Pitt Research
Office of Research Protections

On July 9, the White House Office of Science and Technology Policy (OSTP) released a memo to federal agencies that provides final standardized requirements for research security programs applicable to “covered institutions” that receive greater than $50 million dollars in annual federal research and development (R&D) funding.

Federal agencies have six months to submit plans to OSTP that reflect how each will update their guidance to include these new requirements. As part of this final standardized requirement, agencies are obligated to require covered institutions to certify that they maintain a research security program that includes cybersecurity, foreign travel security, research security training, and export control training.

Covered Institutions will have up to 18 months from the time that federal agencies finalize their updated guidance in which to implement a compliant research security program. ORP's Office of Research Security and Trade Compliance will be collaborating with other University departments in developing Pitt’s research security program and will post final components of our new program to its website as milestones are met.

This past year, ORP made strides in expanding the reach and impact of the University's research endeavors. ORP's Annual Report for FY24 provides a comprehensive look at the accomplishments, challenges, and future goals of the divisions that comprise our Office. Read the full report. 

Overall, the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee (IBC) conducted the following number of protocol reviews:

• IRB: 8,445
• IACUC: 2,800
• IBC: 1,276

Other important highlghts include:

• ORP launched two new websites to provide guidance to investigators on Responsible Conduct of Research and Research Security.
• Accreditation was obtained for a new residency program in diagnostic imaging physics. A grant from the American Association of Physicists in Medicine was secured to offset the costs of the program.
• New forms and processes were developed to assist investigators in entering projects into the FDA-compliant REDCap system.
• Enhanced procedures were implemented across multiple University systems to expand the scope of export control measures. As a result, the number of export control reviews increased from 2,342 in FY23 to 15,233 in FY24, representing a 550% increase.

ClinicalTrials.gov is a comprehensive database managed by the U.S. National Library of Medicine (NLM) of the NIH. It serves as a central resource for information on clinical trials, providing details about federally and privately funded clinical studies conducted around the world.

NLM began an effort to modernize ClinicalTrials.gov in 2019, with the aim to deliver an improved user experience on an updated platform that will accommodate growth and enhance efficiency. On June 25, the legacy version of the public site was retired, and the modernized version became the single experience. You can read more in the NCBI Insights blog, and refer to How to Read a Study Record for guidance on getting the most out of the information in a study record.

The modernized Protocol Registration & Results System (PRS), the interface where data providers (such as Pitt clinical study investigators) provide the information about their studies for display on the public site, is still in development. The Classic and Beta versions of PRS both continue to be available during this process. We will share further information on the PRS modernization with investigators as it becomes available.

Effective September 1, Dr. Kenneth G. Bennet, a faculty member in the Department of Radiology, will assume the Chair position of two key University committees related to radiation safety:

• The Human Use Subcommittee, responsible for reviewing and approving all proposed human research uses of radioactive material and X-ray producing equipment.


• The Radioactive Drug Research Committee, which oversees the research use of radioactive drugs in accordance with Food and Drug Administration (FDA) regulations.

ORP expresses its gratitude to Dr. Scott Mason for his exemplary leadership of these committees over the years, leading up to his upcoming retirement.