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Office of Research

Information for Researchers


News and Information

OPD Becomes ORD

Beginning November 1st, the Office of Proposal Development will be known as the Office of Research Development (ORD). This change brings us more in line with similar offices at research universities across the country, and will also better reflect the range of services currently offered to the FSU community. “Research Development” encompasses a set of strategic, proactive, catalytic, and capacity-building activities designed to facilitate individual faculty members, teams of researchers, and central research administrations in attracting extramural research funding, creating relationships, and developing and implementing strategies that increase institutional competitiveness. Now in our 6th year of serving FSU faculty, ORD will continue to prepare, support, and assist faculty in their research and creative efforts. We invite all faculty to visit our website and explore the array of services we offer, and to contact us with any questions or requests.

Our AAALAC Reaccreditation Site Visit

Our AAALAC reaccreditation site visit is scheduled for December 3-4, 2019. Remember, this is not an inspection – it’s a peer assessment of our animal program! The FSU Animal Care and Use Program has been continuously accredited by AAALAC International since 2002. During the two day visit, the site visit team will tour LAR facilities, investigator maintained animal housing areas, and laboratories where animals are used. Additionally, the team will perform extensive document and medical record review. Our goal for the 2019 site visit is to be commended as an EXEMPLARY Animal Care and Use Program. Achieving exemplary will require everyone’s commitment.

Here is how you can help…

  • Don’t stop your animal work during the visit. You have work to do. Do it! In fact, the site visit team wants to see people working. Follow procedures for use of personnel protective equipment and animal transport. Do not leave post-surgical animals unattended. The team will ask many questions. Be open, transparent, and honest. Provide the necessary information and then STOP talking. If you don’t know the answer to a particular question, admit you don’t know and offer to find the answer.
  • Review your Animal Use Protocol. Know what’s described. Expect the site visitors to compare actual procedures with those described in your protocol. If there are discrepancies between your protocol and actual procedures performed in your laboratory, submit a modification.
  • Be prepared to discuss your participation in the Occupational Health Program. Site visitors typically ask how participants enroll in the program and methods for reporting workplace injuries, including allergies.
  • Familiarize yourself with and follow LAR and ACUC policies and guidelines. LAR policies are available at https://lar.fsu.edu/policies-procedures. ACU policies are available at https://www.research.fsu.edu/research-offices/acuc/policies_guidelines. Site visitors will be provided copies of all policies and guidelines and will observe for compliance.
  • Clean your area, especially surgery and procedure areas. Sanitation is minor, but if we can’t demonstrate attention to cleanliness, the team may wonder what other aspects of our Program are left unattended.
  • Ensure adequate documentation and labeling. Make sure surgery records are available, complete, and consistent with your Animal Use Protocol and the ACUC Peri-Operative Records Policy. Ensure analgesia administration is documented. Make training records easily accessible. Chemicals and drugs used in animals must be labeled and dated accordingly. Properly dispose of expired materials.
  • We will work with the site visit team to identify representative laboratories to visit and coordinate visit times with laboratory personnel. Be available during your scheduled laboratory visit. Again, the site visitors will ask many questions. Be open, transparent, and honest. Provide the necessary information and then STOP talking. If you don’t know the answer to a particular question, admit you don’t know and offer to find the answer.

SRA Open House

RAMP October 2019 Update

RAMP Agreements:  Go-Live Scheduled During the Week of November 12, 2019

We are preparing to launch the third RAMP module and greatly appreciate the time of researchers, administrators and project champions that participated in the RAMP Agreements testing sessions last month – we had roughly 60 attendees!  As a reminder, RAMP Agreements allows for the electronic routing, review and approval of non-financial research agreements and subcontracts.  RAMP Agreements will be available during the week of November 12 and at that time users can utilize the system to route their applicable agreements.  Beginning December 2, it will be required for all applicable agreements to be requested/entered through RAMP Agreements.

Throughout the month of October, we will focus on providing training for central offices as well as the research community.  All researchers and administrators are encouraged to attend one of the upcoming training workshops.  The training will walk participants through the process of completing the online system prompts and demonstrate the workflow process for RAMP Agreements with ample opportunity for questions and answers.  Guides will also be furnished through the RAMP Agreements Help Center and instructional videos will be provided at a later date.

Please email Angie Rowe at arrowe@fsu.edu to reserve your spot for one of the workshops listed below.

Date Time Location
Monday, October 21 3:30 PM - 4:30 PM Dirac Library Instruction Room
Wednesday, October 23 9:00 AM - 10:00 AM Dirac Library Instruction Room
Wednesday, October 30 3:30 PM - 4:30 PM Dirac Library Instruction Room
Friday, November 1 9:00 AM - 10:00 AM Dirac Library Instruction Room

RAMP Grants: Development is Underway

The implementation of the fourth RAMP module continues as the project team has prioritized system requirements for RAMP Grants.  Project team members are excited about the system functionality as it will allow for electronic proposal development and system-to-system submission, where available by sponsor.  Subcontracts created in RAMP Agreements will be linked to awards generated through RAMP Grants.  In addition, RAMP Grants will integrate with OMNI to automate the award setup process, allowing for more efficiencies and overall transparency throughout the award lifecycle.  More information will be shared with campus at various meetings as we work toward an anticipated go-live date of July 1, 2020.

As always, please reach out to us if you have any questions or concerns about RAMP.

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

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

New E-Spear Modules Are Live

Two more eSPEAR modules — our online research administration program — have gone live. The online educational modules now available are Introduction to Research Administration at FSU, Uniform Guidance, Proposal Development, Award Set-Up, Building Budgets and Internal Controls & Audits. The modules remaining in development are Project Management, Financial Reconciliations and Closeout, Issuing and Managing Subcontracts, and Working with PIs. These all can be accessed by following the instructions located at https://www.research.fsu.edu/research-offices/sra/resources-and-training/training/espear/

New Director of Human Subjects

We are pleased to announce a new director of the FSU Human Subjects Office. T. Howard Stone will be joining FSU Sept. 16.

Stone is an attorney who has spent a career focused on bioethics, public health and human subjects’ protection. He has been a faculty member at University of Texas Medical Branch, University of Houston and University of Louisville. He has also worked for the U.S. Armed Forces as a consultant on work related to human subjects and served as the Institutional Review Board Administrator for the Washington State Department of Social and Health Services. Most recently he served as director of the Human Research Protections office for the U.S. Department of the Army.

RAMP September 2019 Project Update

The Agreements module development is almost complete and we have established an estimated go-live date of October 28. This module will result in an electronic process for the initiation, routing and review of non-financial research agreements and subcontracts. Once RAMP Grants is launched next year, we will have the ability to link agreements with new awards generated within the Grants module.

Testing sessions for the Agreements module will be offered this month and we would like to request your participation! As a PI/Researcher, we invite you to meet with our team to test drive the new system and provide us with feedback. The time commitment is only one hour and we have scheduled multiple dates and times for your convenience. Please strongly consider attending one of the sessions listed below and email Angie Rowe at arrowe@fsu.edu to reserve a spot for the session of your choice.

Date Session Times Location
Monday, Sept 16 3:30 pm – 4:30 pm FSU Training Center, Room 211
Tuesday, Sept 17 9:00 am – 10:00 am Dirac Library Instruction Room
Wednesday, Sept 18 9:00 am – 10:00 am Dirac Library Instruction Room
Thursday, Sept 19 3:30 pm – 4:30 pm Dirac Library Instruction Room

Training courses are currently under development and will be offered next month. Detailed information will be shared with campus once the curriculum and timing is finalized.

As always, please reach out to us if you have any questions or concerns about RAMP.

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

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

Foreign Influence on U.S. Research

Issues surrounding foreign influence and international activities in federally-funded research has been an evolving topic, one for which the U.S. Government has shown growing concern. Florida State University is committed to facilitating open and publicly-accessible research and scholarly activities, both domestically and internationally. In some instances, however, restrictions must be placed on such activity in the interest of national security.

The Office of Research has prepared a document titled “Guidance on Foreign Influence & International Activities” that:

  • Summarizes recent federal notices related to disclosing foreign influence and international activities,
  • Describes best practices for FSU researchers, and
  • Provides links to additional information related to international activities.

Answers to frequently asked questions are also provided.

Contact Diana Key, Director of Research Compliance Programs, at (850) 644-8648 or dkey@fsu.edu, if you have any questions or concerns about this topic.

RAMP August 2019 Project Update

The Agreements module is well underway and the project team has worked diligently to establish requirements for the electronic routing of non-financial agreements and subcontracts. Some modifications have been made to tailor the system to meet the needs of the university and Huron has started their development work in preparation for launching this module in October. Project Champions from various colleges and central offices met with members of the project team in July to view the software and provide feedback. A few commented on how they liked the transparency of the contract negotiation process and correspondence features within this module. Testing sessions and training will be offered in late August and throughout September. The details of these activities will be communicated once the curriculum and timing is finalized.

This month we will also begin working on the much anticipated Grants module which will take almost a year to complete. This implementation will provide electronic proposal development and system-to- system submission, where available by sponsor. Additionally, subcontracts created in the Agreements module will be linked to awards generated through the Grants module. Stay tuned as there will be a lot of information to share throughout this journey - we will continue to ask for your feedback to ensure we remain on target to provide advanced technology that supports our research community!

As always, please reach out to us if you have any questions or concerns about RAMP.

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

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

Fall 2019 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 May 10th. Specific program details highlighting the simple straightforward process and deadline dates are listed on the GAP Program webpages. To be considered for Fall 2019 GAP, pre-proposal applications are due in the Office of Commercialization on or before September 13th.

For questions, contact Jessica Tailer at (850) 645 -7217 or email jtailer@fsu.edu.

NIMH Announces New Data Sharing Requirement

On June 17, 2019, the National Institute of Mental Health (NIMH) published the Notice of Data Sharing Policy for the National Institute of Mental Health, which requires that researchers who are funded by NIMH deposit all raw and analyzed data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) from experiments involving human subjects into the NIMH Data Archive (NDA), This Notice applies to all grant applications and awards that involve human subject research submitted after January 1, 2020 and applies to all Funding Opportunity Announcements (FOAs) that NIMH participates in. The Notice does not apply to following types of applications:

  • Fellowship (F)
  • Research Career Development (K)
  • Training (T)
  • Small Business (SBIR/STTR)
  • Small Grants (R03)
  • Education (R25)
  • Awards related to AIDS applications

NIMN requires that submission requests be approved by an institutional official—in FSU’s case, the Vice President for Research. Therefore, the Office of Research Compliance Programs will prepare appropriate instructions, comparable to what was developed for submission of genomic data to dbGaP. Additional information will be made available in the coming weeks to inform preparations for proposal submissions after January 1, 2020.

For questions, please contact Diana Key, Research Compliance Programs, at (850) 644-8648, or dkey@fsu.edu.

Welcome to the New IRB System—Enhanced Electronic Software to Support Human Subjects Research

The RAMP IRB system launched successfully on June 21st and almost 90 submissions have been received to date. Many researchers and students are commenting that the system is user-friendly and that once they get more familiar with the new software, it will be a significant improvement compared to HSRS. RAMP IRB provides for greater transparency, as users can view the workflow diagram to understand the status of their submissions at any point in time. Also, the ‘Add Comment’ feature in RAMP IRB is being used to facilitate communication both within research teams and with the IRB Coordinators, creating a central location for all information on the study workspace.

Importantly, team training can be monitored more conveniently because RAMP IRB syncs with the CITI Program; therefore, investigator training records are updated twice daily and are visible under the ‘Training’ tab on the study workspace. In order for training records to be updated properly, the preferred email address in CITI should match the user’s FSU business or preferred email address.

Over 10 training workshops have taken place throughout campus and they have been well-attended. Some virtual trainings have been provided as well and more training sessions will be scheduled this fall. We have listened to your feedback during these workshops and we are in the process of scheduling specialized training sessions for multi-site study submissions. More information will be communicated as this training is finalized.

We encourage you to visit the Investigator Resources section of the Human Subjects Office website as it contains all relevant materials needed to help you acclimate to the RAMP IRB module, such as helpful videos and webinars. You can also access user guides within RAMP IRB in the Help Center.

Please let us know if you have any questions or concerns. We are here to help!

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

Eric Holmes, Assistant VP for Research
Interim Director, Human Subjects Office
ehholmes@fsu.edu
(850) 644-5929 *email for faster response

RAMP July 2019 Project Update

The RAMP IRB module has launched. Researchers and administrators can now develop and submit Human Subjects Protocols, Amendments, Continuing Reviews and Reportable New Information in RAMP IRB to take advantage of the enhanced electronic submission and review process.

How can you learn more about how to use RAMP IRB?

How can you learn more about how to use the Human Research Protection Program (HRPP) Toolkit?

  • Review the following training resources available on the Human Subjects Office website in the Training and Education section
    • Protocol Writing Workshop
    • Investigator Webinars – 2 part supplemental guides
    • Investigator Manual
  • Review the HRPP Toolkit FAQs provided on the RAMP project website

How can you communicate questions or concerns about RAMP?

We will continue to support RAMP IRB throughout July and the months ahead. In addition, this month we will begin the implementation process for phase I of the Agreements module, which includes non-financial agreements and subcontracts. Meetings will be held with project team members to view demonstrations of the system, make comparisons of system functionality and current business processes and establish system requirements. This module is scheduled to be deployed in October 2019.

Research Misconduct and Research Proposals

Most researchers understand that plagiarism, fabrication and falsification in published journal articles and presentations constitutes research misconduct. However, did you know that these actions are also considered research misconduct when included in research proposals and grant applications? This infographicpublished by Health and Human Services, Office of Research Integrity provides useful tips to avoid research misconduct when writing proposals.

Information about research misconduct and FSU’s policy and procedures is located here. Contact Diana Key, Director of Research Compliance Programs, at (850) 644-8648 or dkey@fsu.edu if you have any questions or concerns about this topic.

Kathleen Haughney
Assistant Director for Research Communications
850-644-1489
@FSUResearch

New IRB System Goes Live This Month – Important Changes Ahead

The Human Subjects Office is prepared to support the research community for the launch of the RAMP IRB module on June 21st.  We would like to share important information at this time as we prepare to transition from HSRS to the RAMP IRB module.

As a reminder, studies that were submitted on or after 4/20/19 that completed the short application, Protocol template, and are in the “Approved” status by 6/14/19, will be migrated to RAMP IRB. 

Training

Protocol Writing Workshops were offered on multiple dates and locations to provide training on using the Human Research Protection Program (HRPP) Toolkit protocol template.  A recording of this workshop, along with other webinars providing guidance on using the protocol and resources contained within the toolkit, are available on the Human Subjects Office website.  Access these training resources by clicking here.  Also, HRPP Toolkit FAQs are available on the RAMP project website and by clicking here.

RAMP IRB Researcher Training Workshops are currently being offered to all individuals involved in human subjects research.  These workshops provide attendees with a walk-through of the process for completing the RAMP IRB system prompts and provide ample opportunity for questions and answers.  Although in-person attendance is strongly encouraged, a recorded workshop will be available in the near future and a notification will be sent out through the IRB Listserv once it is posted.  Please email humansubjects@fsu.edu to register for the workshop of your choice or to be added to the IRB Listserv.

Date

Time

Location

Thursday, June 6

3:30 PM – 4:30 PM

Carothers Hall, Room 304

Monday, June 10 (waiting list)

3:30 PM – 4:30 PM

FSU Training Center, Room 211

Tuesday, June 11 (waiting list)

11:00 AM – 12:00 PM

Student Services Building, Room 301

Monday, June 24

1:00 PM – 2:00 PM

Student Services Building, Room 301

Wednesday, June 26

3:30 PM – 4:30 PM

Carothers Hall, Room 304

Friday, June 28

11:00 AM – 12:00 PM

Carothers Hall, Room 304

Tuesday, July 2

3:30 PM – 4:30 PM

FSU Training Center, Room 211

Tuesday, July 9

9:00 AM – 10:00 AM

FSU Training Center, Room 211

Thursday, July 11

3:30 PM – 4:30 PM

FSU Training Center, Room 211

How to Access RAMP IRB

There are three ways to access the RAMP IRB module. 

How to Obtain Help with RAMP IRB

The Help Center within the RAMP IRB module contains guides and videos to aid in the use of the system.  If you have questions or need further assistance, please email RAMP-IRB@fsu.edu.  This email is checked frequently and a knowledgeable staff member will promptly assist you.  We ask that you email rather than call in order for the team to document the types of questions asked to provide relevant updates to training resources and FAQs.

June 2019 RAMP Project Update

The RAMP IRB Module is scheduled to go-live on June 21, 2019.

Thank you to all of the individuals that participated in the RAMP IRB testing sessions – we had over 40 attendees!  Your feedback was helpful and assisted the team in designing the RAMP IRB training materials.  Our project focus throughout June and July is to provide the training necessary for researchers, administrators, and IRB committee members to help them successfully navigate the RAMP IRB module.  The Human Subjects Office staff have been trained and they are now leading the training workshops. 

We encourage all individuals involved with human subjects research to attend one of the upcoming training workshops.  The training will walk participants through the process of completing the online system prompts and provide ample opportunity for questions and answers.

Please email humansubjects@fsu.edu to reserve your spot for one of the workshops listed below or to be added to the IRB Listserv to receive important announcements.

Date Time Location
Tuesday, June 4 9:00 AM - 10:00 AM FSU Training Center, Room 211
Thursday, June 6 3:30 PM - 4:30 PM Carothers Hall, Room 304
Monday, June 10 (waiting list) 3:30 PM - 4:30 PM FSU Training Center, Room 211
Tuesday, June 11 (waiting list) 11:00 AM - 12:00 PM Student Services Building, Room 301
Monday, June 24 1:00 PM - 2:00 PM Student Services Building, Room 301
Wednesday, June 26 3:30 PM - 4:30 PM Carothers Hall, Room 304
Friday, June 28 11:00 AM - 12:00 PM Carothers Hall, Room 304
Tuesday, July 2 3:30 PM - 4:30 PM FSU Training Center, Room 211
Tuesday, July 9 9:00 AM - 10:00 AM FSU Training Center, Room 211
Thursday, July 11 3:30 PM - 4:30 PM FSU Training Center, Room 211

Although in person attendance is strongly recommended, a recorded training workshop will be made available soon on the Human Subjects Office website (notification will be sent out on the IRB listserv once it is posted) and within the RAMP IRB module once the system is live.

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

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

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

New IRB Changes in Effect: Toolkit Training & RAMP IRB Module Activities

The Human Research Protection Program (HRPP) Toolkit was launched on April 20. It contains a comprehensive collection of documents that will support compliance, contribute to transparency in the IRB process, and aid in the transition to the RAMP IRB module (which will go-live on June 21).

Following are some important reminders related to using the Toolkit:

  • New protocols and continuing reviews (renewals) require the submission of a protocol document that is part of the HRPP Toolkit.
    • For the HRPP Toolkit templates, click on this link
      **NOTE: The submission of a protocol document using the HRPP Toolkit templates is required for ALL new protocols and continuing reviews (renewals) submitted on or after Saturday, April 20. Any submissions that do not use the HRPP Toolkit templates will be returned for corrections.
  • All protocol modifications (changes in protocol) will be presented with the option to either submit using the current application process, or the protocol document that is part of the HRPP Toolkit.
  • All of these submissions will occur in HSRS until the RAMP IRB module is launched in June
  • Training – Protocol Writing Workshops were offered in March and April to provide training on using the HRPP Toolkit documents. If you were unable to attend the workshop or if you need a refresher, please be sure to access the following training resources:
    • Protocol Writing Workshop recording can be accessed on the Human Subjects Office website at this link
    • Webinar – provides supplemental tips on using the documents contained within the HRPP Toolkit
    • Investigator Manual – resource designed to guide you through policies and procedures related to the conduct of Human Research

Information regarding the transition of submissions from HSRS to RAMP IRB:

  • All submissions in the HSRS that have been updated with the HRPP Toolkit templates will automatically be imported into RAMP IRB when the module goes live on June 21st.
  • Any submissions that have not been updated to the HRPP Toolkit templates will not be automatically imported into RAMP IRB. Protocol modifications (changes in protocol) or continuing reviews (renewal) for these submissions will require a new submission in RAMP IRB using the HRPP Toolkit templates. For this reason, the Human Subjects Office highly encourages investigators to begin utilizing the HRPP Toolkit templates as soon as possible.

Please email ramp-irb@fsu.edu for any questions related to the HRPP Toolkit or RAMP IRB module. We are ready to assist you through this transition.

May 2019 RAMP Project Update

The Human Research Protection Program (HRPP) Toolkit is launched and now available for use. As a reminder, the toolkit is the first component of implementing the RAMP IRB module. The toolkit provides updated protocol and consent form templates and are required to be used for submitting new IRB protocols and continuing reviews of existing IRB protocols. For modifications, researchers will have the option to submit using the HRPP Toolkit templates or the current application form. At this time, all submissions should be remitted in the HSRS system.

The RAMP IRB module development is almost complete and we remain on schedule for our go-live date of June 21. This module will result in an electronic process for the development, submission and review of IRB protocols. Once the RAMP IRB module is launched, protocols, continuing reviews, and modifications will be submitted in the new system. Additionally, the submission of Reportable New Information will also be supported within the RAMP IRB module.
We would like to offer you an opportunity to be part of this process. As a PI/Researcher, we invite you to meet with our team to test drive the new system and provide us with feedback. The time commitment is only one hour and we have scheduled sessions at multiple dates and times this month for your convenience. Please strongly consider attending one of the sessions listed below and email humansubjects@fsu.edu to reserve a spot for the session of your choice.

Date Session Times Location
Tuesday, May 21 9:00 – 10:00
10:00 – 11:00
11:00 – 12:00
Student Services Building, Room 301
Thursday, May 23 2:00 -   3:00
3:00 –  4:00
4:00 –  5:00
FSU Training Center, Room 211
Friday, May 24 9:00 – 10:00
10:00 – 11:00
11:00 – 12:00
FSU Training Center, Room 211

Training for the RAMP IRB module will occur this month for the Human Subjects Office team and IRB committee members to ensure they are comfortable in navigating through the module for protocol review workflow. We are currently in the process of developing training workshops for PIs and proxies that will be offered next month. This information will be shared 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

Online Research Administration Education Courses Are Live

As previously announced, a new research administration certification program is currently under development. Almost the entire program will be offered online allowing learners to take the courses at any time and review them as needed. The courses that are now live are "Introduction to Sponsored Research Administration at FSU" and "Uniform Guidance." More information on these courses and how to register is available at https://canvas.fsu.edu/enroll/KHEGRG. Additional courses will be made available as completed. The complete certification program is anticipated to be fully available in early 2020.

April 2019 RAMP Project Update 

The RAMP IRB module development is underway and it remains on schedule for deployment in June.    

The first component of releasing this module is to launch the Human Research Protection Program (HRPP) Toolkit, which will go into effect on April 20.  This toolkit is a comprehensive collection of documents that will support compliance and contribute to transparency in the IRB process.  The HRPP Toolkit forms will be uploaded as part of the submissions into the current HSRS system beginning April 20 until the RAMP IRB module is launched on June 21.  At that time, the HRPP Toolkit forms will be uploaded into the RAMP IRB module. 

Training is essential and Protocol Writing Workshops were offered in March and early April to provide guidance to faculty and students on how to complete their protocols using the HRPP Toolkit forms. For those that were unable to attend, a recorded workshop session will soon be available on the Human Subjects website (a notification will be sent out via the IRB listserv once it is available – to sign up for notifications, please send an email request to humansubjects@fsu.edu). 

Details concerning the IRB changes are being communicated to deans, chairs and faculty this month as we participate in various meetings across campus and respond to any questions or feedback about the new process.  Central office staff are also being educated on the changes to ensure they are ready to support researchers. 

As we look ahead, our focus in May will be testing the new system and providing additional training.  Researchers and administrators will have an opportunity to test drive the RAMP IRB module and share valuable feedback to aid in our training efforts.  Training workshops will also be held to assist with the transition to submitting protocols through RAMP.  These workshop dates and locations will be shared soon.  

For the most current information on RAMP, please visit the RAMP project website.  Stay tuned as we strive to keep you well informed every step of the way! 

If you have any questions, please contact Angie Rowe (arrowe@fsu.edu, or 644-8659) or Kerry Peluso (kpeluso@fsu.edu or 644-8664).

New Human Research Protection Toolkit

The Office of Human Subjects has been working on the development of the Human Research Protection Program (HRPP) Toolkit – scheduled to go live on April 20 This coincides with the implementation of the new Institutional Review Board module through the Research Administration Management Portal, which is set to go live June 21

The toolkit is a comprehensive collection of documents that will support compliance and contribute to transparency in the IRB process.

Beginning April 20, All new protocols and continuing reviews will require the submission of a protocol document that is part of the HRPP toolkit. The HRPP toolkit templates can be found by clicking on this link.

All protocol modifications will be presented with the option to either stay with the current application process, or submit using the protocol document that is part of the HRPP toolkit.  

All submissions in the HSRS system that have been updated with the HRPP toolkit will automatically be imported into RAMP IRB when the module goes live in June. 

Any submissions that have not been updated to the HRPP toolkit will not be imported into RAMP IRB.  Modifications or continuing reviews for these submissions will require a new submission in RAMP IRB using the HRPP toolkit templates. 

To support the HRPP toolkit launch in April, the Office conducted several protocol writing workshops.  If you were unable to attend, a session has been recorded and will be available on the Human Subjects website soon.  We will send out a notification once it is uploaded. 

Human Subjects ListServ 

The Office of Human Subjects Research (the Office) has created an IRB listserv to communicate important information to study teams.  Several messages have already been disseminated using this method.  If you have not received the messages and would like to be added to the listserv, please send an email request to humansubjects@fsu.edu

Understanding Restricted Party Screening 

Multiple U.S. government agencies maintain exclusion lists of individuals, companies, and other organizations that are somehow restricted from doing business with U.S. entities like FSU. As an exporter, FSU is expected to ensure that any export transaction does not include an entity identified on one of the lists of restricted parties. If FSU completes a non-compliant transaction with a restricted party, a violation will have occurred which could lead to severe consequences for the individual making the transaction and the University. 

To ensure that the University has the ability to screen entities for inclusion on lists of restricted parties, FSU subscribes to Visual Compliance™, a web-based tool that allows FSU employees to easily perform restricted party screenings at no cost. A single screening simultaneously searches all U.S., State of Florida, and many foreign exclusion lists and returns the results accompanied by information about the screened entry. 

FSU has unlimited licenses for employees and screening is voluntary. The Office of Research Compliance Programs (ORCP) recommends that departments screen potential foreign visitors who come to FSU for 14 days or less if they will have access to sensitive information or areas. (Visitors approved to visit for more than 14 days are screened by ORCP during the visit approval process.) ORCP also recommends screen foreign collaborators when the transaction is not processed through a central office.  ORCP will conduct screening on behalf of departments upon request. 

Listed below are the types of entities that should be screened. Most of these entities are screened by FSU central offices when they receive transactions; however, employees and departments are may screen them prior to initiating any transactions to avoid any potential issues. 

  • Foreign subrecipients, subcontractors, and suppliers
  • Foreign sponsors of research, travel, and conferences
  • Foreign entities party to other types of agreements (Data Sharing Agreements, Material Transfer Agreements, Non-Disclosure Agreements, Intellectual Property Licenses, International Exchange or Collaboration Agreements, etc.)
  • University-sponsored applicants on H1-B, J-1, and other visas
  • All users of FSU’s DD2345 (Militarily Critical Technical Data Agreement) or other persons being vetted specifically for export compliance/national security purposes; 

For additional information on Visual Compliance (registering for an account, receiving training, and screening instructions, please see this PDF document. Information on Export Controls is located at https://www.research.fsu.edu/research-compliance/export-controls/

Contact Diana Key, Office of Research Compliance Programs (ORCP), (850) 644-8648, for questions about using Visual Compliance.

Proposal Editing Services Available Through OPD

The Office of Proposal Development offers proposal editing services to all FSU faculty. So what should you expect when you ask the Office of Proposal Development staff to take a look at your proposal?  We focus primarily on the “grantsmanship” aspects of the proposal: things like presentation, structure, readability, and focus, as well as more basic concerns like spelling, grammar, and punctuation. These are all critical components of a successful proposal, but it’s very easy to get so engrossed in writing that you forget about them. This is especially true the longer into the process you get, as it’s human nature to avoid finding fault in our own work. Other times you’ve just seen something so much that you stop seeing the details, and only see the product as a whole.

Some of the questions we ask when editing include:

  • Does the proposal follow the formatting instructions in the funding opportunity?
  • What is the PI trying to accomplish? What’s the overall goal of the project?
  • How is it done currently, and what are the limitations of that?
  • What’s new in the PI’s approach, and why do they think it’ll work?
  • Why is this important? What difference does it make it the project is successful?
  • What are the risks and rewards of the proposed project?
  • How much will it cost, how long will it take, and how will the PI make sure that it gets done?
  • What are the metrics for success?
  • Are all acronyms defined, and are all concepts explained?
  • Is it structured like a proposal, and not a publication?
  • Is it difficult to read? Are there lots of walls of text and run on sentences?
  • Does the PI adequately explain all of their proposed tasks?
  • Does the PI make it clear when and where they are addressing the review criteria?

Note on that last question however that OPD does not evaluate how well you’ve addressed the criteria. That’s up to the reviewers. What we try to do is make sure that the proposal has specific statements that are clearly intended to address the questions that the reviewers have to answer. Another question we often get is “How long before the deadline should I send my proposal?” The answer is as soon as possible! The level of detail we can give each proposal is directly related to the amount of time we have. A proposal sent two weeks before the funder’s deadline will get a more in-depth review, while one sent 2 days before might just get a basic review. Also keep in mind that you’ll need time to make any revisions as well.

Want to learn more?  Feel free to contact any of the OPD staff with questions you might have. 

RAMP March 2019 Project Update

ACUC Module

This module launched on January 31.  Nine protocol development workshops were offered throughout January and February to assist researchers and administrators with the transition to the new system.  

The grace period for paper protocol submissions has ended.  New protocols and triennial rewrites should be developed and submitted through RAMP.  Amendments to existing protocols require current forms until a triennial rewrite is entered into RAMP. 

The FSU ACUC desires to help facilitate your research goals.

  • Please contact a LAR veterinarian for assistance with protocol development
  • For assistance completing the SmartForm or for technical assistance with RAMP, please email ramp-acuc@fsu.edu
  • RAMP ACUC Researcher’s Guide is available within the RAMP Help Center
  • FAQs for the ACUC module are located on the RAMP project website

IRB Module

We have started the implementation process for the IRB module within RAMP.  In February, the IRB project team reviewed the software and provided input for designing this module to meet the needs of the IRB community.  Huron will complete development tasks based on the team’s feedback during this month.

A significant component of this implementation includes the adaptation of the Human Research Protection Program (HRPP) Toolkit, which contains streamlined protocol templates and consent forms for drafting compliance documents.  The HRPP Toolkit will launch prior to the system go-live in June.

FSU is fully engaged and ready to take advantage of the many benefits offered through the HRPP Toolkit and IRB module.  Following is an estimated timeline to help guide you on what to expect in the coming months:

  • The HRPP toolkit will launch in early April (protocol development workshops will be offered to assist with the transition).
  • After the toolkit is implemented, the project team will focus their attention on the implementation of the IRB module.
  • In April, researchers and administrators will have various opportunities to have a first-look at the system and provide valuable feedback to enhance the user experience.
  • Training will be offered in May to help with conversion to the new IRB system.

More information will be shared with the IRB community as we reach these important milestones.  We encourage you to visit the RAMP project website at https://ramp.research.fsu.edu for more detailed information on the project timeline, project goals and activities, training and FAQs.  This website is updated periodically to provide timely and helpful information.

If you have any questions, please contact Angie Rowe (arrowe@fsu.edu, or 644-8659) or Kerry Peluso (kpeluso@fsu.edu or 644-8664).

RAMP February 2019 Project Update

The RAMP ACUC module has launched. Researchers and administrators can now develop and submit Animal Use Protocols in the system to take advantage of the electronic submission and review process. 

How can you learn more about how to use RAMP?

  • Attend one of many Protocol Development Workshops being offered – dates, locations and registration instructions can be accessed within the training section of the RAMP project website.
  • Access the ACUC Researcher Guide (available in RAMP within the Help Center tab)
  • Review the ACUC FAQs provided on the RAMP project website
  • For assistance completing the SmartForm (online protocol forms) or for technical assistance, email ramp-acuc@fsu.edu 

How can you communicate questions or concerns about RAMP?

  • Participate in either of the following Town Hall Meetings
    • February 6, 2019 | 9:00am – 10:00am
      College of Medicine, room 1302
    • March 4, 2019 | 3:30pm – 4:30pm
      FSU Training Center, room 205
  • Contact Angie Rowe, arrowe@fsu.edu, or Kerry Peluso, kpeluso@fsu.edu 

This month we will begin the implementation process for the IRB module.  Meetings will be held with IRB staff members to view demonstrations of the system, make comparisons of system functionality and current business processes and establish system requirements.  We remain on schedule to deploy this module in June 2019.

Research Administration Management Portal is Live – Join Us for Town Hall Meetings

The anticipated launch of the RAMP ACUC module has arrived!  Today the first module within our new research system is available for Principal Investigators to develop and submit Animal Use Protocols. 

To assist in the transition, town hall meetings have been organized to brief our research community on the functionality offered within the RAMP ACUC module, when the system should be used, and to address any questions or concerns.  Our aim is to connect with researchers and administrators and provide helpful information on training and resources available to allow for a seamless conversion.

Researchers and administrators, please join us on either of the following dates.  We want to hear from you and hope see you there! 

February 6, 2019 | 9:00am – 10:00am
College of Medicine, room 1302

March 4, 2019 | 3:30pm – 4:30pm
FSU Training Center, room 205 

For more information on training sessions and FAQs, please visit the RAMP project website.

Questions? Contact Kerry Peluso, kpeluso@fsu.edu, or Angie Rowe, arrowe@fsu.edu.

RAMP January 2019 Project Update

The ACUC module is almost finalized and it is scheduled to go-live on January 31, 2019.  We are thrilled to launch the first module within RAMP as we progress along the path to a comprehensive and integrated research system.  Our focus this month is to share information with researchers and administrators on the functionality offered within the ACUC module, provide forums for addressing questions/concerns, and provide opportunities for users to gain the knowledge necessary to successfully navigate the new system. 

Laboratory Animal Resources will be offering protocol development workshops to assist researchers with the transition to RAMP.  These workshops will walk participants through completing the online protocol form, offer best practices for responding to protocol prompts and reviewer comments, and provide ample opportunity for questions and answers.  The workshops are scheduled for January 17, 24, 31 and February 7, 14, 21, 28 at 1:30 p.m.  To register, email Lbrown5@fsu.edu (each class is limited to the first 8 respondents).  Additional workshops will be scheduled for alternative dates/times and this information will be published soon.

The deployment of the ACUC module will adhere to the following implementation schedule, as approved by the FSU ACUC.

  • Beginning January 31, 2019, RAMP will be available for new protocol submissions and triennial rewrites.
  • The ACUC will accept new protocol submissions and triennial rewrites using current forms until 11:59 P.M. on February 28, 2019, to allow investigators who may have begun protocol drafts using current forms an opportunity to complete drafts and submit.
  • Amendments to existing protocols will be submitted using the current forms until a triennial rewrite is entered in RAMP.

Town Hall meetings will be offered next month to provide more information on the new system and transition to it.  Details regarding the dates and locations of these meetings will be announced soon. For additional information about RAMP, please visit the project website at https://ramp.research.fsu.edu.

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

Research Data and Data Use Agreements

A Data Use Agreement (DUA) is a contractual document between a Data User and a Data Provider, describing the provisions associated with the transfer of confidential, protected, or restricted-use data. Examples include records from governmental agencies or corporations, student records information, existing human research subjects data, and limited data sets. Broadly speaking, DUAs can be either Incoming (FSU receives data from an outside entity) or Outgoing (data housed at FSU are shared with an outside entity).

DUAs address important issues such as limitations on use of the data, liability for harm arising from the use of the data, publication, and privacy rights that are associated with transfers of confidential or protected data. The DUA also assures that the Data User is using the data in accordance with applicable law (e.g. HIPAAFERPA), and prevents the inappropriate use of protected or confidential data that could cause harm to the investigator, the University, or individuals whose data is part of the data set.

Sometimes, a transfer of data from one entity to another is addressed in the context of a larger agreement between the parties, such as a subaward agreement or a contractual services agreement.  For data requested from an outside organization, it is the responsibility of that organization to determine whether a DUA should be executed before providing the data.  When sharing data housed or owned by FSU with an outside organization, the University must consider multiple security and compliance criteria before determining whether or not a DUA is needed. The Office of Research Compliance Programs (ORCP) will work with the researcher to develop an appropriate agreement as needed.

All DUAs—Incoming and Outgoing—associated with research projects must be reviewed by ORCP and signed by the Vice President for Research (VPR) prior to receipt of the data by the investigator.

Investigator Responsibilities

It is important for researchers to read the terms of a DUA before forwarding it to ORCP for review. It is the researcher’s responsibility to understand and strictly follow the terms of the DUA. ORCP assumes that a researcher who transmits a DUA to ORCP has read and agrees to conform to those terms. The researcher may or may not be required to sign the DUA (as an acknowledgment rather than institutional acceptance). However, the VPR serves as the authorized signatory for research-based DUAs. DUAs must be routed through ORCP for final sign-off and approval.

Additional Information

Additional information about Data Use Agreements, particularly with regard to human subjects research, may be found here.

Questions about DUAs may be addressed to Diana Key, Director, Research Compliance Programs, at (850) 644-8648 or dkey@fsu.edu.

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.