1. Research Administration Updates
December 14, 2016
11:00 am
IOP Auditorium

2. Topics Covered MUSC Health MyChart Use in Research
Recent Notices (NIH and NSF)
NIH’s GCP Training Requirement for Clinical Trials
Updates, Reminders & Other Announcements

3. Recent Notices
Updated NSF Proposal & Award Policies & Procedures Guide (PAPPG), (NSF 17-1)
Effective for proposals submitted, or due, on or after January 30, 2017
NSF hosting a webinar on January 19th at 1 PM EST 
Registration is required on the NSF outreach events website
NOTE: the current PAPPG (NSF 16-1) guidelines continue to apply until the new PAPPG (NSF 17-1) takes effect
Frequently Asked Questions for the new NSF PAPPG

4. Recent Notices
REMINDER: Update Browsers to Use eRA Modules; New Security Mandated For Websites (Nov 30)
LYNX machines – no action needed
For Non-Lynx machines, confirm your browser is updated:
Browsers eRA uses to develop and test its modules for compatibility, as listed in the eRA Browser Compatibility statement:
Google Chrome®  version and higher
Firefox® version 4 and higher; with Firefox 17, Mozilla® integrates a list of websites supporting the new protocol
Internet Explorer® 11 on Windows® 8.1 and Windows® 7 when KB  or higher is installed (Released on Windows Update in June 2015)  
Browsers that work with the security upgrade, but are not included in the in the eRA Browser Compatibility statement:
Chromium® 
Opera®  version 12 and later
Safari® as of OS X Mavericks
Microsoft® Edge™ and Internet Explorer® 11 on Windows® 10
More information is available at  and OMB M-15-13

5. Recent Notices
eRA Enhancement: Redesigned Section in RPPR to Help Grantees Categorize Products Developed Under a Grant
“Section C – Products” now includes a scrollable list of 14 product categories to help categorize the products being reported.
‘Nothing to Report’ checkbox, if applicable
Guide to Categorizing Products in RPPR’s Section C
Audio or video
Instruments or Equipment
Survey Instruments
Data or Databases
Models
Interventions (e.g. clinical or educational)
Research Material
Physical Collections
New Business Creation
Educational Aids or Curricula
Protocols
Other
Evaluation Instruments
Software

6. Recent Notices NOT-OD-17-002
Adjustment to Stipend Levels for Postdoctoral Trainees and Fellows on Ruth L. Kirschstein National Research Service Awards (NRSA)
Notice provides instructions for requesting one-time supplemental funding to cover the stipend increase
Applies to NRSA stipend levels at years 0, 1 and 2 years of postdoctoral experience
May request funds to cover increases in stipends at these levels from December 1, 2016 up to the end date of the current period of appointment
Institutional Training Grants:
May not increase the number of appointees under the current award
Appointments of affected trainees made via xTrain as of 12/1/2016 will reflect these new stipend levels
Individual NRSA Postdoctoral Fellowships:
The Notice of Award (NOA) for the next budget year will reflect the FY 2017 stipend levels
NIH Research Training FAQs
NOTE: For NIMH specifically, the recipient should submit no later than 12/31/2016 to be considered

7. Recent Notices NOT-OD-17-021
Publication of the Revised NIH Grants Policy Statement (Rev. November 2016) for FY 2017
Applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2016
Previous versions of the NIHGPS remain applicable to awards with budget periods that began prior to October 1, 2016
Examples of Significant Changes:
Consolidates policies on Post-Submission Grant Application Materials
Invention reporting required to be submitted electronically via iEdison
Clarification for revised NIH Parental Leave Policy for Kirschstein-NRSA Trainees

8. Recent Notices NOT-OD-17-022
NIH Implementation of Final Research Performance Progress Reports (Final RPPR)
Final Research Performance Progress Report (F-RPPR, Final-RPPR) will replace the Final Progress Report (FPR) for closeout effective January 1, 2017
NIH will not maintain the current Type 2 policy which states that "whether funded or not" the progress report contained in the Type 2 application may serve in lieu of a separate final progress report
NIH will request that organizations submit an "Interim-RPPR" while their renewal application (Type 2) is under consideration
Will be treated as the annual performance report if the Type 2 application is funded
Will be treated as the Final-RPPR if the Type 2 application is not funded
FAQs and additional information will be available on the NIH RPPR website

9. Recent Notices eRA Enhancements: New Features for xTRACT
xTRACT is the Extramural Trainee Reporting And Career Tracking system and is accessed via eRA Commons
Allows applicants, grantees and assistants to create research training tables for progress reports and institutional training grant applications
Updated software release December 8, 2016
Online Help for xTRACT
Features
Ability to copy data from a recently prepared RPPR Research Training Dataset (RTD) into a Renewal RTD
Ability to copy data from a recently prepared Renewal or RPPR RTD into an RPPR RTD
Improved Performance of Preview/Finalize RTD
Fixes
Adjustment to the auto-population of Faculty Research Support, from NIH and Other Agency Sources, to allow for delayed continuation awards to be included (previously omitted)
Applicants and Entrants Section now prevents a prior institution from being listed multiple times

10. Recent Notices
New Application Instructions and Important Reminders for Appendix Sections and Post-Submission Materials
For applications with due dates on or after January 25, 2017
Applies to NIH, AHRQ and NIOSH applications
If any other materials are included in the appendix your application will be withdrawn and not reviewed  
NOTE: papers and manuscripts are no longer acceptable as appendix materials
NIH guidance materials:
NIH Reminder message
NOT-OD (appendix materials)
NOT-OD (post-submission materials)
Recently Updated NIH Application Guide
Changes to submission guidelines

11. NIH’s GCP Training REQUIREMENT
Quick Review:
After January 1st, 2017 NIH expects “all NIH-funded investigators and staff who are involved with the conduct, oversight or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).”

12. NIH’s GCP Training REQUIREMENT
Scope and Applicability:
GCP training includes the Principles of ICH GCP found in Section 2 of the ICH E6.
GCP training can be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization.
GCP training should be refreshed at least every three years to remain current with regulations, standards and guidelines.
Recipients of GCP training are expected to retain documentation of their training.

13. NIH’s GCP Training REQUIREMENT
Scope and Applicability:
Clinical Trial: Defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Investigator: Individual responsible for the conduct of the clinical trial at a site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

14. NIH’s GCP Training REQUIREMENT
Scope and Applicability:
Clinical Trial Staff:
Individuals identified by the investigator, who are responsible for study coordination, data collection and data management.
Focused on managing participant recruitment/enrollment, maintaining consistent study implementation, data management and ensuring integrity and compliance with regulatory and reporting requirements.

15. NIH’s GCP Training REQUIREMENT
Scope and Applicability :
Clinical Trial Staff (cont’d):
Individuals may also seek informed consent from prospective participants, enroll and meet with research participants and collect and record information from research participants.
May also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

16. NIH’s GCP Training REQUIREMENT
MUSC Compliance Plan:
CITI training module titled “Good Clinical Practice and ICH” will satisfy this requirement per NIH and can be tracked/maintained.
How to access the GCP and ICH CITI course
Login to CITI-MIAMI (
From the Main Menu select “Add a Course”
Select “Human Subjects”
Select the “Basic course” and/or the “Refresher course”
Select “Good Clinical Practice and ICH”

17. NIH’s GCP Training REQUIREMENT
Final Thoughts:
Questions about accessing the course via CITI: Michael Thomas
Anticipate more information (FAQs) from NIH soon
ORSP will continue to share updates as they become available (see below link)

18. Updates VA Blanket or Master-like Agreement for IPA’s
Should be in local VA by end of this week, YES !
ORSP to discuss plans next Tuesday with local VA staff
Hope to share GREAT news soon
Council on Governmental Relations (COGR) informed member institutions the NIH has extended the implementation of the Single IRB (sIRB) requirement until September 27th, 2017
ORSP anticipates an official NIH Notice soon and will continue to share any updates.

19. Reminders
Advance (NIH-6 weeks) permission needed from the agency (i.e. DOD or NIH) when proposals are to exceed $500, of Direct Costs in any one year of the proposed budget
Noncompliance will likely result in a rejected application
Share this reminder as even 3 business days will not allow ORSP or the PI to rectify this issue
Proposals (including Corporate) cannot be reviewed in ORSP without a routed and approved ePDS
ePDS (routed and approved) indicates ORSP is officially allowed to review, approve and assist with the proposal/contract
ePDS captures important/required compliance assurances that must be in order prior to ORSP’s review

20. Final Thoughts Any Announcements? Questions or Comments?
ORSP staff changes
Questions or Comments?
PLEASE complete a survey & THANK YOU
Next ORSP Information Session:
February 15, 11:00 IOP Auditorium