November 2024 Newsletter
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Stay up-to-date with the latest news and resources from the Office of Research Protections (ORP)
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NIH Releases Final Scientific Integrity Policy
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The National Institutes of Health (NIH) recently released its Final Scientific Integrity Policy, intended to uphold the integrity of all NIH scientific activities. This policy, which will take effect on December 30, 2024, seeks to ensure that scientific endeavors are conducted, managed, communicated, and utilized in a manner that maintains their accuracy and objectivity while safeguarding them against suppression, manipulation, and undue influence. The policy enhances current practices by:
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Defining the term “scientific integrity” for consistent use;
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Establishing the new positions of NIH Chief Scientist and NIH Scientific Integrity Official;
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Establishing the NIH Scientific Integrity Council to coordinate scientific integrity activities across the Agency; and
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Adding additional protections against inappropriate political interference.
While the covered individuals for this policy consist primarily of NIH employees, others who engage or assist in NIH scientific activities (e.g., contractors, partners, grantees, and trainees) are strongly encouraged to uphold the principles of scientific integrity described in this policy. Those covered by the policy are expected to:
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Foster an organizational culture of scientific integrity,
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Protect the integrity of the research process,
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Communicate science with integrity, and
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Safeguard scientific integrity.
In addition to this new policy, the NIH Policies and Procedures for Promoting Scientific Integrity (2022) report describes additional robust processes in place to support scientific integrity for NIH-supported extramural research, intramural research, and policies and programs.
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First published by the World Medical Association (WMA) in 1964, the Declaration of Helsinki has recently undergone its tenth revision. Its initial publication was subsequent to research atrocities identified during and after the second World War. Outlined within the Declaration are 37 ethical principles for medical research involving human participants.
Recent revisions to the Declaration include replacement of the term “human subject” with the term “participant.” This change emphasizes respect for participants and recognizes their desire to participate and partner in research.
Another substantial change, as described by Dr. Jack Resneck, Chair of the WMA Declaration revision workgroup, calls out the need for “free and informed consent for the collection, processing, storage and foreseeable secondary use of biological material and for ethics committee approval of such databases and biobanks.”
Finally, and of particular importance, the scope of the document has been broadened beyond physicians, and calls on all individuals and organizations involved in medical research to abide by the outlined ethical principles.
To that end, we encourage everyone involved in the conduct of medical research to read the Declaration, which is considered a cornerstone on human research ethics.
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New Cybersecurity Requirements for DOD-Funded Research
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The Department of Defense (DOD) published its final Cybersecurity Maturity Model Certification (CMMC) program rule on October 15, 2024. This final rule defines cybersecurity requirements for DOD-funded research. DOD contractors approved to handle federal contract information (FCI) or controlled unclassified information (CUI) are required to implement cybersecurity standards at progressively advanced levels commensurate with the type and sensitivity of the information. Moreover, DOD contractors are also required to confirm compliance with
standards through a certification process.
The implementation of the final CMMC rule will occur over an extended period. Contractors, including Pitt, can expect to see CMMC requirements included as contract clauses, beginning in the second half of 2025. DOD contracting officers will require institutions to certify a certain CMMC level as a condition of an award. The University is preparing to be certified to CMMC level II, which will allow faculty and staff to generate, handle and share CUI and FCI whenever a DOD award contains a clause that requires this level of security.
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The University's Broad Scope Radioactive Materials License authorizes the use of radioactive materials at the Pitt campus and UPMC academic hospitals. Regulations require periodic inspections of the Radiation Safety program associated with this license by the Pennsylvania Department of Environmental Protection (DEP).
A team of seven DEP inspectors recently conducted a comprehensive four-day evaluation of all our applications of radioactive materials. This review encompassed bench research, animal research, diagnostic and therapeutic research involving human participants, and clinical diagnostic and therapeutic procedures. Additionally, the inspectors assessed critical components of the Radiation Safety program, including dosimetry, training, shipping, waste management, and related activities.
The inspectors commended the ORP's Radiation Safety Division for its robust oversight of radioactive materials use. They provided only minor recommendations for potential improvements, and no instances of regulatory non-compliance were identified during the inspection.
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2025 Controlled Substance Disposal Dates
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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:
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Wednesday, January 15, 2025
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Wednesday, April 16, 2025
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Wednesday, July 16, 2025
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Wednesday, October 15, 2025
Click to learn more about the Controlled Substance Collection Program.
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As a reminder, except for emergency services, ORP will be closed during upcoming University recesses:
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Thanksgiving Recess | November 28-29, 2024
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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.
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Upcoming Educational & Training Opportunities
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Consider signing up for these training opportunities offered by the Office of Research Protections:
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