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

2. 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

3. 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

4. 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

5. Our Partners are
LBFF
EHS
Sustainability
Operations
ORARC

6. 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

7. Roles and Responsibility

8. Principal Investigator
ESCO
Environmental Safety Compliance Officer
Principal Investigator
Lab
Manager

9. 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

10. 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

11. 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

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

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

14. 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

15. 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)

16. 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

17. 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.

18. When in doubt and/or need assistance, contact us!
Stanley Estime, Assistant Director, Bio & Laboratory Safety Phone: Jackie Kerr, EH&S, Laboratory Safety Advisor Phone: Nadya Yun, EH&S, Biosafety Advisor Phone: compliance/laboratory-biological-safety-education-series/
Reminder: Anonymous form for complaints, questions on website (in addition to past educational/ROMS offering)

19. Useful Resources
ORARC affairs-and-research-compliance/laboratory- biological-safety-education-series/ EH&S Operations facilities
Link to FAQ Page: