Dhanonjoy C. Saha, DVM, PhD
Director, Office of Grant Support
(OGS)
December 16 and 17, 2015
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Who we are?
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What do we do?
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What are our roles and responsibilities?
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What are the recent changes?
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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
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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
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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
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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
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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
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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
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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
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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/gran
t-support/
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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
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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
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Still using the existing Form C
Additional requirements in research strategy
Rigor and Transparency – key areas:
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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
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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:
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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 (NOTOD-16-012)
Instructions 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
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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)
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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
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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
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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
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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
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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
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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
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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
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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
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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 IACUCapproved vertebrate animal research
xTRACT electronic system for creating research
training data tables was created and will be
available
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A new Form FORM-D will be required
Rigor and Transparency
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Vertebrate Animals
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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
Institutional training and individual fellowship applications
will be included
New questions regarding euthanasia will replace the current
Inclusion Forms
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A new optional form will be added—details to come
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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
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Data Safety Monitoring Plans:
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Research Training:
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New Data Safety Monitoring Plan will be required (Form
D) with applications involving clinical trials
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:
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Will allow collection of requests for preference of
awarding component, study section, potential reviewers
in conflict and scientific expertise needed
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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
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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-peerreviewed) and research products can be cited
in both the personal statement and the
contributions to science sections
Graphics, figures and tables are not allowed
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An optional PHS Assignment Request Form to FORMD 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
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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:
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Arial
Garamond
Georgia
Helvetica
Palatino Linotype
Times New Roman
Verdana
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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.
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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) 4303642 or dhanonjoy.saha@einstein.yu.edu