafety Advisor)

Assistant Director’s Role Ensures research compliance within the labs Investigates allegations and findings of non-compliance Reports potential serious and continuing non-compliance to ORARC Associate Dean Collaborate with EH&S to assist labs in ensuring proper corrective actions are implemented

Assistant Director’s Role Provides Quality Improvement services through educational support Assess lab areas/topics requiring additional training (LBFF – Lab & Biosafety Focus Forum) Manage monthly ROMS meetings Facilitate Quarterly Education Sessions Communicates internal/external educational opportunities and policy updates with ROMS list serve Provides laboratory support services to research community Develop tools and resources to assist with maintaining compliance in conducting daily lab activities (e.g. guidance documents, checklists, informational brochures, etc.

When in doubt and/or need assistance, contact us! Stanley Estime, Assistant Director, Bio & Laboratory Safety Phone: 617-432-2164 Email: sestime@hsph.harvard.edu Jackie Kerr, EH&S, Laboratory Safety Advisor Phone: 617-432-5270 Email: jackie_kerr@harvard.edu Nadya Yun, EH&S, Biosafety Advisor Phone: 617-432-5158 Email: nadya_yun@harvard.edu https://www.hsph.harvard.edu/regulatory-affairs-and-research- compliance/laboratory-biological-safety-education-series/ Reminder: Anonymous form for complaints, questions on website (in addition to past educational/ROMS offering)

Useful Resources ORARC https://www.hsph.harvard.edu/regulatory- affairs-and-research-compliance/laboratory- biological-safety-education-series/ EH&S https://www.ehs.harvard.edu/ Operations https://www.ehs.harvard.edu/buildings- facilities Link to FAQ Page: https://www.hsph.harvard.edu/regulatory-affairs-and-research-compliance/faqs-2/