2. Campus Research Administration Meeting
09/19/17

3. Agenda Snacks! F&A: The New Rates are In
RCC – Continuing Education Credits
Implementation Team Updates
Electronic Submissions and “tricking” the system
NIH Forms – E
OSP Update

4. F&A: Implementation of the New Rates
Klugh Jordan

5. RCC: Webinars RCC initiated webinars – On demand, any time
RCC, ORS, ORA, OSP will periodically identify specific webinars of value to the Duke grant management community and select up to four webinars a year as CE options
The webinar review team will view each webinar as it is presented, and develop a brief set of assessment questions relevant to the webinar content
The webinar will be loaded into the LMS for individual registration, as an on-demand CE option.
You may register in the LMS to view the webinar at your convenience, and complete the assessment to validate that you viewed the entire program
Passing score is 80%

6. RCC: Webinars Department/Unit/Group initiated webinars
RCC will review and approve credit for webinars of interest to departments/units/groups on a case by case basis, using the attached form
The webinar leader will provide discussion following the webinar with all attendees
The webinar leader will provide a sign-in sheet to RCC for loading into the LMS so that CE credit can be entered, and tracked over to the Training Tracker

7. RCC: Webinars
Blended option
Departments/Units/Groups may request the option to view a live webinar that has been selected by RCC for institutional viewing.
They may use the attached from to alert RCC that they plan a group viewing and follow-up discussion
The webinar leader will provide RCC with a sign-in sheet of attendees
Important Note: Individuals should remember to register in the LMS following the webinar to complete the required assessment in order to receive credit
Webinar “Catalog” – RCC will post a list of available webinars for credit on the RCC website and will update the list on a regular basis

8. Implementation Team Updates
Holly Verrett
Michelle Rigsbee
Valerie Abbott

9. Electronic Submissions and “tricking” the system
On behalf of NIH leadership, I would like to expand on Dr. Nakamura’s letter by expressing our deep concern regarding your practice of tricking e-validation systems by inserting place-holders into incomplete applications.  It is most unfortunate that an institution with the extensive experience of Duke University would consider it appropriate and reasonable to even attempt to trick e- validation systems on documents as important as NIH grant applications. 

10. Electronic Submissions and “tricking” the system
When an applicant does not submit mandatory sections of the application (unless otherwise specified in the FOA), the agency is not obligated to accept or review an application determined to be ineligible at time of submission. Absent any statutory or regulatory obligation to fund the application, the agency should deem the application non-responsive to criteria outlined within the FOA and NIHs standard application instructions.

11. Electronic Submissions and “tricking” the system
I look forward to hearing back from you in the next 10 days with your assurances that:
You are taking steps to end all practices that led to the events that occurred with this grant submission.
You understand the ramifications of 45 CFR Part (c)(3) and (c)(5), and 45 CFR Part
Given your understanding of those ramifications, you will inform your Principal Investigators that should your office make a similar mistake in the future, you will accept NIH’s decision to deem applications non-responsive.
Sincerely yours,
Michael S Lauer, MD

12. Other submission issues:
Padding your proposal: In your case, 12 pages of additional material were placed in the appendix, none of it allowed by NOT-OD Convenience of the reviewers is not, unfortunately, one reason we can bend the Appendix policy. Your primary source of information when preparing any NIH application should be the SF424 (R&R) Application guide. All instructions common to NIH applications can be found there; only instructions that are unique to the funding opportunity announcement will be in the FOA. The instructions in PA were to “follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.” On pages T-100 and T-101 of the T-series application guide, appendix rules are spelled out.

13. NIH Policy
Allowable appendix materials Beginning with applications submitted to the NIH, AHRQ, or NIOSH for due dates on or after January 25, 2017, the only allowable appendix materials are:
For applications proposing clinical trials (unless the FOA provides other instructions for these materials):
Clinical trial protocols
Investigator's brochure from Investigational New Drug (IND), as appropriate
For all applications:
Blank informed consent/assent forms
Blank surveys, questionnaires, data collection instruments
FOA-specified items. 
If appendix materials are required in the FOA, review criteria for that FOA will address those materials, and applications submitted without those appendix materials will be considered incomplete and will not be reviewed.

14. NIH Policy
Consequences for submitting disallowed appendix materials Applications submitted for due dates on or after January 25, 2017 will be withdrawn and not reviewed if they are submitted with appendix materials that are not specifically listed in this Notice or the FOA as allowed or required.

15. NSF Policy
Appendices
All information necessary for the review of a proposal must be contained in Sections a through i of the proposal. Appendices may not be included unless a deviation has been authorized. Chapter II.A contains further information.

16. Forms - E PHS Human Subjects and Clinical Trials Information Form
40+ new data elements
14 New Attachments
01/25/18 – Program Project Grants deadline
Goals
Consolidate human subjects information currently scattered across multiple PHS forms within an application package
Expand clinical trial data collection
Provide information needed for peer review
Position NIH for future data exchange with ClinicalTrials.gov

17. Forms - E
When HS= Yes on Research & Related Other Project Information form applications must include one of the
following on the new PHS Human Subjects and Clinical Trials Information Form
1 or more full study records, OR
1 or more delayed onset study records, OR
A combination of full and delayed onset study records
• Required form fields vary based on a number of factors, including:
Whether study is delayed onset
Announcement-specific instructions
Human subject exemptions
Whether study involves a clinical trial

18. NIH Definition of a Clinical Trial
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.
Does the study involve human participants?
Are the participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect being evaluated a health-related biomedical or behavioral outcome?

20. Exemptions: Two new categories

21. Multiple Attachments

22. NIH Policy
FORMS-E application packages MUST be used for applications to due dates on or after January 25, 2018 and CANNOT be used for earlier due dates.
Application guide instructions will be posted ~September 25, 2017
eRA will deploy FORMS-E support to production ~October 11, 2017
We will begin posting FORMS-E packages ~October 25, 2017

23. Rollout Strategy Key Stakeholders Representatives ORA John Michnowicz
ORS
Keith Hurka-Owen
ORI
Debbi Nixon, Lori Evans, Paula Morrison
DOCR
Denise Snyder, Lindsey Spangler, Jessica Houlihan
Research Development
Joanna Downer, Martha Payne
Research Administration
Laurianne Torres, Blake Perrault
Research Initiatives
Geeta Swamy, Rebecca Brouwer
Communication
Jill Boy
SON
Robin Thomas

24. OSP Update
Nate Martinez-Wayman
Sharon Brooks