USF HRPP Updates October 2017

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1 USF HRPP Updates October 2017 Julie Moore, J.D., M.S. PA, CIP Associate Director, Research Integrity & Compliance Research Integrity and Compliance

2 Revised Common Rule 45 CFR 46 Effective date and compliance date for all but the single IRB provision in the Rule remains January 19, However, on October 7 th, 2017, HHS requested a 1 year delay in the general implementation date of the Rule, while allowing the use of three burden-reducing provisions during the delay year. Research Integrity and Compliance

3 Revised Common Rule: Major Changes Changes to informed consent, including: content and organization, required elements, posting of ICFs for federally-funded clinical trials Continuing reviews will be eliminated for certain types of research: Expedited research (minimal risk) Studies in data analysis NOTE: USF will still require an administrative check in for these studies Transition period Certain studies will be eligible to transition from the pre-2018 Rule to the 2018 Rule As compliance date nears, be mindful of timing of submitting IRB applications Research Integrity and Compliance

4 NIH Policy Updates Single IRB Policy Policy on Issuing Certificates of Confidentiality Policy on the Dissemination of NIH-Funded Clinical Trial Information Policy on GCP Training for NIH Awardees Involved in Clinical Trials Research Integrity and Compliance

5 NIH Single IRB Policy: The Basics Effective Date: January 25, 2018 Purpose: To enhance and streamline IRB review process for multi-site research Applicability: U.S. sites only Multi-site studies where each site will conduct the same protocol Grants, cooperative agreements, contracts or NIH intramural awards submitted on or after January 25, 2018 Awardee responsibility: Lead PI must include plan for using single IRB in the proposal/application Research Integrity and Compliance

6 If USF is the prime applicant: NIH Single IRB Policy: Operationalizing at USF Currently, USF will cede review of NIH-funded multisite studies to Western IRB. Proposal must be sent to WIRB at least 2 weeks in advance of submission to USF SR, to allow WIRB to provide estimate for the IRB fees portion of the budget. USF IRB administration assists with coordinating this process. Please contact USF IRB administration as soon as you become aware of a proposal for a NIH-funded multi-site study. Research Integrity and Compliance

7 NIH Single IRB Policy: Operationalizing at USF If USF is a subrecipient: At proposal: Contact USF IRB administration to discuss whether USF can agree to rely upon the proposed single IRB and to request a letter of support. Obtain info about sirb fees from the lead site (whether commercial or academic IRB will serve as the sirb). At award: Contact USF IRB administration to discuss process for entering into a reliance agreement (formal contract via which USF cedes IRB review to an external IRB). Research Integrity and Compliance

8 NIH Policy on Issuing Certificates of Confidentiality Effective October 1, 2017, NIH awardees conducting research involving sensitive, identifiable information no longer have to apply for a CoC (retroactive to awards granted on or after December 13, 2016). CoC will automatically be issued as part of the terms/conditions of the award (no separate certificate). All other researchers conducting research involving sensitive, identifiable information may still apply for a CoC via the same process utilized in the past. Research Integrity and Compliance

9 NIH Policy on the Dissemination of Clinical Trial Information Effective Date: January 18, 2017 Purpose: Promote broad and responsible dissemination of information from NIH-funded clinical trials. Applicability: Applies to all NIH-funded clinical trials regardless of phase, type of intervention or whether subject to FDAAA. Research Integrity and Compliance

10 NIH Policy on the Dissemination of Clinical Trial Information Clinical trial : 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. If you are conducting an NIH-funded clinical trial: Include a plan for compliance in your proposal! Ensure that ICD includes a specific statement related to posting of clinical trial information at CT.gov Register your study 21 days post first subject enrollment; report results as required Research Integrity and Compliance

11 NIH Policy on Good Clinical Practice Training for NIH Awardees Conducting Clinical Trials Effective date: January 1, 2017 Applicability: NIH-funded investigators and staff who are responsible for the conduct, management and oversight of NIHfunded clinical trials If you are conducting an NIH-funded clinical trial: To satisfy the requirement, GCP training may be conducted through a class or course, academic training program or professional organization. Refresh training at least q 3 years. Retain documentation of training! Research Integrity and Compliance

12 Resources Revised Common Rule NIH Single IRB Policy Single IRB Policy FAQs NIH Policy on Issuing CoCs NIH Policy on the Dissemination of Clinical Trial Information NIH Policy on GCP Training NIH Video on Policy Changes Research Integrity and Compliance

13 Grants.gov Workspace Overview Becoming a Workspace Wizard September 7, 2017

14 Agenda Objective and Benefits of Workspace Retire Legacy PDF Application Package Live-Demonstration of Workspace Recent Changes from June 2017 Upcoming Changes in November 2017 Questions and Feedback 2 9/7/2017

15 Objective of Workspace To enhance the Grants.gov Apply functionality by providing applicants with a shared, online environment to collaboratively complete and submit grant applications 3 9/7/2017

16 Benefits of Workspace Multiple users can concurrently complete the application forms Reuse/Copy existing Workspace forms Upfront validation allows applicants to correct application errors prior to submission, which minimized the rejection rate Seamless integration between online webforms and offline PDF forms Collaborate with Users External to Your Organization Any changes to the Opportunity Package are immediately reflected in Workspace 4 9/7/2017

17 Retire Legacy PDF Application Package Legacy PDF Application Package will be phased out on December 31, Applicants will no longer be able to download the older, single PDF application package of forms. Applicants can apply for grants using Grants.gov Workspace, which separates the application package into individual forms. Applicants can create a workspace, complete the webforms online or by filling out the separate PDF forms, and submit their application workspace package. The online webforms interface is now available in Grants.gov and is only accessible through Workspace. For any funding opportunities where applicants have downloaded the legacy PDF application package, they will be able to continue to submit that package until March 31, S2S Submissions will continue to be supported. Are you ready? If you have any questions or concerns, please contact us at community@grants.gov. 5 9/7/2017

18 Live Demonstration of Workspace In this live demonstration, we will cover the following key actions for applying on Grants.gov using Workspace: Workspace Process and Roles Overview Creating a Workspace Managing Participants & Roles Completing Online and Offline Workspace Forms Submitting via Workspace 6 9/7/2017

19 Workspace Resources For more information about Grants.gov Workspace, please visit our various Workspace resources: Grants.gov Workspace Overview Grants.gov Workspace Training Video Series Grants.gov Community Blog articles on Workspace Grants.gov Online User Guide Grants.gov Applicant Support Grants.gov Community Blog articles: 7 Tips for Transitioning Your Organization to Grants.gov Workspace Grants.gov Workspace for Colleges and Universities (3 Part Series) Grants.gov Workspace Roles and Access Levels Training video: Lfmc Blog: Defining Grants.gov Workspace Roles and Access Levels 7 9/7/2017

20 Upcoming Changes in November 2017 Workspace Enhancements Reuse/Copy across form versions Streamline Workspace creation Subscription Management View and Manage subscriptions New subscription types: News and Saved Searches One-Click Subscribe to Opportunity Requires Grants.gov account/login Streamline Account Creation & Login New Forms Status Report for In Progress Forms 8 9/7/2017

21 Grants.gov Helpdesk Support If you have any issues or questions while you are using Workspace to complete your application, please contact the Grants.gov Support Center at or call /7/2017

22 Feedback If you have general questions, feedback or concerns about workspace functionality or user-based suggestions and/or requirements, for transformation efforts, please 10 9/7/2017

23 Connect with Grants.gov Stay connected, with Grants.gov, to find out more about what s coming; new and interactive training opportunities; and, updated resources to assist with Find, Apply and Succeed objectives. Follow us on Video tutorials on YouTube Subscribe to our blog: Blog.Grants.gov? Bookmark our Online User Guide Us: Community@grants.gov 11 9/7/2017

24 GRANTS.GOV WORKSPACE OVERVIEW SUPPLEMENT FOR RELEASE /7/2017

25 OVERVIEW What Is Workspace? Why Use Workspace? The Process Creating a Workspace Managing Participants & Roles Completing Workspace Forms Submitting Via Workspace Organization Management Grantor Actions 13 9/7/2017

26 WHAT IS WORKSPACE? The online space where you work on your grant application Workspace is a shared, online environment where members of a grant team may simultaneously access and fill out forms within an application. 14 9/7/2017

27 WHAT IS WORKSPACE? The top section of each workspace contains key information about the application status. Each workspace has 4 tabs: Forms, Participants, Activity and Details Some have 2 more tabs based on grantor agency services (currently NIH-only): Grantor Image and Preview Grantor Validation 15 9/7/2017

28 WHAT IS WORKSPACE? The Forms tab contains individual forms that are part of the workspace application package. Key Actions: Fill out webforms (if available) Lock/Unlock forms Download/Upload PDF forms Reuse forms 16 9/7/2017

29 WHAT IS WORKSPACE? The Participants tab lists the members, or Participants, of a workspace who work as a team to complete the required forms for a federal grant. 17 9/7/2017

30 WHAT IS WORKSPACE? The Activity tab lists the actions that Participants have taken within the workspace. 18 9/7/2017

31 WHAT IS WORKSPACE? The Details tab lists submission history, including links to download every submitted (and resubmitted) application. 19 9/7/2017

32 WHY USE WORKSPACE? 1 Workspace helps to streamline the collaboration process on a federal grant application. 20 9/7/2017

33 WHY USE WORKSPACE? 2 Workspace helps applicants to save time by allowing for the reuse of forms across multiple workspaces. 21 9/7/2017

34 WHY USE WORKSPACE? 3 Forms are validated when they are uploaded to the workspace, virtually eliminating lastminute submission errors. 22 9/7/2017

35 WHY USE WORKSPACE?? 4 Workspace is easy to learn thanks to contextsensitive help articles accessible on every page and window. 23 9/7/2017

36 WHY USE WORKSPACE? Resources Video: Introducing Workspace Functionality Workspace Overview Page on Grants.gov 24 9/7/2017

37 CREATING A WORKSPACE After logging in, create a workspace by visiting the View Grant Opportunity page and clicking the Package tab. If the application package is compatible with Workspace, you will be able to create a new workspace. 25 9/7/2017

38 CREATING A WORKSPACE Resources Video: How to Create a Workspace Online User Guide: Create a Workspace 26 9/7/2017

39 MANAGING PARTICIPANTS & ROLES Adding Participants: Click the Add from Workspace Organization button to search for a user within your organization Click the Add by Username button to add a user from outside your organization Removing Participants: Click the Remove link on the Participant record in the workspace Reassigning Ownership: Click the Make Owner link in the Actions column 27 9/7/2017

40 MANAGING PARTICIPANTS & ROLES Roles: AOR role (automatically receive Manage Workspace role) Manage Workspace role Account Types: E-Business Point of Contact (EBiz POC) Individual Applicant Organization Applicant 28 9/7/2017

41 MANAGING PARTICIPANTS & ROLES Access Levels: Workspace Owner Workspace Participant AOR with MPIN AOR with standard access AOR with expanded access* Form Level *AORs with expanded access are able to view and submit the application for any workspace within the organization. 29 9/7/2017

42 MANAGING PARTICIPANTS & ROLES This timeline shows how each user fits into the workspace workflow: 30 9/7/2017

43 MANAGING PARTICIPANTS & ROLES Resources Video: Understanding User Roles and Access in Workspace Video: How to Add Participants to a Workspace Video: How Do I Add Participants Who Are Outside My Org? Online User Guide: Manage Participants in a Workspace 31 9/7/2017

44 COMPLETING WORKSPACE FORMS Key Actions: Fill out webforms (if available) Download and Upload PDF forms Lock/Unlock forms 32 9/7/2017

45 COMPLETING WEBFORMS Webform Basics: Complete online forms in web browser Navigate by clicking sections Tab through form fields Required fields have red asterisk 33 9/7/2017

46 COMPLETING WEBFORMS Filling Out Fields: Open text entry Drop-down menu Dates/calendar 34 9/7/2017

47 COMPLETING WEBFORMS Filling Out Fields: Radio buttons (multiple choice) Attach files within online form 35 9/7/2017

48 COMPLETING WEBFORMS More Features: Hover mouse over form fields for help Error messages explain how to fill out form fields 36 9/7/2017

49 COMPLETING WEBFORMS More Features: Autosave occurs every 5 minutes Complete SF-424 first to prepopulate form fields and save time 37 9/7/2017

50 COMPLETING WEBFORMS Save: Stores your form data & attachments to Workspace Check for Errors: Form validation & field-level errors Close: Exits the online form 38 9/7/2017

51 COMPLETING PDF FORMS PDF Form Basics: Option to download PDF forms to complete in Adobe software Upload PDF forms to workspace Upon uploading, data shared between online and PDF versions of forms 39 9/7/2017

52 COMPLETING PDF FORMS PDF Form Basics: Tab through form fields Required fields have red border and yellow shading Hover mouse over form fields for help Error messages explain how to fill out form fields 40 9/7/2017

53 COMPLETING WORKSPACE FORMS Workspace Features: Reuse past forms Cross-form validations Data retained for three years 41 9/7/2017

54 COMPLETING WORKSPACE FORMS Resources Video: How to Complete Forms in a Workspace Video: Reuse a Saved Workspace Form Online User Guide: Forms Tab Managing Forms 42 9/7/2017

55 SUBMITTING VIA WORKSPACE Process: Workspace Owner notifies users with AOR role User with AOR role submits Workspace Owner or user with AOR role may choose to Reopen Workspace 43 9/7/2017

56 SUBMITTING VIA WORKSPACE Resources Video: How to Submit an Application in Workspace Video: Reopen a Workspace for Additional Edits Online User Guide: Check Application in Workspace Online User Guide: Submit a Workspace Package 44 9/7/2017

57 ORGANIZATION MANAGEMENT Key Actions EBiz POC and users with AOR with MPIN can perform workspace actions at organization level EBiz POC cannot create or submit a workspace 45 9/7/2017

58 ORGANIZATION MANAGEMENT Resources Online User Guide: Manage Applicants Online User Guide: Manage Workspaces 46 9/7/2017

59 Closeout of Sponsored Awards

60 CCHIP 011 is the policy that outlines the procedures for final invoicing and financial reporting on sponsored awards. Overview: Award closeouts generally require that a series of final reports be submitted to the project's sponsoring agency. It is essential that these be prepared and sent on time. The terms and conditions of the award will specify what should be sent, when and to whom.

61 Due to changes in Federal Regulation Uniform Guidance (b) Unless the Federal awarding agency or pass-through entity authorizes an extension, a non-federal entity must liquidate all obligations incurred under the Federal award not later than 120 calendar days after the end date of the period of performance as specified in the terms and conditions of the Federal award

62 Non-Federal entities (like USF) are still required to incur the obligation within the period of performance, but are now also required to liquidate obligations within 120 calendar days after the end date of the period of performance as specified in the terms and conditions of the Federal award. To simplify: The cash must have gone out the door in order to be included in final invoicing or reporting.

63 USF will discontinue the practice of including non-liquidated obligations ( Pending Charges ) in all invoicing and reporting.

64 To clarify the time-frame in which final adjustments can be made, USF has established an Adjustment Period, defined as the period immediately following the award s end date which provides time for all final transactions (payroll, expenditure transfers, final adjusting entries, etc.) to post to the General Ledger. The Adjustment Period should be used to record and correct all expenses on the General Ledger, and is not an extension of the project period all transactions must be reasonable, allowable, allocable, and incurred within the award period established by the terms and conditions of the award.

65 The adjustment period begins the first day following the end date of the award, and continues until 30 days prior to the invoice and/or report due date per the terms of the agreement, up to a maximum of 60 days. Example: Award Period: July 1, 2016 June 30, 2017 Final Invoice due to sponsor: September 30, 2017 (90 days) Adjustment Period: July 1, 2017 August 30, 2017

66 Closeout Begins Award End Date AWARD PERIOD ADJUSTMENT PERIOD FINAL INVOICE/REPORT PREPARATION/ SUBMISSION Prior months/years Last 90 Days of the Award Period 1-60 Days After the Project End Date Days After the End Date * This timeline represents a typical award in which final invoicing and/or reporting is due to the sponsor within 90 days, and is subject to change based on the terms and conditions of the award.

67 In these instances, the adjustment period is equal to 0 days in duration or, stated otherwise, all adjustments must be made prior to the end date of the project. If an adjustment period is desired for such projects: At the written request of the PI to the award s Post-Award Transaction s Team Grant Financial Administrator (GFA), the award s end date can be advanced, internally within USF s financial system (FAST), up to 60 days prior to the end date established in the terms and conditions of the award. Upon receipt of this request, Sponsored Research will change the end date (including the KK definitions, or KK-end date ) within FAST, and will use the requested date as the end date of the award. This will include for the purposes of determining the project period as it relates to the allowability of charges, and override requests.

68 Post-Award Invoicing & Reporting will prepare the invoice and/or financial report for the sponsor based exclusively on transactions posted to the General Ledger. The principal investigator (PI) and/or department/college is responsible for any expenses that are not posted to the General Ledger at the close of the adjustment period.

69 It is the PI s responsibility to request a no-cost extension through their Sponsored Research Administrator (SRA) no later than 30 days prior to the award expiration, or as otherwise required by the terms and conditions of the award.

70 Only expenses posted to the General Ledger can be included in the invoice or report with the sole possible exception of retroactive expenditure transfers (RETs), which have been approved by Sponsored Research and forwarded to payroll for processing, but are delayed due to a known system limitation within USF s Payroll System (GEMS).

71 Post-Award Invoicing & Reporting is instructed to report in accordance with the procedures outlined in this CCHIP. Therefore, it is expected that compliance with all invoicing, reporting, and close-out procedures are strictly followed, without exception. As such, Post-Award Invoicing & Reporting will operate on the assumption that, at the close of the Adjustment Period all expenses related to the project have been reviewed, adjustments posted if necessary, and that all costs are properly posted, are reasonable, allowable, allocable, and incurred within the project period and, as a result, will submit a final invoice and/or financial report based solely upon the information available in the General Ledger as reflected in the University s Financial Accounting System (FAST).

72 This CCHIP is effective for all reporting periods ending on or after January 1, 2018 and rescinds all previous versions pertaining to the Closeout of Sponsored Awards.

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