Research Administration Updates March 15, 2017 11:00 am IOP Auditorium

Topics Covered IRB Fee Changes – Stacey Goretzka, IRB Manager & Dr. Aimee Mcrae-Clark, Director, Office of Research Integrity New VA/MUSC Master Contract for Personnel Services – ORSP Revised Budget Worksheet Tool – ORSP Recent Notices, Updates and Reminders - ORSP

MUSC IRB Fee Schedule Aimee McRae-Clark, Pharm.D., Director, Office of Research Integrity Stacey Goretzka, CIP IRB Manager

Updates to IRB Fee Schedule Industry Sponsored Research - Change in IRB fee schedule for: -Continuing Reviews -Amendments Single IRB Review Fees

Continuing Reviews Current Fee: $500 (at least annually) New Fee: $750 (at least annually) Effective date: New studies approved on July 1, 2017 and after.

Amendments Current Fee: $0 New Fee: $500 Applies to both full board and expedited amendments as well as change in PI amendments. New fee does not apply to change in personnel amendments or administrative changes (as defined by MUSC policy HRPP 3.6 http://academicdepartments.musc.edu/research /ori/irb/HRPP/HRPP%20Guide%20Section%203.6). Effective Date: New studies approved on July 1, 2017 and after.

How we compare to other universities

Single IRB Review (or Central IRB) MUSC serves as single IRB (central IRB) for multi-site studies: $2,506 Initial Non-MUSC Site Review $1,093 Annual Management (Continuing Review for each Non-MUSC Site)

VA Contract for MUSC Personnel Services Received executed copy on 2/28/17 Effective dates 2/15/17 through 2/14/18; $15 million Can be extended for up to 4 more years Replaces the use Intergovernmental Personnel Agreements (IPAs) for the ONLY following: Lab Specialist 1 and 2 Program Assistant Research Specialist 1,2,3 Program Coordinator 1 and 2 Engineer/Associate Engineer 2 Occupational Therapist 2 Physician’s Assistant

VA Contract for MUSC Personnel Services Continued from previous slide Program Manager 1 Graduate Assistant Graduate Research Assistant Postdoctoral Scholar Staff Scientist Instructor Research Instructor Research Associate Research Assistant Professor Biostatistician NOTE: If not on the list, must use the IPA mechanism

VA to Contract MUSC Process Step 1: VA notifies ORSP via e-mail (orsp@musc.edu) of the intent to contract with a Statement of Work (SOW) SOW contains: position classification title, dates of service, amount of funding, duties to be performed for VA and the MUSC departmental contact name

VA to Contract MUSC Process Step 2: ORSP ensures information is complete and will forward via e-mail to the appropriate MUSC departmental contact Step 3: Departmental contact (e.g. grants administrator, business manager, etc.) vets proposed arrangements within the department and upon consensus an approved ePDS and budget, matching VA amount listed on SOW, is routed to ORSP for final MUSC review and approval

VA to Contract MUSC Process Step 4: After ORSP review, VA is notified by ORSP the SOW has been approved Step 5: After getting MUSC approval of the SOW from ORSP, VA initiates a Task Order (TO) request to match the SOW from the VA central headquarters office

VA to Contract MUSC Process Step 6: When TO is ready, the local VA will send it to ORSP for review and approval Step 7: ORSP will review/verify the TO matches the details of the department-approved SOW; provided all matches, ORSP signs and returns TO via e-mail to the local VA

VA to Contract MUSC Process Step 8: Local VA coordinates and secures a fully executed TO from the VA headquarters office Step 9: Once the local VA has the fully executed TO, the local VA prepares a Purchase Order and sends ORSP the fully executed TO and the Purchase Order

VA to Contract MUSC Process Step 10: ORSP uses fully executed TO, Purchase Order, SOW, budget and ePDS to initiate award udak account set-up with MUSC’s Grants Accounting Office Step 11: GCA notifies department per standard procedures when award udak is established

VA to Contract MUSC Process Final Reminders: All Task Orders (TOs) under must pay 26% F&A costs, as most of these services will be conducted off campus in VA space; Off campus F&A rate applies ORSP created a budgeting tool for INTERNAL USE ONLY All Task Orders (TOs) must pay adequate fringe benefit rates MUSC must recover the costs (all costs) associated with VA contracting for MUSC services All MUSC departments must consider the financial arrangements to ensure costs are adequately covered

VA PSA Tool Demo https://academicdepartments.musc.edu/research/orsp/restricted/VA_PSA_Worksheet_v1.xlsx

Budget Worksheet Revisions Budget worksheet is provided for convenience and to assist departmental personnel in calculating F&A on research projects Multi-Functional – Provides for 5 budget years 10 subcontracts 26 named personnel Tailored to MUSC References institutional object codes for expenditure categories Defaults to institutional rates (F&A and Fringe Benefit) http://academicdepartments.musc.edu/research/orsp/proposal_preparation/forms.html

Budget Worksheet Revisions Added additional information fields at top of page PI Name will show at the top of all other worksheets

Budget Worksheet Revisions Separate line for Tuition Remission (excluded from F&A calculation) Bottom section split into two sections to align with NIH budgets Materials and Supplies Other

Recent Notices NOT-OD-17-041 Impact of Washington, DC Area Federal Office Operating Status on NIH Grant Application Due Dates Grant application due dates will move to the next business day when the OPM operating status on the original due date is: Federal offices are closed – Emergency and telework-ready employees must follow their agency’s policies Open - Early departure Immediate departure – Federal offices are closed Shelter-in-place No Change to Other Submission Policies Guidelines for Applicants Experiencing System Issues Due Dates on Holidays/Weekends Weather/Other Disasters (impacting applicant institutions)

Recent Notices NOT-OD-17-042 Update and Clarification: NIH Continuous Submission Policy  Consolidation of earlier Notices – NO CHANGE to the policy Continuous Submission applies to R01, R21, and R34 applications submitted by continuous submission eligible PD/PIs and MPIs to FOAs with standard due dates  The NIH Late Policy applies to All other types of applications submitted by continuous submission eligible PD/PIs and MPIs All applications submitted by all other PD/PIs and MPIs Reviewers can check their eRA Commons Personal Profile for continuous submission eligibility Applicants Eligible for Continuous Submission listing Continuous Submission FAQs

Recent Notices NOT-OD-17-043 Update on Clinical Trial Funding Opportunity Announcement Policy New Effective Date January 25, 2018 NIH Transition Plan Spring 2017 New "PHS Human Subjects and Clinical Trials Information" form Consolidates several forms used to collect human subject information Expands NIH data collection requirements for clinical trials NIH to provide additional information to the community on the new form and implementation plans Fall 2017 Expire existing clinical trial FOAs by January 24, 2018 Update remaining active FOAs to include the latest approved forms and to indicate that clinical trial applications are not allowed for due dates on or after January 25, 2018 Issue new clinical trial FOAs with clinical trial-specific review criteria, forms, and instructions for due dates on or after January 25, 2018

Reminders/Updates Outgoing Subawards/Subcontracts Pre-Award items Subrecipient vs Contractor Subrecipient application requirements Contractor quotes for services Post-Award items Did budget or scope of work change? Human/animal research? Risk assessment New “How Do I” on ORSP website Call ORSP’s Becky Timpner at 792-8702 with questions

Final Thoughts Any Announcements? Questions or Comments? PLEASE complete a survey & THANK YOU Next ORSP Information Session: April 19th, 2017 @ 11:00 IOP Auditorium