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Congruency: Animal Protocol & Grant Application NIH Notices DOD’s eBRAP System ORSP 3 Business Day Deadline Discussion Whistleblower Protection Pilot.

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Presentation on theme: "Congruency: Animal Protocol & Grant Application NIH Notices DOD’s eBRAP System ORSP 3 Business Day Deadline Discussion Whistleblower Protection Pilot."— Presentation transcript:

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3 Congruency: Animal Protocol & Grant Application NIH Notices DOD’s eBRAP System ORSP 3 Business Day Deadline Discussion Whistleblower Protection Pilot Program Reminders

4 Congruency Between PHS Grant Applications and Approved Animal Research Protocol(s) Cyndi Rosenblatt, MPA, CPIA IACUC Program Manager

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?

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

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

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)

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

10 What doesn’t change? – PI doesn’t 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

11 Take Home Message – New way of handling requirement that’s been in place for many years – No delay or extra step on the PI’s side if protocol procedures are congruent with grant procedures – May be delays if congruency can’t be confirmed

12 NOT-OD 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

13 NOT-OD 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 template text NOT-HS 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 1/1/15—4/1/15 if progress report is received only 2 months prior to anniversary date

14 NOT-OD 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

15 DOD now utilizing the Electronic Biomedical Research Application Portal (eBRAP) systemeBRAP – Replaces DOD’s 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 – ORSP’s role

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

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

18 April 13, 2005 MUSC’s University Research Council established the 3 business day deadline; required ALL proposals (complete proposal package) to ORSP 3 business days prior to the sponsor’s 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 ORSP’s official definition of “complete proposal package”

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

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 don’t take the risk!

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.

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 in the predominant native language of the workforce Include such requirements in any agreement made with subcontractor or subgrantee

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 all those identified as having worked on a federally sponsored project since 7/1/13 – The plan is twice per year (December and June)

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.

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)

26 Provisions under 41 U.S.C 4712 – To qualify under the statute, the employee’s 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.

27 Modular Budget Concern Raised to ORSP – Let’s 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.


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