Congratulations!
You’ve Been Funded!
Information Gathered by the Research
Facilitation Team
HOSPITAL ADMINISTRATION CLINICAL TRIALS FACILITATOR
THE GRADUATE TUITION BENEFIT PROGRAM (TBP)
GENERAL CLINICAL RESEARCH CENTER (GCRC)
THE RESEARCH FACILITATION TEAM
A Collaboration between the
Center for Rehabilitation Research and the
Putting the “U” in
Funding
INSTITUTIONAL REVIEW BOARD
A Quick overview of the IRB
The
Institutional Review Board (IRB) ensures that all University Research that
involves with Human Subjects or Animals in research is ethical and safe. You must get IRB approval for each study you
conduct that involves people or animals.
If you have any questions, the IRB staff are available to help you. You can contact them at:
Phone:
(801) 581-3655
Email: irb@hsc.utah.edu
Prior to completing an IRB Study Application you must
complete one of three training initiatives.
1. Collaborative IRB Training
Initiative (CITI) or
2. VA Good Clinical Practice Training or
3. Human
Participant Protections Education for Research Teams
The Institutional
Review Board Website can answer most of your questions.
Obtaining IRB Approval for Your
Study
Before you
can begin your research project, you must obtain approval from the University’s
Institutional Review Board (IRB). This process is completed online through a
system called ERICA.
- You can access ERICA from the IRB Homepage: http://www.research.utah.edu/irb/index.html
Finding Answers to Your Questions
§
Visit
the following two links for answers to almost any question that you may have
regarding your IRB application:
o
http://www.research.utah.edu/irb/guidelines/index.html
o
http://www.research.utah.edu/irb/guidelines/faq.html
The Basics
- To start a new research
project, submit a New Study
Application.
- The application will be
reviewed. The IRB will email you and let you know if revisions are needed.
Revisions are very common and are usually quite simple, especially if
you’ve followed all of the guidelines and used the appropriate templates.
- Once your study is approved,
you will receive an email that indicates the date of review, the type of
review, and when the approval expires (generally one year from the review
date).
- You will need to turn in a Renewal Application if you have not
completed your study be the expiration date. The IRB will email you to let
you know when a renewal is due (the email is generally sent 45 days prior
to the expiration date).
- If the protocol of your study
needs to change in any way during the course of your research, you must
turn in an Amendment. You can
not start implementing the changes until you receive approval from the
IRB. For example, if your study was approved for participants 25-30 years
old, but you need to change that to 25-35 year olds, you cannot recruit
31-35 year olds until the IRB approves your amendment.
- Once your study is completed,
you will need to turn in a Final
Report.
Dates you
should be aware of:
IRB Review Dates
The IRB meets on the first four Wednesdays of each month. Applications
must be received by Noon on the deadline dates. The deadline dates, as of
December 28, 2006, are:
|
IRB Panel
|
Deadlines |
Meeting
Dates |
|
Panel 1 |
Mar 19,
2007 |
Apr 4,
2007 |
|
Panel 2 |
Mar 26,
2007 |
Apr 11,
2007 |
|
Panel 3 |
Apr 2,
2007 |
Apr 18,
2007 |
|
Panel 4 |
Apr 9,
2007 |
Apr 25,
2007 |
|
Panel 1 |
Apr 16,
2007 |
May 2,
2007 |
|
Panel 2 |
Apr 23,
2007 |
May 9,
2007 |
|
Panel 3 |
Apr 30,
2007 |
May 16,
2007 |
|
Panel 4 |
May 7,
2007 |
Mar 23,
2007 |
|
Panel 1 |
May 16,
2007 |
Jun 6,
2007 |
|
Panel 2 |
May 25,
2007 |
Jun 13,
2007 |
|
Panel 3 |
Jun 4,
2007 |
Jun 20,
2007 |
|
Panel 4 |
Jun 11,
2007 |
Jun 27,
2007 |
|
Panel 1 |
No
Meeting |
No
Meeting |
|
Panel 2 |
Jun 20,
2007 |
Jul 11, 2007 |
|
Panel 3 |
Jun 29,
2007 |
Jul 18,
2007 |
|
Panel 4 |
Jul 9,
2007 |
Jul 25,
2007 |
|
Panel 1 |
Jul 16,
2007 |
Aug 1,
2007 |
|
Panel 2 |
Jul 23,
2007 |
Aug 8,
2007 |
|
Panel 3 |
Jul 30,
2007 |
Aug 15,
2007 |
|
Panel 4 |
Aug 6,
2007 |
Aug 22,
2007 |
|
Panel 1 |
Aug 15,
2007 |
Sep 5,
2007 |
|
Panel 2 |
Aug 24,
2007 |
Sep 12,
2007 |
|
Panel 3 |
Sep 3,
2007 |
Sep 19,
2007 |
|
Panel 4 |
Sep 10,
2007 |
Sep 26,
2007 |
|
Panel 1 |
Sep 17,
2007 |
Oct 3,
2007 |
|
Panel 2 |
Sep 24,
2007 |
Oct 10,
2007 |
|
Panel 3 |
Oct 1,
2007 |
Oct 17,
2007 |
|
Panel 4 |
Oct 8,
2007 |
Oct 24,
2007 |
Update from the IRB, March 26, 2007
The
HOSPITAL ADMINISTRATION CLINICAL TRIALS FACILITATOR
Meet Lisa Weaver
Lisa Weaver
Clinical Trials Facilitator
Hospital
A150L
(801)
585-0770
The
Hospital Clinical Trials Facilitator will provide hospital oversight for the
budgeting, compliance, and billing processes related to clinical trials. The
purpose of this position is to mitigate risk and maximize reimbursement for
clinical trials taking place in the hospital. This position works to establish
guidelines for research patient flow and care in hospital clinics.
As
of May 1, 2004 all Detailed Budgets with research related Patient Care costs
must be reviewed and approved by the Hospital Clinical Trials Facilitator. The
Detailed Budget must be signed by the Principal Investigator and must be
accompanied by a Patient
Care Classification Form when submitted for review and approval.
All
pricing for Patient Care procedures can be obtained from the Price Lists on
this website or from the Hospital Clinical Trials Facilitator. Please do not
contact individual departments to negotiate "reduced costs" for your
study; negotiated "reduced costs" will no longer be honored by the
hospital. Commercially sponsored studies will be charged at 60% of the normal
patient charge. Federally funded studies will be discounted at a varying rate
depending on the Medicare allowable rate.
Hospital
Facility Fees will apply to all research clinic visits. The amount charged is
based on the level of visit.
The
For studies
done at Primary Children's
Detailed
budgets that contain ONLY Pharmacy or ARUP research related costs will NOT
require review and approval by the Hospital Clinical Trials Facilitator.
If you would
like help in creating your Detailed Internal Budget and/or Patient Care
Classification Form, please contact the Hospital Clinical Trials Facilitator.
For questions
regarding study patient registration and billing process, please contact Lisa Weaver.
THE GRADUATE TUITION BENEFIT PROGRAM (TBP)
Covering the Basics
Many of you are blessed with graduate students who can help
you with your research projects. In return for their dedication, you want to
provide them the opportunity to qualify for a tuition waiver. As is everything
in a graduate student’s life, this can be confusing and overwhelming. The
following tips will help you and your student make it through.
Q: Is there a minimum amount of
money I need to pay my graduate student so they qualify for the TBP?
A: Yes. The amount of money you pay
will determine how much of a tuition waiver the student will receive. They can
qualify for 50%, 75%, or 100%. Required minimum support level is annually
indexed to general salary increases to prevent gradual erosion of established
graduate student salaries and stipends.
The minimum support levels per semester are:
|
Academic Year |
|
100% |
|
75% |
|
50% |
|
2006-07 |
$ |
5,000 |
$ |
3,750 |
$ |
2,500 |
|
2007-08 |
|
5,250 |
|
3,938 |
|
2,625 |
|
2008-09 |
|
5,500 |
|
4,125 |
|
2,750 |
Q: Can my student get a tuition
waiver for the summer?
A: Summer tuition waivers are
generally not covered.
Q: How many hours per week can I
expect my graduate student to work?
A: It depends on what percentage you
want them to qualify for. You can expect up to 20 hours of work a week (0.50
FTE) from students receiving a 100% tuition benefit, 15 hours a week (0.375
FTE) from students receiving a 75% tuition benefit, and 10 hours a week (0.25
FTE) from students receiving a 50% tuition benefit. No student is required to work
more than 20 hours a week (0.50 FTE) in order to receive a tuition benefit.
Q. How many credit hours does my
student need to register for?
A: Students participating in the TBP
must be full-time (at least 9 credit hours throughout the semester, regardless
of the percentage level of their waiver).
Q:
How many credit hours will the TBP pay for?
A: The TBP covers 9 graduate credit
hours to a maximum of 12 credit hours (except for RAs whose tuition benefit is
a minimum of 9 and a maximum of 11 credit hours in Fall and Spring semesters
and 3 credit hours in Summer semester).
Q: Can my student have another job
on campus and still qualify for the TBP?
A. Yes, but they need to be mindful
of their FTE. Students working one or more on-campus jobs with a combined FTE
greater than a 0.74 FTE are ineligible for a tuition waiver.
Q: How many semesters can my student
receive a tuition waiver?
A: Students may participate in the
TBP for a limited number of semesters, which need not be sequential. Time
limits for participation in the TBP are as follows:
- Students in a Master's program
are limited to two years (4 semesters) of tuition benefit support.
- Students in a doctoral program
who entered with a Bachelor's degree are limited to five years (10
semesters) of tuition benefit support.
- Students in a doctoral program
who also received a Master's degree at the
- Students entering a doctoral
program with a Master's degree from another university are eligible for
four years (8 semesters) of tuition benefit support.
Q: Who keeps track of how many times
a student receives a waiver?
A: The student and department should
maintain an accurate count. If the student receives more than he or she is
eligible for, he or she may be billed retroactively for the tuition of the
ineligible semester(s).
Q: Who takes care of the necessary
paperwork to be sure my student receives a waiver?
A: You will need to work with the
student and your department administrator to be sure all of the bases are
covered. Here are some of the responsibilities:
|
You: |
Budget
for the appropriate salary levels |
|
Student: |
Residency
and credit hour requirements must be met; be registered by the 15th day of
the term you want the waiver; be sure the tuition waiver has gone through
(check the CIS system). |
|
Dept.
Administrator: |
PAN form
needs to be filled out correctly Student must be listed on the home
department's TBP Web list, e.g., the department that accepted you for
graduate study as a degree-seeking student. |
For more
information, visit the
HOW TO HIRE
Hiring human resources for your research project
If you are
hiring a staff level position you must work with your department/division to do
that and it must go through Human Resources.
You do not
need to go through Human Resources to hire a Graduate Assistant or a temporary
employee (4 months or less).
If you are
hiring a Graduate Assistant you will need to gather all the information that is
required for a PAN form that your administrator will then need to use to make
sure the Graduate Assistant is paid. For Tuition Reimbursement you will work
with the student’s home department. The
student’s home department must input the students name into the Graduate
Benefits Program website.
SPENDING YOUR RESEARCH MONEY
There are
five processes:
1)
Purchase Card*
This is a Master Card that allows you to purchase your items
both on campus and off. You must save
receipts and document your purchases.
2)
Administrator uses his/her purchase
card and makes the purchase for you
You will need to ask your administrator what their
preference is for this process.
3)
Campus Order Form
You administrator can fill our a campus order and you then
take it to the campus vendor and make the purchase.
4)
Outside Vendor Purchase Order form
(if your purchase is over $5,000 you must go through the Purchasing Department
- http://uuhsc.utah.edu/purchasing/ )
If you are purchasing equipment or other supplies from
sources outside of the University, you can use an Outside Vendor Purchase Order
Form.
5)
Check Request
If you are paying an independent contractor or consultant
you will probably want to use a check for that.
See your administrator for the process.
You will need the person’s or organization’s tax ID and a W9 form.
Please see your department/division
administrator for forms and processes. Remember that your administrator
will need time to process your requests.
Don’t wait until the last minute.
*Purchase
Card
If you will be making small frequent purchases a
http://www.purchasing.utah.edu/pcard/index.html
What is the Purchasing Card?
The University offers a MasterCard for use by University
employees when procuring small-dollar items that would normally be purchased
using other paper-based methods. In many cases the card can be used in lieu of
a Limited Purchase Order (LPO), Limited Purchase Check (LPC), some Campus
Orders and most Blanket Orders acquired on a Purchase Order.
Transactions made on the card are billed directly to the
University and paid automatically. This means:
Your credit is not checked or affected by card ownership or
usage
Use the card with any merchant who accept MasterCard including on campus.
The Process In a Nutshell:
·
Make
the transaction if allowed
·
Retain
the receipt or acquire the proper documentation
·
Wait
until the transaction comes through on the on-line secure reallocation system
·
Reallocate
it into the proper account if necessary
·
Review
and acquire signatures on the monthly paper statement sent from Purchasing
·
Retain
records at your location for seven years
Participant Reimbursement
According
to Michelle Thomas (581-6338) in Accounts Payable, this is what is needed for
participant reimbursement:
There are
several options (check request, limited purchase request, petty cash, gift
cards), but she strongly encourages using a check request.
You can access the necessary forms at http://www.ap.admin.utah.edu/. Choose Accounts Payable
Forms, then Templates. You will need the Check Request form, IRS Form W9, and
Patient Reimbursement Request. Some of these can be filled out online and then
printed - instead of choosing Templates, choose Online Forms.
For more information, go to the Accounts Payable home page, and click the link
at the bottom that says "Brief discussion on how to process payments for
human subjects."
Waiver of the SS#
Social
Security numbers are typically required for payments to human subjects
(research projects). Accounts Payable
has had difficulty getting this information from PIs and their staff. Tax Services has indicated that departments
can request a waiver of the SS# requirement if the “confidentiality of the
subject exceeds the need to obtain the SS#.”
Only the IRB Committee can make this determination. Therefore, when faculty request approval to
conduct research with human subjects, they should request a review and/or
waiver to override compliance with the Federal requirements to obtain social
security information to pay those subjects if it is applicable.
NIH GRANT CYCLES
For Your
Future Grant Submissions
|
Mechanism(s) |
Program
Description |
Application |
Cycle I |
Cycle II |
Cycle III |
|
P Series |
Program Project Grants and Center Grants Transition to SF424 (R&R): On
Hold |
January 25 |
May 25 |
September 25 |
|
|
R18/U18 |
Research Demonstration |
January 25 |
May 25 |
September 25 |
|
|
T Series |
Institutional National Research |
January 25 |
May 25 |
September 25 |
|
|
C06/UC6 |
Construction
Grants |