1. Research Administration Updates
March 15, 2017
11:00 am
IOP Auditorium

2. Topics Covered
IRB Fee Changes – Stacey Goretzka, IRB Manager & Dr. Aimee Mcrae-Clark, Director, Office of Research Integrity
New VA/MUSC Master Contract for Personnel Services – ORSP
Revised Budget Worksheet Tool – ORSP
Recent Notices, Updates and Reminders - ORSP

3. MUSC IRB Fee Schedule Aimee McRae-Clark, Pharm.D.,
Director, Office of Research Integrity
Stacey Goretzka, CIP
IRB Manager

4. Updates to IRB Fee Schedule
Industry Sponsored Research - Change in IRB fee schedule for:
-Continuing Reviews
-Amendments
Single IRB Review Fees

5. Continuing Reviews Current Fee: $500 (at least annually)
New Fee: $750 (at least annually)
Effective date: New studies approved on July 1, 2017 and after.

6. Amendments Current Fee: $0 New Fee: $500
Applies to both full board and expedited amendments as well as change in PI amendments.
New fee does not apply to change in personnel amendments or administrative changes (as defined by MUSC policy HRPP /ori/irb/HRPP/HRPP%20Guide%20Section%203.6).
Effective Date: New studies approved on July 1, and after.

7. How we compare to other universities

8. Single IRB Review (or Central IRB)
MUSC serves as single IRB (central IRB) for multi-site studies:
$2,506 Initial Non-MUSC Site Review
$1,093 Annual Management (Continuing Review for each Non-MUSC Site)

9. VA Contract for MUSC Personnel Services
Received executed copy on 2/28/17
Effective dates 2/15/17 through 2/14/18; $15 million
Can be extended for up to 4 more years
Replaces the use Intergovernmental Personnel Agreements (IPAs) for the ONLY following:
Lab Specialist 1 and 2
Program Assistant
Research Specialist 1,2,3
Program Coordinator 1 and 2
Engineer/Associate Engineer 2
Occupational Therapist 2
Physician’s Assistant

10. VA Contract for MUSC Personnel Services
Continued from previous slide
Program Manager 1
Graduate Assistant
Graduate Research Assistant
Postdoctoral Scholar
Staff Scientist
Instructor
Research Instructor
Research Associate
Research Assistant Professor
Biostatistician
NOTE: If not on the list, must use the IPA mechanism

11. VA to Contract MUSC Process
Step 1:
VA notifies ORSP via of the intent to contract with a Statement of Work (SOW)
SOW contains: position classification title, dates of service, amount of funding, duties to be performed for VA and the MUSC departmental contact name

12. VA to Contract MUSC Process
Step 2:
ORSP ensures information is complete and will forward via to the appropriate MUSC departmental contact
Step 3:
Departmental contact (e.g. grants administrator, business manager, etc.) vets proposed arrangements within the department and upon consensus an approved ePDS and budget, matching VA amount listed on SOW, is routed to ORSP for final MUSC review and approval

13. VA to Contract MUSC Process
Step 4:
After ORSP review, VA is notified by ORSP the SOW has been approved
Step 5:
After getting MUSC approval of the SOW from ORSP, VA initiates a Task Order (TO) request to match the SOW from the VA central headquarters office

14. VA to Contract MUSC Process
Step 6:
When TO is ready, the local VA will send it to ORSP for review and approval
Step 7:
ORSP will review/verify the TO matches the details of the department-approved SOW; provided all matches, ORSP signs and returns TO via to the local VA

15. VA to Contract MUSC Process
Step 8:
Local VA coordinates and secures a fully executed TO from the VA headquarters office
Step 9:
Once the local VA has the fully executed TO, the local VA prepares a Purchase Order and sends ORSP the fully executed TO and the Purchase Order

16. VA to Contract MUSC Process
Step 10:
ORSP uses fully executed TO, Purchase Order, SOW, budget and ePDS to initiate award udak account set-up with MUSC’s Grants Accounting Office
Step 11:
GCA notifies department per standard procedures when award udak is established

17. VA to Contract MUSC Process
Final Reminders:
All Task Orders (TOs) under must pay 26% F&A costs, as most of these services will be conducted off campus in VA space; Off campus F&A rate applies
ORSP created a budgeting tool for INTERNAL USE ONLY
All Task Orders (TOs) must pay adequate fringe benefit rates
MUSC must recover the costs (all costs) associated with VA contracting for MUSC services
All MUSC departments must consider the financial arrangements to ensure costs are adequately covered

18. VA PSA Tool Demo

19. Budget Worksheet Revisions
Budget worksheet is provided for convenience and to assist departmental personnel in calculating F&A on research projects
Multi-Functional – Provides for
5 budget years
10 subcontracts
26 named personnel
Tailored to MUSC
References institutional object codes for expenditure categories
Defaults to institutional rates (F&A and Fringe Benefit)

21. Budget Worksheet Revisions
Added additional information fields at top of page
PI Name will show at the top of all other worksheets

22. Budget Worksheet Revisions
Separate line for Tuition Remission (excluded from F&A calculation)
Bottom section split into two sections to align with NIH budgets
Materials and Supplies
Other

23. Recent Notices NOT-OD-17-041
Impact of Washington, DC Area Federal Office Operating Status on NIH Grant Application Due Dates
Grant application due dates will move to the next business day when the OPM operating status on the original due date is:
Federal offices are closed – Emergency and telework-ready employees must follow their agency’s policies
Open - Early departure
Immediate departure – Federal offices are closed
Shelter-in-place
No Change to Other Submission Policies
Guidelines for Applicants Experiencing System Issues
Due Dates on Holidays/Weekends
Weather/Other Disasters (impacting applicant institutions)

24. Recent Notices NOT-OD-17-042
Update and Clarification: NIH Continuous Submission Policy 
Consolidation of earlier Notices – NO CHANGE to the policy
Continuous Submission applies to R01, R21, and R34 applications submitted by continuous submission eligible PD/PIs and MPIs to FOAs with standard due dates 
The NIH Late Policy applies to
All other types of applications submitted by continuous submission eligible PD/PIs and MPIs
All applications submitted by all other PD/PIs and MPIs
Reviewers can check their eRA Commons Personal Profile for continuous submission eligibility
Applicants Eligible for Continuous Submission listing
Continuous Submission FAQs

25. Recent Notices NOT-OD-17-043
Update on Clinical Trial Funding Opportunity Announcement Policy
New Effective Date January 25, 2018
NIH Transition Plan
Spring 2017
New "PHS Human Subjects and Clinical Trials Information" form
Consolidates several forms used to collect human subject information
Expands NIH data collection requirements for clinical trials
NIH to provide additional information to the community on the new form and implementation plans
Fall 2017
Expire existing clinical trial FOAs by January 24, 2018
Update remaining active FOAs to include the latest approved forms and to indicate that clinical trial applications are not allowed for due dates on or after January 25, 2018
Issue new clinical trial FOAs with clinical trial-specific review criteria, forms, and instructions for due dates on or after January 25, 2018

26. Reminders/Updates Outgoing Subawards/Subcontracts Pre-Award items
Subrecipient vs Contractor
Subrecipient application requirements
Contractor quotes for services
Post-Award items
Did budget or scope of work change?
Human/animal research?
Risk assessment
New “How Do I” on ORSP website
Call ORSP’s Becky Timpner at with questions

27. Final Thoughts Any Announcements? Questions or Comments?
PLEASE complete a survey & THANK YOU
Next ORSP Information Session:
April 19th, 11:00 IOP Auditorium