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Office of Research

Information for Researchers


News and Information

New Compliance Training Opportunities

The Office of Research has expanded its Collaborative Institutional Training Initiative (CITI) subscription by adding a module covering the Revised Common Rule (under the Human Subjects course) and a new course package in Information Privacy and Security.

The Revised Common Rule course is intended to help the research community understand the revisions to the Common Rule issued on January 19, 2017, with a general compliance date of January 21, 2019. The course provides a detailed review of the regulatory changes to 45 CFR 46, Subpart A, “Federal Policy for the Protection of Human Subjects” (the Common Rule). It also provides a comprehensive review for learners across the research enterprise. This module is complemented by topic-focused modules that provide in-depth review of key areas affected by the revised Common Rule.

The Information Privacy and Security course package consists of courses on (1) Health Privacy, focusing on HIPAA, (2) Information Security, and (3) the Family Educational Rights and Privacy Act (FERPA). Each course includes content for individuals who only need basic information, as well as content tailored to specific roles, applications, devices, and settings. It is suitable for anyone who works with individually identifiable health data (HIPAA-defined "PHI"), FERPA-covered educational records and data, or has responsibilities for setting policies and procedures with respect to these types data.

FSU Faculty, staff and students can sign up for the free CITI courses to access the applicable training. Registration and login instructions are published here.

Questions about this training may be addressed to Diana Key, Director, Research Compliance Programs.

International Travel

When you travel internationally to conduct University research-related business, you need to know your responsibilities under U.S. export control regulations. Traveling abroad and taking certain items, providing certain services, or meeting with certain people can present export control problems. The Office of Research Compliance Programs (ORCP) provides guidance on how to avoid running afoul of U.S. export control regulations when traveling internationally.

Travel to most countries does not present an export control problem; however, travel to some countries may present a problem that is easily addressed if we create and maintain records that show that the travel was exempt from the export control regulations. Even so, when an export control license is required for travel, it is crucial that we obtain it prior to the trip as violations of U.S. export control laws carry severe civil and criminal penalties for both FSU and the offending individual.

Please consult ORCP’s International Travel Guidance for advice and requirements related to  international travel before you travel. Topics addressed are:

  • Sanctioned Countries and Restricted Parties
  • Safety and Security
  • Advice Related to the Purpose of the Trip
  • Export of Equipment or Data
  • Other FSU Resources related to International Travel
  • Best Practices - advice from other universities

Working with the ORCP well ahead of your international trip is the best way to ensure that your travel, items, and information can be taken abroad without a license or violation of the export control laws and/or regulations.

Questions about export controls and international travel may be addressed to Diana Key, Director, Research Compliance Programs.

Research Administration Management Portal (RAMP) Update

ACUC Module Slated to Go Live in January 

As previously announced, the first module to go live as part of the RAMP Project (Huron Research Suite) will be the ACUC Module.  The system has been tested and is functioning as designed.  The module is on schedule to go live on the anticipated date of January 31, 2019.  

The system testing occurred during November and early December.  Twelve testing sessions were offered at multiple locations on campus for Principal Investigators to test drive the system and provide feedback.    Also, the project team conducted testing with the ACUC Committee to gather their comments and address questions on business processes.  The ACUC core team completed their testing of the system as well to ensure the requirements identified in the discovery phase were properly configured within the module by Huron.  Feedback from all groups was recorded throughout the testing process and this information will aid the ACUC in designing training that is suitable to meet the needs of end users.  

Once implemented, Principal Investigators, or their proxies, will be required to submit all new protocols and triennial submissions through RAMP.  Any amendments to active paper protocols will continue to be managed through the current process until the protocols expire (to minimize the effort required of FSU researchers).  All protocols will be transitioned to RAMP no later than January 31, 2022.    

Communication through faculty meetings and other campus meetings will occur in January to provide relevant details about the ACUC module.   Training sessions on the new system will be scheduled for the core team, committee and ancillary reviewers to ensure they are comfortable in navigating through the module for protocol workflow and review.  Training for PIs and proxies will be discussed soon and we will share this information with campus once the curriculum and timing is finalized.  

If you have any questions or concerns, please do not hesitate to contact one of us. 

Kerry Peluso, Assistant Vice President for Research Administration and Finance
kpeluso@fsu.edu

(850) 644 – 8664 

Angie Rowe, Project Manager, Office of Research
arrowe@fsu.edu
(850) 644-8659

Human Subjects Research Office Updates

Revised Common Rule

On January 21, 2019, the Revised Common Rule will go into effect.  The Human Subjects Office is creating a section on the Human Subjects website that will outline the changes.  We are also updating our Standard Operational Procedures to comply with the new regulations.  Please check our website over the next few weeks, as this is where you will find new information that may affect your studies. 

Human Subjects Protections Training

Human Subjects Protections training is required for all engaged study team members; no research study can be approved by the FSU IRB unless evidence of current training is submitted with IRB applications.  In September 2018, the NIH Human Subjects Training was removed and is no longer offered.  The FSU IRB requires the Collaborative Institutional Training Initiative (CITI) Human Subjects Research (HSR) Training, which must be refreshed every three years.  Please contact our office if you have questions or need assistance with registering for the training(s) as appropriate for your research study.

New IRB Protocol Template Coming

The FSU IRB is working on an implementation plan for a formal protocol to be submitted for every study.  We will be contacting departments beginning in January to help provide training and education in advance of requiring the protocol.  Please feel free to contact our office with any questions or to arrange training for your department at humansubjects@fsu.edu.

New NSF Proposal Changes 

A revised version of the NSF Proposal & Award Policies & Procedures Guide (PAPPG), (NSF 19-1) has been issued. 

The new PAPPG will be effective for proposals submitted, or due, on or after January 28, 2019.  Significant changes include: 

  • Addition of Research.gov as an option for proposal preparation and submission, and proposal file updates;
  • Revision of eligibility standards for unaffiliated individuals;
  • Specification that conference proposals over $50,000 and all equipment proposals must include the Collaborators and Other Affiliations information in the proposal submission;
  • Revision of resubmission guidelines for NSF programs that accept proposals at any time;
  • Implementation of NSF’s policy on sexual harassment and other forms of harassment, or sexual assault;
  • Specification that proposers are required to have a policy or code-of-conduct that addresses sexual harassment, other forms of harassment, and sexual assault, and that includes clear and accessible means of reporting violations of the policy or code-of-conduct.  This policy or code-of-conduct must be disseminated to conference participants prior to attendance at the conference as well as made available at the conference itself;
  • Emphasis on the importance of training faculty in the responsible and ethical conduct of research;
  • Incorporation of existing patent policy into the PAPPG.  This policy was previously implemented by regulation at 45 CFR 650; and
  • Numerous clarifications and other changes throughout the document.

You are encouraged to review the by-chapter summary of changes provided in the Introduction section of the PAPPG.  

A webinar to brief the community on the changes to the new PAPPG will be held on November 27 at 2 PM EST Sign up to be notified when registration is available on the outreach notifications website, by selecting “All NSF Grants and Policy Outreach Events & Notifications.”   

While this version of the PAPPG becomes effective on January 28, 2019, in the interim, the guidelines contained in the current PAPPG (NSF 18-1) continue to apply.  We will ensure that the current version of the PAPPG remains on the NSF website, with a notation to proposers that specifies when the new PAPPG (including a link to the new Guide) will become effective. 

If you have any questions regarding these changes, please contact the DIAS/Policy Office at policy@nsf.gov.

Huron Research Suite Transitions to “RAMP” – Project Update

We are excited to announce that our research system has been re-branded with a new name specifically for FSU. Project team members from across campus submitted and voted on creative name ideas and ultimately selected RAMP, which stands for “Research Administration Management Portal”. A project website has been developed to share pertinent information with the research community as we navigate through different phases of the project. The website will be the central source of information about the project and updates will continue to be provided on the website and within the Research Newsletter. Please visit the RAMP website at http://ramp.research.fsu.edu to view general information, project governance, the implementation timeline and announcements. Frequently asked questions will also be posted to the project website in the near future for your convenience.

During the course of October, Huron continued their work on the development of the ACUC module to meet FSU’s requirements. The development phase should conclude in mid-November and the modified system will be available for testing to ensure it is working properly as designed. The system will result in an electronic process for the development, submission and review of ACUC protocols. The project remains on course for the estimated go-live date of January 31, 2019.

Principal Investigators are encouraged to participate in one hour sessions to test drive the system beginning November 14th in an effort to provide essential feedback to the project team. These sessions are scheduled for the following dates and locations.

Date Session Times Location
November 14 9:00 – 10:00
10:00 – 11:00
11:00 – 12:00
FSU Training Center, Room 211
November 15 9:00 - 10:00
10:00 – 11:00
11:00 – 12:00
FSU Training Center, Room 211
November 16 9:00 – 10:00
10:00 – 11:00
11:00 – 12:00
Carothers Hall, Room 304
November 26 9:00 – 10:00
10:00 – 11:00
11:00 – 12:00
Student Services Building, Room 301

Additionally, ancillary and committee reviewers will have an opportunity to offer their input on the module in late November and those session dates will be communicated soon. Training will be provided at various locations in January as we approach implementation and detailed information will be furnished accordingly.

If you have any questions or concerns, please do not hesitate to contact one of us.

Kerry Peluso, Assistant Vice President for Research Administration and Finance
kpeluso@fsu.edu
(850) 644-8664

Angie Rowe, Project Manager, Office of Research
arrowe@fsu.edu
(850) 644-8659

Responsible Conduct of Research Training Reminder

Certain federal agencies have adopted requirements for training on the responsible conduct of research for individuals supported by or participating in projects funded by those agencies. FSU’sPolicy on Responsible Conduct of Research (RCR) Training outlines policy and procedures for ensuring compliance with these requirements. Postdoctoral fellows, graduate students, and USDA/NIFA project staff must complete their training within two months of their initial appointment or assignment to the grant.  Undergraduates must complete their training within one month of their initial appointment or assignment to the grant. Training options are explained at https://www.research.fsu.edu/research-compliance/rcr/. If you have questions, please contact Diana Key at dkey@fsu.edu.

Huron Research Suite – Project Update

The project is progressing well and is on schedule.  The Discovery and Planning phase is complete.  This phase involved project team members viewing demonstrations of the new system modules, evaluating their current business processes, and providing feedback to aid in the design of our comprehensive research system.  These meetings provided the information necessary for developing the project plan.  Notable accomplishments from the work performed thus far are the completion of a project charter to guide us on the work ahead, detailed project deliverables, and the implementation timeline for each module.  The estimated go-live dates for each module are as follows:

  • ACUC – January 31, 2019
  • IRB – June 21, 2019
  • Agreements (Phase I) – August 30, 2019
  • Grants – July 1, 2020
  • Agreements (Phase II) – July 1, 2020
  • Export Control – November 6, 2020

The ACUC team completed the onboarding phase. This involved detailed training/discussion sessions and gathering of system requirements to determine best approach for alignment with FSU business processes and higher education best practices.  Huron developers are now working on these requirements to fulfill the necessary changes to meet FSU’s needs for the ACUC module.  Members of the project team have met with the ACUC Committee and committee members have been offered opportunities to be closely involved in the process.  Once completed, the implementation period will begin which will include testing, training and ultimately deployment of the system.  Broad communication will be provided to all who interact with the ACUC.   

Further information about the project, as well as training opportunities, will be shared with campus as we continue to progress through the project path this fall.  A project website will be launched in late October and will contain detailed project information.  If you have any questions or concerns, please do not hesitate to contact one of us. 

Kerry Peluso, Assistant Vice President for Research Administration and Finance
kpeluso@fsu.edu
(850) 644-8664 

Angie Rowe, Project Manager, Office of Research
arrowe@fsu.edu
(850) 644-8659

NSF Issues Notification Requirements Regarding Findings of Sexual Harassment, Other Forms of Harassment, or Sexual Assault

Effective 10/21/2018, the National Science Foundation (NSF) is implementing a new requirement that all findings/determinations of sexual misconduct (sexual harassment or sexual violence) or discrimination, by an NSF funded PI or co-PI, be reported to the NSF.  Based on the reported conduct, the NSF will then determine if there will be any impact to the award amount or assigned PI/co-PI. This new term and condition will be effective for any new award, or funding amendment to an existing award, made on or after the effective date of the revision. 

FSU’s Offices of the Vice President of Research and Human Resources are working together to ensure that the proper procedures are in place to ensure compliance with these conditions, while ensuring confidential protection where required.  

The details of this notice are available at: https://www.federalregister.gov/documents/2018/09/21/2018-20574/notification-requirements-regarding-findings-of-sexual-harassment-other-forms-of-harassment-or

Applicable University policies are available at:

Questions regarding the new NSF reporting requirements or the applicable University policies may be directed to: Amber Wagner, Deputy Title IX Coordinator, amwagner@fsu.edu or 850-645-1458.

New Online Research Administrator’s Educational Program

The Office of the Vice President for Research is pleased to announce that the development of a comprehensive online program for research administration education is currently in production.  The program will provide the foundation of knowledge that administrator’s need to have to administer research projects at FSU.  The program will be called eSPEAR.  The curriculum for this program has been developed by a Committee which includes members of both central and departmental/college offices.

The goal of this project is to ensure that FSU’s administrators have the knowledge they need to best assist our researchers in making decisions about their projects and ensuring the best use of the research funds received from outside sponsors.  This program will the based on SRA’s current educational program as well as additional materials that will be developed by the Committee and others from both central and departmental/college offices.  While the program is expected to be fully completed during FY20, individual modules will be rolled out sooner.

Further information about this program, including the expected availability of individual modules, will be shared via the Office of Research Newsletter.  Questions regarding this program should be addressed to Kerry Peluso at kpeluso@fsu.edu.

Fall 2018 GAP Announcement: 

Are you a member of the FSU research community currently working on new discoveries in your lab that might have value as a commercially available product? Would up to $50,000 in additional funding help you get your idea closer to the point where an outside company would be interested in licensing that product or idea? If you answered yes to any of these questions, the FSU Grant Assistance Program (GAP) may be for you. 

GAP is a competitive grant program designed to help FSU Researchers move their research towards commercialization. The competitions are managed by the Office of Commercialization and are held twice a year, spring and fall semesters. The next competition will be held on December 4th. Specific program details highlighting the simple straightforward process and deadline dates are listed on the GAP Program webpages. To be considered for fall 2018 GAP, pre-proposal applications are due in the Office of Commercialization on or before October 5th. 

For questions, contact Beverlyn Samuels at (850) 644-9318 or email bsamuels@fsu.edu.

The Path to Implementation of an Integrated Research Administration System Begins at FSU

The Office of Research is very pleased to announce the upcoming university-wide implementation of the Huron Research Suite.  This multi-year, multi-phased project will provide FSU researchers and administrators with comprehensive tools to support the administration of research within one integrated system.  This software includes electronic proposal development and routing as well as system-to-system proposal submission (where available by sponsor).   It will also provide tools for the development and management of IRB and IACUC protocols and for the management of subcontracts, contract negotiations, and export controls.  Five modules will be included as part of this project (IRB, IACUC, Export Controls, Grants and Agreements). 

This software solution has been successfully implemented in many other universities who have reported success in reducing the administrative burden related to research administration while increasing transparency and efficiency.  Some of the positive outcomes  include Penn State reporting  a 46% reduction in the average number of days from submission to approval of IRB protocols (expedited and full board reviews) and MD Anderson reporting a 10.6% reduction in average time to approval for new IACUC protocols and a 34.5% reduction in average time to approval for IACUC amendments.  Other schools have consistently noted the benefits of electronic proposal routing noting that it has provided them with a streamlined approach to building, tracking, processing, and submitting proposals on behalf of the University.  

Currently, the project is in the discovery and planning phase.  Departmental administrators, researchers, and central department staff members are meeting with Huron consultants to provide the information and input necessary to create a project roadmap and timeline that will best support our research community.  The project is anticipated to last for approximately 24-30 months.  Throughout the project, we will provide updates via newsletters, a project website, email communications, town hall forums, departmental meetings, and other communication channels.  Our goal is to keep you informed on a timely basis throughout this project and to ensure you are aware of, and fully prepared for, any changes prior to them occurring.    

As noted above, we are in the preliminary stage of this project, so there is nothing that you need to do now.  Further information will be shared in September.  If you do have questions about the project, we encourage you to contact one of us. We welcome your feedback as we embark on this journey together to enhance research administration at FSU. 

For more information on the Huron Research Suite, please visit https://vimeo.com/191231871.

New Procedures for Award Notifications and Approvals

Procedure for Notifying Principal Investigators of New Grant Awards and Amendments

In order to set up sponsored projects in a quick and efficient manner, Sponsored Research Administration (SRA) is modifying the approval procedure for new grant awards and amendments having standard terms and conditions. SRA will continue to send the award documents to the Principal Investigator (PI) and grants project manager for review and to identify any inaccuracies in the award document. If the PI does not notify SRA of any issues within 48 hours, SRA will set up the project as proposed and awarded.

As mentioned above, this new procedure will only apply to those grants and award documents that have standard terms and conditions acceptable to FSU including the Federal-wide Research Terms and Conditions (RTCs), NSF Grant General Conditions and Cooperative Agreement Conditions, NIH Standard Terms of Award, DOE Standard Research Terms and Conditions, NASA Agency RTC Specific Requirements, DOC Financial Assistance Standard Terms and Conditions, and the USDA NIFA Agency-Specific Terms and Conditions.

SRA will continue to use the existing procedure for all other award documents whereby we request that the PI review the award document for programmatic and technical accuracy and provide SRA with a concurrence email. Awards without standard terms and conditions will not be set up until the PI’s concurrence has been received by SRA.

Approvals Required ONLY when the Award Received is greater than 10% from Proposed Budget

Currently, if an award is received with a total that is different from the proposed budget, SRA requires the approval of the PI, Chair and Dean on the budget summary and/or budget amendment form. Going forward, approvals will only be required when awards are received with changes that are greater than 10% from the proposal. Therefore, the PI, Chair and Dean approval will no longer be required for awards received that are 10% or less than proposed.

Issuance of a Revised Proposal and Award Policies and Procedures Guide (NSF 18-1)

The NSF Proposal & Award Policies & Procedures Guide (PAPPG), (NSF 18-1) has now been issued.

The new PAPPG will be effective for proposals submitted, or due, on or after January 29, 2018.  Significant changes include: 

  • Addition of a new eligibility subcategory on international branch campuses of U.S. Institutions of Higher Education;
  • Revision of eligibility standards for foreign organizations;
  • Implementation of the standard Collaborators and Other Affiliations (COA) template that has been in pilot phase since April;
  • Increase in the Budget Justification page limitation from three pages to five pages;
  • Restructuring of coverage on grantee notifications to and requests for approval from NSF, including referral to the Prior Approval Matrix available on the NSF website; and
  • Numerous clarifications and other changes throughout the document.

You are encouraged to review the by-chapter summary of changes provided in the Introduction section of the PAPPG.  

A webinar to brief the community on the new PAPPG will be held on December 8 at 2 PM EST. Sign up to be notified when registration is available on the outreach notifications website, by selecting “All NSF Grants and Policy Outreach Events & Notifications.”

While this version of the PAPPG becomes effective on January 29, 2018, in the interim, the guidelines contained in the current PAPPG (NSF 17-1) continue to apply.  We will ensure that the current version of the PAPPG remains on the NSF website, with a notation to proposers that specifies when the new PAPPG (including a link to the new Guide) will become effective. 

If you have any questions regarding these changes, please contact the NSF Policy Office on (703) 292-8243 or by e-mail to policy@nsf.gov.

The National Academies’ Committee on Return of Individual-Specific Research Results Generated in Research Laboratories: A Call for Public Comments 

The National Academies of Sciences, Engineering, and Medicine (the National Academies) is soliciting public comments to help inform the deliberations of a new consensus study committee.  The committee is tasked with reviewing the current evidence base and practices related to the return of individual research results generated in laboratories that perform tests on human biospecimens, and providing recommendations on the ethical, social, operational, and regulatory aspects of return of these results.  The study task covers a broad range of research from preclinical, basic biomedical sciences to clinical sciences and will consider the variety of disciplines therein including, but not limited to oncology, proteomics, pharmacokinetics, gynecology, genetics and genomics, toxicology, microbiome research, and others. More information can be found on the study’s website. 

Persons wishing to provide written comments should email returnofresults@nas.edu. The National Academies requests that comments be submitted by Friday, October 20, 2017 to allow committee consideration in advance of their October meeting. However, comments will be accepted throughout the study process.  Please note that any written information shared with the committee will be placed within a Public Access File (PAF), and may be provided to the public upon request. 

Additionally, the committee will be holding a public comment period at its next in-person meeting in Washington D.C. on Wednesday, October 24 from 4:30–5:30PM ET.  Individuals wishing to provide comments at the meeting must register here. Please note that in-person comments will be limited to 3 minutes in length. 

Please feel free to forward this call for comments to any interested colleagues. 

VP Ostrander’s Message to Researchers about Compliance Issues

Read the August 21 letter to Faculty and Staff.