|
Tip Sheet Volume 2:8
Research Compliance
Compliance
is an important issue when conducting research, whether or not
it's funded by industry. There are four committees at Iowa State
charged with ensuring compliance when research involves animals,
humans, biohazards, or radiation. The following provides a brief
overview of each committee.
Committee On Animal
Care (COAC)
Chair: Michael Wannemuehler, mjwannem@iastate.edu,
www.iacuc.iastate.edu/
The Animal Welfare Act is a federal
law passed in 1966 to regulate animal research facilities, animal
dealers and exhibitors, operators of animal auction sales, and
carriers and intermediate handlers of animals in shipment. The
act requires that research institutions have: 1) an effective
Institutional Animal Care and Use Committee; 2) a veterinary
care program in place; 3) all personnel using or caring for live
animals be qualified to do so; and 4) a mechanism in place for
reporting concerns regarding animal care and use at the institution.
All research involving the use of live
vertebrate animals must be approved by the COAC.
Institutional
Review Board (IRB)
Chair: Rick Sharp, rlsharp@iastate.edu,
http://grants-svr.admin.iastate.edu/vpr/humansubjects/contact_info.html
The Office for Human Research Protections
(OHRP) within the U.S. Department of Health and Human Services
is the federal agency that oversees human research compliance
at all major research universities. Federal regulations require
each institution conducting federally funded human subjects research
to have an IRB to enforce compliance with federal regulations.
Like most universities, ISU has agreed to follow federal guidelines
for all human subjects research conducted on campus. Research
using human subjects encompasses a broader range than many investigators
realize. In additional to traditional biomedical and clinical
studies, human subjects research includes social and behavioral
research, such as surveys, exercise and nutrition studies, learning
experiments, etc. Central to all human subjects research is the
concept of beneficence, captured in risk/benefit assessments.
Other important guidelines concern informed consent of the subjects
and data confidentiality issues.
All research involving the use of humans
must be approved by the IRB.
Biohazards and
Public Health Committee (BPHC)
Chair: Chris Minion, fcminion@iastate.edu,
www.ehs.iastate.edu/biosafety/bioservices.htm#bphc
As required by the May 7, 1986, Federal
Register and amendments, the BPHC serves as the institutional
biosafety committee in all matters involving recombinant DNA
studies. The BPHC also is responsible for reviewing the biological
and public health and safety programs at Iowa State University
and for setting policies that comply with federal, state, and
local regulations and recommendations.
Radiation Safety
Chair: Daniel B. Bullen, dbullen@iastate.edu, www.ehs.iastate.edu/radiation/services.htm#rsc
Research projects that involve the use of radioactive material
or radiation-producing devices must be authorized by the Iowa
State University Radiation Safety Committee (RSC). The principal
function of the RSC is to establish university policy for the
safe use of radioactive materials and radiation-producing devices
that comply with federal, state, and local regulations.
If you have any questions about this
tip sheet or working with industry, please contact:
Lisa Lorenzen
Biotechnology Industrial Liaison Phone: (515) 294-0926
1210 Molecular Biology Building Email: llorenze@iastate.edu
Acknowledgement: A special
thanks to Wolfgang Kliemann, Sonja Klocker, and the above-listed
websites for their assistance.
|
