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Pitt Research
Office of Research Protections

Warm Holiday Wishes from ORP!

Happy holidays

As the holiday season approaches, the Office of Research Protections (ORP) extends its gratitude to the University community for fostering a culture of innovation while upholding regulatory excellence. This year, our shared commitment to compliance was recognized through accolades from government inspections:

  • FDA Review: The Institutional Review Board was inspected by the Food and Drug Administration from May 16-24, 2024.
  • Radiation Safety Inspection: The Pennsylvania Department of Environmental Protection inspected our radiation safety program in October-November 2024.
  • Animal Care Oversight: The USDA conducted its annual inspection of the animal care and use program in January 2024.

Additionally, ORP participated in several initiatives to facilitate regulatory-compliant research, including the following:

  • A  residency program in diagnostic imaging physics, created in collaboration with the Department of Radiology, was accredited. This program aims to strengthen the pipeline of medical physicists at Pitt and UPMC.
  • A Research Security and Trade Compliance website was introduced to raise awareness and provide valuable resources for the research community.
  • An FDA-compliant data capture system (REDCap) was implemented in partnership with Health Sciences IT to facilitate management of clinical trial data.
  • A secure cyber environment for projects involving controlled unclassified information was initiated in collaboration with Pitt Information Technology (Pitt IT). The completion date is anticipated sometime during the first half of 2025.

These achievements underscore the strong collaboration between ORP and the University community, and we look forward to advancing our shared mission in 2025.

Wishing you a joyful holiday season filled with reflection, connection, and inspiration. Here’s to a new year of fresh ideas and continued success!

— The Office of Research Protections Team

Recognizing the Contributions of Our Research Committees

The Office of Research Protections extends its heartfelt gratitude to the dedicated University and community members who volunteer their time to serve on our numerous committees, including the Institutional Review Board, Institutional Animal Care and Use Committee, Conflict of Interest Committees, and Institutional Biosafety Committee, amongst others.

Their expertise, thoughtful contributions, and commitment are vital to advancing the University's mission and supporting innovative, groundbreaking research. These committee members play a key role in fostering a culture of excellence, ensuring that our research is conducted with the highest standards of integrity and compliance.

If you would like to volunteer your time to serve on an ORP committee, please contact Dr. Bill Yates, Vice Chancellor for Research Protections.

Dr. John Maier Appointed Chair of COI Committee


Dr. John S. Maier, who currently serves as Vice Chair of the Conflict of Interest Committee (COIC), will assume the role of Chair in 2025. Dr. Maier serves as an Assistant Professor of Family Medicine and the Director of Innovation and Stratgeic Initiatives.

ORP thanks outgoing Chair, Dr. Craig Wilcox, for his dedicated service to the COIC.

Online Enrollment Now Available for Animal Exposure Surveillance Program

Purchasing

The University is pleased to launch a streamlined online enrollment process for the Animal Exposure Surveillance Program (AESP). Participation in the AESP is mandatory for all University members who work with vertebrate animals. The program is designed to identify and enroll animal users in preventive medicine initiatives, while providing essential occupational health information related to the handling and care of animals.

In alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), a secure and convenient online form has been developed to facilitate enrollment in the program. This online option is available exclusively to current University employees, including student employees, following their official hire date.

For non-employee participants, including students who are not on the University payroll, enrollment must be completed using a paper form. These forms can be submitted either in person or via fax to MyHealth@Work.
Learn More and Enroll in the AESP

New Policy on Dual Use Research of Concern (DURC)


Dual Use Research of Concern (DURC) refers to life sciences research that, while conducted for beneficial purposes, has the potential to be misapplied in ways that could pose significant threats to public health, agriculture, the environment, or national security. This type of research involves biological agents and toxins that require careful oversight to ensure their safe and ethical use.

On May 6, 2024, the White House Office of Science and Technology Policy (OSTP) released the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential, accompanied by an Implementation Guide. This new policy, set to take effect on May 6, 2025, will replace previous DURC policies.

Key features of the updated policy include:

  • Expanded Coverage: The policy applies to a broader range of biological agents and encompasses nine distinct categories of experiments.
  • Clear Oversight Framework: Principal investigators are required to evaluate their research for DURC potential. Institutions must review and oversee DURC in accordance with federal guidelines and develop risk mitigation plans as needed. Federal funding agencies will assess and approve DURC proposals, ensuring they meet established safety and security standards.

To assist impacted researchers in adapting to these new regulations, training and outreach sessions will be conducted in early 2025.

2025 Controlled Substance Disposal Dates

The University of Pittsburgh's Controlled Substance Guidelines require that expired or unwanted containers of controlled substances (containing a residual volume) be discarded through a Reverse Distributor.

To reduce costs and to simplify the process of discarding expired or unwanted controlled substances, the Department of Environmental Health and Safety (EH&S) has arranged for a Reverse Distributor (Heritage Environmental Services) to visit campus on a quarterly basis.

The following are the controlled substance pickup dates for 2025:

  • Wednesday, January 15, 2025
  • Wednesday, April 16, 2025
  • Wednesday, July 16, 2025
  • Wednesday, October 15, 2025


Learn more about the Controlled Substance Collection Program.
Watch the Video "Controlling Controlled Substances"

Upcoming Holiday Recess: ORP Deadlines and Closures


As a reminder, except for emergency services, ORP will be closed during the upcoming University recess:

  • Winter Recess | December 23, 2024 — January 1, 2025 

During the Winter Recess, protocol submissions and other inquiries will not be addressed until campus reopens on January 2, 2025. If you will require our services over the recess, please contact us as soon as possible.

Upcoming Educational & Training Opportunities

Consider signing up for these training opportunities offered by the Office of Research Protections:
Roc the Panther

Learn More About How ORP Can Support You >

Roc the Panther

View Upcoming ORP Events >

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