FAQs

Answers to Frequently Asked Questions (FAQs)

 

Q. How far before a grant deadline do I need to involve your office?
A. As early as possible, but at least one month before the deadline.

Q. How do I get registered at grants.gov?
A. Contact Nancy Alsip at 502.852.2905.

Q. Can you help me prepare my manuscript or grant for online submission?
A. Yes, we can organize your paper, including the references, to match the required format for any journal or agency. We can also put the document through the online submission process for you.

Q. I don't have much experience with style guidelines for publication. Can you edit my paper or grant to improve it?
A. Yes, we have extensive experience working with various style and formatting requirements.

Q. What training do I have to complete to be involved in research?
A. You need to complete the Human subjects protection (CITI) and HIPAA training.  Depending on the trial specifics you may also need GCP training, Biosafety training, and protocol specific training.

Q. What is F&A rate for my project?
A. The rate that applies is dependent upon the type of sponsored project and the location of the work performed.  Please review the most current F&A rates prior to developing your project budget to ensure you are including the correct amount.

Q. Can you please explain RIF?
A. RIF is a research infrastructure fund that is an allocation of the University’s F&A that is charged to a sponsored project each month that has expenses post.  The institution allows for 10% of the total F&A to be transferred back to the PI RIF account and another 10% to the Department RIF account.   Only Investigators and Co-investigators are eligible for RIF allocation.

Q. How much will it cost me to get editing and/or submitting a manuscript?
A. We charge an hourly for editing work. We will review the manuscript and give you a cost estimate for your approval before starting any project.

Q. What is Cost Share?
A. Cost sharing is that portion of the University contribution to a sponsored project, cost sharing is also known as a matching or in-kind contribution. “In-kind” means obligation of costs already incurred by the University. For example, a faculty member’s salary will be paid regardless of whether or not this proposal is funded. However, if the proposal is funded, a certain portion of that salary will be dedicated to time and effort on the project and will comprise cost sharing if not directly paid by the project. In-kind cost sharing also includes non-cash contributions to sponsored projects including donations of equipment and supplies or effort contributed by individuals not paid by the institution.

Q. How do you calculate effort percent?
A. 10% effort is roughly equivalent to one half day per week.

Q. What is a clinical trial?
A clinical trial is a research study that involves humans with specific health conditions. The trials allow the examination of a proposed drug or therapy in a controlled environment to determine its safety and effectiveness in treating patients with certain conditions.

Q. What are the risks of participating in a research study?
A. The risks for each study are different. Some possible risks of taking part in a research study are:

  • The experimental treatment may not be as good as or better than the standard treatment.
  • If an experimental treatment is better than the standard treatment, it may not work for everyone.
  • New drugs and treatments may have side effects that are unknown to the researchers.

Q. Will I have to pay for everything?
A. Each trial will have its own specific guidelines for financial reimbursement. Please read the study consent form very carefully to determine what that reimbursement may or may not be. Please discuss the compensation and subject injury sections of the study consent with your research coordinator and the principal investigator.

Q. Will my health information be kept confidential?
A. Yes, your personal health information will be kept confidential. Each subject receives the privacy documents that explain how medical information may be used and disclosed.

Q. Do the study monitors have access to the electronic records?
A. Yes, with advance notice, study monitors can get access to the EMR systems at the study sites. Please communicate with the clinical coordinator prior to your visit to the site.

Q. Can you use a Central IRB?
A. No.  The University of Louisville has two Institutional Review Boards.

Q. Can you submit the study to your local IRB before a final contract is  signed?
A. Yes.  Contract negotiation and IRB review are often being done concurrently.

Q. What's your average IRB turn-around time?
A. Initial review letters are typically received from our IRB within 24-48 hours following board meetings.