1. UCLA Department of Medicine Office of Research Administration
Award Life Cycle
UCLA Department of Medicine Office of Research Administration

2. with strong emphasis on NIH
Pre-Award Basics
with strong emphasis on NIH
UCLA Department of Medicine Office of Research Administration

3. UCLA Department of Medicine Office of Research Administration
Different Funding Sources: Grants/ Cooperative Agreements, Contracts, & Clinical Trials
UCLA Department of Medicine Office of Research Administration

4. Grants & Cooperative Agreements
A grant is a type of financial assistance awarded to an organization for the conduct of research or other program as specified in an approved proposal. For an award to be considered a grant, it will contain the following elements:
Statement of work allows the PI significant freedom to change the emphasis within the general area of work as the project progresses
Deliverables are minimal, consisting typically of reports
Separate accounting procedures are required
Grants most often use the cost-reimbursement method of payment
A cooperative agreement is a type of grant that provides substantial involvement between the sponsor and awardee in carrying out the activity contemplated by the award.
UCLA Department of Medicine Office of Research Administration

5. UCLA Department of Medicine Office of Research Administration
Contracts
A contract is an agreement to acquire services that primarily benefit the sponsor. For an award to be considered a contract, it normally must contain all of the following elements:
Detailed financial and legal requirements included with a specific statement of work
A specific set of deliverables and/or reports to the sponsor
Separate accounting procedures
Legally binding contract clauses
UCLA Department of Medicine Office of Research Administration

6. UCLA Department of Medicine Office of Research Administration
Contracts
Contracts, by their nature, are restrictive, meaning there is little flexibility on the part of the academic department to rebudget funds without prior sponsor approval. Invoicing on contracts can be more complex, especially if tied in with milestones or tasks that must be completed by the PI before an invoice can be submitted and/or paid.
UCLA Department of Medicine Office of Research Administration

7. UCLA Department of Medicine Office of Research Administration
Clinical Trials
The controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes. Such studies may be conducted under an industry-developed protocol or an investigator-developed protocol.
UCLA Department of Medicine Office of Research Administration

8. UCLA Central Pre-Award Offices
UCLA Department of Medicine Office of Research Administration

9. UCLA Central Pre-Award Offices
NON-PROFIT SPONSOR OCGA
Grants & Cooperative Agreements – OCGA Analyst
Contracts – OCGA Officer
Clinical Trials – OCGA Analyst or Officer
Grants.gov Grants/S2S < $500K – DOM DRA (DOM only)
FOR-PROFIT/INDUSTRY SPONSOR TDG or CTC&SR
Research Contracts & Grants (excluding Clinical Trials) – Technology Development Group (TDG)
formerly known as Office of Intellectual Property & Industry Sponsored Research (OIP-ISR)
Clinical Trials – Clinical Trials Contracts & Strategic Relations (CTC&SR)
formerly known as Clinical Trials Administration Office (CTAO)
UCLA Department of Medicine Office of Research Administration

10. Pre-Award Office Matrix
UCLA Department of Medicine Office of Research Administration

11. Periods of Performance
UCLA Department of Medicine Office of Research Administration

12. UCLA Department of Medicine Office of Research Administration
Project Period
The Project Period is the total time for which support of a project has been programmatically approved.
A project period may consist of one or more budget periods.
See sample 3 year project period below:
UCLA Department of Medicine Office of Research Administration

13. UCLA Department of Medicine Office of Research Administration
Budget Period
A budget period is the interval of time, usually 12 months, into which the project period is divided for budgetary and funding purposes.
Example: An award with a project period of July 1, 2017 – June 30, 2020 would have 3 budget periods:
(1) July 1, 2017 – June 30, 2018*
(2) July 1, 2018 – June 30, 2019*
(3) July 1, 2019 – June 30, 2020**
*NIH progress reports are typically due months before each budget period end date, except the last budget period. In this example, May 1st or May 15th.
**NIH final reports are due 90 days after project period end date. In this example, September 30, 2020.
UCLA Department of Medicine Office of Research Administration

14. Understanding NIH Award Numbers
UCLA Department of Medicine Office of Research Administration

15. UCLA Department of Medicine Office of Research Administration
NIH Grant Numbers
Example: 2 P01 HL A1
2 = Type Code: type of application
P01 = Activity Code: differentiates research-related programs supported by NIH
HL = Institute Code: 2 letter code for name of the NIH Institute or Center (IC) assigned
= Serial #: unique 5 or 6 digit # assigned by Center for Scientific Review (CSR) that identifies the specific application
26 = Support Year: year of support
A1 = Suffix Code (if applicable): identifies Supplements (S1), Resubmissions (A1), or a fellowship institutional allowances
UCLA Department of Medicine Office of Research Administration

16. Example: 2 P01 HL030568-26A1 Common NIH Type Codes
Type 1 – New
Type 2 – Renewal (Competing Continuation)
Type 3 – Additional Support
Competing Revision – expands scope of work
Administrative Supplement – covers increased costs
Type 5 – Non-competing Continuation
Type 7 – Change in Grantee Institution
Type 9 – Change in NIH Awarding Institute
UCLA Department of Medicine Office of Research Administration

17. NIH Definitions of Most Common Type Codes
New (Type 1) – refers to an application not previously proposed.
Renewal, aka Competing Continuation (Type 2) – An application requiring competitive peer review and Institute/Center action to continue beyond the current competitive segment. In other words, submitted during/after last year of project period.
Non-Competing Continuation aka Progress Reports (Type 5), – A year of continued support for a funded grant. Progress reports for continued support do not undergo peer review, but are administratively reviewed by the Institute/Center and receive an award based on prior award commitments. In other words, submitted near the end of each budget period, except last budget period.
UCLA Department of Medicine Office of Research Administration

18. Example: 2 P01 HL030568-26A1 Common NIH Activity Codes
T&F Series – Research Training & Fellowships
K Series – Career Development Awards
R Series – Research Grants
U Series – Cooperative Agreements
P Series – Program Projects/Center Grants
Comprehensive list
UCLA Department of Medicine Office of Research Administration

19. Example: 2 P01 HL030568-26A1 Institute Codes
The NIH is made up of 27 Institutes and Centers (IC), each with a specific research agenda, often focusing on particular diseases or body systems.
Each of them has a 2 letter code associate, i.e.
CA = NCI – National Cancer Institute
HL = NHLBI – National Heart, Lung, Blood Institute
AI = NIAID – National Institute of Allergy and Infectious Diseases
UCLA Department of Medicine Office of Research Administration

20. Example: 2 P01 HL030568-26A1 NIH Definitions of Suffix Codes
Resubmission (A1) – An application that has been previously submitted, but was not funded, and is being resubmitted for new consideration. Applicants must make significant changes to the application and can only resubmit once the summary statement is available.
Previous NIH term was “revision”.
Revision (S1) – A request of an increase of support funding in a current budget period for expansion of the project's approved scope or research protocol. Applicants must apply and undergo peer review.
Previous NIH term was “competing supplement”.
UCLA Department of Medicine Office of Research Administration

21. UCLA Department of Medicine Office of Research Administration
Sponsor Guidelines
UCLA Department of Medicine Office of Research Administration

22. Proposal Application Guidelines
Read all sets of guidance thoroughly!
In some cases there may be multiple sets of guidelines. For example, NIH has:
SF424 (R&R) – “vanilla” guidelines that cover the standard proposals – i.e. formatting, page limitations & general content info.
NIH Grants Policy Statement – terms & conditions of NIH grant awards. NIH’s interpretation of the Uniform Guidance, a.k.a. cost principals. Although this policy governs the funded award (post-award), it is important to be familiar with them at the proposal preparation stage.
Funding Opportunity Announcement (FOA) – see next slide.
UCLA Department of Medicine Office of Research Administration

23. Funding Opportunity Announcements (FOA)
The FOA is the proposal specific instructions.
These instructions supersede anything in the SF424 guidelines.
Types of NIH FOAs:
Program Announcement (PA)
PAR
PAS
Request for Application (RFA)
Request for Proposal (RFP)
UCLA Department of Medicine Office of Research Administration

24. Program Announcement (PA)
A formal statement about a new or ongoing extramural activity or mechanism. It may serve as a reminder of continuing interest in a research area, describe modification in an activity or mechanism, and/or invite applications for grant support. Most applications in response to PAs may be submitted to a standing submission date and are reviewed with all other applications received at that time using standard peer review processes.
NIH may also make funds available through
PARs – PAs with special receipt, referral, and/or review considerations
PASs – PAs with set-aside funds
Unless otherwise specified in the PA, new applications (and associated renewal and revision applications) submitted in response to PAs are treated as investigator-initiated.
UCLA Department of Medicine Office of Research Administration

25. Request for Application (RFA) & Request for Proposal (RFP)
RFA – A formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. An RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, and the application submission dates. Applications submitted in response to an RFA are usually reviewed by a Scientific Review Group (SRG) specially convened by the awarding component that issued the RFA.
RFP – Announces that NIH would like to award a contract to meet a specific need, such as the development of an animal model.
RFAs & RFPs have a single application receipt date and are published in the NIH Guide for Grants and Contracts.
UCLA Department of Medicine Office of Research Administration

26. Solicited vs. Unsolicited
Solicited (also known as Targeted Research) – Research funded as a result of an Institute set aside dollars for a specific scientific area. Institutes solicit applications using research initiatives.
Unsolicited (also known as Investigator-Initiated Research) – Research funded as a result of an investigator, on his or her own, submitting a research application.
For NIH, PIs can submit unsolicited proposals using the NIH’s Parent Announcements.
UCLA Department of Medicine Office of Research Administration

27. UCLA Department of Medicine Office of Research Administration
Parent Announcements
Electronic grant applications must be submitted in response to an FOA. For applicants who wish to submit what were formerly termed Investigator-Initiated or Unsolicited applications, NIH has developed Parent Announcements. Responding to such an umbrella Parent FOA ensures that the correct application package is used and enables NIH to receive the application from Grants.gov.
Some NIH Institutes or Centers may not participate in all parent announcements.
UCLA Department of Medicine Office of Research Administration

28. UCLA Department of Medicine Office of Research Administration
Summary of Types of FOA
Payline: A percentile-based funding cutoff point determined by balancing the projected number of applications coming to an NIH Institute with the amount of funds available.
UCLA Department of Medicine Office of Research Administration

29. UCLA Department of Medicine Office of Research Administration
Sponsor Due Dates
UCLA Department of Medicine Office of Research Administration

30. NIH Standard Due Dates for Competing Applications
Grant applications & associated documents (i.e. reference letters) are due 5:00 PM local time* of the application organization.
Cycle due dates separated by activity code.
Renewal/Resubmission/Revision applications may have different due dates than new applications.
AIDS & AIDS-related dates apply to all activity codes.
Provides Earliest Project Start Dates.
* For non-NIH Sponsors, please pay close attention to due times, i.e. Guidelines with 5 pm Eastern Standard Time = 2 pm UCLA /Pacific Standard Time.
UCLA Department of Medicine Office of Research Administration

31. NIH PI Continuous Submission
Why? Commitment to recognize outstanding service in the NIH peer review process and/or Advisory Groups
What? Allows appointed members to submit their research grant applications (R01, R21, or R34) with standard due dates only (i.e. does not apply to applications with specific due dates) on a continuous basis & have those applications undergo review in a timely manner.
Who? List of Reviewers Eligible for CS
How does this affect UCLA internal due dates?
OCGA (5 day policy) vs. DOM DRA (3 day policy)
“Soft” deadline vs. “hard” deadline
Must include Cover Letter that states eligibility of PI for CS
UCLA Department of Medicine Office of Research Administration

32. NIH Policy for Late Application Submission
Different from Continuous Submission privileges
Two week window of consideration after the application due date
Temporary or ad hoc service by a PD/PI on an NIH advisory group during the two months preceding or the two months following the application due date.
For PDs who are eligible for CS, this policy applies to activities not covered und CS (i.e. other than R01, R21, R34 opportunities that use standard due dates)
Must include cover letter to explain reason for late submission
UCLA Department of Medicine Office of Research Administration

33. Electronic Submission Tools
UCLA Department of Medicine Office of Research Administration

34. Methods Electronic Submission: Cayuse S2S vs. NIH’s ASSIST
ASSIST (Application Submission System & Interface for Submission Tracking)
Cayuse System-to-System (S2S)
Purchased by the University from Evisions, Inc. to easily facilitate proposal development and electronic submission
Available for use with all NIH, DOD, NSF, HRSA, and AHRQ applications
Sends the information to Grants.gov upon submission
NIH’s online system for proposal submission
Originally launched for multi-project applications (Ps)
Has since expanded to include R01, K (excluding KM1 and K12), R03, and R21 applications
*Optional*
Use eCommons ID to login.
UCLA Department of Medicine Office of Research Administration

35. Other Electronic Submission Websites
Some Sponsors have their own electronic tools
ProposalCENTRAL
Sample sponsors – ACS, ALA, etc.
SmartSimple
UC Sponsors – TRDRP, BCRP, etc.
AHA
eBRAP
CDMRP/DOD
HRSA Handbook
NSF FastLane
UCLA Department of Medicine Office of Research Administration

36. UCLA Department of Medicine Office of Research Administration
Proposal Documents
UCLA Department of Medicine Office of Research Administration

37. Typical NIH Proposal Sections
Face Page/SF424 RR Purple=Fund Manager
Performance Sites Green=PI
Project Summary/Abstract
Project Narrative/Relevance to Public Health
Bibliography/Reference Cited
Facilities & Other Resources / Equipment
Biographical Sketch for all Key Personnel
Budget & Budget Justification
Research Plan – including Specific Aims Research Strategy, Human & Animal Subject, LOS, etc.
Internal Proposal Paperwork
UCLA Department of Medicine Office of Research Administration

38. Internal Proposal Paperwork
EPASS (Extramural Proposal Approval and Submission Summary)
Extremely important for correct award setup
A Conflict of Interest (COI) disclosure forms
Federal PHS agency: eDGE date on third page of EPASS
Non-PHS Federal agency (i.e. DOD): Form 740
Non government sponsor: Form 700U and 700U Addendum
DOM PI Responsibilities for human subjects research only
PI Exception Form
For PIs who are not Policy 900 PIs
UCLA Department of Medicine Office of Research Administration

39. UCLA Department of Medicine Office of Research Administration
Pre-Award Strategies
UCLA Department of Medicine Office of Research Administration

40. UCLA Department of Medicine Office of Research Administration
Send out a monthly to all PIs requesting information on upcoming proposal deadlines.
Start EARLY!
Web search for agencies guidelines, instructions & forms. Read through guidelines thoroughly, highlighting important instructions.
Meet with your PI in person. Use the Proposal Intake Form to help guide your discussion.
If the agencies does not provide a checklist of items required for submission, use the proposal’s Table of Contents as a checklist.
Ask your colleagues for examples of similar proposals that were successfully funded.
Review all documents provided to you for compliance with agencies guidelines, and format to create consistency within the proposal.
Ask for help if you need it!
UCLA Department of Medicine Office of Research Administration

41. UCLA Department of Medicine Office of Research Administration
Determine the proposal’s complexity
Have you submitted to this agency before, and are aware of their guidelines/policies?
Is it a limited submission?
Subawards, foreign and/or domestic?
Detailed budget vs. Modular budget?
Paper vs. Electronic vs. Both?
Number of Key Personnel?
PI’s habits, e.g. always late/always early, expectations, etc.?
Animals and/or human subjects?
Budget over $500,000 direct cost in any given year?
Agency provides only non-fillable forms?
Will the grant be submitted via OCGA or DOM DRA?
Do you have numerous proposals due on, or around, the same deadline?
UCLA Department of Medicine Office of Research Administration

42. Links from Today’s Class
DOM ORA Website – Pre-Award Sections (includes pre-award manual, forms & reference material)
Proposal Preparation
Proposal Intake Form
Budget Preparation
FOA Questions
Composite Benefit Rates
OCGA Proposal Preparation
Commonly Needed Information
NIH Forms & Applications
SF424 (R&R) Forms and Instructions (Grants.gov)
NIH Glossary & Acronym List
Links from Today’s Class
UCLA Department of Medicine Office of Research Administration

43. Survey Link http://goo.gl/forms/C3gdjsL5y1
We appreciate if you would take a few moments to complete a short 5 question anonymous survey to help us improve your training experience. Thank you!
UCLA Department of Medicine Office of Research Administration