|
Tip Sheet Volume
6:2
Compliance: Biohazards and Public
Health
The 1986 Federal Register required
all institutions receiving support for recombinant DNA research from the
National Institutes of Health (NIH) to form a biosafety committee to
oversee research involving recombinant DNA. The responsibility of the ISU
institutional biosafety committee was later expanded to include hazardous
biological materials, including recombinant DNA, transgenic plants or
animals, infectious agents (of humans, animals, or plants), toxins of
biological origin, and administration of experimental biological products
to animals. The following information describes the activities of ISU’s
Biohazards and Public Health Committee (BPHC).
Responsibilities of the
Biohazards and Public Health Committee
The BPHC reviews and sets conditions for conducting research and teaching
that involves hazardous biological materials, recombinant DNA, or
transgenic animals, reviews programs involving biological safety and
public health protection at ISU, and sets policies that comply with
federal, state, and local regulations. These responsibilities include
assessing the adequacy of laboratory facilities, containment and safety
practices, the appropriate training and expertise of project personnel,
and compliance with all applicable regulations. In addition, the
University must report any significant problems, violations, accidents, or
illnesses associated with recombinant DNA usage to the NIH Office of
Biotechnology Activities.
Application and Authorization
The ISU Biohazards and Public Health Committee Project Review Form must be
completed and submitted to the Office of Research Compliance prior to
conducting research with hazardous biological materials. The project can
be approved, require modifications to secure approval, or can be denied.
If the project is not approved, a written notification will be provided
that explains the decision and identifies possible conditions or
modifications to the project that would make it acceptable. For projects
that require approval of both the BPHC and the Committee on Animal Care (COAC),
a single application may be filed, the ISU Research Compliance Review Form
– Use of Animals in Research, including the appropriate biohazardous agent
sections. The single application is submitted to the COAC, but is reviewed
by both committees. Each committee issues a separate approval.
Annual Renewal
Authorization for ongoing projects must be
renewed annually. Every five years, a new application must be submitted
and reviewed by the BPHC. As a courtesy, the principal investigator will
receive a reauthorization reminder approximately 60 days before the
authorization anniversary date.
Reminder: The use of animals in a research project
requires additional approval from the ISU Committee on Animal Care and the
use of human subjects in a research project requires approval from the ISU
Institutional Review Board.
Contact Information: Additional information about
BPHC policies and procedures can be found at:
http://www.compliance.iastate.edu/bphcHome.aspx. For questions, please
contact Narda Huyke, BPHC Administrator, at nardah@iastate.edu, 294-5412.
Additional Information
This Tip Sheet was originally published as version 3.4 and has been updated
to reflect current policies and personnel.
If you have any questions about this tip sheet please contact:
Lisa Lorenzen, 2810 Beardshear, Phone: (515) 294-0926, Email:
llorenze@iastate.edu
|