Grant Center: Institutional Review Board
Instructions for Institutional Review Board
All research involving the use of human subjects conducted by Fitchburg
State College (FSC) faculty, staff, or students, or sponsored, in
part or in whole, by FSC must be reviewed and approved prior to
the start of the project and then conducted in full compliance with
IRB
policies and procedures.
It is the responsibility of researchers to refer their projects
to the appropriate review committee whenever humans are used as
subjects in research, even if the researchers do not consider the
subjects to be at risk.
All federal and state grant applications involving human subjects
must have approval from the IRB before the grant application can
proceed through the internal review process.
The establishment of FSC IRB and its policies and procedures are
primarily derived from Title 45, Part 46, of the CODE
OF FEDERAL REGULATIONS (45 CFR 46 ). The policies and procedures
are intended to provide a resource for the preparation and submission
of research applications for IRB reviews.
The type of review required depends upon the nature of the research,
the subjects, and the risk imposed upon the subjects. A decision
tree to aid in the researcher's determination of the proper
type of review is included at the end of Section I. In all cases
the researchers must complete the application
and Researcher
Assurance Statement. (Instructions
for application)
To facilitate processing and to optimize service, we encourage
investigators to utilize e-mail for all inquiries. Messages
will be reviewed frequently by the IRB Chair, who will respond either
by e-mail or telephone, depending on the nature of the question.
IRB Committee Chair, Sara Pollak Levine, PhD, slevine@fsc.edu
U.S. Department of Health and Human Services web
site
Office for Human
Research Protection
Office
of Research Integrity
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