Upcoming Changes in NIH Policies and Procedures in Grant

Application

Dhanonjoy C. Saha, DVM, PhDDirector, Office of Grant Support

(OGS)

December 16 and 17, 2015

Introduction

Who we are? What do we do?

What are our roles and responsibilities?

What are the recent changes?

What is Office of Grant Support?

The Office of Grant Support (OGS) is comprised of only three individuals who provide pre-award administrative assistance to the College community

Our goal is to enable faculty scholars to

submit grant proposals and to manage subsequent non-financial responsibilities of the award, resubmission, and renewal processes

What Do We Do?

Help develop or review proposal budgets Review and ensure pre-submission regulatory

requirements Help with creating and managing electronic

grant submissions Assist with required registrations for

submissions Help with submissions of grant proposals to

granting agencies or sponsors Negotiate budgets and other related terms and

conditions of the awards with the sponsors

What Do We Do? …

Manage Awards Committee nominations (for limited submissions)

Help with submission of non-competing applications, Just-in-Time, Supplemental Materials, RPPR and ….

Assist with communications or communicate with grant-making agencies

Help with preparing and submitting Final Invention Statements

Help with finding resources for improving grant applications

eRA Manager AOR (Authorized Organizational Representative),

SO (Signing Official) Application assembly and submission Application withdrawal request Cayuse System primary contact – User ID,

password, application unlock eRA Commons issues related to submission eRA Commons back up for Cynthia Cardillo –

User ID, password Final Invention Statement Grants.gov account and related issue

eRA Manager… Just-in-time submission Limited submission application management Post-submission material and communication No Cost Extension NYS Grants Gateway User ID Compliance communication with sponsors (IRB,

IACUC, IBC) OPAS submission Other (all Federal) electronic submission portal

User ID, password and task

Pre-award Analyst AOR, SO Budget development, review and budget revisions (pre-

award only) Budget review for No Cost Extension Collaboration letter review and preparation for signature Face page review and processing for signature Indirect cost reduction/waiver, no salary support request

processing Letter of Intent (LOI) and Statement of Work (SOW)

review and processing Other (all non-federal including NYS Grants Gateway)

electronic submission portal User ID, password and submission

RPPR (Research Performance Progress Report) review and submission via eRA Commons

Director AOR, SO, Business Official Agreement and contract negotiation with

sponsor Funding Opportunities Grant Development NYS Grants Gateway submission and approval Any other tasks and items related to pre-award

application management

What Can We Do?

Find funding opportunities -- small or large grants -- state, federal, private, foundation

Target dissemination of funding opportunities to interested trainees and faculty members

Interpret proposal guidelines and help with building application materials-- eligibility, forms, institutional data

Grantsmanship: assist with team-building, writing, editing, proofreading, proposal review and critique and creating more competitive proposals

Visit us at - http://www.einstein.yu.edu/administration/grant-support/

Upcoming Changes in NIH SubmissionNOT-OD-16-004; NOT-OD-16-011

Administrative and Scientific Two Phases of Implementation

Rigor and transparency in research Vertebrate animals Inclusion reporting Data safety monitoring Research training Appendices Font requirements Bio-sketch clarifications

Implementations and Deadlines

Using existing (FORM-C) forms and updated instructions and will impact due dates on or after January 25, 2016

New form (FORM-D) and instructions and will impact due dates on or after May 25, 2016

Phase I - January 25, 2016

Still using the existing Form C Additional requirements in research strategy Rigor and Transparency – key areas:

The scientific premise of the research Rigorous experimental design for unbiased results Consideration of relevant biological variables Authentication of Key Biological and or Chemical

Resources Additional rigor and transparency questions will

be considered by reviewers Authentication of Key Biological and or Chemical

Resources PDF attachment need to be uploaded

Rigor and TransparencyNOT-OD-16-011

The four areas of focus shall apply to the full spectrum of research, from basic to clinical -- need to consider how all four areas apply to the proposed research

Reviewers will assess whether these areas have been appropriately addressed by the applicant

Exceptions: Research grant activity codes excluded from this policy

include C06, G08, G11, G12, G13, G20, R13, S06, S10, S21, SB1, U13, U55, UB1, UC6, UC7, UG4, UH4, X02, and 333.

RRRGs or components (P30, P40, P41, P2C, R24, R28, U24, U41, U42,U2C) may have slightly revised review language

Career Development Award application instructions and review language – implementation date, May 25, 2016 (NOT-OD-16-012)

Research StrategyInstructions will be updated to include the following additional guidance for the Significance and Approach sections of the Research Strategy Significance: Description of the scientific premise for the

proposed project, including consideration of the strengths and weaknesses of published research or preliminary data

Approach: Description of the experimental design and methods proposed and how they will achieve robust and unbiased results

Explanation of how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans For example, strong justification from the scientific literature, preliminary

data, or other relevant considerations, must be provided for applications proposing to study only one sex (see NOT-OD-15-102 for NIH expectations about sex as a biological variable)

Scientific Premise and Scientific Rigor The scientific premise: The general strengths and

weaknesses of the prior research cited by the applicant, which form the basis for the proposed research -- expected that this would include attention to the rigor of the previous experimental designs, as well as the incorporation of relevant biological variables and authentication of key resources

The scientific premise will be reviewed as part of the Significance criterion, i.e., the importance of the problem, critical barriers to progress, how the proposed project will improve scientific knowledge, and how the field will change if the aims are achieved

Scientific Premise and Scientific Rigor… Scientific rigor: Strict application of the

scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results -- full transparency would help reproducibility of the findings

Robust and Unbiased: Using methods to reduce bias -- such as having multiple individuals recording assessments, using independent, blinded assessors, etc. These are goals, not absolute standards to be met, and may vary across scientific disciplines

Authentication of Key Biological and/or Chemical Resources

Briefly describe methods to ensure the identity and validity of key biological and/or chemical used/proposed in the studies. These may or may not be generated with NIH funds

These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics

Use the FORM-C forms. PDF and upload document (titled "Authentication of Key Resources Plan") in the "Other Attachments" section of the "Other Project Information" form

Application Review

Reviewers will be asked to consider additional review questions in order to assess rigor and transparency

Scored Review Criteria Significance: Is there a strong scientific premise for the

project? Approach:

Have the investigators presented strategies to ensure a robust and unbiased approach? 

Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

Additional Review Considerations Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources

Vertebrate Animals

Updated guidance on criteria to be addressed including justifications, minimization of pain and distress and euthanasia

Description of veterinary care and justification of the number of animals will no longer be required

A description of the method of euthanasia is required only if the method is not consistent with AVMA guidelines

Vertebrate Animals Application Review Criteria

As applicable for the project proposed, reviewers will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of procedures involving animals including

species, strains, ages, sex and total number to be used; (2) justifications for the use of animals versus alternative

models and for the appropriateness of the species proposed;

(3) interventions to minimize discomfort, distress, pain and injury; and

(4) justification for the euthanasia method if not consistent with the AVMA Guidelines for the Euthanasia of Animals

Definition of Child

Will now mean under 18 years old rather than under 21

Must include a plan of how children will be used in human subject research or why not if they won’t be used

Research Training

Recruitment and retention to increase diversity—emphasis will be recruitment 

Human subjects—explanation needed that trainees will only participate in IRB-approved or exempt research

Vertebrate animals -- description needed that trainees will only participate in IACUC-approved vertebrate animal research

xTRACT electronic system for creating research training data tables was created and will be available

Phase 2 - May 25, 2016 A new Form FORM-D will be required Rigor and Transparency

Institutional training and individual fellowship applications will be included

The PHS 398 Research Plan form will include a new "Authentication of Key Biological and/or Chemical Resources" attachment field

Vertebrate Animals Institutional training and individual fellowship applications

will be included New questions regarding euthanasia will replace the current

Inclusion Forms A new optional form will be added—details to come

Inclusion Form

An optional PHS Inclusion Enrollment Report form to FORM-D will be added to the application packages

The new form, with additional study descriptors, will replace the optional Planned Enrollment Report and Cumulative Inclusion Enrollment Report forms found in FORM-C application packages

Details are upcoming

Phase 2 - May 25, 2016… Data Safety Monitoring Plans:

New Data Safety Monitoring Plan will be required (Form D) with applications involving clinical trials

  Research Training:

Research training data table will reduce tables to 8 and extend trainee outcome tracking from ten years to fifteen

  New optional PHS assignment request form:

Will allow collection of requests for preference of awarding component, study section, potential reviewers in conflict and scientific expertise needed

New Font guidelines Font must be 11 points or larger Type density must be no more than 15

characters per linear inch (including characters and spaces)

Line spacing must be no more than six lines per vertical inch

Recommended fonts are: Arial, Garamond, Georgia, Helvetica, Palatino Linotype, Times New Roman, and Verdana

Bio-sketch A URL for a publication list is optional and,

if provided, must be to a government website (.gov) like My Bibliography

Publications (peer-reviewed and non-peer-reviewed) and research products can be cited in both the personal statement and the contributions to science sections

Graphics, figures and tables are not allowed

New PHS Assignment Request FormNOT-OD-16-008

  An optional PHS Assignment Request Form to

FORM-D application packages to provide a consistent way to collect application referral information, including:

Awarding component (NIH Institute) assignment preference

Study Section preference List of potential reviewers in conflict, and why List of scientific expertise needed to review the

application

Font Size, Type Density and Spacing Font size:  must be 11 points or larger (smaller text in

figures, graphs, diagrams and charts is acceptable as long as it is legible when the page is viewed at 100%)

Type density:  must be no more than 15 characters per linear inch (including characters and spaces)

Line spacing: must be no more than six lines per vertical inch

The following fonts are recommended: Arial Garamond Georgia Helvetica Palatino Linotype Times New Roman Verdana

Research Performance Progress Reports

  Research Performance Progress Reports

(RPPR) submitted January 25, 2016 or later will be expected to emphasize rigorous approaches taken to ensure robust and unbiased results. Rigor should be addressed in the RPPR for any grant that funds research or training in research. 

This includes non-competing continuation reports (Type 5) for grants reviewed and awarded before implementation of the policy.

Thank You

For general information, please contact the Office of Grant Support at (718) 430-3643 or preaward@einstein.yu.edu

For pre-award budget -- Gerard McMorrow at (718) 430-3580 or gerard.mcmorrow@einstein.yu.edu

For Cayuse, eRA Commons and any other help -- Regina Janicki at (718) 430-3643 or Regina.janicki@einstein.yu.edu

For any other help -- D. C. Saha at (718) 430-3642 or dhanonjoy.saha@einstein.yu.edu

Any Questions?