Agenda ORS Updates: ORS Staffing Update Training and Development Update Document Management Project Update PHS Public Access Policy Keith Hurka-Owen NSF FastLane Changes Susan Lasley FCOI Policy Updates Brian Lowinger Office of Sponsored Programs Updates Nate Martinez-Wayman
ORS Staffing Update Newest Hires (Fully Staffed 12/10/12) Shonta Holloway, Awards and Compliance Specialist Newest Departure (Last day 02/28/13) Donna Senator New Portfolio Assignments
Training and Development Update Entry Level Workshops Aimed at new staff or staff new to grants administration. Target staff who want to but couldnt get in to RAA. Three to Four Part Series Grants, Contracts and Compliance 101 Roles and Responsibilities Proposal Submission Process Grants, Contracts and Compliance 102 How to Build a Budget Grants, Contracts and Compliance 103 The Awards Process
Document Management Project Automating Four Key Grant Management Processes CAS/RebudgetingUnder development Notice of Grant Award--First planning meeting WBSE set-up Award Closeout
Document Management Project Team Structure Working Group Steering Committee Dept. Advisory Group RACI Working Group: meeting every other week. Reports to Steering Committee. Departmental Advisory Group: Reviews and advises the Working Group. Steering Committee: Reports to RACI. Resolves issues around process and policy.
Document Management Project Debbi NixonADG (Technical Project Lead - NOA) Amy BarbeeORA (Functional Project Lead - NOA) Heather QuadlinOSP (Functional Project Lead - FCS) Beth SizemoreASM (Technical Lead - FCS) Michele GrowORS Renee Puryear Jennifer Barrows Biology (Campus Rep) Windy BattenPsychiatry (SOM Rep) Notice of Award and Fund Code Set up Working Group
Document Management Project Departmental Advisory Group Debbie NixonNOA Lead Beth Sizemore FCS Technical Lead Amy BarbeeNOA Lead Heather Quadlin FCS Functional Lead Mary Robyn TudorSSRI Cherie LahtiDHVI Will SmithDept. of Medicine / Cell Therapy Sharon ShulzePratt Beth SizemoreASM Patricia Terrell Economics Esther DemarcoMGM Tasha Owens (Working Group for FCS)Center (DCRI)
Document Management Project Steering Committee Jim Luther Todd Or Paula Morrison John Michnowicz Chris Tobias Keith Hurka-Owen Nate Martinez-Wayman
Document Management Project RACI: http://finance.duke.edu/raci/ Tim Walsh, Chair and Vice President for Finance Kyle Cavanaugh, Vice President for Administration Scott Gibson, Executive Vice Dean for Administration Sally Kornbluth, Vice Dean for Basic Science Jim Roberts, Executive Vice Provost for Finance and Administration Jim Siedow, Vice Provost for Research
NIH Public Access Policy The NIH Public Access Policy applies to all peer- reviewed articles that arise, in whole or in part, from direct costs funded by NIH, or from NIH staff, that are accepted for publication on or after April 7, 2008. Institutions and investigators are responsible for ensuring that any publishing or copyright agreements concerning submitted articles fully comply with this Policy.
NIH Public Access Policy PubMed Central (PMC) is the NIH digital archive of full-text, peer-reviewed journal articles. Its content is publicly accessible and integrated with other databases (see: http://www.pubmedcentral.nih.gov/).http://www.pubmedcentral.nih.gov/ The final, peer-reviewed manuscript includes all graphics and supplemental materials that are associated with the article.
NIH Public Access Policy How do my publications submitted to PubMed?
Beginning March 18th FastLane will begin checking for all GPG required sections of proposals.
l Project Summary * Project Description References Cited Biographical Sketch(es) Budget Budget Justification Current and Pending Support Facilities, Equipment & Other Resources Supplementary Documentation -- Data Management Plan * -- Postdoctoral Mentoring Plan (where applicable) * * These proposal sections are already being auto- compliance checked. GPG Required Sections of the Proposals
Separately Submitted Collaborative Proposals Lead Organization: Project Summary Project Description References Cited Biographical Sketch(es) Budget Budget Justification Current and Pending Support Facilities, Equipment and Other Resources Supplementary Documentation – Data Management Plan – Postdoctoral Mentoring Plan (if applicable) Non-Lead Organization: Required Sections Biographical Sketch(es) Budget Budget Justification Current and Pending Support Facilities, Equipment and Other Resources
What FastLane Will / Will Not Check FastLane will check for the presence of GPG required sections of the proposal. If a section is not included, FastLane will not permit submission of the proposal. Biosketches: one file or many? FastLane will not check: Formatting Page Length (except for Project Summary) Content
Solicitation Deviations Some solicitation deviate from the standard GPG instructions. Conferences, workshops, symposia. International travel grants. Not Applicable must be Entered in the text field, or Uploaded in a document.
COMPLYING WITH THE U.S. PHS FINANCIAL CONFLICTS OF INTEREST REGULATIONS Brian Lowinger, J.D. Asst. Director of Compliance and Contracts Office of Research Support 919.681-8540 Brian.firstname.lastname@example.org
What You Need to Know 1. A secondary interest can impact a primary interest, and therefore cause a financial conflict of interest 2. Duke policy and federal regulations require compliance 3. For PHS funded research, each investigator (anyone responsible for the design, conduct, or reporting of research), including a collaborator or consultant, must submit a conflict of interest disclosure form The information that must be disclosed includes non- Duke employment and income, equity, intellectual property rights, fiduciary responsibilities, and more Report sponsored travel if it meets specific criteria 4. Use SPS to make anyone an investigator
Organizations that Require Compliance with the U.S. PHS Financial Conflict of Interest Regulations U.S. Public Health Service includes the following components: National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA) Substance Abuse and Mental Health Services Administration (SAMHSA) Office of the Assistant Secretary for Preparedness and Response (ASPR) Office of Global Affairs (OGA) Agency for Toxic Substances and Disease Registry (ATSDR) Health Resources and Services Admin. (HRSA) Indian Health Service (IHS) Agency for Healthcare Research and Quality (AHRQ) Office of the Assistant Secretary for Health Other Agencies/Entities that Reportedly Have Adopted the PHS FCOI Rule Administration on Aging (AoA) Administration for Children and Families (ACF) Alliance for Lupus Research (ALR) American Cancer Society (ACS) American Heart Association (AHA) Arthritis Foundation (AF) California Breast Cancer Research Program (CBCRP) California HIV/AIDS Research Program (CHRP) Juvenile Diabetes Research Foundation (JDRF) Lupus Foundation of America (LFA) Susan G. Komen for the Cure
What Must Be Disclosed Each individual/investigator required to provide a disclosure form must include all significant financial interests of >$5,000 for him/herself and his/her immediate family Significant Financial Interest means receiving anything of monetary value, including: a. Payments for services (consulting, lectures, advisory board payments, or honoraria); b. Equity interests: stocks, stock options, or other ownership interests. $5,000 threshold is not applicable for equity in privately held entity. Exclusion for Phase I – SBIR/STTR; c.Intellectual property rights (royalties not paid through Duke – N/A but still disclosed); and d.Gifts, gratuities, or donations. The term does not include: a.Salary or other payment from Duke; b. Investments whose stock purchases you cannot control: mutual funds/retirement accounts; c. Income from seminars, lectures, or teaching engagements sponsored by…..or income from service on an advisory committee or review panel for the following: a public agency or a nonprofit entity, academic teaching hospital, institution of higher education, or research institute affiliated with an institution of higher education; d. Payments made to Duke by outside organizations; and e. Private Diagnostic Clinic distributions.
PHS FCOI SPONSORED TRAVEL REPORTING General Requirement Investigators are required to disclose certain information about sponsored or reimbursed travel taken on or after August 24, 2012 Reporting Is Required If: The investigator is paid for research that is sponsored/funded by the PHS The travel is reimbursed or sponsored by some external entity (see exceptions) The travel is related to institutional responsibilities to Duke (e.g. being sponsored to speak about your research) Reporting Is Not Required If Travel Is Sponsored By: An institution of higher education (as defined in 20 U.S.C. § 1001(a)) A federal, state or local government agency An academic teaching hospital A medical center, or A research institute that is affiliated with an institution of higher education Using the Duke Travel Web Site You Must Report: The identity of the sponsor (report the primary sponsor rather than the intermediary) The purpose of the trip (speaking, consulting, meetings, etc.) The destination for the trip, and The duration of the travel, specifically the date you left and the date you returned
TRAVEL FAQs Nature of ArrangementMust Disclose? Travel paid for by industry (directly paid to the individual, not through Duke) Yes Travel paid for by a non-profit foundationYes Travel paid for by a professional society (e.g. American Cancer Society)Yes Travel for work related to a company-sponsored contract with DukeNo (if paid through Duke) Travel to an academic medical center paid for by that centerNo Travel to a university paid for by the university to give a lectureNo Travel to a board meeting in another state paid for by a private foundationYes Travel to a research meeting paid for with Duke department fundsNo Travel to an advisory board meeting for a nonprofit for which you are reimbursed by the nonprofit Yes Travel paid for by the American Cancer Society to an academic meeting to present NIH grant-funded research Yes Travel to another university to give a seminar where the university reimburses you, but the university received funding for the seminar from a private company No, if the reimbursement came from Duke Travel that combines a trip to an advisory board paid for by the company and a family vacation for which you paying for myself Pay for personal trip separately and disclose the duration of the business portion of the trip)
Reporting Deadlines Annually: Submit an updated disclosure form at least annually. The annual notice was sent on March 5, 2013. At Time of Application: Each PI, key personnel, investigator, and subrecipient, if applicable, planning to participate in PHS (e.g. NIH) funded research must have completed a disclosure form Within 30 Days of a Change: Submit an updated disclosure form within 10 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a reportable significant financial interest
Important Links Duke faculty and students, submit FCOI and sponsored travel information at https://adgapps.duhs.duke.edu/coi_form https://adgapps.duhs.duke.edu/sb Subrecipients report the information using the forms at https://ors.duke.edu/gcc-forms. Use Form A at initial planning and Form B at application or later on in process https://ors.duke.edu/gcc-forms Consultants and other vendors use the Outside Services Agreement found on the Office of Procurements web site: http://finance.duke.edu/procurement/forms/index.php#OSA http://finance.duke.edu/procurement/forms/index.php#OSA