Changes to the
NIH Guidelines
- What They Mean to You David W. Emery, PhD
Research Associate Professor of Medicine
&
Chair, Institutional Biosafety Committee
Eric Stefansson
Manager
EH&S Research and Occupational Safety Office
BioSafety-’13-MRAM
Types of Biohazardous Research
• Infectious agents
- Microorganisms (E. coli → Tuberculosis)
- Viruses (AAV → HIV)
- All human source materials (including cell lines)
• Recombinant DNA
- Transfer DNA/RNA to or from microorganisms
or any living cells
- Transgenic mice
- Transgenic plants
- Clinical gene therapy trials
- Synthetic DNA (PCR, sequencing, etc…)
• Select Agents (high security)
• Laboratory settings
• Live animals
• Clinical trials & Field tests
BioSafety-’13-MRAM
Oversight of Biohazardous Research
- a team approach -
EH&S
Research
& Occupational
Safety (ROS)
Institutional
Biosafety
Committee
Investigator
with help from
Administrators
BioSafety-’13-MRAM
EH&S / ROS
• Staffed by biosafety professionals
• Responsible for administering biosafety programs and
monitoring compliance with applicable regulations & policies.
• Key Functions:
• Facility design and approval authority
• Review research protocols and identify hazards
• Provide training, consultation, clearances and set OH
requirements
• Site assessments/inspections
• UW Biohazard Safety Manual
• Support IBC
BioSafety-’13-MRAM
Institutional Biosafety Committee
• Composed of faculty, staff, and community members
• Committee meetings open to public - public trust!
• Key Functions:
• Review & recommend institutional policies for research
involving rDNA and biological agents.
• Review individual research proposals for compliance with
Federal, State, local, and institutional regulations:
- Biosafety containment levels (BSL1, 2, 3)
- Adequacy of facilities, SOPs, training
• Independent approval authority for specific proposals.
• Monitor and assure compliance with the NIH Guidelines
BioSafety-’13-MRAM
Federal Authority for IBC
 Institutions receiving funding from the National Institutes
of Health must assure that ALL research is carried out in
compliance with the NIH Guidelines for Research Involving
Recombinant DNA (& Infectious Agents).
(http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html)
 Assurance of compliance is accomplished through the
Institutional Biosafety Committee (IBC) in collaboration
with the Institutional Health and Safety Departments.
(http://www4.od.nih.gov/oba/IBC/IBCrole.htm)
BioSafety-’13-MRAM
Biosafety Standards
Biosafety standards are defined and codified:
•
•
•
•
•
•
•
•
Institution (Administrative Policy, EH&S/RBSO, IBC)
NIH Guidelines
CDC/NIH BMBL Biosafety in Microbiological and
Biomedical Laboratories
US Department of Agriculture
Select Agent Rule, 42 CFR Part 73
WISHA/WAC Occupational Health & Safety Standards
WAC 296-820 Bloodborne Pathogens Standard
Seattle Municipal Code Infectious Waste Management
BioSafety-’13-MRAM
Biosafety Standards
Biosafety standards are defined and codified:
•
•
•
•
•
•
•
•
Institution (Administrative Policy, EH&S/RBSO, IBC)
NIH Guidelines
CDC/NIH BMBL Biosafety in Microbiological and
Biomedical Laboratories
US Department of Agriculture
Select Agent Rule, 42 CFR Part 73
WISHA/WAC Occupational Health & Safety Standards
WAC 296-820 Bloodborne Pathogens Standard
Seattle Municipal Code Infectious Waste Management
BioSafety-’13-MRAM
What Changed ?
 In September 2012 the National Institutes of Health (NIH)
Office of Biotechnology Activities (OBA) published final changes
to the NIH Guidelines which it deemed necessary to reflect the
emerging technologies involving "synthetic DNA"...
 Prior to these changes, recombinant DNA was defined, in part,
as "joining segments of DNA from different sources"; the new
rules were necessary to capture the use of recDNA generated by
artificial synthesis (synthetic DNA).
 This precipitated several other changes to NIH Guidelines...
BioSafety-’13-MRAM
What Changed ?
(continued)
• Synthetic DNA is treated the same as Recombinant DNA
• Recombinant DNA outside of cells remains "exempt" from
the NIH Guidelines, with some exceptions
• New rules for recDNA prepared in liposomes, other "vehicles"
• New definition and rules for "safe" recDNA inside cells
• New rules for chemically modified recDNA
• New rules for drug resistance genes in pathogenic agents
• New rules for synthetic DNA that exists in nature
• New rules for clinical gene therapy
• New rules for risk assessment
• Reconfirm concept that all recDNA is hazardous
BioSafety-’13-MRAM
What You Need To Do
• Ask your investigators to review their research programs to
determine if these changes to the NIH Guidelines apply to
their research.
• If they received Biological Use Authorization during the past
three years and they believe their research approval would
be impacted by these changes, they will need to submit a
Request for Change form no later than February 28.
• If they are currently working without an EH&S Biological
Use Authorization and they believe their research falls under
the amended NIH Guidelines, they will need to submit a BUA
application no later than February 28.
BioSafety-’13-MRAM
What You Need To Do
continued...
• On the eGC1 "Compliance Questions", be sure to mark
"yes" on EHS-1 if the research involves anything with DNA,
including synthetic DNA, as well as microorganisms, or
human tissue culture (at a minimum).
- this will eventually trigger follow-up by OSP and EH&S if the
grant is funded, but does NOT currently place a hold on funding like
animal and human subject "just in time" approvals.
• Be aware that these changes will soon appear in the UW
Biosafety Manual and associated documents, as well as the
UW Administrative Policy Statement.
BioSafety-’13-MRAM
Deadlines
• All new applications and change forms must be submitted
no later than February 28, 2013.
• If you miss this due-date, your application my not be
reviewed and approved be the end of March 2013
(the due-date set by the NIH).
• Please remember that failure to comply with the NIH
Guidelines, including properly registering your research,
puts your funding, and that of your colleagues, as risk.
BioSafety-’13-Outreach
References / Contacts
• EH&S Research and Occupational Safety office:
206-221-7770, ehsbio@uw.edu
• Biological Use Authorization applications:
http://www.ehs.washington.edu/forms/rbs/bua.docx
http://www.ehs.washington.edu/forms/rbs/buachange.docx
• NIH Guidelines:
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
• FAQs for changes to the NIH Guidelines:
NIH: http://oba.od.nih.gov/oba/faqs/Synthetic_FAQs-Sept-2012.pdf
EH&S: http://www.ehs.washington.edu/rbsresplan/rdna.shtm
BioSafety-’13-Outreach
? QUESTIONS ?
BioSafety-’13-MRAM