Introduction
Grants and
contracts are made to institutions rather than to individuals. It is the responsibility of the University to ensure that
all research conducted under its auspices is carried out in such a
manner that the rights and welfare of human and animal subjects,
society, the environment and researchers are protected, and that
research activities are in compliance with all applicable State
and Federal regulations.
Activities defined as
"under the auspices of the University" include
activities conducted as part of University employment, as part of
course credit or fulfillment of a degree requirement, activities
involving use of University resources, or involving publication
that credits University affiliation.
Research
Compliance Officer
The Research
Compliance Officer is the resource person on research compliance
matters for the University community and coordinates all such compliance activities
for the University. Principal investigators are encouraged to
consult with the Research Compliance Officer at the planning
stages of research to determine if any regulations or safety
policies apply to their research and what steps must be taken to
comply with them. Please
contact the Division of Sponsored Research and Training at (305)
348-2494.
Research
Requiring Compliance Review
Regulation and
safety policies apply to many different categories of research.
Regulations and standards change frequently and University
policy requires review of research activities that a principal investigator may
not have consider as requiring review. EH&S recommends that researchers
contact the Research Compliance Office for assistance.
Human
Participants
University policy seeks to ensure that the rights and welfare of human
subjects are adequately protected in research conducted under its
auspices. In addition, federal and state laws and regulations
require these protections. In order for the University to fulfill
its responsibility and to comply with the law and regulations, all
human subjects research conducted under University auspices must
receive appropriate review and approval.
Animal
Subjects
It is the
policy of the University to establish, implement, and maintain
proper measures of ensuring the appropriate care and use of all
animals involved in research, research training, or other
educational activities conducted under the auspices of the
University.
Responsible
Conduct
The Research
Compliance Officer is responsible for the establishment of
policies and procedures for the review, inquiry, or investigation
of all allegations of misconduct in all research conducted under
the auspices of the University.
Controlled
Substances in Research
The Controlled
Substance Safety Officer (x70289) establishes policy and maintains oversight over
the use of controlled substances in all research conducted under
the auspices of the University.
Hazardous
Materials
There
are four major areas of concern: toxic chemicals, chemical carcinogens,
highly flammable materials and infectious
agents. Various State and Federal regulations are involved with
each category, and each requires different responses and
compliance standards. Any investigator considering the
utilization/disposal of such materials should contact the
Lab Safety Compliance Officer, the Fire Safety Officer or the
Biosafety Officer at (305) 348-262,1 before beginning any research.
Potential
Health Hazards
The following
policy encompasses all activity at FIU
:
1.
It
is the responsibility of the Principal Investigator/Instructor to inform
all individuals using or exposed to toxic substances, animals
which are a biohazard, or hazards associated with experiments
involving sensory stress, of the possible consequences of their
use or exposure to them. The publications of the National
Institute of Occupational Safety and Health (NIOSH), the
Environmental Protection Agency (EPA), or similar agencies will
serve as sources for identifying toxic chemicals and reagents. It
is the obligation of the individual(s) doing the research to
report all instances of toxic contamination, or suspicion of
contamination or injury of any sort, to the Principal
Investigator/Instructor , who will inform the Director of Environmental
Health & Safety.
2.
Any
individual who becomes ill and believes it is related to a
research effort should inform the Principal
Investigator/Instructor
and
contact the Human Resources office, Workers Compensation section
at x73273. If the individual's own physician is consulted, the
Human Resources office, Workers Compensation section must be
notified of the visit if it is suspected that the condition may
have resulted from research activity.
3.
Notification of a any injury or suspect exposure must be provided
to the Director, Environmental Health & Safety, by the direct
supervisor of the injured researcher.
4.
The
Director, Environmental Health & Safety will investigate the
conditions and occurrences related to the reported injury. A report of
findings and recommendations will be submitted to the Vice
President for Research and to the Principal
Investigator / Instructor.
The responsibility for corrective actions rests with the direct supervisor
of the injured individual.
Radioactive
Material
All research
involving radioactive materials or machines and equipment that
emit ionizing radiation must receive approval from the Radiation
Safety Committee for the purchase, possession, use,
transportation, and disposal of such material or equipment.
Application forms are available from the Radiation Safety Officer
(x70289). Since approval of a protocol usually takes at least two
weeks from the receipt of an application, the Investigator should
consider this timeframe in planning the research.
The
procedures involved in purchasing, possessing, using, transporting
and disposing of radioactive material are detailed in the
University manual, "FIU Radiation Control Manual." Investigators are advised to consult this manual
when planning to use radioactive materials. Copies are available
from the Radiation Safety Officer, who is also available to answer
questions concerning research involving radioactive material.
Recombinant
DNA
Florida
International University is in the process of establishing a
program to conduct research involving the use of Recombinant
DNA (RDNA). Application for approval from the National Institutes
of Health and the Florida State Department of Health are being
processed. Responsibility for the review and approval of research
involving RDNA will rest with the Institutional Biosafety
Committee (IBC), which will be formalized by July 2004.
Although
state and federal regulations exempt some RDNA research from prior
review and approval, the criteria for deciding whether prior
review is necessary are somewhat complex, therefore all
researchers conducting any type of RDNA research will
be required to inform the IBC about the nature of the experiments
they are conducting, even if they are considered exempt from
regulations.
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