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October 21, 2014Research Administrators Workgroup Agenda Announcements / Updates Pre-award updates (Chanda Robe) Changes in eCOI process (OII: Kim Lincoln, Juliane Blyth, Emily Sobiecki) InfoEd Update (PHS RM: Katie McGroggan) Q & A – All 2 Announcements/Updates Research Town Meeting 4 Strategic Problem Solving Meeting coming up! We received very helpful feedback and will get together to discuss problem solving, sharing best practices as well as SharePoint resources 5 Announcements New Post Award Administrator Thao Phan Starting10/27 6 Controlled Substances DEA Researcher Registration holders at area hospitals have recently been inspected by the DEA, with little advanced notice. If the DEA alerts you that an agent will be coming notify the McLean Compliance Officer, Jennifer Mahoney ASAP at 617-855-2598. To be sure that Research Administration and Compliance have the appropriate documentation in the event of a DEA or MA DPH site visit, planned or otherwise, it’s important that we have three items on file for those of you who have controlled substances (CS)* physically present in their lab / research area, and we must have these items by 10/31/2014. 7 Controlled Substances- continued 1. Current copy of your DEA Registration (DEA Form 223) 2. Current copy of your MA Controlled Substance Registration Certificate 3. Inventory of ALL controlled substances (in date and expired) in your lab / research area; such Physical inventory to be performed on 10/31/2014 – use attached biennial inventory form Please send copies of your DEA and MA CS Registrations, as well as your CS inventory to: Renee Brathwaite, [email protected] 8 Pre-Award Updates Chanda Robe, Pre-Award Grant Administrator October, 21, 2014 Pre-Award Updates • October Grant Deadlines • 22 Grant Submissions- 10/5/2012- 10/17/2014 • NARSADs 10/26/2014- 6 pending • Errors in NIH SF424 Applications • No Review Vs. Expedited Review • NIH Continuous Submission • Internally, setting a hard deadline to replace the upcoming deadline. More helpful to manage the workload on both ends. 10 Pre-Award Updates Training Sessions • What we have done already? • Sponsored by the CAO Office • Proposal Preparation and InfoEd PD 101- offered on 4/23/2014 • Management Workshop Series Budget Building & Financial Oversight- offered on 9/9/2014 • Departmental and Individual training as requested 11 Pre-Award Updates • What other trainings would you like to see? • Subcontracts • Completing an SF424 package • Please let us know! 12 Changes to eCOI Process Office for Interactions with Industry September, 2014 7/7/2015 - #774222v3 13 IMPORTANT • Federal COI regulations require that • Each Investigator who is planning to participate in the PHS-funded research disclose to the Institution’s designated official(s) the Investigator’s significant financial interest (SFI) (and those of the Investigator’s spouse and dependent children) no later than at the time of application for PHS-funded research. • The institution review disclosures of significant financial interests (SFIs) from each Investigator to determine whether an Investigator’s significant financial interest (SFI) is related to PHS-funded research and, if so related, whether the SFI is a financial conflict of interest (FCOI). 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 14 IMPORTANT • Who is an Investigator? • Investigator = project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS (“DCR”), which may include, for example, collaborators or consultants. • “DCR” designation is not a new concept • “DCR” designation is first step in COI review process • “DCRs” should be designated by PI or in consultation with PI 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 15 CHANGES • Ability to clearly identify investigators (= people responsible for the design, conduct or reporting of research = “DCR”) separate from the “Key”/”OSC”/”Non-Key” designation in InfoEd • New screens in InfoEd PD and PT and Insight Agreements for viewing and maintaining DCR flag throughout the grant life cycle • Automatically identify any DCR added through payroll after the proposal is activated • Only DCR = Yes will go through the COI process (current process automatically enrolls Key & OSCs in COI process) • Streamline the eCOI process to require additional relatedness questions only after proposal is funded (not at proposal submission). Reduces burden on investigators at proposal. 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 16 Proposal Submission – DCR designation • New DCR screen – lists personnel from Budget page • All investigators who are DCRs on the project must be listed on DCR page and therefore must be listed on the Budget page, even if they have 0% effort and $0 cost • Default DCR settings by Personnel Type o PI defaults to DCR=YES and cannot be changed. o Key personnel defaults to DCR = YES and can be changed. o Non-key personnel & Other Significant Contributor default to blank and need to be set to YES/NO. • The DCR page must be completed before submitting the proposal to final routing 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 17 Sample Screen - PD DCR designation box 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 18 Proposal Submission: eCOI Form • eCOI form only for people with DCR = YES, no longer all Key and OSC personnel. • At proposal submission, the DCRs are only required to update Significant Financial Interests (SFIs) and certify that SFI information is correct. This first step in the eCOI process is called “Financial Interest Certification.” • Investigators do not need to complete additional questions about how their interests relate to the project. This second step will be required only if the project receives or is likely to receive funding. Office for Interactions with Industry | 617-643-7752 | [email protected] 19 Post Submission – DCR Designation • DCR’s in PD imported to new screen in PT to view and maintain DCR flag after proposal submission • At JIT Pending DA/PI (or Agmt In Unexec. Agmt Rec’d): o Email sent to PI to confirm DCRs on the proposal. No action required if DCR listing in email is correct (DA’s cc’d on email) 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 20 Sample Screen - PT • Ongoing maintenance of DCRs takes place in PT DCR designation box 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 21 Post Submission – eCOI form • At JIT- Submitted to Sponsor: o Email sent to the DCRs to complete step 2 of the eCOI process: to verify interests and answer “Relatedness questions” for each reported interest. This step is called the “eCOI form.” o Forms automatically go to OII to complete COI review. 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 22 After Fund Activation • After fund activation: • Maintain DCR designation after fund activation in PT (e.g., add personnel, change DCR designation if roles/responsibilities change) • Anyone added or changed to DCR=YES will receive eCOI form and notice to complete COI training course. • Individuals with a professional job code who are added to the fund through payroll will be added to PT with DCR designation defaulted to Yes and will receive eCOI form and notice to complete COI training course. • Quarterly and Annual emails notify PI’s of DCR’s. No action required if DCR listing in emails is correct. (Dept Admins cc’d). 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 23 Sample Screen - Insight Insight screen is view only (in Agreements module) • Shows DCR designation • Shows COI Training Status • Changes made to InfoEd DCR designation page feed over 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 24 COI Process - Unchanged • Process for non-Partners investigators (i.e. collect paper form) • COI review outcomes recorded in COI Deliverables in InfoEd record and note is placed in Activity Log • PHS-funded research: cannot spend any funds until COI review is completed • Foundation funded research: can activate fund prior to completion of COI review Office for Interactions with Industry | 617-643-7752 | [email protected] 25 Timeline & Contacts • Go live: October 17, 2014 • Small group training sessions (no need to RSVP) BWH 10/3: 11a-12noon – BWH Medical Records Conf Room (Pike L1, near Nesson Elevators) 10/16: 9:00a - 10:00a - BWH Medical Records Conf Room 10/20: 3:00p – 4:00p - BWH Medical Records Conf Room MGH 10/6: 10:00a – 11:00a - MGH Yawkey 4-810 10/8: 2:00p – 3:00p - MGH Yawkey 4-810 10/27: 10a - 11a - MGH Yawkey 4-810 10/29: 3:00p – 4:00p - MGH CNY 149 Conf A • Urgent review requests/fund activation deadlines: email OII ([email protected]) • Unsure? Need help? OII contacts: Jules Blyth (643-7836); Kim Lincoln (6438605); Emily Sobiecki (724-8091) • OII Intranet: http://pulse.partners.org/OII/index.html 7/7/2015 Office for Interactions with Industry | 617-643-7752 | [email protected] 26 InfoEd Update McLean DRAW Meeting October 21, 2014 27 Agenda PD Usability Project Overview Usability Improvement Areas Deliverables Why they are used Types Workflow process Resources Questions 28 PD Usability - Overview Worked with members of the InfoEd Subcommittee and reviewed feedback from end users to determine usability items Identify ways to improve the use of InfoEd PD for our end users. Covers instructional text updates, the coversheet, hiding/showing fields and general cleanup. Will not include improvements to the budget section of PD unless they are general updates. Any items determined to be budget related will be done in another project 29 PD Usability - Improvement Areas Setup Questions Upload Docs/DRAFT Routing Coversheet & PIQ Form Submit to Final Routing Routing General Site/PD Improvements 30 PD Usability - Initial Setup Questions • Expand proposal title length 31 PD Usability - Additional Setup Questions 32 PD Usability - Additional Setup Questions 33 PD Usability - Upload Docs/Draft Routing 34 PD Usability - Coversheet & PIQ Form 35 PD Usability - Submit to Final Routing Bring users directly to the “Submit for Internal Review” subtab on the page vs. them having to click to open it. 36 PD Usability - Routing Improve instructional text to cut down on confusion when proposals are rejected or approved Multi-PI signoff through the use of an additional role in budgeting 37 PD Usability - General Site Improvements Indicate Read-Only vs. Edit view Add a progress bar for every save in PD Resources section in the navigation to house manuals, RAS link, etc Expand mailbox view to include the full subject line 38 Deliverables 39 Deliverables – why are they used? 1. Increases transparency 2. Eases administrative burden 3. Decreases e-mail traffic 4. Consolidates pending work lists 5. Improves turnaround times 6. Streamlines processes across RM 40 Deliverables - Types Pre Award Post Award Just in Time Progress Report Conflict of Interest Research Finance Final Invoice- Outgoing Financial Report FSR Revision Relinquishing Statement Subcontract Invoice Departments Everything! (Depending on award mechanism) Advance Account Agreement In Agreement In- Modification Award Renewal/Revision Carryforward DUA In DUA Out GWAS In Invention Report Notice of Award RSA In RSA Out Subcontract Agreement Out Subcontract Agreement Out- Modification Subcontract PSA Out Subcontract PSA Out- Modification 41 Deliverables – Workflow Process Allows RM to send notifications on deliverables processes needing review/signoff to PIs and other support staff while maintaining a history and allowing for reminders 2 types of workflow: Alert Signoff Required 42 Resources Manuals: https://partnershealthcare.sharepoint.com/sites/phr mdepartments/prd/rag Help Desk: [email protected] 43 Questions? 44 QUESTIONS? Contact: Raquel Espinosa [email protected] 617-855-2868 45