| Investigators preparing a first grant application often
have questions about the internal reviews and institutional signatures
required before submission. Who, for instance, is the "Official Signing
for Applicant Organization" so prominently featured on the face sheet of
federal grant applications?
Here are some general principles about who should approve
your grant application, and why:
First, responsible local
administrators should have input very early on.
Every project, however small, has an impact on its
surroundings: office or desk space must be found; support personnel must
be enlisted to help; photocopiers, computers, and other basic equipment
must be available. Most importantly, your own time must be freed up so
that you can successfully complete your project.
Even before you start writing your proposal, you should
talk over its goals and work scope with these administrators -- usually
the Division and Department Chair(s) -- to be sure that commitments necessary
for the project, in terms of time, space and equipment can be made. At
the same time, you will want to discuss how the proposed project fits the
overall goals of the Division/Department.
When deciding whom to approach at this stage, investigators
should consider where the local impact of the project will be felt:
Which unit will release staff time for this activity? Which unit
will supply space, equipment and support personnel? If more than
one unit will be affected the administrator of each should be approached.
In addition, any project which will require the space or resources of an
ambulatory clinic needs the prior approval of the appropriate clinic administrator.
(See the Project
Resource Inventory in the Bureau Institutional
Approval Forms)
If your project will require time, effort or supplies
from Pharmacy or the Clinical Labs -- over and above that normally required
for patient care -- you must make sure that these departments also are
able and willing to make these commitments. (See the Pharmacy
and Laboratory Commitment Forms in the Bureau
Institutional Approval Forms)
These administrators should have a chance to review the
proposed project twice: Once informally before the application process
is begun, and once formally when the application is ready to be submitted.
Second, the institution
as a whole must approve the commitments entailed by the project.
Every project also has an institution-wide impact.
The institution has an interest in seeing that projects substantially reflect
its goals, that the quality of patient care is maintained, and that the
costs incurred by the project are reasonable. Officials representing
the institution as a whole should have the chance to review the proposal
to approve any institution-wide commitments.
This institutional level of review is most efficiently
achieved by using one office as a central coordinator to obtain appropriate
reviews from other central offices. Once these reviews are obtained,
institutional approval can be given by that office. A designated official
from this office would therefore sign as the "Official Signing for Applicant
Organization". At CCH the Director of Research Development serves
as this official. At other Bureau affiliates, the Chief Operating
Officer supplies this signature.
Third, an official of the
administrative agent, if any, such as the Hektoen
Institute, should review the proposal.
This ensures that the administrative agent is committed
to take on its responsibilities should the grant be funded. (See the Administrative
Agent Form in the Bureau Institutional Approval
Forms)
Fourth, any proposed research
utilizing human subjects or vertebrate animal subjects must be approved
by the appropriate committee before the research begins.
For research involving human subjects see the
Bureau Institutional Approval Forms to apply for review by the
Scientific Committee (Institutional Review Board). For research with
vertebrate animals see the IACUC Approval Forms
to apply for review by the Institutional Animal Care and Use Committee.
This requirement is in accordance with both federal and institutional regulations.
Most federal grants programs will allow this approval to be "pending" at
the time of submission. In other words, the application to the subject
protection committee should be completed before grant submission, but the
review process need not be. At Cook County Hospital, the Scientific
Committee's approval of a protocol given a full (not expedited) review
must also be ratified by the Executive Medical Staff before research begins.
Finally, any extraordinary
safety issues that might be raised by this research must be answered.
If your project will entail the handling or use of potentially
hazardous substances, over and above those
employed in clinical care, you must obtain Safety Office approval
(See the Safety Review Form
in the Bureau Institutional Approval Forms).
If you will be employing recombinant DNA techniques, the Recombinant DNA
Subcommittee of the Hospital Safety Committee must also approve the project.
In summary, there are five
levels at which internal approval of a grant application may be necessary:
-
The local level: Division and Department Chair(s), Clinic
Director, or equivalent administrator.
-
The institutional level: A designated officer of the Hospital
or Bureau entity, who coordinates reviews from other central administrators.
-
An officer of the administrative agent (i.e. the Hektoen
Institute), if the grant will not be administered by Cook County.
-
The subject protection committee (IRB or IACUC), when appropriate.
-
The Hospital Safety Office and Safety Committee when appropriate.
See also:
Insitutional Approval Forms
Application Forms Checklist
Download Bureau Forms for Institutional
Approval
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