01/10/02
Section 2 – Frequently Asked Questions
REMINDER
The week of January 14-18 is the proposal deadline for several of our major
funding agencies such as, American Heart Association- National, American Heart
Association-FL, and American Cancer Society, Florida Division. ORA would like
to remind the College of Medicine that submitting proposals to our office as
early as possible will expedite the review and signatory process. For specific
dates and other deadlines, go to our Funding Opportunities
page.
FREQUENTLY
ASKED QUESTIONS
|
Agency |
Grant Type |
Electronic Deadline |
Hard Copy Deadline |
|
American Heart-National |
Scientist Development Grant Application |
January 14, 2002, 5:00 p.m. CST |
January 21, 2002 5:00 p.m. CST (One original and 5 duplicated copies) |
|
American Heart-National |
Established Investigator Grant Application |
January 14, 2002, 5:00 p.m. CST |
January 21, 2002 5:00 p.m. CST (One original and 5 duplicated copies) |
|
American Heart-National |
Grant-in-Aid Application |
January 15, 2002, 5:00 p.m. CST |
January 22, 2002 5:00 p.m. CST (One original and 5 duplicated copies) |
|
American Heart-Florida |
Predoctoral & Postdoctoral Fellowship Applications |
January 18, 2002 5:00 EST |
January 25, 2002, 5:00 p.m. EST (One original and 5 duplicated copies) |
|
American Heart-Florida |
Scientist Development Grant Application |
January 18, 2002 5:00 EST |
January 25, 2002, 5:00 p.m. EST (One original and 5 duplicated copies) |
|
American Heart-Florida |
Beginning Grant-in-Aid Application |
January 18, 2002 5:00 EST |
January 25, 2002, 5:00 p.m. EST (One original and 5 duplicated copies) |
|
American Heart-Florida |
Grant-in-Aid Application |
January 18, 2002 5:00 EST |
January 25, 2002, 5:00 p.m. EST (One original and 5 duplicated copies) |
Applications for all programs must be received
electronically on the deadline. Applicants
are strongly advised to complete their required electronic submission early in
case technical difficulties are encountered. Applicants who encounter technical
difficulties with the electronic submission must contact the National or
Affiliate office whichever is appropriate, prior to the deadline to resolve the
situation. Please be reminded that the Hard Copy/Paper submission must be
identical to the electronic submission, otherwise the application is subjected
to rejection.
2) “American Heart does not pay Collaborating
Investigators salaries. Do I need
to submit a Cost Sharing letter if I include them on the budget with effort and
no salary compensation?”
3) “For American Heart Association grants, is the
indirect cost taking on the total direct cost or the total cost?”
National Affiliate
Sample SDG Budget Sample SDG Budget
+ fringes 3,835(18.93% fringe amt for 5,209 (18.93% fringe amt. for
a MD w/o Health Ins.) a MD w/o Health Ins.)
24,091(maximum amt. allowed if taking 10% IDC) 32,727 (maximum amt. allowed if taking 10% IDC)
Project Costs 35,000 (min. to be spent on project) 40,000 (min. to be spent on project)
Total Direct Cost 59,091 72,727
Indirect Cost 5,909 (10% on total direct cost) 7,273 (10% on total direct cost)
Maximum
yr. amt 65,000 80,000
Sample EIG Budget N/A
+ fringes 4,486(18.93% fringe amt for
a M.D. w/o Health Ins.)
28,182 (maximum amt. Allowed if taking 10% IDC)
Project Costs 40,000 (min. to be spent on project)
Total Direct Cost 68,182
Indirect Cost 6,818 (10% on total direct cost)
Maximum yr. amt 75,000
PI Salary 27,327 12,612
+ fringes 5,173(18.93% fringe amt for 2,388 (18.93% fringe amt for
a M.D. w/o Health Ins.) a M.D. w/o Health Ins.)
Total Salary 32,500(total amt. Allowed for PI salary/fringes) 15,000
Project Costs 32,500 (min. to be spent on project) 39,545
Total Direct Cost 65,000 54,545
Indirect Cost 6,500 (10% on total direct cost) 5,455 (10% on total direct cost)
Maximum yr. amt 71,500 60,000
The following is the information
that should appear on the Administrative Information form of the AMH
application:
11.
Sandra Goldstein
12.
Division of Sponsored Research
21.
Division of Sponsored Research
5.)“Do I need to complete a Financial Conflict
for my American Heart Association grant?
Yes, according to the AMH guidelines,
“investigators and institutions are required by the American Heart Association
to comply with the PHS regulations, Final Rule 42 CFR Part 50, Subpart F,
Responsibility of Applicants for Promoting Objectivity in Research”. DSR has
instructed those submitting AMH proposals to use the PHS Disclosure form.
|
Agency |
Grant Type |
Electronic Deadline |
Hard Copy Deadline |
|
National Institutes of Health |
New, Competing |
N/A |
February 1, 2002, 5:00 p.m. EST (One original and 5 duplicated copies) |
7) “Whose name and information do I put on the
NIH face page?”
For section 13, Administrative Official
to be notified if award is made:
Name-Thomas E. Walsh, Ph.D
Title-Director
Address-University of Florida
PO Box 115500, 219 Grinter Hall
Gainesville,
Florida 32611-5500
Fax- (352) 392-4522
E-mail-ufawards@rgp.ufl.edu
For section 14, Official signing
for application organization:
Name-Leave Blank
Title-Leave Blank
Address- University of Florida
PO Box 115500, 219 Grinter Hall
Gainesville,
Florida 32611-5500
Fax- (352) 392-4522
E-mail-Leave
Blank
*For item
A. Positions and Honors. List in chronological order previous
positions, concluding with your present position. List any honors. Include
present membership on any Federal Government public advisory committee.
*For item B. Selected peer-reviewed publications (in chronological order). Do
not include publications submitted or in preparation.
For item C. Research Support. List selected ongoing or completed (during
the last three years) research projects (federal and non-federal support).
Begin with the projects that are most relevant to the research proposed in this
application. Briefly indicate the overall goals of the projects and
responsibilities of principal investigator identified above.
*A & B together, may not
exceed two of the four page limits.
9) “What information do I need to include in my
application if I have Human Subjects involved in my research?”
If you marked "Yes" for Item 4 on the Face Page of the application and did not claim any exemptions from the regulations, create a section entitled "Protection of Human Subjects." In this section, you must provide information to address all four evaluation criteria below as they apply to the research you are proposing.
1. RISKS
TO THE SUBJECTS
2. ADEQUACY OF PROTECTION AGAINST RISKS
3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS
4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED
See NIH guidelines for specific instructions on completing
the evaluation criteria
|
Applications that fail to comply with this requirement will be designated as incomplete and will constitute grounds for the PHS to return the application without peer review. |
The following table is intended to provide guidance on what must be addressed
in the Human Subjects Research section.
|
SCENARIO |
HUMAN SUBJECTS |
EXEMPT |
CLINICAL RESEARCH |
CLINICAL
TRIAL |
REQUIREMENTS |
|
A |
No |
N/A |
N/A |
N/A |
|
|
B |
Yes |
No |
Yes |
No |
|
|
C |
Yes |
No |
Yes |
Yes |
|
|
D |
Yes |
Yes |
No |
N/A |
|
|
E |
Yes |
No |
No |
N/A |
|
.
IMPORTANT DEFINITIONS
Clinical Research: NIH defines human
clinical research as: (1) Patient-oriented research. Research conducted with human
subjects (or on material of human origin such as tissues, specimens and
cognitive phenomena) for which an investigator (or colleague) directly
interacts with human subjects. Excluded from this definition are in vitro
studies that utilize human tissues that cannot be linked to a living
individual. Patient-oriented research includes: (a) mechanisms of human
disease, (b) therapeutic interventions, (c) clinical trials, or (d) development
of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes
research and health services research. Note: Studies falling under Exemption 4
for human subjects research are not considered clinical research by this
definition.
Clinical Trial: For purposes of reviewing applications submitted to the NIH, a clinical trial is operationally defined as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious and effective. Clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases:
Phase I clinical trials are done to test a new biomedical or behavioral intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g. determine a safe dosage range, and identify side effects).
Phase II clinical trials are done to study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.
Phase III studies are done to study the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.
Phase IV studies are done after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
NIH-Defined Phase III Clinical Trial: For the purpose of the Guidelines an NIH-defined Phase III "clinical trial" is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.
Include five collated sets of all appendix
material, in the same package with the application, following all copies of the
application. Identify each item with the name of the principal investigator. Do
not intermingle appendix materials with the application.
New, Revised, Competing Continuation and Supplemental applications may include the following materials in the appendix:
For specific questions not addressed within this newsletter,
please contact the Office of Research Affairs at (352) 392-5398.
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