Report to the Faculty, Staff, and Community Office for Research Protections | 2011 - 2014
The Office for Research Protections (ORP) at Penn State partners with researchers and scholars to facilitate a culture of outstanding integrity, responsibility, and trust in Penn State research. The ORP and the Penn State research community work together to ensure that research at the University is conducted in accordance with federal, state, and local regulations and guidelines that protect human participants, animals, students, and personnel involved with research. ORP programs are recognized and accredited by the two major associations that promote responsible research with human participants and laboratory animals. The ORP also offers education and training to faculty, staff, students, and the community; guides and assists researchers with management of real or perceived conflicts of interest; and supports investigations and corrective actions related to noncompliance and misconduct. The ORP’s initiatives are realized through the work of six programs and their supporting staff and committees: • The Human Research Protection Program • The Quality Management Program • The Animal, Biosafety, and Isotope Program • The Conflict of Interest Program • The Science Diving Program • The Education Program The activities and accomplishments of these programs are summarized in the following pages. Additional information can be found at www.research.psu.edu/orp. We are proud to work together with members of the University and the community, and we extend our thanks for their service and dedication to reaching these goals.
Candice A. Yekel Associate Vice President for Research Director, Office for Research Protections
Human Research Protection Program
The HRPP’s turnaround time for new studies (from submission to final approval), at all review levels, has remained consistently below the AAHRPP national standards. Since the July 2014 introduction of our new Centralized Application Tracking System (CATS), the average turnaround time for full review of new studies is just 29 days.
Full Reviews
80
Exempt Determinations
40
20
0
2011
2012
2013
PI Time
2014
2011
2012
2013
2014
2011
2012
2013
2014
HRPP Time
Quality Management post-approval reviews
Quality Management Program The Quality Management Program works to ensure that compliance with federal regulations, state laws, University policies, and approved study protocols is maintained as it applies to research involving human participants. Quality Management activities within the Human Research Protection Program include, but are not limited to: onsite post-IRB approval reviews, mapping of various internal and external processes, and tracking a variety of data to identify trends and needs for training or changes. Starting in 2014, the Quality Management Program began conducting site assessments prior to IRB approval for FDA-regulated studies, and implemented a new PI self-assessment process for post-IRB approval reviews without a site visit.
Expedited Reviews
60
Days
The Human Research Protection Program (HRPP) manages all human participant research studies at University Park and all other campus locations, with the exception of the College of Medicine located at the Hershey Medical Center. The HRPP provides support to two Institutional Review Boards (IRB). The HRPP also maintains University and IRB policies and guidelines involving research with human participants, and ensures compliance with federal, state, local and institutional regulations and policies. Penn State’s HRPP is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
HRPP and principal investigator (PI) mean approval time for new studies, by review level
On-site visits
Studies reviewed (by IRB level)
20
15
10
5
0
Exempt
2011
Expedited
2012
2013
Full
2014
Other
Directed
Routine
Animal, Biosafety, and Isotope Program The Animal, Biosafety, and Isotope (ABI) program facilitates the activities of the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), and the University Isotopes Committee (UIC) in reviewing and approving regulated experiments and teaching activities that involve vertebrate animals, regulated biohazardous materials, and/or radioactive materials. The ABI program ensures that Penn State research and teaching programs comply with all applicable federal, state, local, and institutional regulations and policies.
Biosafety Program
Isotope Program
The Institutional Biosafety Committee (IBC) reviews research and teaching activities involving the use of materials that have the potential to pose a danger to the health and safety of researchers and the community, including recombinant DNA and biohazardous agents.
The University Isotopes Committee (UIC) ensures that Penn State complies with regulations established by the United States Nuclear Regulatory Commission and the Pennsylvania Department of Environmental Protection Bureau of Radiation Protection for containing, controlling, and transporting radioactive materials.
Animal Care and Use Program The Institutional Animal Care and Use Committee (IACUC) is a standing committee at Penn State that oversees and evaluates all aspects of animal care and use at Penn State. The committee's composition and responsibilities are mandated by the Animal Welfare Act (Public Law 99-198). In 2014, the Animal Care and Use Program at Penn State achieved a 31 percent reduction in IACUC committee review time (from protocol submission until final approval) compared to 2013. Penn State’s Animal Care and Use Program is fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
Median IBC approval time, from initial submission to final approval
Median IACUC approval time, from initial submission to final approval 40
20
30
15
50
Protocols submitted to the University Isotope Committee
40
20
10
5
10
0
Protocols
Days
Days
30
New 2011
Modification 2012
2013
Annual Review 2014
0
20 10
2011 New Studies
2012
2013
Modifications
2014
0
Modification 2011
2012
New 2013
2014
Conflict of Interest Program The Conflict of Interest Program (COI) manages all Significant Financial Interest Disclosures (SFID) for Penn State faculty, staff, and students, and provides support to both the individual and institutional conflict of interest committees. The COI Program also maintains the University's individual and institutional COI Research Administration policies, guidelines, and procedures and strives to ensure compliance with all federal, state, and local COI regulations and guidelines. COI Program staff are available to answer individual inquiries; meet with faculty, staff, and students; and present educational COI workshops and training throughout the year.
Financial disclosures containing one or more significant financial interests compared to disclosures indicating “no significant financial interest�
40
5000
30
3750 Disclosures
Disclosures
Total financial disclosures reviewed by the COI committee, and fraction for which the committee determined a conflict of interest existed
20
10
0
2500
1250
2011
2012
Total disclosures reviewed
2013
Conflict identified
2014
Conflict identified
0
2011 *
2012
2013
No significant financial interests disclosed
2014
One or more financial interests disclosed
(human participant research only)
* For 2011, all disclosures indicated significant financial interests
Science Diving Program The Science Diving Program supervises all compressed gas diving for scientific and educational purposes at the University. The program is administered by a Diving Control Board and the operations of the program are defined by a set of Dive Standards. From 2012-2014, the program supported 60 divers who completed 711 dives. During this period, 36 students enrolled in advanced science diving academic courses offered through Penn State’s College of Earth and Mineral Sciences. The Penn State Science Diving Program is an Organizational Member of the American Academy of Underwater Sciences.
Education Program The Education Program promotes and protects the integrity of research conducted at Penn State by providing education and training to faculty, staff, students, and the community. Educational initiatives include administering required training for researchers whose work involves animals or human participants, providing training for research administrators, and delivering programs (classes, workshops and seminars) addressing research ethics and the responsible conduct of research (RCR). The Education Program developed and administers Penn State’s Scholarship and Research Integrity (SARI@PSU) program, designed to offer Penn State researchers and scholars comprehensive, multilevel training in the responsible conduct of research (RCR), in a way that is tailored to address the issues typically faced by individual disciplines. SARI@PSU addresses RCR issues through two initiatives: an online RCR training program offered by CITI (Collaborative Institutional Training Initiative at the University of Miami), and interactive, discipline-specific, discussion-based activities.
Graduate student participation in SARI@PSU
Education Program events 3000
120
18000
2500 90
13500
1500 60 1000 30
500
0
Workshops 2011
2012
Participants 2013
2014
0
Participants
2000
9000
4500
0
2011 Total Participants
2012
2013 Completed SARI@PSU
2014
Committees and Boards Supported by the Office for Research Protections
The membership of each committee may include faculty, staff, administrative officials, and community members.
Institutional Review Boards (two boards) Institutional Animal Care and Use Committee Institutional Biosafety Committee University Isotope Committee Individual Conflict of Interest Committee Institutional Conflict of Interest Committee Centralized Application Tracking System (CATS) Advisory Committee Centralized Application Tracking System (CATS) Executive Committee Diving Control Board Research Misconduct Committee (convenes as needed)
Office for Research Protections
The 330 Building, Suite 205, University Park, Pennsylvania 16802 Phone: 814-865-1775 • Fax: 814-863-8699 • ORProtections@psu.edu www.research.psu.edu/orp Penn State is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to minorities, women, veterans, individuals with disabilities, and other protected groups. U. Ed. RES 15-22