OPERA NIH Update – Spring 2008 NCURA Region VI/VII Regional Meeting Portland Office of Policy for Extramural Research Administration Joe Ellis, Director

OPERA

NIH Update – Spring 2008NCURA Region VI/VII Regional Meeting

Portland

Office of Policy for Extramural Research Administration

Joe Ellis, Director OPERA

OPERA

NIH Budget News and Priorities

3

Final NIH AppropriationsFY 2008

• NIH received a total of $29.457 billion• Increase of $329 million from

FY2007• Average competing award

expected to increase by 1%• Average noncompeting

award also increases by 1% but implementation will vary by IC.

• No change to NRSA stipend levels or funding policies

More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-036.html

4

FY2008 NIH Budget $29.457 Billion

53%

10%

11%

6%3%

10%5%2%

Research Project Grants (53%) Research Centers (10%)

R&D Contracts (11%) Other Research (6%)

Training (3%) Intramural Research (10%)

Research Mgmt & Support (5%) All Other (2%)

$15.61 B

5

Extramural Funding (Research and Training)

Extramural Funding = 83% of Total Budget

83%

5%

2%

10%Extramural Funding Research Mgmt & Support

Intramural All Other

6

Extramural Funding

Extramural Funding = 83% of Total Budget

87%

13% Research and Training Grants (87%)

R&D Contracts (13%)

7

Quick and Easy Search:New Tools to Search NIH Funding

• New reports, data and analyses website released in March, 2008.

• Replaces the current Award Information and Data web page and will provide:– Quick access to “Frequently Requested Reports”– FAQs on how success rates are computed and questions

on the NIH budget– Search tools for locating data and reports quickly and

easily– Links to funding estimates for certain research areas,

conditions, and diseases.• Foundation for broader NIH-wide Research Portfolio

Online Reporting Tool (RePORT)

More at: http://report.nih.gov

8

NIH Award Funding Estimates for Various Diseases and Conditions

• New web site combines data from NIH ICs explaining research spending and priorities to Congress and the public in approximately 360 research areas.

• Reports actual and estimated spending figures for FY 2004-2009; not “set-asides” or “allocations”.

• Meets requirements of the NIH Reform Act of 2006.

View the site at: http://www.nih.gov/news/fundingresearchareas.htm

Research/Disease Area FY 2006 FY 2007 FY 2008

(Dollars in Millions and Rounded) Actual Actual Estimate

Acute Respiratory Distress Syndrome $74 $48 $48

Agent Orange and Dioxin 17 18 18

Aging 2,431 2,462 2,461

Alcoholism 511 521 521

Allergic Rhinitis (Hay Fever) 4 5 5

9

President’s Budget Request for FY 2009

• Requested a total of $29.457 billion for NIH• Same as FY2008

• Estimated 9,757 new and competing renewal Research Project Grants• Approximately 14 less

than FY2008 and 566 less than FY2007

More at: http://officeofbudget.od.nih.gov

10

President’s Budget RequestFY 2009

Areas of Focus:– Bolster funding to new investigators especially in

novel and recently emerging areas of opportunity – Goal of sustaining 1,500 new investigators each year achieved in FY 2007.

– Encourage established investigators through investigator-initiated research projects, which remain the workhorse of NIH research.

– Roadmap/Common Fund – Incubator for new ideas and initiatives that accelerate the pace of discovery

– Global Fund for HIV/AIDS, Tuberculosis and Malaria– NRSA Funding Policy – Proposed 1% stipend increase

More at: http://officeofbudget.od.nih.gov/ui/HomePage.htm

11

NIH Priority: Roadmap for Medical Research

• “Version 1.5” Builds on Success of Original Roadmap

• NIH is Focusing on Three Roadmap “Themes”:– Research Teams of the Future– Re-engineering the Clinical Research Enterprise– New Pathways to Discovery

• Includes two recently added pathway areas, the Human Microbiome Project and New Initiative in Epigenomics.

• New Roadmap programs to be selected in Spring, 2008 – Stay Tuned!

More at: http://nihroadmap.nih.gov

12

NIH Priority: Blueprint for Neuroscience Research

• Cooperative effort among 16 ICs to accelerate Neuroscience research.

• RFAs in 2007-2009 will focus on three themes, respectively:– Neurodegeneration during disease and aging;– Neurodevelopment throughout the lifespan; and– Neuroplasticity, from molecular to behavioral levels.

• Available neuroscience resources include: animal models; imaging tools; neuroinformatics (computational biology); core facilities; cells, tissue, and DNA; gene and protein expression; and training.

More at: http://neuroscienceblueprint.nih.gov

13

NIH Priority: Continued Focuson New Investigators

Available at: http://grants.nih.gov/grants/new_investigators/index.htm

14

Updated Definition of “New Investigator”

• Definition updated to provide more detailed guidance• “New” investigators cannot have successfully competed as a

PD/PI for an NIH-supported research project other than…– R03, R13/U13, R15, R21, R25, R34, R36, R41, R43 R55,

or R66 grants– F05, F03, F31, F32, F34, F37, or F38 grants– K01, K08, K22, K23, K25, or K99/R00 grants– G07, G08, G11, G13, G20, S10, S15, X01, X02, C06, or

UC6 grants.• PD/PI’s who did not initially compete for a major research

grant but were later designated as PD/PI are still considered “new”.

• All PD/PIs must meet the new investigator definition to receive special consideration on multi/PI grants.

Available at: http://grants.nih.gov/grants/new_investigators/resources.htm

15

NIH/CSR Shortens Review for New Investigators

• New investigators unsuccessful in a R01 grant submission who are readily able to address the concerns and issues identified in the Summary Statement may shorten the time to the next review.

• Available for all CSR study sections reviewing new investigator R01 applications submitted for standard receipt dates (not including RFAs and PARs with special dates).

• Policies and practices include:– Resubmission applications to be considered at the next

cycle must be submitted by March 20, July 20, or November 20.

– New Investigators who do not choose this option may use the standard resubmission dates for subsequent submissions (March 5, July 5, or November 5).


16

Pathway to Independence(K99/R00)

• Facilitates timely transition from mentored postdoctoral research to independent research position at earlier stage.

• Primary, long-term goal is to increase and maintain strong cohort of new and talented, NIH-supported independent investigators.

• Provides up to 5 years of support consisting of two phases: – Initial phase (K99): 1-2 years of mentored support for

highly promising, postdoctoral research scientists. – 2nd Phase (R00): Up to 3 years of independent support

contingent on securing an independent research position.

• Standard K Submission Dates (February 12, June 12, October 12)

• Program Announcement PA-07-297

Qs and As at: http://grants.nih.gov/grants/new_investigators/QsandAs.htm

17

NIH Director’sNew Innovator Award (DP2)

• Stimulates highly innovative research and supports promising new investigators.

• Awards provide up to $1.5 million in direct costs for (up to) a 5 year project period.

• Highly Popular: NIH received nearly 2,200 applications in FY2007 and funded 29.

• Program continues with applications due March 31, 2008 (RFA-RM-08-114).

More at: http://grants.nih.gov/grants/new_investigators/innovator_award

18

NIH Director’s Bridge Award (R56) Updated and Expanded

• Continued, limited funding for new and established PIs who have submitted a competing renewal, who just miss the nominal funding payline for the IC.

• Additional funded time for PIs to strengthen a resubmission. • Selectees will receive one-year of funding up to $500,000

DC + applicable F&A (increased from $333,000)

• Cannot apply, cannot self-nominate! Criteria: – Must have < $400,000 in other support (total costs) from

all sources to fund research (increased from $200,000)– A1s and only the most meritorious A2s are now eligible– Applications submitted in FY2007 that are still being

considered for funding & FY2008 submissions


OPERA

New Scientific and Grants Management Policies

20

Enhancing Peer Review at NIH

• Initial Public Consultation Period– RFI for public comment period in Summer, 2007 – Regional Consultation Meetings held Fall, 2007

• Final Draft Report submitted to Dr. Zerhouni in February 28, 2008 and available for public comment until March 17, 2008.

• NIH will formally announce the new initiatives it plans to implement in Spring, 2008.

More at: http://enhancing-peer-review.nih.gov

The Charge: “Fund the best science, by the best scientists, with the least administrative burden…”

21

Enhancing Peer Review: Selections from the Draft Final Report

• Challenges identified in 7 broad areas:– Reducing administrative burden on applicants,

reviewers, and NIH staff– Enhancing the rating system– Optimizing support at different career stages– Optimizing support for different types of science– Reducing stress on the support system of science– Meeting the need for continuous review of NIH

peer review

More at: http://enhancing-peer-review.nih.gov

22

Enhancing Peer Review: SelectChallenges and Recommendations

• Recommendations under consideration for pilot testing and community feedback include:– Shortening the length of applications– Providing unambiguous feedback by scoring all

applications and including a “Not Recommended for Resubmission” option

– Eliminating “Special Status” of amended applications by considering all applications as “New”

– Linking potential review service to most prestigious NIH awards

– Employing an editorial board model for review of interdisciplinary research

– Instituting a minimum effort requirement for investigators on RPGs

– Pilot ranking early-career investigators against each otherMore at: http://enhancing-peer-review.nih.gov

23

Continuous Submission Process for NIH Study Section Members

• Chartered Study Section member must be the PD/PI. Multi-PI applications are eligible if one or more PD/PI is an appointed Study Section member.

• Limited to R01, R21 and R34 (including AIDS-related) applications submitted for standard due dates.

• Not available for temporary or ad hoc reviewers, or reviewers for other Federal agencies.


Appointed members of chartered Study Sections may submit applications as they are developed and NIH

will review within 120 days of receipt.

24

Clarification of NIH Policy on Late Application Submission

• Late applications – Generally are not accepted, except in rare instances. Unaccepted

late applications will be returned without review– Permission is not granted in advance– Must be accompanied by a cover letter with compelling reasons for

the delay (including timing and nature of the cause of the delay) – Regular Standing Submission dates – Late applications must be

received within two weeks of standing submission date– Expedited Standing Submission dates – Late applications must be

received within one week of standing submission date.

• NIH will not consider accepting late applications for the Special Receipt Dates for RFAs and PARs


NIH expects grant applications to be submitted on time.

25

Centralized NIH Database of Human Genome Data

• Facilitates rapid and broad access to Genome-Wide Association Study (GWAS) datasets

• Policy addresses:– Principles governing the repository – Data sharing procedures and requirements– Research participant protection and privacy– Data Access Committees– Intellectual property and publication rights– Oversight and governance of repository

• Implementation guidance now available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-013.html

GWAS Website: http://grants.nih.gov/grants/gwas

26

Revised NIH Parental Leave Policy for NRSA Awards

• NRSA programs affected: F30, F31, F32, F33, T32, T34, T35 and NRSA portion of T90 awards.

• Applies to adoption or birth of a child when those in comparable training positions at the grantee organization have access to this level of paid parental leave.

• Either parent is eligible for leave.• The use of parental leave must be approved by the training

Program Director.

Trainees on institutional training grants and individual fellowships may receive stipends for up to 60

calendar days (equivalent to 8 work weeks) for parental leave per year.


27

Revised Policy on Concurrent Support from K Awards and Research Grants

• Effort may be reduced to no less than 6 person-months (or 50% full-time professional effort) and replaced with effort from the research award so the total research effort commitment remains at 9 person-months (75% effort).

• K awardee must be one of the named PIs on a competing research grant application or sub-project director on multi-component research or center grant or cooperative agreement.

Recipients of mentored career development (K) awards may reduce effort on their K award in its final two years when they successfully compete for a peer-

reviewed research grant from any Federal agency.


28

FY 2008 Legislative Mandates• Most provisions identical to existing requirements in

Appropriations from FY 2005-2007• Ban on False and Deliberately Misleading Scientific

Information– Similar to existing research integrity, fraud and false

claims restrictions– No significant changes expected for grantees.

• Restriction on Employment of Unauthorized Alien Workers– Similar to existing Immigration and Nationality Act

requirements– No significant changes expected for grantees

• NIH Public Access Policy– No longer optional – compliance mandated by law


29

Revised Public Access Policy

• Compliance mandated by Public Law 110-161• Applicable to:

– Peer-reviewed articles,– Accepted for publication on or after 4/7/08, and– Arising from direct grant or contract funds active in FY

2008, and beyond. • Full-text articles to be made publicly available on NLM’s

PubMed Central no later than 12 months after date of publication


All investigators funded by NIH must submit to PubMed Central an electronic version of their final, peer-reviewed

manuscripts upon acceptance for publication.

30

How to Comply

• Address copyright issue: Institutions and investigators are responsible for ensuring that publishing/copyright agreements allow submission.

• Submission of articles to NIH: Upon acceptance for publication, deposit final manuscript in NIH Manuscript Submission (NIHMS) system. Many journals will submit articles on behalf of author.

• Citing Articles in Applications & Progress Reports: Beginning with 5/25/08 submission date, when citing articles authored or co-authored by the applicant(s) that fall under the Policy, include the PubMed Central ID or NIH MS ID number for each article.

More at: http://publicaccess.nih.gov/FAQ.htm

31

NIH Public Access Policy

• Starting May 25, 2008, all applications, proposals or progress reports must include the PMC or Manuscript Submission reference number when citing NIH-funded articles.

• Manuscripts will be made publicly available within 12 months after the official date of publication.

• Institutions and investigators must ensure that any publishing or copyright agreement fully complies with this policy.

• Required by Consolidated Appropriations Act, 2008 (P.L. 110-161)


All peer-reviewed articles that arise from direct costs funded by NIH, and are accepted for publication on or after April 7, 2008,

must be submitted to NLM’s PubMed Central.

32

Registration of Clinical Trials

• Expansion of existing ClinicalTrials.gov registry.• Includes Phase II-IV clinical trials of drugs and devices

subject to FDA regulation.• Increased number of data elements that must be submitted.• Not limited to trials for serious or life threatening diseases.• Competing applications and progress reports grants with NIH-

funded trials must include a certification of submission.• NIH encourages registration in ClinicalTrials.gov of ALL

clinical research trials funded by NIH, whether required under the law or not.


The FDA Amendments Act (P.L. 110-85) mandates registration and results reporting at ClinicalTrials.gov

by sponsors of applicable clinical trials.

33

Registration of Clinical Trials (continued)

Detailed Requirements:• Effective December 26, 2007, all ongoing trials of drugs and

devices for serious or life-threatening diseases are to be registered in ClinicalTrials.gov database

• All other trials are to be registered within 1 year• New trials are to be registered within 21 days after the first

patient is enrolled• Registration information must be posted publicly within 30

days of submission for drug trials, or 30 days of FDA approval for device trials

• Civil penalties to be levied for noncompliance if trials are not properly registered.

• NIH will verify registration before funds are released. See requirements for competing applications and noncompeting progress reports at NIH Guide Notice NOT-OD-08-023.

34

FY 2008 NIH Salary Cap

• An individual's base salary is NOT constrained by the legislative provision for a limitation of salary. An institution may pay an individual's salary amount in excess of the salary cap with non-federal funds.

• Grantees should provide information on full salary needs (if more than the cap) so NIH can adjust based on future limits.

• Salary Cap Summary (Historical Information): http://grants.nih.gov/grants/policy/salcap_summary.htm


Effective January 1, 2008, salary and wages on NIH grants limited to an annual rate of $191,300

(equal to Executive Level I).

35

Goal: Encourage collaboration among equals when that is the most appropriate way to address a scientific problem, a “Team Science” approach.

• NIH Implementation Plans for Recognition of Multiple PIs on Federally-Funded Research Projects – http://rbm.nih.gov/NIH_Multi_PIs.doc

• Multiple Principal Investigator website and FAQs: – http://grants.nih.gov/grants/multi_pi/index.htm

Multiple Principal Investigators Supporting Team Science

36

Elimination of Paper Notification of Award Letters (NoAs)

• As of January 1, 2008, NIH is no longer providing paper notification of NoA letters.

• NoAs are sent solely by e-mail and award letters are accessible through the eRA Commons.

• All award recipients must be e-mail enabled!– Edit your institutional profile in the eRA

Commons.– If already enabled, confirm that the address is

correct.More at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-002.html

37

Electronic FSR Submission Required

• As of October 1, 2007, NIH requires all Financial Status Reports (FSRs) to be submitted using the electronic FSR system in the eRA Commons.

• Applies to both domestic and foreign grantees.

• Does not apply to other Federal agencies.


38

Federal Funding Accountability and Transparency Act (FFATA)

• Prepare for potential increased attention and scrutiny when data is made publicly available.

• NIH is actively involved with a variety of Federal-wide committees to implement the act and is tailoring processes to meet its requirements.

• FFATA may require form changes in the 424 (R&R) and PHS 398 to capture performance site information. - Stay Tuned

More at: www.FederalSpending.gov

Public Law 109-282 requires information on every grant, including 1) the amount, 2) descriptive purpose of the grant, and 3) name and location of recipient of primary performance location. This includes data on all subawards over $25,000.

OPERA

Highlights of New and Existing Grant Requirements

40

Financial Conflict of Interest (FCOI) Activities

NIH continues to enhance and promote compliance with the FCOI Regulation (42 CFR Part 50, Subpart F)

• NIH system-wide review of FCOI policies, procedures, and guidance

• eRA Commons FCOI module/reporting tool for grantees (implementation expected 10/08)

• Updated FAQs and an online tutorial– For grants, cooperative agreements, and contracts

• Articles in NIH Extramural Nexus • Web based reporting and tracking tool for NIH staff• Pilot Compliance Program on FCOI • NIH Targeted Site Reviews • FCOI mailbox ([email protected])• NIH Guide Notices

Web Postings and Resources at: grants.nih.gov/grants/policy/coi/index.htm

41

Pilot FCOI Compliance Program

• NIH selected a number of institutions for review of their FCOI policy and related information.– Assess compliance with 42 CFR Part 50 Subpart F– An outgrowth of the NIH Targeted Site Reviews – Desk reviews, not site visits

• Results of the pilot program will be shared with the grantee community for educational purposes to enhance and improve FCOI compliance.


42

FCOI Targeted Site Reviews

• Targeted Site Reviews are an initiative to determine whether grantee institutions have:– Fully implemented the FCOI regulations as they pertain to

grants and cooperative agreements (42 CFR Part 50 Subpart F), and;

– Complied with reporting requirements. • Eighteen site reviews completed in FY 2006

– “Observations from NIH’s FY 2006 Targeted Site Reviews on Financial Conflict of Interest” have been posted on the OER Conflict of Interest page: http://grants.nih.gov/grants/policy/coi/index.htm

– Guide Notice: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-048.html

FCOI questions for NIH? [email protected]

43

AAMC-AAU Report

• Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research (February 2008)

• Calls on medical schools and major research universities to develop and implement institutional FCOI policies within the next two years and to refine individual FCOI standards– Policies on individual FCOI in human subjects research– Policies on institutional FCOI in human subjects research– Implementation of COI policies

• Report includes practical resource information in its Appendices

Entire report available at: http://www.aamc.org/newsroom/pressrel/2008/080228.htm

44

• An Investigator is not just the Principal Investigator or Senior/Key Personnel conducting the PHS-sponsored research.

• Recipient institutions are encouraged to broadly consider an individual’s role, rather than title, and their degree of independence when applying the definition.

FCOIDefinition of Investigator

Investigator – Principal Investigator (PI) and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding. The term “Investigator” includes the Investigator’s spouse and dependent children.

45

FCOI Summary of Reporting Requirements

1. At the time of application: Investigators must submit known significant financial interests to the institution.

2. Prior to the expenditure of funds: The institution must report a financial conflict of interest to the NIH and assure that it has been managed, reduced, or eliminated.

3. FCOI identified after the initial report: The institution must report within 60 days of identification and assure that it has been managed, reduced, or eliminated.


46

FCOI - Subrecipients

• If the grantee institution performs NIH-funded research through “subgrantees, contractors, or collaborators,” the grantee institution must take reasonable steps to ensure compliance by requiring either: – Subrecipient Investigators to comply with the grantee

institution’s policy OR– Subrecipient institutions to provide assurances to the

grantee institution that will enable it to comply

Subrecipients should report identified FCOIs to grantee institution. Grantee institution reports to NIH.

47

FCOI Information to be Reported

• All FCOI reports should include the following information:

– Grant number;– Name of Principal Investigator (PI) or contact PI if

multiple PI award;– Name of Investigator with the FCOI; and– Distinguish which method was used to protect the

research from bias (e.g., managed, reduced, or eliminated).

48

OIG Report - NIH: Conflict of Interest in Extramural Research

• Recommendations in January 2008 report– Increase oversight of grantee institutions to ensure their

compliance with Federal FCOI regulations.– Require grantee institutions to routinely provide details

regarding the nature of FCOI and how they are managed, reduced or eliminated.

– Require Institutes to forward to the Office of Extramural Research (OER), NIH, all FCOI reports received from grantee institutions and ensure OER’s database includes all FCOI reports provided by grantee institutions.

Full report available at: http://oig.hhs.gov/oei/reports/oei-03-06-00460.pdf

49

FY 2008 OIG Audit Work PlanSelected Highlights

• Colleges’ and Universities’ Compliance with Cost Principles– Cost transfers, effort reporting, and other areas

• University Administrative and Clerical Salaries• Are salary costs appropriately charged?

• Use of Data and Safety Monitoring Boards in Clinical Trials• NIH Monitoring of Extramural Conflicts of Interest

– How NIH monitors extramural grantees’ FCOI and the effectiveness of NIH’s oversight

• Grantee Management of Financial Conflicts of Interest in Research Funded by the NIH– Monitoring of FCOIs, nature of FCOIs, and how FCOIs

managed (for FCOIs reported to NIH in FY 2006)

FY 08 Work Plan: http://oig.hhs.gov/publications/workplan.html#1

50

Audit Requirements

• Audits are due within the earlier of 30 days after receipt of the auditor’s report(s) or 9 months after the end of the grantee’s audit period.

• Grantees delinquent in submitting audits risk the imposition of sanctions and potential loss of Federal funds.

All NIH Grantees that expend $500,000 or more within a year in Federal awards are

subject to an audit requirement.

51

Summary of Audit Requirements

(same as For-Profits)

Foreign

For-Profits

Hospitals

Non-Profits

Colleges &

Universities

Federal Audit Clearinghouse

1201 E. 10th Street

Jeffersonville, IN 47132

Questions:

1-800-253-0696

National External Audit Review CenterHHS Office of Inspector General

HHS Office of Audit Services1100 Walnut Street, Suite 850

Kansas City, MO 64106-2197

Phone: 800-732-0679/816-426-7725

OMB Circular A-133

45 CFR Part 74.26 (d)

NIH Grants Policy

Statement (same as For-Profits)

State & Local

Governments

Where to Submit Audit ReportsSource of Audit Requirement

Grantee Type

52

Closeout Final Reports

• Documents are due within 90 days of project period end date– Final Financial Status Report (now required

electronically)– Final Inventions Statement & Certification– Final Progress Report

• Failure to submit timely reports may affect future funding to the organization!


Grantees are strongly encouraged to submit closeout documents electronically through the eRA

Commons!

53

NIH Centralized Processing Center

• NIH encourages electronic submission of closeout documents through the eRA Commons.

• Centralized office accepts receipt of all non-financial, paper-based closeout documents– Final Progress Report– Final Invention Statement and Certification

• Mail to the Central NIH unit at:NIH Centralized Processing Center6705 Rockledge Drive, Room 2207, MSC 7987 Bethesda, MD 20892-7987 (for regular or US Postal Service

Express mail) Bethesda, MD 20817 (for other courier/express mail

delivery only)

54

Renewed Focus on Protecting Sensitive Data in Research

• Federal Information Security Management Act (FISMA) requires that all information systems which contain Federal data, electronic or hard copy, must be protected from unauthorized access. – Public Law 107-347– Access to data should be limited through password

protection and other appropriate means. – Personally identifiable, sensitive and confidential

information should not be housed on portable electronic devices, but if they must be used the data should be encrypted.

• FISMA applies to grantees but only when they collect, store, process, transmit, or use information on behalf of HHS.

All other grantees still have responsibility to protect personally identifiable, sensitive and confidential data.


55

NIH Policy on Data Sharing

Applicant Resources:• Data Sharing Chart: Quick guide for identifying data sharing

regulation/policy/guidance documents applicable to NIH funding http://grants.nih.gov/grants/policy/data_sharing/data_sharing_chart.doc

• Data Sharing Main Page: http://grants.nih.gov/grants/policy/data_sharing


Investigators submitting a research application requesting $500,000 or more of direct costs, in any single budget period to NIH, must include a plan for sharing final research data for research purposes, or

state why data sharing is not possible.

56

NIH Policy on Sharing of Model Organisms

Applicant Resources:• Data Sharing Main Page available at: http://

grants.nih.gov/grants/policy/model_organism/index.html– Frequently Asked Questions– Sample Sharing Plans

Investigators submitting an NIH application/proposal are expected to include a specific plan for sharing and distributing unique model organism research

resources generated using NIH funding in the application/proposal OR state appropriate reasons for why such sharing is restricted or not possible.


OPERA

Requirements and Compliance Assistance for OHRP / OLAW

58

• “What Investigators Need to Know About the Care and Use of Laboratory Animals”

– Brochure explains the requirements for using animals in PHS-supported research

– Contact OLAW to request multiple copies

• FAQs on “PHS Policy on Humane Care and Use of Vertebrate Animals” available on the OLAW website

• IACUC 101 is a series of workshops on the roles and responsibilities of IACUCs, including federal policies and regulations regarding animal welfare.

– March 26, 2008: Atlanta, GA

– April 15, 2008: Galveston, TXMore at: http://olaw.nih.gov

OLAW Compliance Assistance

59

Policy on UnAllowable Costs for Activities Involving Animals

• Absence/suspension of valid Assurance filed with OLAW

• Absence/suspension of valid IACUC approval of the animal activity: – Failure to obtain IACUC approval for animal activity.

– Continuing animal activities after IACUC approval has expired.

– Continuing animal activities after suspension of IACUC approval.

• Institutions must report noncompliant situations to:– OLAW ([email protected] or 301-594-2061)

– Institute/Center (IC) supporting the award

More at: Notice NOT-OD-07-044 at http://olaw.nih.gov

Institutions are not permitted to charge grants or contracts for animal activities when terms and

conditions are not upheld.

60

Consortium Agreements: Subawards and Animals (Cont.)

• Prime grantee is accountable to NIH and must confirm Assurance and IACUC approval (dated within 3 years)

• Animal welfare requirements apply to all consortium participants and sub-projects– Inter-Institutional Assurance is needed:

• Prime grantee has no animal program; animal work is being conducted at an Assured performance site

– Foreign Assurance is needed: • Direct support to a foreign institution• Domestic prime grantee with a foreign performance

site using animals (Domestic grantee’s IACUC approves animal activities performed at foreign site)

GPS Page 224 at: http://grants.nih.gov/grants/policy/nihgps_2003/index.htm

61

Public Outreach Materials from OHRP

• Informational pamphlets on becoming a research volunteer.

• Call OHRP at (800) 447-477 for up to 50 free copies.

• Now available in Spanish!

More at: http://www.hhs.gov/ohrp/outreach/

62

New Online Tutorial on Protecting Human Research Participants

• Free, on-line tutorial now available that satisfies the NIH human subjects training requirement

• Designed for those involved in the design and/or conduct of research involving human participants.

• Replaces the NCI Human Participant Protections Education for Research Teams Course previously available for this requirement.

• Available at: – http://phrp.nihtraining.com/users/login.php


OPERA

Application Forms and Electronic Submission

64

Changes to NIH Application Forms

• New PHS 398 forms approved for optional use until May 24, 2008. Use will be mandatory for submission dates after May 25.– Changes will also be incorporated into PHS 398 components

used in the SF424 (R&R) form set. Grants.gov development of these forms is pending.

– The new PHS 2271 form is currently available and must be used for appointments made on/after May 1, 2008.

– The PHS 3734 and HHS 568 forms have also been renewed and are now available.

• New PHS 2590 forms available and required for all progress reports.

All Forms Available at: grants.nih.gov/grants/forms.htm

65

Upcoming eSubmission Form Changes

• Transition to Adobe-based 424 forms continues but no firm dates set yet. – F, T, and K transition from PHS 398 to Adobe 424 (R&R) – Transition of current PureEdge-based 424 (R&R)

applications – Transition of Complex Mechanisms still on hold.

• FFATA may require form changes in the 424 (R&R) to capture performance site information.

• Other 424 (R&R) changes also possible during OMB renewal.• A few OMB-approved changes to the PHS 398 components

NIH is attempting to coordinate all these changes into a single transition to minimize impact on the

community. – Stay Tuned!

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Read & Follow All Instructions!

• Avoid having to submit corrected applications – read and follow all application guide and announcement instructions– Look for the HHS logo in the

application guide for any special instructions or fields not marked as mandatory on the federal-wide form that are required by NIH

More at: http://grants.nih.gov/grants/funding/424/index.htm

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Avoid Common Errors

NIH-specific requirements:• Use PDF format for text attachments• R&R Senior/Key Person Profile(s) form

– Include eRA Commons Username in the “Credential, e.g. agency login” field for all individuals assigned a PD/PI role.

– Include the Organization Name for all Senior/Key Persons listed

• R&R Budget form - Senior/Key Person effort must be greater than zero

More at: http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm

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Track Your Application

• Clicking “Submit” is NOT the last step!– It is the applicant’s responsibility to track the

application through the submission process– Use eRA Commons to check for submission

errors/warnings and to view your assembled application

• If you can’t view your application in eRA Commons – we can’t review it!

More at: http://era.nih.gov/ElectronicReceipt/

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Recent Changes

• Responded to applicant feedback…– Reduction of correction window

in eRA Commons from 5 days to 2 days.

– Enhanced application guide instructions

– Extended application viewing times through Federal holidays

More at: http://era.nih.gov/ElectronicReceipt/

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Future Changes

• Grants.gov Adobe eForms– Platform Independent

(PC and Mac compatible)

– Advanced Search Features

– Will have the same ‘look & feel’ as current forms to ease the transition

– No firm transition date set

More at: http://www.grants.gov/aboutgrants/program_status.jsp

OPERA

eRA Commons

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Servicing Other Agencies

• Continuing to service HHS partners– Agency for Healthcare Research & Quality (AHRQ)– Centers for Disease Control and Prevention (CDC)– Food & Drug Administration (FDA)– Substance Abuse & Mental Health Services

Administration (SAMHSA)– Veteran’s Health Administration (VA)

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Enhanced eRA Commons Features – 10/2007

• Electronic Streamlined Non-competing Award Process (eSNAP)– Changes to Institutional Profile

Assurances/Certifications– Updated to include changes to multi-PI Leadership

Plan and research with Select Agents

• Delegation of PI status to assistant for reviewing electronic applications

• Ability to monitor the electronic submission of reference letters


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Enhanced eRA Commons Features (cont.)

• Updated Status screens.– Added ability to search and track applications by

Grants.gov tracking number.– Reorganized application/grant data to separate

applications requiring further action in the submission process from all others.

• While the screens may look different, all the information you’re used to seeing is still available (plus more!)


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Coming Soon: X-Train

• X-Train is a new system to improve the administration of NIH Training Grants.– Allows PIs and staff to electronically submit

appointment forms and termination notices – Allows institutional staff to track status and timing

of appointment actions– Will be available through eRA Commons

• Pilot begun December 2007 with over 90 training grants at 9 universities.

• Full production release expected Spring 2008

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Profile Maintenance

• PIs have an obligation to keep information in their Personal Profile current and need to update it regularly

• Profile data used in other electronic processes (e.g., Summary Statements, eNotifications)– Degrees– Position Titles– Addresses - e-mail & postal

OPERA

Technical Assistance and Training Resources

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SBIR/STTRPipeline to Partnerships

• Showcase of SBIR/STTR grantee technology available to potential strategic partners and investors for development opportunities.

• Searchable index organized by technology and stage of development.

More at: http://www.ott.nih.gov/p2p/p2p_writeup.html/

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Redesigned OER Web Site

• Office of Extramural Research home page – Links to funding opportunities, grants policy,

application and forms, awarded grant data

• Redesign based on focus groups and visitor feedback– New search tools– Comprehensive glossary and acronyms list– New content walks through the NIH grant-making

process

• Also improved & updated eRA web site

Visit at: http://grants.nih.gov/grants/oer.htm

80 OER web site located at http://grants.nih.gov/grants/oer.htm

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Redesigned eRA Web Site

• Services for Applicants - 'plain language' factsheets on eRA services

• Commons - overview, quick link to system,user guides, release notes, FAQs and other resources

• NIH & Grantor Agencies - highlights services and system modules available for NIH staff andother Federal agencies

• News & Events - eRA updates and info onupcoming workshops/seminars

Visit at: http://era.nih.gov/

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Summary of Helpful NIH Web Pages

• NIH Searchable Database of RFAs, PAs, and Guide Notices http://grants.nih.gov/grants/guide/index.html

• NIH Grants Policy Statement (Rev. 12/03) http://grants.nih.gov/grants/policy/nihgps_2003/index.htm

• NIH Extramural Nexus – Bimonthly newsletter for the extramural communityhttp://grants.nih.gov/grants/nexus.htm

• Electronic Submission of Grant Applications Homepagehttp://era.nih.gov/ElectronicReceipt/index.htm

• CRISP database - Search to analyze an Institute’s portfolio of funded projects, research areas, and more http://crisp.cit.nih.gov/crisp/crisp_querty.generate_screen

• Grant Application Basics http://grants.nih.gov/grants/grant_basics.htm

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New OER Outreach Webpage

New OER Outreach Webpage

• NIH Regional Seminars on Program Funding and Grants Administration– Funding Opportunities for New Investigators– Application Preparation and the Review Process– Grant Administration Issues, Hot Topics, and More…

• National Animal Welfare Workshops• Office of Human Research Protections Workshops• NIH Small Business Research Workshops• Office of Research Integrity Workshops and Conferences

Visit at: http://grants.nih.gov/grants/outreach.htm

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NIH Regional Seminars on Program Funding and Grants Administration

• Yearly seminars to educate research administrators, investigators new to NIH, and trainees.

• Due to the popularity of these seminars and availability of space - Early Registration is Highly Recommended!

• Seminar and Registration Information: http://grants.nih.gov/grants/seminars.htm

Interested in hosting? Contact us!


2008 Regional Seminars: March 25-26, 2008 in San Antonio, TX - Past

June 19-20, 2008 in Chicago, ILNIH electronic research administration labs

offered in conjunction with the two-day seminar.

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NIH OER Listserv Addresses and Instructions

• Office of Biotechnology Activities (OBA):– https://list.nih.gov/archives/oba_news.html

• Office of Human Research Protections (OHRP): – http://www.hhs.gov/ohrp/news/distributionlist.html

• Office of Laboratory Animal Welfare (OLAW):– http://grants.nih.gov/grants/olaw/references/list.htm

• eSubmission: – http://era.nih.gov/ElectronicReceipt/listserv.htm– Separate listservs available for scientists and administrators

• NIH Guide for Grants and Contracts:– http://grants.nih.gov/grants/guide/listserv.htm– The official publication for NIH medical and behavioral research

Grant Policies, Guidelines and Funding Opportunities

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Grants Information:Who to Contact!

• Institutional Resources – First, utilize the expertise of your organization’s Office of Sponsored Programs

Application Specific Questions• Administrative - Contact the Grants Management

Specialist at the awarding Institute/Center• Scientific/Programmatic - Contact the designated

Program Official/Director at awarding Institute/Center

• Review Questions - Contact the assigned Scientific Review Officer

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• Grants Administration individuals at all NIH ICs:– http://grants.nih.gov/grants/staff_list_grants_admin.htm

• NIH Chief Grants Management Officers: – http://grants.nih.gov/grants/stafflist_gmos.htm

• Grants Policy Interpretation & Consultation:– E-Mail: [email protected]– Phone: 301-435-0949

• Compliance Issues:– E-Mail: [email protected]– Phone: 301-435-0949

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• General Application Questions: (e-Submission guidelines, resources & referrals, application review & award process, etc.)– E-Mail: [email protected]– Phone: 301-435-0714

• Customer Support for Grants.gov: (navigating forms, aspects of submitting through the system, resources available, etc.)– E-Mail: [email protected]– Webpage: http://grants.gov/– Phone: 1-800-518-4726

• eRA Commons Help Desk: (Commons registration help, application verification, Commons functionality questions, etc.)– Webpage: http://ithelpdesk.nih.gov/era/– Phone: 301-402-7469 (Toll Free: 866-504-9552)

Enter your own help ticket!

OPERA

Thank You!

Any Questions?

OPERA

Frequently Asked Questions

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#1 – How do I prepare for eSubmission?

• Grants.gov requires a three-step registration process for the organization to submit electronically

• eRA Commons registration is also required for both the organization and the PI– These are separate processes that can be done

simultaneously.• All registrations must be completed prior to

application submission.

It is critical for institutions to begin these registrations at least 2 – 4 weeks before applications are due!

More at: http://era.nih.gov/ElectronicReceipt/preparing.htm

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#2 – How do I submit a multiple-PI application?

• Applications– NIH Grant Applications Forms (PHS 398 and SF424 R&R) accommodate

more than one PI– Leadership Plan required describing roles, responsibilities, and the working

relationship of the identified PIs.

• Principal Investigators– The Contact PI will be responsible for communication between the NIH and

the leadership team (and will be listed first on the application)– All PIs share the responsibility and authority for leading and directing the

project.

• New Investigator Policies– New Investigator box on the application may only be checked when all PIs

are classified as New Investigators.

• Review Criteria– Standard NIH review criteria have been modified accordingly.

• Awards Involving More than One Institution– PIs from different institutions will be managed though subcontracts for now.

More at: http://grants.nih.gov/grants/multi_pi/

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#3 – Are there any fellowship programs for individuals from minority or disadvantaged

groups?

However, note that a revised FOA includes the following changes:

• Effective January 1, 2007: Now 3 submission dates--April 13, August 13, and December 13.

• Added new bullet in “Content and Form of Application Submission” section to require information that must be submitted by applicant Institution in a letter certifying the applicant’s eligibility (See FOA for further details.)

• Updates information on Tuition/Fees and Institutional Allowance, published in the NIH Guide: NOT-OD-06-093.

FOA at: http://grants.nih.gov/grants/guide/pa-files/PA-07-106.html

Yes.

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#4 - Does NIH still accept unsolicited grant applications?

Other funding opportunity announcements include:• Program Announcements

– Statement of new or ongoing NIH interest in a certain research area.

• Requests for Applications (RFAs)– Statement soliciting applications in a well-defined

scientific area to accomplish specific program objectives.

All Available at: http://grants.nih.gov/grants/guide/index.html

Yes. Use Parent Announcements (available on Grants.gov and NIH web pages) for “unsolicited” or “investigator-initiated” applications.

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#5 – Can foreign applicants submit modular budgets?

• Receiving detailed budgets from foreign applications allows NIH staff to assist applicant community with applicable regulatory and policy requirements for grant funding expenditure.

• However, domestic (U.S.) institutions with subawards to foreign (non-U.S.) institutions may use modular budgets.


No.

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#6 – Are fellowship candidates required to register in eRA Commons?

• PI Role in the Commons does not provide special status – only a record in the system that provides administrative authority to see pertinent application documents (e.g. summary statements, scores, submission status, etc.)

• Individual Fellows registered by any organization other than the sponsoring organization should not have more than one eRA Commons account.


Yes. Applicant organizations should register any individual fellows submitting applications to NIH and AHRQ

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#7- Are consortium F&A costs included as part of an applicant’s direct costs?

• This policy applies to:– $250K direct cost calculation for modular budgets– $500K direct cost calculation for NIH data sharing

policy and requirement to contact IC staff for unsolicited applications requesting over $500K

• This policy does not apply to:– Small Business Innovation Research (SBIR) grants– Small Business Technology Transfer (STTR) grants


No. Applicants are to exclude the facilities and administrative (F&A) costs requested by consortium participants when determining if the budget exceeds a direct cost limit.

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#8 – May I reduce my level of effort on a K award?

Requirements:• Individual has a full-time appointment with their institution.• The minimum percentage of effort commitment required

for the K award is covered by that appointment.Alternatively:• In the last two years of support individuals may reduce the

level of effort on most K awards and replace with an NIH research grant or subproject.– Awardee must serve as a PI or subproject Director– Effort may be reduced to no less than 50% and be

replaced by effort from the research award so total effort commitment remains at or above 75%.


Yes. Recipients may reduce their commitment of total professional effort in some circumstances.

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#9 – How do I calculate person-months in a 9-month academic year?

• Person months are the metric expressing amount of effort faculty and other senior/key personnel devote to a project

• How are person-months calculated? – Multiply the percentage of effort by the number

of months of the appointment. For example:• 10% of a 9 month academic year appointment

equals .9 person months (9 x .1 = .9 person months)

• 10% of a 12 month calendar appointment equals 1.2 months (12 x .10 = 1.2 person months)

More at: http://grants.nih.gov/grants/policy/person_months_faqs.htm

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#10- What are the requirements for recombinant DNA research?

• Institutional Biosafety Committees must review and certify proposed recombinant DNA research.

• Serious adverse events in human gene transfer research must be reported promptly!– Usually within 15 days, but– Within 7 days if life threatening or fatal.– Annual reporting is also required.

• Full text of the guidelines are available:– http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.– Site also includes available training opportunities.


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#11 – Does NIH have a cap on consultant fees?

HOWEVER, • Grantees must have written policies for paying

consultants that:– Are consistently applied regardless of fund source.– Include conditions for paying consultant fees.

• Consultants must be properly classified.– Consultants are defined as individuals who provide

professional services or advice for a fee, but normally are not employees of the organization. This also includes firms that provide advice or services.

No. There is no cap on consultant fees and the NIH salary cap does not apply.

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#12 – How different does a “new application” have to be?

• More significant differences than normally encountered in resubmission applications.– Rewording the Title and Specific Aims is not sufficient.– Incorporating minor changes in response to reviewer

comments is not sufficient

• Research Plan changes should produce a significant change in direction and approach. All research plan sections should have substantial changes, particularly the Specific Aims and Research Design and Methods sections.

“New applications” are expected to be substantially different in content and scope

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#13 – As PI, what happens if I change institutions mid-grant?

• Transfer approval is not automatic and requires approval from both NIH and the original grantee organization.

• Contact your GMO before moving to initiate the transfer process.

• Grants to individuals may not be transferred but individual fellowships may transfer to a new sponsoring institution.

Prior, written approval is required for transferring legal and administrative authority for a grant to a different organization.