Compliance Step-by-Step Procedure

	Step 1: Obtaining Funding and Budget Development
	Step 2: Proposal Submission to OSPA
	Step 3: Committee Approval
	Step 4: Continuing Review
	Step 5: Project Closure
				

The following items are not intended to be an all inclusive list of the steps involved during the development of a proposal. Rather it is a guide of the basic steps that must be followed for compliance and to serve as a resource for investigators. For a concise listing of research compliance links, please go to Quick Links.

Step 1 : Obtaining Funding and Budget Development

If you need assistance locating funding resources go to the ISU Funding Resources home page, which centralizes both on-campus and off-campus funding resources. During the development stage of your proposal, the Office of Sponsored Programs Administration (OSPA) can provide guidance on obtaining and completing the appropriate forms, advice on budgets and cost sharing, organizational information, and financial administration of awards. The Biotechnology Industrial Resources web page also has very helpul advice for faculty in their industry tip sheets for faculty. There are tips sheets that range from examples of budget formats for industrial projects, an overview of confidentiality agreements to the areas of research most commonly funded by industry.

Step 2 : Proposal Submission to OSPA

Your proposal must be reviewed and approved by the Office of Sponsored Program Administration (OSPA), before it is submitted to an external funding agency. All documents that obligate Iowa State University personnel, facilities, intellectual property, or other resources in any way require an authorized ISU signature. This signature assures that appropriate policies, procedures and legal requirements have been addressed. For an overview about the signatures that are required, please go to the the tip sheet entitled signatures on the Biotechnology Industrial Resource web page.

OSPA tracks and maintains records of the progress of proposals prepared and submitted through Iowa State University. Negotiation of awards is also conducted by this office as well as the activities required to establish new awards in the Sponsored Programs Accounting Office. All proposals are due in OSPA a minimum of three full working days prior to the day you need it back. This is to allow for sufficient time for appropriate review and approval.

When your proposal is submitted for review and approval by OSPA, it must be accompanied by an ISU Proposal Data Form (gold sheet). The gold sheet is an internal document that contains important information about proposals being submitted for external funding. This information is entered into the proposal database maintained in OSPA. Specifically, the gold sheet is used by principal investigators/co-principal investigators, departments, colleges, centers/institutes, the Office of the Vice-Provost for Research (VPR), and the Office of Sponsored Programs Administration to:

• Make sure that credit is given to all principal investigators and co-principal investigators for submissions and awards - only principal investigators/co-principal investigators listed on the gold sheet are entered into the database.
• Track submissions and awards by sponsor and purpose - this allows the VPR office to target specific sponsors and to assemble teams for research in specific areas.
• Identify potential research compliance issues as well as potential for conflict of interest - the federal government has recently stepped up its control of research compliance; at ISU the gold sheet is the form that serves as the first reporting tool for compliance.
• Monitor matching funds and cost sharing by all units across campus - this ensures that matching funds and cost share is available to principal investigators from the indicated sources once an award is received.
• Monitor space needs - to ensure that appropriate space is available when an award is granted.
• Document the indirect cost rate (IDC) - this is crucial for overhead incentives for principal investigators/co-principal investigators and units on campus.

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Step 3: Committee Approval

If your proposal involves animal subjects, human subjects, radioisotope or radiation producing device use, recombinant DNA, human, animal or plant pathogens, or biological toxins, you must obtain approval from the appropriate administrative review committee(s). You must obtain the approval before initiating any work on the project and before the Office of Sponsored Programs Administration will process your award. All investigators, whether they are undergraduate students, graduate students, professional and scientific staff or faculty with either internal or external funding are required to obtain any necessary approval(s) before initiating any research project.

Iowa State University currently has four research compliance review committees, which report to the Office of the Vice President for Research and Economic Development and Advanced Studies. The purpose of these committees is to review and approve all relevant proposals to ensure that they are in compliance with University, local, state, federal and funding agency regulations for research compliance.

The following table is designed to assist investigators in locating the appropriate committee(s) to submit applications for approval(s). If you need further assistance, please contact the Research Compliance Officer by phone (515) 294-3115 or e-mail. dament@iastate.edu

If changes are made to the approved protocol, it is the responsibility of the principal investigator to notify the committee(s) of the changes and receive approval before implementing them. Each committee has different procedures for reporting changes to the protocol; please contact the respective office or go to their web site for further information.

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Step 4: Continuing Review

When you obtain approval from the appropriate administrative review committee(s) it will be granted for a specific amount of time. In most cases, federal law requires continuing review of active research projects, at least annually, to ensure that they are still compliant with the applicable regulations. The principal investigator will receive a notice prior to the renewal application deadline. It is the investigators responsibility to submit applications for continuing review in sufficient time to permit the review and approval of the application prior to its expiration date. Each committee has different time requirements that it adheres to for submission of renewal applications. It is the responsibility of the investigator to be aware of and follow the respective guidelines. If an application renewal is not received and approved before the renewal date, the approval for the project will lapse and all work must stop until approval is once again obtained. Each individual committee has established guidelines in the event that approval lapses and the subsequent procedures that must then be followed. Please contact the respective office or go to their web site for further information.

This renewal process does not apply to projects approved by the Radiation Safety Committee. The Department of Environmental Health and Safety (EH & S) was empowered by the Radiation Safety Committee to provide continuous oversight of authorized radiation users. Each authorization is reviewed on a quarterly basis to ensure compliance. Those users who are not compliant have their authorization for use of radioisotopes or radiation-producing devices revoked and must follow the procedures established by EH & S to re-obtain approval.

Step 5 : Project Closure

Once the project is complete, the principal investigator must notify the appropriate review committee(s) so that the file can be moved to inactive status. Please contact the respective office or go to their web site for further information about project closure.

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