Research Administration Updates July 20, 2016 11:00 am IOP Auditorium

Topics Covered VA IPA Update – John Midolo, VA Research Activity Reporting– Jennifer Hutson, MUSC GCA Recent Notices/Updates FCOI-Related Changes to the ePDS Use of Clearing Accounts/UDAKs w/Clinical Trials Reminders & Announcements

VA Updates: IPAs and Budget July 20th, 2016

Introduction Dianne Whaley, Budget Analyst Hans Meth, Budget Analyst Dianne.Whaley@va.gov Hans Meth, Budget Analyst Hans.Meth@va.gov John Midolo, MPH, Administrative Officer John.Midolo@va.gov

Initiating VA-MUSC IPA Initiating IPA - Skillset or expertise not found in the VA and/or non-US citizen and/or too vested at MUSC to hire at the VA PI contacts VA Research budget team for status of funds. VA verifies funds to employ IPA and eligibility of employee PI will work with BM to Complete IPA form: See annotated IPA. Completed IPA routed to ORSP w/ePDS ORSP reviews, approves, and signs VA reviews IPA and completes cover sheet for signature routing. Minimum lead time of 15 business days. VA Research Adjusts PI Funds ACOS > HR > Chief of Staff > Associate Director Completed IPA sent to ORSP for award activation

Canceling VA-MUSC IPA Contacts VA Dianne Whaley – Dianne.Whaley@va.gov PI Notifies VA Research budget team with 30 days notice per IPA contract MUSC VA Cancelling IPA VA Research budget team notifies ORSP of cancellation ORSP notifies MUSC BM ORSP notifies MUSC's GCA of IPA Termination Contacts VA Dianne Whaley – Dianne.Whaley@va.gov Hans Meth – Hans.Meth@va.gov MUSC ORSP – ORSP@musc.edu MUSC accounting sends final invoice to VA

Please stay tuned for updates Future Initiatives Working with ORSP to develop services contract Positions to be included, but not limited to; Project Coordinators Research Assistants Laboratory Specialist Allow us flexibility to add and remove people from studies more efficiently Improve accuracy of accounting and billing Please stay tuned for updates

Activity Reporting Jennifer Hutson Office of Grants and Contracts Accounting Activity Reporting

Activity Reporting Updates and Reminders Important dates for FY 2016 reports Due dates: July 30th All reports due no later than August 15th Most faculty should not be reporting 100% effort charged to sponsored projects If they have administrative, clinical, and teaching activities that cannot be reimbursed through most grants If an unrestricted funding source needs to be added process the PEAR through TEAMWORKS as soon as possible Contact hutsonj@musc.edu or trussell@musc.edu to reopen any submitted Activity Reports for corrections Reminder: Activity Reports and PEARs must match K awards : no adjustment required if all activities fall into the scope of the award  

Activity Reporting Updates and Reminders UMA employee paid from MUSC sponsored projects must complete Activity Reports Reports must equal 100% Reopening reports from the first 2 quarters of FY 2016 require written justification Online training course and quiz for coordinators Mandatory for new coordinators Refresher course for all coordinators

Office of Research and Sponsored Programs Notices and updates

Notices & Updates NOT-OD-16-092 Modification of ‘No-Cost Extension’ and ‘Carryover of Funds’ Policies for the NIH Pathway to Independence Award (Parent K99/R00) No-Cost Extension May be allowed to complete the K99 phase Requires NIH prior approval Carryover of Funds Carryover from K99 to R00 may be allowed Consult with the awarding Institute/Center (IC) regarding carryover NOTE: All prior approval requests need to be coordinated with ORSP.

Notices & Updates NOT-OD-16-094 Final NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research Applies to domestic awardees and domestic sites Foreign sites not expected to follow this policy Not applicable to career development, research training or fellowship awards Effective for all competitive grant applications with receipt dates on/after May 25, 2017 Effective for contract solicitations issued on/after May 25, 2017 Applications will need to include a plan for use of sIRB Will update when more information is available

Notices & Updates NOT-OD-16-109 Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research Primary Activities Protocol and Informed Consent Review Included as Indirect or F&A costs Secondary Activities Review of site-specific considerations May be charged as Direct Costs IRB will establish cost center rates with GCA

Notices & Updates NOT-OD-16-105 Revised NIH Parental Leave Policy for Ruth L. Kirschstein National Research Service Awards Applies to ALL Kirschstein-NRSA trainees and fellows Effective June 13, 2016 May receive stipends for up to 60 calendar days (8 work weeks) per year for parental leave Must provide advanced notice and follow grantee institution’s policy MUSC Sick Leave Policy MUSC Family & Medical Leave Policy

Notices & Updates NOT-OD-16-120 OMB Approval for SF424 R&R Forms Used Federal-wide Underway – Continue to Use Current Forms Until Further Notice Federal-wide (Research & Related or R&R) forms Most expired June 30, 2016 Remainder will expire September 30, 2016 Disregard expiration dates on current R&R forms

Notices & Updates Question “How to manage a leave-of-absence for a fellow or trainee?” FAQ: An unpaid leave-of-absence (e.g. >15 calendar days of sick leave, or >60 calendar days parental leave) on a fellowship requires prior approval from the awarding NIH Institute/Center (IC) Must follow institutional leave policies If approved, IC issues a revised Award to extend end date NO SPENDING from award during leave-of-absence Except for continuation of health coverage if that is the policy of the institution

Financial Conflict of Interest Individuals with FCOI Disclosure Out of Date Old Procedure COI Officer notified Individual worked with COI Officer to complete FCOI disclosure prior to proposal submission New Procedure Contact person listed on ePDS is notified Individual with out of date disclosure is notified Contact person works with individual(s) to complete FCOI disclosure prior to proposal submission

Financial Conflict of Interest ePDS System adjustment to handle new procedure Proposal Contact information will be linked to netID to facilitate email notifications Name and netID fields edited using the “Change contact person” button Phone, fax and location fields can be edited on screen Contact information defaults to person creating the ePDS

Financial Conflict of Interest First Section of Email Notification Contains GCR#: <gcrnum> PI name: <PI Name> Title: <Title> Sponsor: <Agency> Deadline Date: <Deadline> (Same for both ePDS Contact and Investigator)

Financial Conflict of Interest 2nd section of Email to ePDS Contact The following proposal has personnel with out of date disclosures: <Proposal Header information>   Name of Person(s) that must complete a conflict of interest disclosure: <list of all persons with FCOI disclosure out of date status> Please contact these individuals and assist them in getting their annual disclosure filed. It is a web based form found at the following URL: http://academicdepartments.musc.edu/coi/ Proposal applications cannot be submitted until all disclosures are filed. 

Financial Conflict of Interest 2nd Section of Email to Non-compliant Investigator You are listed as an investigator on the following proposal: <Proposal Header information>   Our records show that you have either not completed the required conflict of interest disclosure or it has been over a year since the previous one was filed. Federal regulations require any investigator (as defined by 42 CFR Part 50 Subpart F) involved in research to comply with an approved conflict of interest policy that requires annual disclosure. The disclosure is a web based form found at the following URL: http://academicdepartments.musc.edu/coi/ Proposal applications cannot be submitted until all disclosures are filed.

Financial Conflict of Interest Prepare for these Changes in FCOI Take a pro-active approach prior to proposal routing Think about new employees; notify them early on View COI reporting tool for “completion” and “non-completion” http://academicdepartments.musc.edu/coi/Reporter_Instructions/reporterinstructions.htm Federal regulations prohibit submission of non-compliant FCOI proposals

Clearing Accounts? Clearing or Suspense UDAKs/Accounts are used to manage personnel and/or specific non-personnel expenses on fixed-price Corporate Clinical Trials Established at each department’s discretion Great for legitimate study start-up costs occurring pre-award Helps with quarterly activity reporting – employees may report their activity under one Clearing UDAK versus multiple clinical projects With HR approval, Temp. Grant Employees/positions may be funded temporarily by a Clearing UDAK Clearing account balances MUST be zeroed out at the end of each fiscal year

Want a Clearing Account? To Establish a Clearing UDAK/Account, Visit: http://academicdepartments.musc.edu/vpfa/policies/grants/4-1.06.htm Please Contact “your” GCA Grants Administrator with questions: Distribution of Grants by Administrator

Reminders New minimum salary level for Executive, Administrative, and Professional workers to be exempt from overtime under the Fair Labor Standards Act (FSLA) increased $47,476/year or $913/week Effective December 1, 2016 Research Impact at MUSC – (Think Postdocs) NIH to increase awards for post-doctoral NRSA recipients NIH has not announced when or any parameters MUSC’s HR Working on a Timeline and Implementation Plan See HR Memo dated 5/18/16, Changes to Overtime Rules So more to come on this important change

Reminders Award Closeout Requirements (final reports) Departing or retiring faculty; final reports done? Students (e.g. F30 training awards) http://academicdepartments.musc.edu/research/orsp/policies_procedures/policy_extramural_award_closeout ClinicalTrials.gov Compliance is a MUST Questions/Concerns/Problems: Call ORSP All Slides are posted on ORSP Website http://academicdepartments.musc.edu/research/orsp/

Final Thoughts Any Announcements? Questions or Comments? PLEASE complete a survey & THANK YOU Next ORSP Information Session: August 17th, 2016 @ 11:00 am, IOP Auditorium