Slide 2 Slide 3 Congruency: Animal Protocol & Grant
Application NIH Notices DODs eBRAP System ORSP 3 Business Day
Deadline Discussion Whistleblower Protection Pilot Program
Reminders Slide 4 Congruency Between PHS Grant Applications and
Approved Animal Research Protocol(s) Cyndi Rosenblatt, MPA, CPIA
IACUC Program Manager Slide 5 Congruency This is not a new
requirement. In a nutshell: Does the Vertebrate Animal Section in
the grant match the approved animal protocol(s) listed as
supporting documentation? Slide 6 Regulatory Applicability All
PHS-funded research with an animal component Agency for Healthcare
Research and Quality (AHRQ) Agency for Toxic Substances and Disease
Registry (ATSDR) Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA) Health Resources and Services
Administration (HRSA) Indian Health Service (IHS) National
Institutes of Health (NIH) Substance Abuse and Mental Health
Services Administration (SAMHSA) Current Practical Applicability
All NIH grants that include a Vertebrate Animal Section Slide 7
What you need to know Side-by-side congruency reviews NEW or
transferred PHS funding Initial awards Competitive renewals JIT
received on or after January 1, 2015 ALL PHS funds awarded on or
after March 1, 2015 (regardless of when JIT received) ORSP will
notify IACUC Office of pending award and IACUC Office confirms
congruency Slide 8 What you need to know Your ORSP Grants
Administrator is there to help you Make sure you forward JIT
notices Provide all active AR#s that support the work described on
the to-be-funded grant VAS procedures described in IACUC
protocol(s) Slide 9 What you need to know VAS procedures NOT
described in IACUC protocol(s) IACUC Office will be in contact with
PI May be simple clarification May require new protocol or
amendment to current protocol MAY DELAY FUNDING Slide 10 What
doesnt change? PI doesnt have any extra steps to take this is all
done through ORSP and IACUC Office One protocol may describe
procedures from one or many grants One grant may cover procedures
in one or many protocols Slide 11 Take Home Message New way of
handling requirement thats been in place for many years No delay or
extra step on the PIs side if protocol procedures are congruent
with grant procedures May be delays if congruency cant be confirmed
Slide 12 NOT-OD-15-013 Clarifies the 4-year PostDoc research
experience limit for K99 applicant eligibility Describes situations
when time is not counted against the 4-year limit o Parental or
other well-justified leave, < 12-months family care
responsibilities disability or illness active military duty PostDoc
clinical training (no research) Additional clarifications in the
FAQsFAQs Slide 13 NOT-OD-15-014 Reminder and clarification of the
RPPR requirement for all type 5 progress reports in eRA Commons
Supersedes all references to use of the PHS 2590 for annual non-
competing continuation progress reports NIH is updating the
automated reminder e-mail template text NOT-HS-15-001 AHRQ
requiring the RPPR for all progress reports due on/after 1/1/2015
(excludes multi-year funded awards) AHRQ is standardizing the
progress report due dates o 3 months prior to award anniversary
date o No penalty from 1/1/154/1/15 if progress report is received
only 2 months prior to anniversary date Slide 14 NOT-OD-15-015 NIH
has revised the definition of Clinical Trial o A research study in
which one or more human subjects are prospectively assigned to one
or more interventions (which may include placebo or other control)
to evaluate the effects of those interventions on health-related
biomedical or behavioral outcomes Designed to make the distinction
between clinical trials and clinical research studies clearer Also,
to enhance the precision of the information NIH collects, tracks,
and reports on clinical trials No changes have been made to the NIH
definition of a Phase III clinical trial Applies to competing grant
applications and contract proposals submitted to NIH for the
1/25/15 due date and subsequent due dates Further information &
resource materials are available from the NIH Office of Science
PolicyNIH Office of Science Policy Slide 15 DOD now utilizing the
Electronic Biomedical Research Application Portal (eBRAP)
systemeBRAP Replaces DODs use of the CDMRP e-receipt system for
pre- and full applications Concept based on eRA Commons, NOT nearly
as robust Applicable User Roles PI must be affiliated with MUSC in
eBRAP Alternate Submitter designated by PI in the pre-Application,
similar to the ASST role in eRA Commons, but must also have the PI
role AOR ORSPs role Slide 16 Pre-Applications Submitted by PI in
eBRAP NOTE: MUSC is listed as South Carolina, Medical University of
can make it tricky to find Full Applications Created and submitted
using Cayuse424 Cayuse424 -> Grants.gov -> eBRAP system Slide
17 eBRAP System Notes Validation takes longer than eRA Commons
Files uploaded in Cayuse424 and transferred as one file to
Grants.gov become individual files in eBRAP System validation is
inconsistent & may indicate missing files Could be missing,
corrupted, or a system error The Fix is to delete application,
re-upload the file and re-submit the application 2 nd Tier
validation in eBRAP by PI is required to submit PI must log in to
validate application PI may replace individual files after
application deadline DOES NOT apply to the project narrative or
budget Replacing the project narrative or budget requires a
resubmission and must be done prior to the application deadline
Slide 18 April 13, 2005 MUSCs University Research Council
established the 3 business day deadline; required ALL proposals
(complete proposal package) to ORSP 3 business days prior to the
sponsors submission deadline date. Response to conversion from
paper to electronic submissions Many other institutions have
deadlines > 3 days Complete proposal package is defined as
defined as ALL required sections (e.g. budget, science, face page,
etc.) of the proposal are completed and submitted to ORSP via the
ePDS and/or Cayuse424. For ORSP to designate a submission as a
complete proposal package it must be accompanied by a fully routed
and approved ePDS. Link to ORSPs official definition of complete
proposal package
http://academicdepartments.musc.edu/research/orsp/proposal_preparation/
Slide 19 FY 14 Facts: 64% of proposals did not meet 3 day deadline
~30% of these were NIH 14% NEW 10% NON-COMPETING 4% RESUBMISSIONS
1% COMPETING CONTINUATIONS ~34% of these were Other (non-NIH) 27%
NEW 4% NON-COMPETING 2% RESUBMISSIONS 1% COMPETING CONTINUATIONS
Slide 20 Benefits of Meeting Deadline More thorough ORSP review
Average years of experience in grants administration 19.6 years
(non-corporate) 14.5 years (corporate) The more eyes the better
Surprises can be managed Conflict of Interest compliance (e.g. out
of date disclosure) Time can fix fatal errors; No time = No fix =
No $ Electronic systems can get overwhelmed close to submission
deadlines, so dont take the risk! Slide 21 Same MUSC TEAM, so how
can we improve? Any suggestions? How can ORSP help? More proactive
approach in proposal planning Departmental/unit deadlines? Impose
hard stops? Only takes one What is reasonable? FY 15 data identical
to FY 14, no improvement noted Need buy-in from the entire MUSC
research community for improvement to occur. Slide 22 What: Federal
pilot program that requires all grantees, their subgrantees and
subcontractors to: Inform their employees working on any federal
award they are subject to whistleblower rights and remedies of the
pilot program Inform their employees in writing of employee
whistleblower protections under 41 U.S.C. 4712 in the predominant
native language of the workforce Include such requirements in any
agreement made with subcontractor or subgrantee Slide 23 Who:
Applies to all employees working for contractors, grantees,
subcontractors and subgrantees on federal grants and contracts
When: Went into effect on 7/1/13 and runs through January 1, 2017
How: ORSP to notify via e-mail all those identified as having
worked on a federally sponsored project since 7/1/13 The plan is
twice per year (December and June) Slide 24 Provisions under 41
U.S.C 4712 An employee of a contractor, subcontractor, grantee (or
subgrantee) may not be discharged, demoted, or otherwise
discriminated against as a reprisal for whistleblowing. The
whistleblower protections cannot be waived by any agreement,
policy, form or condition of employment. Slide 25 Provisions under
41 U.S.C 4712 Whistleblowing is defined as making a disclosure that
the employee reasonably believes is evidence of any of the
following: Gross mismanagement of a federal contract or grant A
gross waste of federal funds An abuse of authority relating to a
federal contract or grant A substantial and specific danger to
public health or safety A violation of law, rule, or regulation
related to a federal contract or grant (including the competition
for, or negotiation of, a contract or grant) Slide 26 Provisions
under 41 U.S.C 4712 To qualify under the statute, the employees
disclosure must be made to: A Member of Congress, or a
representative of a Congressional committee An Inspector General
The Government Accountability Office A federal employee responsible
for contract or grant oversight or management at the relevant
agency An official from the Department of Justice, or other law
enforcement agency A court or grand jury A management official or
other employee of the contractor, subcontractor, grantee, or
subgrantee who has the responsibility to investigate, discover, or
address misconduct. Slide 27 Modular Budget Concern Raised to ORSP
Lets NOT short ourselves Test the modular budget by plugging in
details ORSP can provide assistance, call us! First timers may need
more attention Those that have had budget issues in the past MUST
prepare and submit budgets that cover the costs of the project
proposed.
