Project Development and Proposal Preparation Flashcards

A PI proposes to use existing patient data collected for clinical care purposes in a new research study. The first question the research administrator should ask is:

Answer: Does this research require IRB review and approval?

Any research involving human subjects data requires IRB determination—whether full review, expedited, or exempt—before the project can begin.

What distinguishes a cooperative agreement from a grant in terms of federal agency involvement?

Answer: Cooperative agreements involve substantial federal programmatic involvement during performance

Under 2 CFR Part 200, a cooperative agreement is distinguished from a grant by the substantial involvement of the federal agency in carrying out the project activities.

A research administrator is reviewing a proposal budget and finds that the PI has included $10,000 for an office computer to be used primarily for writing the grant report. This cost is most likely:

Answer: Unallowable as a direct cost because it primarily serves administrative purposes

General-purpose equipment used primarily for administrative tasks cannot be charged as a direct cost; it must be covered by indirect (F&A) costs.

Which of the following best describes the 'period of performance' for a federal award?

Answer: The time interval during which the recipient may incur allowable costs

The period of performance is the time frame specified in the award document during which the recipient is authorized to incur costs and carry out project activities.

When a PI discovers a potential conflict of interest related to a proposed research project, the appropriate immediate action is to:

Answer: Disclose the conflict to the institution's designated official

Federal regulations require disclosure to the institution's designated official, who then determines whether a management plan is needed—not unilateral action by the PI.

A proposal submitted to the Department of Defense includes sensitive technology. Which regulatory framework governs export control considerations for this proposal?

Answer: EAR (Export Administration Regulations) and ITAR (International Traffic in Arms Regulations)

EAR and ITAR govern the transfer of controlled technologies, data, and equipment to foreign nationals or governments, which is a key compliance area for defense-related research.

A research administrator is preparing a modular budget for an NIH R01 application. What is the maximum direct cost per year allowed under the modular budget format?

Answer: $250,000

NIH modular budgets are used for applications requesting $250,000 or less in direct costs per year, submitted in $25,000 increments.