1. Research Administration Updates
July 12, 2017
11:00 am
IOP Auditorium

2. Topics Covered
Research Advertising & Branding Update – Loretta Lynch-Reichert, Office of Strategic Initiatives and Policy Management
New Online Resources from the Office of Clinical Research – Kate Lenert, OCR
Revenue, Accounts Receivable and Cash – Cathy Carroll, GCA
Recent Notices, Updates and Reminders – ORSP
Latest Epic Upgrades & Tools for Clinical Research Teams – Melissa Habrat, BMIC/SCTR

3. Office of Clinical Research
Kate Lenert, MET Associate Director Research Learning & Development

4. OCR Web Resources
The Office of Clinical Research (OCR) has a webpage on the MUSC Horseshoe (Internal)
Research Master ID Site:
Required when submitting to eIRB
 The horseshoe sites may only be accessed from MUSC computers on campus.

5. OCR Web Resources Internal Site:
Internal Site:
A description of PRA Statuses as indicated on your SPARCDashboard after you submit your study for PRA
Definitions of Terms as they apply to clinical billing compliance
Information about ClinCard by Greenphire: Participant Reimbursement
Research Matters Blog site

6. Short Informational Modules for Study Teams in MyQuest
1. Step 1: How to Submit a Study for Prospective Reimbursement Analysis through SPARCRequest©
2. New:  Step 2: Overview of Documentation Review by the PRA Team. 
Explains what happens once you submit a request for PRA review in SPARCRequest©
what the PRA team is looking for
PRA Statuses explained, and
How to send and receive notifications.
3. How to create a Research Master ID

7. Contact:
Office of Clinical Research Roper Medical Office Building Suite

8. Revenue, Accounts Receivable and Cash
Grants & Contracts Accounting – Cathy Carroll
Revenue, Accounts Receivable and Cash

13. Research and Sponsored Programs
News and Updates

14. Recent Notices NOT-OD-17-066
Additional Change to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials
Expands the NIH, AHRQ, and NIOSH policy to include citations to issued patents as allowable post-submission materials for grant applications submitted for due dates on or after September 25, 2017.
A citation of a patent must include the names of the inventors, patent title, issued patent number (including country designation, e.g, US for USA), filing date, and the date the patent was issued, e.g.:
Smith, Samuel S., and John J. Jones. Method of citing issued patents. US Patent #,###,###, filed December 31, 2015, and issued December 27, 2016.
Copies of patent applications or patents, or any other materials related to a patent application or granted patent will not be accepted as post-submission materials, unless specified in the Funding Opportunity Announcement (FOA) for which the application was submitted or in a special Guide Notice.

15. Recent Notices NOT-OD-17-068
Reminder: Authentication of Key Biological and/or Chemical Resources
As described in NOT-OD and NOT-OD , applicants proposing the use of established key biological and/or chemical resources are expected to include a plan to authenticate these resources in the "Authentication of Key Biological and/or Chemical Resources" attachment.
The "Authentication of Key Biological and/or Chemical Resources" attachment is only for established key biological and/or chemical resources.
All other methods and any data must be included within the page limits of the research strategy. 
Applications identified as non-compliant with this limitation will be withdrawn from the review process (see NOT-OD ).

16. Recent Notices NOT-OD-17-074
NIH Reminds Recipients to Submit Complete, Timely and Accurate Progress and Financial Reports
Required by the NIH Grants Policy Statement, a term and condition of all NIH grant awards.
Additional information about NIH reporting requirements described above can be found in the NIH Grants Policy Statement under section 8.4 Monitoring and Final Federal Financial Report at
Additional information on the eRA Commons Modules, User Guide, and documentation for submitting progress and financial reports is available at
NOTE: Failure to submit complete and accurate progress and financial reports may affect future funding to the organization and may result in a delay of continued support.

17. Recent Notices NOT-OD-17-076
Revision: Notice of Extension of Effective Date for Final NIH Policy on the Use of Single Institution Review Board for Multi-Site Research
NIH is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research to January 25, 2018.  
The policy will apply to all competing grant applications for due dates on or after January 25, 2018. 
For R&D contracts, the policy will apply to all solicitations issued on or after this effective date.

18. Recent Notices NOT-OD-17-084
Revision: Ruth L. Kirschstein National Research Service Awards (NRSA) Predoctoral Stipends, Training Related Expenses, Institutional Allowance, and Tuition/Fees Effective for Fiscal Year 2017
Replaces NOT-OD  and corrects the effective date for the increased stipend levels and the fellowship awards subject to the budgetary levels described.
Effective with all Kirschstein-NRSA awards made on or after October 1, 2016.

19. Recent Notices NOT-OD-17-086
NIH Fiscal Policy for Grant Awards - FY 2017
Implements the Consolidated Appropriations Act, 2017 (Public Law ), signed by President Trump on May 5, 2017. 
FY 2017 Funding Levels: Generally to be fully restored if the non-competing award was made with reduced funding as described in NOT-OD
Ruth L. Kirschstein National Research Service Awards (NRSA): NIH will increase NRSA stipends by approximately 2 percent on average.
New Investigators: NIH will continue to support new investigators on R01 equivalent awards at success rates comparable to that of established investigators submitting new (Type 1) R01 equivalent applications.
Salary Limits: increased to $187,000 effective January 8, 2017.
Other Legislative Mandates: described in NOT-OD
Additional Information: Will be posted at 

20. Recent Notices NOT-OD-17-087
Revision: Guidance on Salary Limitation for Grants and Cooperative Agreements
Replaces NOT-OD and clarifies that this is the final guidance for FY2017 by removing the term “interim” from the title of the guidance.
$187,000, effective January 8, 2017.
Past salary cap levels: 

21. NIH Update eRA Commons Reduction of Duplicate Accounts
In late July 2017, NIH will begin sending notifications to individuals who likely have more than one Commons account. 
For security, these s will only include instructions on how to determine whether you have duplicate accounts. 
The process for identifying and selecting the preferred account takes place within eRA Commons, after logging in with your credentials.

22. Important NIH Update
NIH’s Next Generation Researchers Initiative (
Announced in a June 8 NIH Director’s statement, and in recognition of the call for such action in the 21st Century Cures Act.
Intention is to bolster support for early-stage and mid-career investigators.
Approx. $210 million budget this year, and ramp up to $1.1 billion after 5 years, subject to funding availability.
Track impact of NIH funding decisions for early- and mid-career investigators.
Greater emphasis on NIH funding mechanisms aimed at early- and mid-career investigators.
Encourage multiple approaches to develop/test metrics to assess the impact of NIH grant support on scientific progress.
NOTE: The Grant Support Index (GSI) will not be implemented.

23. Reminders Allowable Appendix Materials (NOT-OD-17-035)
For applications proposing clinical trials (unless the funding opportunity announcement (FOA) provides other instructions for these materials):
Clinical trial protocols
Investigator's brochure from an Investigational New Drug (IND) application, as appropriate for the goals of the research proposed in the application.
For all applications:
Blank informed consent/assent forms
Blank surveys, questionnaires, and/or data collection instruments
Other items only if they are specified in the FOA as allowable
No other items are allowed in the Appendix.  Simply relocating disallowed materials to other parts of the application will result in a noncompliant application (NOT-OD ). 
Applications submitted for due dates on or after January 25, 2017, will be withdrawn as noncompliant if they are submitted with Appendix materials that are not specifically listed in NOT-OD and this Notice, or specified in the individual FOA as allowed or required.

24. Reminders
Prior approval* to exceed $500,000 in direct costs in an unsolicited application
Longstanding NIH policy, see: NOT-OD
Optional prior approval via eRA Commons, see: NOT-OD
Requests to submit an unsolicited application that will exceed $500,000 in direct costs will now have an option to submit this request electronically through eRA Commons, under a new Prior Approval Module.
After initial communication with the NIH, a PO may open up a request form for the Principal Investigator (PI) in eRA Commons. The PI will complete the form and submit it back to the initiating PO for review.
Instructions for how to use this new system can be found in the Prior Approval User Guide. For more information on the policy, see section of the NIH Grants Policy Statement.
*Request approval no later than 6 weeks before submission
Please ask your PIs if they plan to exceed the $500,000 threshold and ensure they have the Program Official’s prior approval.

25. Final Thoughts Any Announcements? Questions or Comments?
PLEASE complete a survey & THANK YOU
Next ORSP Information Session:
August 16th, 11:00 IOP Auditorium