IRB, Office of Research Development COOK COUNTY BUREAU OF HEALTH SERVICES
Office of Research Development

      
Friday, Sep 03, 2010
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WHO SIGNS FOR A GRANT APPLICATION, AND WHY?
 
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:

  1. The local level: Division and Department Chair(s), Clinic Director, or equivalent administrator.
  2. The institutional level: A designated officer of the Hospital or Bureau entity, who coordinates reviews from other central administrators.
  3. An officer of the administrative agent (i.e. the Hektoen Institute), if the grant will not be administered by Cook County.
  4. The subject protection committee (IRB or IACUC), when appropriate.
  5. 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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