A Review of Recent A Review of Recent Changes to NIH Changes to NIH

Forms & Forms & Instructions Instructions

Jane TolbertJane Tolbert

ORPAORPA

December 15, 2009December 15, 2009

Today’s TopicsToday’s Topics

Important DatesImportant Dates Changes common to all applicationsChanges common to all applications Changes specific to the SF424 Changes specific to the SF424

Forms (electronic submissions)Forms (electronic submissions) Changes Specific to the PHS 398 Changes Specific to the PHS 398

forms (paper submissions)forms (paper submissions) Reminder of PHS 2590 changesReminder of PHS 2590 changes Available ResourcesAvailable Resources

Important DatesImportant Dates

Effective January 25, 2010 all grant Effective January 25, 2010 all grant applications must use the new forms applications must use the new forms and instructionsand instructions

The The grant deadlinegrant deadline determines determines which forms should be usedwhich forms should be used

Deadlines prior to 1/25/10 – old formsDeadlines prior to 1/25/10 – old forms Deadlines on or after 1/25/10 – new Deadlines on or after 1/25/10 – new

formsforms

Changes Common to All Changes Common to All Applications (paper or Applications (paper or

electronic)electronic)

Shortened Page LimitsShortened Page Limits Restructured Research PlanRestructured Research Plan Bios tailored to each applicationBios tailored to each application Resources tailored to each Resources tailored to each

applicationapplication

New Page LimitsNew Page Limits Introduction – 1 page Introduction – 1 page

3 pages for certain mechanisms (see FOA for details)3 pages for certain mechanisms (see FOA for details) Specific Aims – 1 pageSpecific Aims – 1 page Research Strategy Research Strategy

For R03, R21, R36, SC2, SC3, F awards – 6 pagesFor R03, R21, R36, SC2, SC3, F awards – 6 pages For R01, R10, R15, R21/R33, R24, R33, R34, DP3, G08, G11, For R01, R10, R15, R21/R33, R24, R33, R34, DP3, G08, G11,

G13, SC1, X01, single project U01 – 12 pagesG13, SC1, X01, single project U01 – 12 pages For R25 – 25 pagesFor R25 – 25 pages For P grants - for each project and core of multi-component For P grants - for each project and core of multi-component

applications – 6 or 12 pagesapplications – 6 or 12 pages For individual K awards – 12 pagesFor individual K awards – 12 pages For institutional K awards and institutional training awards – 25 For institutional K awards and institutional training awards – 25

pagespages Everything else – follow FOA instructionsEverything else – follow FOA instructions

See http://enhancing-peer-review.nih.gov/page_limits.html for See http://enhancing-peer-review.nih.gov/page_limits.html for further detailsfurther details

Restructured Research Restructured Research PlanPlan

Specific AimsSpecific Aims Should also include the impact of the results of the

proposed research on the research field

Research Strategy Research Strategy SignificanceSignificance InnovationInnovation ApproachApproach

Preliminary Studies for New Applications Preliminary Studies for New Applications For new applications, include information on For new applications, include information on

Preliminary Studies as part of the Approach Preliminary Studies as part of the Approach section. section.

Progress Report for Renewal and Revision Applications Progress Report for Renewal and Revision Applications For renewal/revision applications, provide a For renewal/revision applications, provide a

Progress Report as part of the Approach section. Progress Report as part of the Approach section.

SignificanceSignificance Explain the importance of the problem or Explain the importance of the problem or

critical barrier to progress in the field that critical barrier to progress in the field that the proposed project addresses.the proposed project addresses.

Explain how the proposed project will Explain how the proposed project will improve scientific knowledge, technical improve scientific knowledge, technical capability, and/or clinical practice in one capability, and/or clinical practice in one or more broad fields.or more broad fields.

Describe how the concepts, methods, Describe how the concepts, methods, technologies, treatments, services, or technologies, treatments, services, or preventative interventions that drive this preventative interventions that drive this field will be changed if the proposed aims field will be changed if the proposed aims are achieved.are achieved.

InnovationInnovation Explain how the application challenges and seeks Explain how the application challenges and seeks

to shift current research or clinical practice to shift current research or clinical practice paradigms.paradigms.

Describe any novel theoretical concepts, Describe any novel theoretical concepts, approaches or methodologies, instrumentation or approaches or methodologies, instrumentation or interventions to be developed or used, and any interventions to be developed or used, and any advantage over existing methodologies, advantage over existing methodologies, instrumentation, or interventions.instrumentation, or interventions.

Explain any refinements, improvements, or new Explain any refinements, improvements, or new applications of theoretical concepts, approaches applications of theoretical concepts, approaches or methodologies, instrumentation, or or methodologies, instrumentation, or interventions.interventions.

ApproachApproach Describe the overall strategy, methodology, and Describe the overall strategy, methodology, and

analyses to be used to accomplish the specific aims of analyses to be used to accomplish the specific aims of the project. Unless addressed separately in Item 15 the project. Unless addressed separately in Item 15 (Resource Sharing Plan), include how the data will be (Resource Sharing Plan), include how the data will be collected, analyzed, and interpreted as well as any collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.resource sharing plans as appropriate.

Discuss potential problems, alternative strategies, and Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the benchmarks for success anticipated to achieve the aims.aims.

If the project is in the early stages of development, If the project is in the early stages of development, describe any strategy to establish feasibility, and describe any strategy to establish feasibility, and address the management of any high risk aspects of the address the management of any high risk aspects of the proposed work.proposed work.

Point any procedures, situations, or materials that may Point any procedures, situations, or materials that may be hazardous to personnel and precautions to be be hazardous to personnel and precautions to be exercised. A full discussion on the use of Select Agents exercised. A full discussion on the use of Select Agents should appear in Item 11, below.should appear in Item 11, below.

BiosketchBiosketch

New format:New format: A. Personal Statement B. Positions & HonorsB. Positions & Honors C. Selected Peer-reviewed Publications D. Research Support

Sample available at: Sample available at: http://grants1.nih.gov/grants/funding/phs398/biohttp://grants1.nih.gov/grants/funding/phs398/biosketchsample.pdfsketchsample.pdf

BiosketchBiosketch Personal StatementPersonal Statement

Should describe why the individual’s experience and Should describe why the individual’s experience and qualifications make him/her particularly well-suited qualifications make him/her particularly well-suited for their role (e.g., PD/PI, mentor) in the project for their role (e.g., PD/PI, mentor) in the project

Positions & HonorsPositions & Honors As beforeAs before

PublicationsPublications NIH NIH encouragesencourages applicants to limit the list of applicants to limit the list of

selected peer-reviewed publications or manuscripts selected peer-reviewed publications or manuscripts in press to no more than 15. Publications may be in press to no more than 15. Publications may be selected on the basis of selected on the basis of recency, importance to the field, and/or relevance to the proposed research.

Research SupportResearch Support As before - list both selected ongoing and completed As before - list both selected ongoing and completed

(during the last three years) research projects (during the last three years) research projects

ResourcesResources

Include the following information:Include the following information: As before, identify the facilities and resources As before, identify the facilities and resources

availableavailable How does the scientific environment How does the scientific environment

contribute to the probability of success (e.g., contribute to the probability of success (e.g., institutional support, physical resources, and institutional support, physical resources, and intellectual rapport)? intellectual rapport)?

How will the proposed studies benefit from How will the proposed studies benefit from unique features of the scientific environment unique features of the scientific environment or subject populations? Will the proposed or subject populations? Will the proposed studies employ useful collaborative studies employ useful collaborative arrangements?arrangements?

Resources for ESIResources for ESI

Early Stage InvestigatorsEarly Stage Investigators Additional requirements for ESI applicantsAdditional requirements for ESI applicants describe institutional investment in the describe institutional investment in the

success of the investigator:success of the investigator: resources for classes, travel, training; collegial resources for classes, travel, training; collegial

support such as career enrichment programs, support such as career enrichment programs, assistance and guidance in the supervision of assistance and guidance in the supervision of trainees involved with the ESI’s projecttrainees involved with the ESI’s project

availability of organized peer groups; logistical availability of organized peer groups; logistical support such as administrative management and support such as administrative management and oversight and best practices training; oversight and best practices training;

financial support such as protected time for financial support such as protected time for research with salary support.research with salary support.

Changes to the SF424Changes to the SF424

Grant Application Face PageGrant Application Face Page The Competition ID field will read The Competition ID field will read “Adobe “Adobe

Forms B”Forms B”

SF424 Cover Component (Face Page)SF424 Cover Component (Face Page) New 4b – agency-assigned routing # (ignore for New 4b – agency-assigned routing # (ignore for

now)now) Item 13 – now only requires congressional Item 13 – now only requires congressional

district of applicant (previously applicant and district of applicant (previously applicant and project)project)

Item 18 – new section (use only if indicated)Item 18 – new section (use only if indicated) Other items – complete as beforeOther items – complete as before

Changes to the SF424Changes to the SF424

Project/Performance Site Project/Performance Site New checkbox (New checkbox (I am submitting an application as an I am submitting an application as an

individual … etcindividual … etc) – do NOT check) – do NOT check The Congressional District is required for The Congressional District is required for

all performance sitesall performance sites Format for congressional district infoFormat for congressional district info

For one district use NY-028For one district use NY-028 For all districts in a given state use NY-allFor all districts in a given state use NY-all For the whole US use US-allFor the whole US use US-all Outside the US use 00-0000Outside the US use 00-0000

Changes to the SF424Changes to the SF424

Other Project InfoOther Project Info New question under Human subjects sectionNew question under Human subjects section

Is the research exempt from Federal Regulations? Is the research exempt from Federal Regulations? Yes or No answer required if human subjects are Yes or No answer required if human subjects are involvedinvolved

New question 5 (Response REQUIRED)New question 5 (Response REQUIRED) Is the research performance site designated a Is the research performance site designated a

historic place?historic place? Updated Resources section (refer back to Updated Resources section (refer back to

changes common to all applications)changes common to all applications) All other sections as before All other sections as before

Changes to the SF424Changes to the SF424

Senior/Key PersonnelSenior/Key Personnel Revamped bio (refer back to changes Revamped bio (refer back to changes

common to all applications)common to all applications) New fields for degree type and degree year New fields for degree type and degree year

((optionaloptional; NOT mandatory); NOT mandatory) Everything else as beforeEverything else as before

Cover Page SupplementCover Page Supplement New Investigator box is goneNew Investigator box is gone Eligibility determined by data in NIH Eligibility determined by data in NIH

CommonsCommons

Changes to the SF424Changes to the SF424

Research Plan ComponentResearch Plan Component Slots for Introduction, Specific Aims, Slots for Introduction, Specific Aims,

Research StrategyResearch Strategy Introduction – 1 pageIntroduction – 1 page Specific Aims – 1 pageSpecific Aims – 1 page Research Strategy – dependent on mechanismResearch Strategy – dependent on mechanism

Refer back to changes common to all Refer back to changes common to all applications for details on the content of the applications for details on the content of the Research Strategy sectionResearch Strategy section

Changes to the PHS398Changes to the PHS398 New forms are dated June 2009 (PHS 398 rev New forms are dated June 2009 (PHS 398 rev

06/09)06/09) Face Page – no new investigator check boxFace Page – no new investigator check box Table of contents – revisedTable of contents – revised Bios – refer to changes common to all Bios – refer to changes common to all

applicationsapplications Resources – refer to changes common to all Resources – refer to changes common to all

applicationsapplications Research Plan – refer to changes common to all Research Plan – refer to changes common to all

applicationsapplications Personal Data form – no more Personal Data form – no more

Other Notable ItemsOther Notable Items

Reminder: all post-docs need an eRA Reminder: all post-docs need an eRA Commons user name Commons user name

Institutional Training Grants will Institutional Training Grants will transition to electronic submission transition to electronic submission effective 1/25/2010effective 1/25/2010

Revised Table 12A (part of the Revised Table 12A (part of the institutional training application)institutional training application)

now requires data on the % of students who now requires data on the % of students who attain a doctoral degree and the average time to attain a doctoral degree and the average time to receive the doctoral degreereceive the doctoral degree

Reminder: Changes to the Reminder: Changes to the PHS 2590PHS 2590

Current forms are dated PHS 2590 (rev. Current forms are dated PHS 2590 (rev. 06/09)06/09)

Use is mandatory after October 1, 2009Use is mandatory after October 1, 2009 New All Personnel ReportNew All Personnel Report

PD/PI(s) should be listed on the formPD/PI(s) should be listed on the form regardless of the source of compensation all personnel regardless of the source of compensation all personnel

who participated in the project for at least one person who participated in the project for at least one person month should be listedmonth should be listed

New Biosketch FormatNew Biosketch Format only required as part of the progress report for only required as part of the progress report for newnew

senior/key personnel since the previous submission senior/key personnel since the previous submission (uses new format and includes personal statement).(uses new format and includes personal statement).

NIH ResourcesNIH Resources

Forms and instructions for the electronic Forms and instructions for the electronic SF 424 (R&R) applications are available SF 424 (R&R) applications are available at at http://grants.nih.gov/grants/funding/424/ihttp://grants.nih.gov/grants/funding/424/index.htmndex.htm

Forms and instructions for paper-based Forms and instructions for paper-based PHS 398 applications are available at PHS 398 applications are available at http://grants.nih.gov/grants/funding/phs39http://grants.nih.gov/grants/funding/phs398/phs398.html8/phs398.html

More NIH ResourcesMore NIH Resources NIH Enhancing Peer Review site NIH Enhancing Peer Review site

(http://enhancing-peer-review.nih.gov/index.html(http://enhancing-peer-review.nih.gov/index.html))

Enhancing Peer Review Listserv at Enhancing Peer Review Listserv at https://list.nih.gov/archives/enhancingpeerreviewhttps://list.nih.gov/archives/enhancingpeerreview.html.html

A sample biosketch is available at A sample biosketch is available at http://grants.nih.gov/grants/funding/2590/bioskethttp://grants.nih.gov/grants/funding/2590/biosketchsample.pdfchsample.pdf

Summary of changes Summary of changes http://enhancing-peer-review.nih.gov/docs/applichttp://enhancing-peer-review.nih.gov/docs/application_changes.pdfation_changes.pdf

ORPA ResourcesORPA Resources

Recent orpa-ls Recent orpa-ls The ORPA Guide to Assembling the The ORPA Guide to Assembling the

SF424 (revisions in progress)SF424 (revisions in progress) Your ORPA RAYour ORPA RA

Happy Holidays!Happy Holidays!