Research Administration Updates December 14, 2016 11:00 am IOP Auditorium

Topics Covered MUSC Health MyChart Use in Research Recent Notices (NIH and NSF) NIH’s GCP Training Requirement for Clinical Trials Updates, Reminders & Other Announcements

Recent Notices Updated NSF Proposal & Award Policies & Procedures Guide (PAPPG), (NSF 17-1) Effective for proposals submitted, or due, on or after January 30, 2017 NSF hosting a webinar on January 19th at 1 PM EST  Registration is required on the NSF outreach events website NOTE: the current PAPPG (NSF 16-1) guidelines continue to apply until the new PAPPG (NSF 17-1) takes effect Frequently Asked Questions for the new NSF PAPPG

Recent Notices REMINDER: Update Browsers to Use eRA Modules; New Security Mandated For Websites (Nov 30) LYNX machines – no action needed For Non-Lynx machines, confirm your browser is updated: Browsers eRA uses to develop and test its modules for compatibility, as listed in the eRA Browser Compatibility statement: Google Chrome®  version 4.0.211.0 and higher Firefox® version 4 and higher; with Firefox 17, Mozilla® integrates a list of websites supporting the new protocol Internet Explorer® 11 on Windows® 8.1 and Windows® 7 when KB 3058515 or higher is installed (Released on Windows Update in June 2015)   Browsers that work with the security upgrade, but are not included in the in the eRA Browser Compatibility statement: Chromium®  Opera®  version 12 and later Safari® as of OS X Mavericks Microsoft® Edge™ and Internet Explorer® 11 on Windows® 10 More information is available at https://https.cio.gov/ and OMB M-15-13

Recent Notices eRA Enhancement: Redesigned Section in RPPR to Help Grantees Categorize Products Developed Under a Grant “Section C – Products” now includes a scrollable list of 14 product categories to help categorize the products being reported. ‘Nothing to Report’ checkbox, if applicable Guide to Categorizing Products in RPPR’s Section C Audio or video Instruments or Equipment Survey Instruments Data or Databases Models Interventions (e.g. clinical or educational) Research Material Physical Collections New Business Creation Educational Aids or Curricula Protocols Other Evaluation Instruments Software  

Recent Notices NOT-OD-17-002 Adjustment to Stipend Levels for Postdoctoral Trainees and Fellows on Ruth L. Kirschstein National Research Service Awards (NRSA) Notice provides instructions for requesting one-time supplemental funding to cover the stipend increase Applies to NRSA stipend levels at years 0, 1 and 2 years of postdoctoral experience May request funds to cover increases in stipends at these levels from December 1, 2016 up to the end date of the current period of appointment Institutional Training Grants: May not increase the number of appointees under the current award Appointments of affected trainees made via xTrain as of 12/1/2016 will reflect these new stipend levels Individual NRSA Postdoctoral Fellowships: The Notice of Award (NOA) for the next budget year will reflect the FY 2017 stipend levels NIH Research Training FAQs NOTE: For NIMH specifically, the recipient should submit no later than 12/31/2016 to be considered

Recent Notices NOT-OD-17-021 Publication of the Revised NIH Grants Policy Statement (Rev. November 2016) for FY 2017 Applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2016 Previous versions of the NIHGPS remain applicable to awards with budget periods that began prior to October 1, 2016 Examples of Significant Changes: Consolidates policies on Post-Submission Grant Application Materials Invention reporting required to be submitted electronically via iEdison Clarification for revised NIH Parental Leave Policy for Kirschstein-NRSA Trainees

Recent Notices NOT-OD-17-022 NIH Implementation of Final Research Performance Progress Reports (Final RPPR) Final Research Performance Progress Report (F-RPPR, Final-RPPR) will replace the Final Progress Report (FPR) for closeout effective January 1, 2017 NIH will not maintain the current Type 2 policy which states that "whether funded or not" the progress report contained in the Type 2 application may serve in lieu of a separate final progress report NIH will request that organizations submit an "Interim-RPPR" while their renewal application (Type 2) is under consideration Will be treated as the annual performance report if the Type 2 application is funded Will be treated as the Final-RPPR if the Type 2 application is not funded FAQs and additional information will be available on the NIH RPPR website

Recent Notices eRA Enhancements: New Features for xTRACT xTRACT is the Extramural Trainee Reporting And Career Tracking system and is accessed via eRA Commons Allows applicants, grantees and assistants to create research training tables for progress reports and institutional training grant applications Updated software release December 8, 2016 Online Help for xTRACT Features Ability to copy data from a recently prepared RPPR Research Training Dataset (RTD) into a Renewal RTD Ability to copy data from a recently prepared Renewal or RPPR RTD into an RPPR RTD Improved Performance of Preview/Finalize RTD Fixes Adjustment to the auto-population of Faculty Research Support, from NIH and Other Agency Sources, to allow for delayed continuation awards to be included (previously omitted) Applicants and Entrants Section now prevents a prior institution from being listed multiple times

Recent Notices New Application Instructions and Important Reminders for Appendix Sections and Post-Submission Materials For applications with due dates on or after January 25, 2017 Applies to NIH, AHRQ and NIOSH applications If any other materials are included in the appendix your application will be withdrawn and not reviewed   NOTE: papers and manuscripts are no longer acceptable as appendix materials NIH guidance materials: NIH Reminder message NOT-OD-16-129 (appendix materials) NOT-OD-16-130 (post-submission materials) Recently Updated NIH Application Guide Changes to submission guidelines

NIH’s GCP Training REQUIREMENT Quick Review: After January 1st, 2017 NIH expects “all NIH-funded investigators and staff who are involved with the conduct, oversight or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).” https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html

NIH’s GCP Training REQUIREMENT Scope and Applicability: GCP training includes the Principles of ICH GCP found in Section 2 of the ICH E6. GCP training can be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. GCP training should be refreshed at least every three years to remain current with regulations, standards and guidelines. Recipients of GCP training are expected to retain documentation of their training.

NIH’s GCP Training REQUIREMENT Scope and Applicability: Clinical Trial: Defined by NIH as 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. Investigator: Individual responsible for the conduct of the clinical trial at a site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

NIH’s GCP Training REQUIREMENT Scope and Applicability: Clinical Trial Staff: Individuals identified by the investigator, who are responsible for study coordination, data collection and data management. Focused on managing participant recruitment/enrollment, maintaining consistent study implementation, data management and ensuring integrity and compliance with regulatory and reporting requirements.

NIH’s GCP Training REQUIREMENT Scope and Applicability : Clinical Trial Staff (cont’d): Individuals may also seek informed consent from prospective participants, enroll and meet with research participants and collect and record information from research participants. May also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

NIH’s GCP Training REQUIREMENT MUSC Compliance Plan: CITI training module titled “Good Clinical Practice and ICH” will satisfy this requirement per NIH and can be tracked/maintained. How to access the GCP and ICH CITI course Login to CITI-MIAMI (https://www.musc.edu/citi) From the Main Menu select “Add a Course” Select “Human Subjects” Select the “Basic course” and/or the “Refresher course” Select “Good Clinical Practice and ICH”

NIH’s GCP Training REQUIREMENT Final Thoughts: Questions about accessing the course via CITI: Michael Thomas mailto:thomi@musc.edu 843-792-8652 Anticipate more information (FAQs) from NIH soon ORSP will continue to share updates as they become available (see below link) http://academicdepartments.musc.edu/research/orsp/policies_procedures/policy_nih_gcp_training

Updates VA Blanket or Master-like Agreement for IPA’s Should be in local VA by end of this week, YES ! ORSP to discuss plans next Tuesday with local VA staff Hope to share GREAT news soon Council on Governmental Relations (COGR) informed member institutions the NIH has extended the implementation of the Single IRB (sIRB) requirement until September 27th, 2017 ORSP anticipates an official NIH Notice soon and will continue to share any updates.

Reminders Advance (NIH-6 weeks) permission needed from the agency (i.e. DOD or NIH) when proposals are to exceed $500,000.00 of Direct Costs in any one year of the proposed budget Noncompliance will likely result in a rejected application Share this reminder as even 3 business days will not allow ORSP or the PI to rectify this issue https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-005.html Proposals (including Corporate) cannot be reviewed in ORSP without a routed and approved ePDS ePDS (routed and approved) indicates ORSP is officially allowed to review, approve and assist with the proposal/contract ePDS captures important/required compliance assurances that must be in order prior to ORSP’s review

Final Thoughts Any Announcements? Questions or Comments? ORSP staff changes Questions or Comments? PLEASE complete a survey & THANK YOU Next ORSP Information Session: February 15, 2017 @ 11:00 IOP Auditorium