1. Research Administration Updates
July 20, 2016
11:00 am
IOP Auditorium

2. Topics Covered VA IPA Update – John Midolo, VA Research
Activity Reporting– Jennifer Hutson, MUSC GCA
Recent Notices/Updates
FCOI-Related Changes to the ePDS
Use of Clearing Accounts/UDAKs w/Clinical Trials
Reminders & Announcements

3. VA Updates: IPAs and Budget
July 20th, 2016

4. Introduction Dianne Whaley, Budget Analyst Hans Meth, Budget Analyst
Hans Meth, Budget Analyst
John Midolo, MPH, Administrative Officer

5. Initiating VA-MUSC IPA
Initiating IPA - Skillset or expertise not found in the VA and/or non-US citizen and/or too vested at MUSC to hire at the VA
PI contacts VA Research budget team for status of funds. VA verifies funds to employ IPA and eligibility of employee
PI will work with BM to Complete IPA form: See annotated IPA. Completed IPA routed to ORSP w/ePDS
ORSP reviews, approves, and signs
VA reviews IPA and completes cover sheet for signature routing. Minimum lead time of 15 business days.
VA Research Adjusts PI Funds
ACOS > HR > Chief of Staff > Associate Director
Completed IPA sent to ORSP for award activation

6. Canceling VA-MUSC IPA Contacts VA Dianne Whaley – Dianne.Whaley@va.gov
PI Notifies VA Research budget team with 30 days notice per IPA contract
MUSC VA
Cancelling IPA
VA Research budget team notifies ORSP of cancellation
ORSP notifies MUSC BM
ORSP notifies MUSC's GCA of IPA Termination
Contacts VA
Dianne Whaley –
Hans Meth –
MUSC
ORSP –
MUSC accounting sends final invoice to VA

7. Please stay tuned for updates
Future Initiatives
Working with ORSP to develop services contract
Positions to be included, but not limited to;
Project Coordinators
Research Assistants
Laboratory Specialist
Allow us flexibility to add and remove people from studies more efficiently
Improve accuracy of accounting and billing
Please stay tuned for updates

8. Activity Reporting Jennifer Hutson
Office of Grants and Contracts Accounting
Activity Reporting

9. Activity Reporting Updates and Reminders
Important dates for FY 2016 reports
Due dates: July 30th
All reports due no later than August 15th
Most faculty should not be reporting 100% effort charged to sponsored projects
If they have administrative, clinical, and teaching activities that cannot be reimbursed through most grants
If an unrestricted funding source needs to be added process the PEAR through TEAMWORKS as soon as possible
Contact or to reopen any submitted Activity Reports for corrections
Reminder: Activity Reports and PEARs must match
K awards : no adjustment required if all activities fall into the scope of the award

10. Activity Reporting Updates and Reminders
UMA employee paid from MUSC sponsored projects must complete Activity Reports
Reports must equal 100%
Reopening reports from the first 2 quarters of FY 2016 require written justification
Online training course and quiz for coordinators
Mandatory for new coordinators
Refresher course for all coordinators

11. Office of Research and Sponsored Programs
Notices and updates

12. Notices & Updates NOT-OD-16-092
Modification of ‘No-Cost Extension’ and ‘Carryover of Funds’ Policies for the NIH Pathway to Independence Award (Parent K99/R00)
No-Cost Extension
May be allowed to complete the K99 phase
Requires NIH prior approval
Carryover of Funds
Carryover from K99 to R00 may be allowed
Consult with the awarding Institute/Center (IC) regarding carryover
NOTE: All prior approval requests need to be coordinated with ORSP.

13. Notices & Updates NOT-OD-16-094
Final NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research
Applies to domestic awardees and domestic sites
Foreign sites not expected to follow this policy
Not applicable to career development, research training or fellowship awards
Effective for all competitive grant applications with receipt dates on/after May 25, 2017
Effective for contract solicitations issued on/after May 25, 2017
Applications will need to include a plan for use of sIRB
Will update when more information is available

14. Notices & Updates NOT-OD-16-109
Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research
Primary Activities
Protocol and Informed Consent Review
Included as Indirect or F&A costs
Secondary Activities
Review of site-specific considerations
May be charged as Direct Costs
IRB will establish cost center rates with GCA

15. Notices & Updates NOT-OD-16-105
Revised NIH Parental Leave Policy for Ruth L. Kirschstein National Research Service Awards
Applies to ALL Kirschstein-NRSA trainees and fellows
Effective June 13, 2016
May receive stipends for up to 60 calendar days (8 work weeks) per year for parental leave
Must provide advanced notice and follow grantee institution’s policy
MUSC Sick Leave Policy
MUSC Family & Medical Leave Policy

16. Notices & Updates NOT-OD-16-120
OMB Approval for SF424 R&R Forms Used Federal-wide Underway – Continue to Use Current Forms Until Further Notice
Federal-wide (Research & Related or R&R) forms
Most expired June 30, 2016
Remainder will expire September 30, 2016
Disregard expiration dates on current R&R forms

17. Notices & Updates
Question “How to manage a leave-of-absence for a fellow or trainee?”
FAQ: An unpaid leave-of-absence (e.g. >15 calendar days of sick leave, or >60 calendar days parental leave) on a fellowship requires prior approval from the awarding NIH Institute/Center (IC)
Must follow institutional leave policies
If approved, IC issues a revised Award to extend end date
NO SPENDING from award during leave-of-absence
Except for continuation of health coverage if that is the policy of the institution

18. Financial Conflict of Interest
Individuals with FCOI Disclosure Out of Date
Old Procedure
COI Officer notified
Individual worked with COI Officer to complete FCOI disclosure prior to proposal submission
New Procedure
Contact person listed on ePDS is notified
Individual with out of date disclosure is notified
Contact person works with individual(s) to complete FCOI disclosure prior to proposal submission

19. Financial Conflict of Interest
ePDS System adjustment to handle new procedure
Proposal Contact information will be linked to netID to facilitate notifications
Name and netID fields edited using the “Change contact person” button
Phone, fax and location fields can be edited on screen
Contact information defaults to person creating the ePDS

20. Financial Conflict of Interest
First Section of Notification Contains
GCR#: <gcrnum>
PI name: <PI Name>
Title: <Title>
Sponsor: <Agency>
Deadline Date: <Deadline>
(Same for both ePDS Contact and Investigator)

21. Financial Conflict of Interest
2nd section of to ePDS Contact
The following proposal has personnel with out of date disclosures:
<Proposal Header information>
Name of Person(s) that must complete a conflict of interest disclosure:
<list of all persons with FCOI disclosure out of date status>
Please contact these individuals and assist them in getting their annual disclosure filed. It is a web based form found at the following URL:
Proposal applications cannot be submitted until all disclosures are filed. 

22. Financial Conflict of Interest
2nd Section of to Non-compliant Investigator
You are listed as an investigator on the following proposal:
<Proposal Header information>
Our records show that you have either not completed the required conflict of interest disclosure or it has been over a year since the previous one was filed. Federal regulations require any investigator (as defined by 42 CFR Part 50 Subpart F) involved in research to comply with an approved conflict of interest policy that requires annual disclosure.
The disclosure is a web based form found at the following URL:
Proposal applications cannot be submitted until all disclosures are filed.

23. Financial Conflict of Interest
Prepare for these Changes in FCOI
Take a pro-active approach prior to proposal routing
Think about new employees; notify them early on
View COI reporting tool for “completion” and “non-completion”
Federal regulations prohibit submission of non-compliant FCOI proposals

24. Clearing Accounts?
Clearing or Suspense UDAKs/Accounts are used to manage personnel and/or specific non-personnel expenses on fixed-price Corporate Clinical Trials
Established at each department’s discretion
Great for legitimate study start-up costs occurring pre-award
Helps with quarterly activity reporting – employees may report their activity under one Clearing UDAK versus multiple clinical projects
With HR approval, Temp. Grant Employees/positions may be funded temporarily by a Clearing UDAK
Clearing account balances MUST be zeroed out at the end of each fiscal year

25. Want a Clearing Account?
To Establish a Clearing UDAK/Account, Visit:
Please Contact “your” GCA Grants Administrator with questions:
Distribution of Grants by Administrator

26. Reminders
New minimum salary level for Executive, Administrative, and Professional workers to be exempt from overtime under the Fair Labor Standards Act (FSLA) increased
$47,476/year or $913/week
Effective December 1, 2016
Research Impact at MUSC – (Think Postdocs)
NIH to increase awards for post-doctoral NRSA recipients
NIH has not announced when or any parameters
MUSC’s HR Working on a Timeline and Implementation Plan
See HR Memo dated 5/18/16, Changes to Overtime Rules
So more to come on this important change

27. Reminders Award Closeout Requirements (final reports)
Departing or retiring faculty; final reports done?
Students (e.g. F30 training awards)
ClinicalTrials.gov Compliance is a MUST
Questions/Concerns/Problems: Call ORSP
All Slides are posted on ORSP Website

28. Final Thoughts Any Announcements? Questions or Comments?
PLEASE complete a survey & THANK YOU
Next ORSP Information Session:
August 17th, 11:00 am, IOP Auditorium