Research division reports
Environmental Health and Safety:
Select agent program renewal
USU underwent a select agent program compliance inspection. The inspection was conducted by two USDA inspectors. The program review lasted four days and included select agent facilities, review of all select agent documentation and interviews with select agent personnel. The inspection was closed out with full compliance status after a few questions were addressed.
Successful LARC and USTAR select agent lab shutdowns
The USTAR building was shut down in November 2015 and the LARC was shut down in May 2016. The shutdown included conducting refresher training for all select agent personnel, plan specific exercises, certification of all equipment and HEPA filters, and maintenance of all building mechanical, plumbing and electrical systems.
Each lab was re-certified by World BioHazTec. This certification included HVAC system failure testing which is required by the select agent program.
During the LARC shutdown the security system was upgraded to new thumb readers on the shower room doors and anteroom door. Two independent number pad locks were replaced by two prox-card readers that communicate through the USU i-net system.
Biosafety level 2 & 3 oversight
EHS conducted inspections of BSL-2 & 3 labs and provided BSL-2 & 3B Blood Borne Pathogens training for approximately 225 faculty, staff and students.
USU Eastern environmental health and safety program
Frequent trips were made to the USU Eastern Campus to provide safety training, establish OSHA safety programs and address safety concerns. Safety training was conducted on Blood Borne Pathogens, Hazard Communication, Lock Out/Tag Out, Fork Lift Operations, Aerial (Scissor) Lift Operations, Confined Space Entry, Respiratory Protection and Ergonomics. There have been approximately 150 people trained these areas.
Oversight has been provided to establish a LO/ TO Program, Confined Space Program, Hazard Communication Program, Aerial Lift Operator Program and Fork Lift Operator Program.
Several Safety Concerns were raised by a few USU Eastern Employees. These concerns were investigated and addressed with the individuals and the appropriate USU Eastern administration.
Asbestos, hazardous material projects
Building renovations and demolitions require identification and removal of hazardous materials.
EHS has been involved in over 50 hazardous material projects of varying sizes in last 12 months. These projects have been on the Logan Campus, USU Eastern Campus and Tooele Campus. This averages approximately one project every week. These projects include identifying the material and the location of the material; scheduling and conducting a bid walk with contractors for the project; and overseeing the removal (abatement) of the hazardous material.
Ongoing occupational safety oversight for facilities, Housing, Food Services, Regional Campuses
There was continued oversight and training for OHSA required occupational safety programs. Training was conducted in forklift operation, LOTO, Confined Space, Electrical Safety.
Additional EHS officers
Two additional Environmental Health and Safety Officers will be hired. One will be located at the Logan Campus and a second located at USU Easter Campus.
Continued application of radioactive waste volume reduction resulted in reducing the amount of waste to ship off-site for disposal by 128 pounds.
1,566 containers totaling 77,894 pounds received, half the waste received last year.
EHS continued to complete general administrative duties including a yearly supply assessment and purchasing, attendance at the College and University Hazardous Waste Conference, improving On-Site Systems to improve waste pick up, developed a plan to deal with Nitric acid release in EL203 and a waste management plan specific for the UWRL. EHS completed and submitted the Biennial Report for Disposal of Hazardous Waste including summation of all waste generated by USU. Notably, USU had a successful Air Quality Inspection by Utah DAQ.
Shipping dangerous goods
- Dangerous goods shipments to New Jersey for the Anti-Viral Group
- Developed a plan for a 500-gallon waste water sample transported from Mississippi to USU for remediation studies
- Working with the University of Utah to develop a Program for controlling the shipping of Dangerous Goods across campus
Emergency response/clean ups
- Accidental explosive neutralization of Nitric Acid/KOH in EL203
- Diesel fuel spill at the Fine Arts Building
- Repairs to the silver recovery units in the Fine arts
- “Unknown” spill at Veterinary Science
Phase I site assessments
- Phase I site assessments
- Blanding Campus Building Trades Lots
- Caine Dairy
- Blanding Heavy Equipment
- New Science Building in Tooele for Hazardous Waste Management
- Created 241 specialty maps
- Created 26 evacuation plans
- Created 16 assembly point maps
- Created 127 computer fixes
- Created 30 asbestos abatement drawings
- Went “live” with the new Emergency Response Information submittal website
- Assisted/trained the Facilities Department in creating a GIS project/database for “Building Insurance Policies” for all USU buildings in the State of Utah
- Attended 2 EOC training classes
Chemical hygiene training
EHS personnel provided safety training for 1,080 people in 25 safety training course offerings, as well as were involved in responding to numerous indoor air quality (IAQ) concerns throughout the campus community. Most issues were identified and dealt with at the time of the call. A few of the issues were not immediately obvious and more intensive investigation was conducted.
APLU National Laboratory Safety Task Force
Mark McLellan, vice president and dean of graduate studies, sat as the co-chair of the APLU National Laboratory Safety Task Force on which Steve Bilbao participated. Over the course of more than a year the task force developed “A guide to implement a safety culture in our universities.” The document included 20 recommendations for a safety culture drawn from expertise from many resources, along with tools and resources for implementation. As a result, Mark was awarded CSHEMA’s top safety award for administration, the “Administrator Who Cares” award.
USU safety and health policy #337
EHS worked with Mark McLellan, Jeff Broadbent, and other campus leaders and faculty to revise USU Policy #337. This was approved by the Board of Trustees in May 2016. Primary changes included specific responsibilities for all levels of the campus community from the President to laboratory worker. Reorganized university committee structure to improve communication channels for safety related concerns.
Institutional Review Board:
The 2015-2016 academic year was a landmark year for the Institutional Review Board. More research applications (protocols) were submitted and reviewed than any year in the IRB’s history – 1,181 total reviews took place. Along with the increase in protocols came an increase in the complexity of USU’s human subjects research portfolio, with more than 30 protocols filed for research to be conducted in international locations.
Both abroad and at home, USU researchers are working with an increasingly diverse participant population. Not surprisingly, this has resulted in a growing need for high-quality translations of informed consent documents. In April 2016, the IRB Director was awarded an internal grant to assist researchers in defraying the cost of obtaining certified translations. Awarded by the Utah State University Diversity Council, the terms of the grant allow for the translation of up to two pages of consent documents if 1) the document will receive a relatively wide distribution; 2) the population also receives an advertisement or information about a service or organization that is relevant to the population of study; and 3) the study is not otherwise funded or supported. This initiative aligns with the strong social justice values that the Utah State University IRB incorporates in each of its protocol reviews.
The USU IRB hopes that in addition to learning something of value about the population of study, researchers can work to provide support and information that is relevant to the day-to-day lives of the individuals giving their time to the research project. For example, a study seeking Hispanic and Latino teenagers as participants might provide information about college scholarships directed toward Latino youth along with a translated consent form, so that parents receiving the form will also learn about a potential opportunity for their children.
In March of 2016, the IRB worked with the Office of Compliance Assistance to finalize the AAHRPP accreditation narrative for the second reaccreditation of USU’s Human Research Protection Program. Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) is an assurance to the research community, participants included, that USU units diligently work to maximize protections to human participants in research. Among the initiatives highlighted in the reaccreditation narrative are USU’s new Institutional Conflict of Interest policy, the increase in staffing levels to the IRB, and changed Standard Operating Procedures to better effectuate human subjects research protections.
The IRB received feedback from researchers during the last academic year that one of the biggest hurdles faced by researchers included long review times. The USU IRB finally achieved full staffing in November 2015, with the addition of Johanna Phelps-Hillen as IRB Coordinator. Phelps-Hillen is a Ph.D. candidate at the University of South Florida whose technical communication coursework focuses on public policy; specifically, how IRBs effectuate the human subjects research protections laid out in federal regulations. Her addition to the IRB office has contributed expertise in qualitative research, in-depth knowledge of regulatory policy, and increased efficiency in protocol review. With full and expert staffing, the IRB has been able to decrease exempt and expedite protocol review timeframes by ten days from the previous reporting year.
During the upcoming academic year, IRB staff look forward to wrapping up development of a new online protocol management system with Kuali to replace the current Protis system. The USU IRB also expects to significantly revise its policies and procedures in alignment with release of a Final Rule for the Protection of Human Subjects in Research by the Department of Health and Human Services and fifteen other federal departments and agencies. The Rule, expected to be released this fall, contains substantial changes to the regulatory framework governing human subjects protections and is intended to decrease administrative burden while strengthening protections for research participants.
Laboratory Animal Research Center and Institutional Animal Care and Use Committee:
Following final approval from the Office of Naval Research, the LARC has completed a transition in the method of charging per diem rates for animal care. Consistent with the majority of academic research institutions, the LARC now charges animal care fees on a per cage rather than per animal basis for most species. The transition was successful and smooth due to the support and cooperation from the LARC staff, Administrative Staff within the Office of Research and Graduate Studies, and from the University researchers.
The LARC Director has received a Facilities Improvement Grant from the National Institutes of Health to purchase and install an additional autoclave in the 650 Bioinnovations building to support the infectious disease research facilities housed there. This autoclave will be in addition to existing decontamination equipment and will expand the capabilities of the facility to ensure ongoing safe operation of vital infectious disease research activities at USU.
The IACUC and LARC at USU continue in their dedication to high quality animal care and welfare. In March 2016, the LARC at USU participated in a triennial site visit with representatives from the Association for the Assessment and Accreditation for Laboratory Animal Care International (AAALAC). The site visit is a vital component of maintaining accreditation of the animal care program with AAALAC. The site visitors identified areas in which they believed USU could improve its program. The LARC is currently acting on those recommendations and remains committed to maintaining AAALAC accreditation and excellence in laboratory animal care.
In 2015 Dr. Aaron Olsen, the LARC Director, was appointed as the chair of the Animal Handling and Welfare Review Panel with the United States Department of Agriculture Agricultural Research Services (USDA-ARS). The panel was established in response to a news article alleging abuse
and misuse of animals at a USDA-ARS research facility. The review panel visited multiple USDA- ARS research sites and provided feedback and recommendations to the USDA on animal use and welfare oversight practices at its research facilities. The panel submitted a final report to the USDA in July 2015. Subsequent to the panel’s efforts it has been selected to receive the Abraham Lincoln Honor Award from the USDA. This award will be formally presented to the panel members by the Secretary of Agriculture in a ceremony in Washington D. C. in September 2016.
In FY16, Research Development (RD) partnered with Extension to hire a proposal development specialist. This individual began working with Extension faculty and staff in December 2015.
Additionally, a proposal development specialist was hired into the College of Science. This individual will begin working with Science faculty in July 2016.
The RD Division now consists of a director, a part-time program assistant, and 5 proposal development specialists (Agriculture, Education, Engineering, Extension, Science).
The grant writing seminar tailored specifically to faculty and focused on “writing to the review process” was offered once in the FY16:
- 1 seminar—fall semester
- 49 faculty and research staff attended
In addition, a grant writing seminar specifically tailored to the arts and humanities faculty was offered in FY16:
- 1 seminar—fall semester
- 12 faculty attended
Grant writing seminars tailored specially to the needs of graduate students were offered twice in FY16:
- 1 seminar—fall semester
- 1 seminar—spring semester
- 159 graduate students and/or postdocs attended
All seminars were presented by Grant Writers’ Seminars and Workshops (www.grantcentral.com). Research and Graduate Studies covered all seminar expenses for participants, including material costs, lunch, and breaks.
The Proposal Writing Institute completed training its eighth cohort in FY16. Twelve faculty members were selected via a competitive application process to participate in this 4-week, intensive proposal writing training opportunity.
Including this most recent cohort, the Proposal Writing Institute has trained 98 faculty over the years. At the end of FY16, those faculty submitted 109 proposals worth $62 million that can be tied directly to the projects worked on during the Institute. Of those submitted proposals, Institute faculty have received 21 awards worth $9 million.
The Funding Finder database is the primary USU- provided resource for faculty to find funding opportunities. The database includes federal agency and private foundation/organization funding opportunities; limited submission opportunities; internal seed funding opportunities; undergraduate/graduate funding opportunities; faculty prize/recognition opportunities; and funding agency notifications regarding changes to policy/ procedures, funding priorities, agency-specific training/educational opportunities, etc.
All faculty are encouraged to sign up for the weekly Funding Finder Newsletter, which can be done by visiting the main page https://fundingfinder.usu.edu/core/login/?next=/. edu/) and clicking the Sign Up button. There are currently 517 newsletter subscribers (450 faculty, 46 staff, 21 graduate students).
The Grant-writing Experience through Mentorship (GEM) program provides funding to enhance the professional development of new investigators through one-on-one research and grant-writing interactions with successful research mentors. The purpose of this program is to build USU’s research capability and increase extramural funding for scholarly activities by enhancing the proposal development skills of newly hired USU researchers.
The Research Catalyst (RC) program provides funding to help applicants develop new initiatives or directions in their discipline that will lead to new externally funded grants. The purpose of this program is to build USU’s research capability and increase external funding for scholarly activities from government agencies and private sources. The Seed Program to Advance Research Collaborations (SPARC) program provides funding to catalyze development of interdisciplinary research teams and projects that involve scholarly research in more than one department, research center, college, or institution. Successful SPARC proposals require mutual effort by researchers from multiple disciplines. They must also provide outcomes that enhance USU faculty success in securing new, large-scale, interdisciplinary, externally-funded grants.
GEM, RC, and SPARC awardees are required to develop and submit at least one proposal to an external funding agency within three months of project completion. Because proposal submission deadlines vary widely among different agencies, funding for Research seed grant programs is offered twice yearly, with start dates of January 1 or July 1.
For FY16, the Research seed grant program received 29 applications and made 18 awards through its biannual competition cycles:
- GEM—3 applicants, 2 awards
- RC—21 applicants, 12 awards
- SPARC—5 applicants, 4 awards
Research Integrity and Compliance:
During FY16 Research Integrity & Compliance (RIC) responded to five regulatory actions.
- The Office of Management & Budget promulgated Uniform Guidance which combines eight circulars into one document. This has had some impact on USU’s systems, and RIC plays a coordinating role among administrative units to make sure internal control systems are responsive to the new guidance. During the coming year, additional elements of the regulations will be implemented, and RIC will continue to monitor USU’s progress.
- The Office of Human Research Protections (OHRP) in the Department of Health and Human Services issued a Notice of Proposed Rule Making that has potentially far reaching impacts on USU’s Human Research Protection Program (HRPP). USU, along with many institutions of higher education and academic medical centers, provided comments and participated in forums to alert OHRP of the negative consequences that would follow from many of the regulatory changes being proposed. During the current year, a Final Rule may be issued,and compliance with the new regulations may require significant effort by USU.
- The Export Control regulations overseen within the Departments of Commerce and State have been under review for the last several years. During FY16, a major effort to harmonize the two sets of regulations came to fruition, and USU has been developing training and internal controls to achieve compliance with the harmonized rule. We have established a partnership with Sponsored Programs to identify and negotiate terms and conditions that are related to export control regulations, and we provide support in meeting requirements under the regulations and monitoring compliance with teams conducting export controlled projects.
- The Office of Science & Technology Policy (OSTP) promulgated rules during FY15 that required all federal agencies to develop rules regarding the sharing of data that is acquired under federal funding. Those agency-specific policies became available during FY16, and USU has been developing policy, procedures and systems to respond to data sharing requirements. RIC has been playing a collaborative role in developing a new Research Data policy, which will likely be adopted in the coming year.
- Policies related to Information Security and treatment of Protected Health Information related to the Health Insurance Portability and Accountability Act (HIPAA) are also being developed at USU, and RIC is representing Research in the development of these policies.
In addition to its governance role at the university, RIC also manages several systems that support research compliance activities. The following compliance systems developed and implemented by RIC are now overseen and maintained by the division:
Research Financial and Administrative Training Series (RFAST)
RFAST is an online system used to provide training to all individuals within the university that conduct sponsored research. The training consists of modules that provide baseline training in areas including budgeting, grant preparation, post-award administration and regulatory compliance. The system provides evidence that USU’s researchers have been trained to utilize its internal control systems to apply best practices to its portfolio of grants and contracts.
Responsible Conduct of Research (RCR) Training
RCR training is gaining increasing emphasis among federal funding agencies. USU’s RCR training is delivered to students through USU 6900, “Research Integrity,” which is a zero-credit course offered every semester that exposes students to key topics in research ethics such as research collaboration, mentor/trainee relationships, and conflicts of interest. In addition to RCR training for students, RIC also coordinates an annual New Faculty Mentoring Workshop to help incoming faculty establish mentoring practices that integrate RCR topics.
Conflicts of Interest (COI)
Responsibility for disclosure and management of conflicts of interest resides with RIC. We maintain a system known as iComply to support faculty members in disclosing financial interests that may represent conflicts of interest, and we assess whether disclosed interest give rise to COIs that require management, reduction or elimination. During FY16, we also developed and prepared to implement a system for identification of potential institutional conflicts of interest (ICOI). These types of conflicts arise when the university or its leadership have financial interests that may also be related to research being conducted at USU. This new system is being implemented during FY17.
Beginning in Fall 2016, a new centralized granting system, Kuali Research, will be utilized by the campus community. Sponsored Programs implemented Kuali Researcher in October and has been using the module internally. Sponsored Programs staff have been training with Kuali Researcher, developing training materials, and conducting focus groups in preparation of a campus-wide roll out.
Kuali Researcher offers campus-wide authentication and routing. Using Kuali, researchers will be able to complete proposal applications and all required proposal materials electronically, replacing the need for paper copies of the Proposal Approval Form (SP- 01) and budget template.
Sponsored Programs staff continued to work with faculty on proposal preparation, proposal review, proposal submission, award set up, award monitoring, and award close out. During FY16, Sponsored Programs processed 1080 award actions for $98.5 million in award funding and submitted 1157 proposals in FY16 for $261.7 million.
Sponsored Programs staff represented Utah State University at over 9 regional or national research administration meetings during FY16. Two Sponsored Programs staff received certification from the Research Administrators Certification Council, the highest certification in research administration.