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UMBRELLA PROJECTS
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U-MIC
University of Michigan IRB Collaborative
Umbrella projects
OHRP
IRB review not required for projects lacking
immediate plans for involvement of human subjects
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U-MIC
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Umbrella projects
Certain types of applications and proposals lack
definite plans for the involvement of human subjects
either because the specific human subject activities
have not yet been fully developed or because human
subject research was not anticipated at the time of the
application. In such cases, the application or proposal
need not be reviewed by the IRB prior to an award
(see 45 CFR 46.118 and 46.119).
OHRP memo, 2000
“IRB Review of Applications for HHS Support”
Developed by:
U-MIC
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Umbrella projects
Certain types of applications and proposals lack
definite plans for the involvement of human subjects
either because the specific human subject activities
have not yet been fully developed or because human
subject research was not anticipated at the time of the
application. In such cases, the application or proposal
need not be reviewed by the IRB prior to an award
(see 45 CFR 46.118 and 46.119).
OHRP memo, 2000
“IRB Review of Applications for HHS Support”
Developed by:
U-MIC
5
Umbrella projects
Certain types of applications and proposals lack
definite plans for the involvement of human subjects
either because the specific human subject activities
have not yet been fully developed or because human
subject research was not anticipated at the time of the
application. In such cases, the application or proposal
need not be reviewed by the IRB prior to an award
(see 45 CFR 46.118 and 46.119).
OHRP memo, 2000
“IRB Review of Applications for HHS Support”
Developed by:
U-MIC
6
Umbrella projects
Certain types of applications and proposals lack
definite plans for the involvement of human subjects
either because the specific human subject activities
have not yet been fully developed or because human
subject research was not anticipated at the time of the
application. In such cases, the application or proposal
need not be reviewed by the IRB prior to an award
(see 45 CFR 46.118 and 46.119).
OHRP memo, 2000
“IRB Review of Applications for HHS Support”
Developed by:
U-MIC
7
Umbrella projects
Certain types of applications and proposals lack
definite plans for the involvement of human subjects
either because the specific human subject activities
have not yet been fully developed or because human
subject research was not anticipated at the time of the
application. In such cases, the application or proposal
need not be reviewed by the IRB prior to an award
(see 45 CFR 46.118 and 46.119).
OHRP memo, 2000
“IRB Review of Applications for HHS Support”
Developed by:
U-MIC
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Umbrella projects
granting agencies
•
•
request documentation of IRB approval before releasing funds
may request approval documentation even for research that
will not directly or immediately involve human subjects
 training grant
 program project
 center grant
 project that will eventually involve human subjects
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.118
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Umbrella projects
umbrella projects
or
dry applications
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U-MIC
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Umbrella projects
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U-MIC
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Umbrella projects
expedited review
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Umbrella projects
umbrella applications
that do anticipate a
human subjects
research component
that do not anticipate
a human subjects
research component
must receive IRB approval
before starting research
may be able to terminate
after grant is finalized
•
•
amend umbrella application to
become a standard application
or
create a separate standard
application
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Umbrella projects
Contact the IRB for
more information about
umbrella projects.
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THANK YOU.
Lark Speyer
IRBMED
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U-MIC
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