The Office for Research Protections will be closed for Penn State's winter break starting at 5 PM on December 23, 2025.  The office will re-open on January 5, 2026.  Submissions will not be reviewed d...

Penn State’s “GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)” in CITI has been updated to reflect the ICH E6(R3) guidelines, which were adopted by the FDA. Upd...

The ORP's fall newsletter just came out: read now. Be sure to sign up to make sure you receive our next newsletter!  

IACUC Guideline 2 has been updated to provide new options for collecting biological samples for mouse genotyping: ear biopsy, tail tip amputation, and minimally invasive procedures with four non-tissu...

AI is a powerful tool that requires human oversight to ensure it is used with integrity. Penn State offers guidance for the use of generative AI in research; these recently updated best practices are ...

The HRPP allows students/trainees to act as Principal Investigator (PI) for their projects, such as human subjects research related to their thesis or dissertation.  Starting November 3, CATS IRB will...

The Office for Research Protections will be closed for the University’s December break starting December 24, 2025; the office will re-open on January 5, 2026. IBC submissions will not be reviewed duri...

The Human Research Protection Program announced upcoming changes to the Toolkit Library at the recent quarterly webinar. Highlights of changes, starting November 1: Updated Protocol Templates Sectio...

Changes for Faculty Advisors on Student/Trainee Studies As of November 3, a faculty advisor must be assigned as PI proxy on all new studies with a student PI. Only one faculty advisor will be designat...

NIH-funded researchers working with human biospecimens are prohibited from "directly or indirectly distributing" human biospecimens obtained from U.S. persons with institutions or persons located in "...

In September 2025, the National Institutes of Health (NIH) launched a Biosafety Modernization Initiative. This effort aims to modernize and strengthen biosafety policy, practices, and oversight. As a ...

The Office for Research Protections will be closed for the University’s December break starting December 24, 2025; the office will re-open on January 5, 2026. IRB submissions will not be reviewed duri...

To accommodate the University’s winter holiday closing schedule, the Institutional Animal Care and Use Committee’s (IACUC) final 2025 protocol review will occur on Monday, December 15, 2025.  For a su...

This is a reminder that all NIH researchers identified as Senior/Key Personnel must disclose to NIH any other support they receive to “ensure there is no scientific, budgetary, or commitment overlap.”...

To further support Penn State's mission of “research with integrity,” the Office for Research Protections is establishing a standing committee composed of faculty members with relevant subject matter ...

Ask Courtney Karmelita, the University’s research integrity officer, when colleagues should discuss authorship for a research project, her answer is emphatic: “Before they start the collaboration!” Fo...

Starting out in a collaboration?  Questions about who should receive credit for authorship?  Interested in starting a conversation with your students about authorship?  The ORP has assembled a series ...

Did you miss the ORP summer newsletter?  Catch up now! Be sure to sign up to make sure you receive our next newsletter this fall.

Beginning October 2025, researchers applying for funding from NSF will be required to have taken Research Security training prior to submitting a funding application. Key Points: Who: All covered ind...

There are three new standard procedures for collecting biological samples for mouse genotyping in the CATS IACUC system. The standard procedures include ear biopsy, tail tip amputation, and a minimall...

IACUC Guideline 17 has been updated to reflect new contact information for anonymous reporting through the Penn State Ethics and Compliance Hotline: Text the Penn State Hotline at 1-888-778-8173 or ac...

There is a new form available to report adverse and non-compliance events to the IACUC, per IACUC Guideline 26. The form is available on the left navigation menu of the IACUC website. An IACUC-reporta...

Penn State’s Human Research Protections Program (HRPP) hosted its quarterly webinar on July 23, 2025 with updates for researchers and study teams. Here are the highlights: Clinical Trials Office (CTO)...

The PRAMS platform is sunsetting, and the Office for Research Protections is actively working with the University Isotopes Committee and the Office of Research Information Systems to develop the Radia...

CATS IRB, the submission system for the IRB, was successfully upgraded on July 26. Many updates were for system functionality and do not affect user interaction, but there are a few key updates for re...

The Office for Research Protections, with support from the Senior Vice President for Research and in collaboration with University Libraries, announces the release of University Policy RP15: Research ...

We are pleased to announce the release of the Core Facilities Authorship Guidelines, now available for reference and use. These guidelines were developed through a collaborative effort involving facul...

The Office for Research Protections is pleased to sponsor a second Provost Endorsement: Research Integrity and Setting Up Successful Research Environments, which falls under Domain 2: Research Scholar...

After a two-year pause, the Scientific Diving course will return in Fall 2025, offered by the Scientific Diving Program within the Office for Research Protections (ORP). The course will resume as a La...

The National Institutes of Health (NIH) announced a new Public Access Policy that goes into effect on July 1, 2025. The new NIH Public Access Policy requires Author Accepted Manuscripts accepted for p...

The HRPP's quarterly webinar in April began with an announcement that the program was fully reaccredited by AAHRPP. Updates were given on the current HRPP team, including promotions and welcoming Harr...

Attention: an Executive Order released on 5/5/25 has paused planned May 2025 policy changes to Dual Use Research of Concern (DURC). We are awaiting new federal guidance. In the interim, the IRE will r...

Both Penn State’s human and animal research protection programs have once again achieved full, continued accreditation from their respective accrediting bodies, the Association for Accreditation of Hu...

At Penn State, we deeply value and encourage international collaboration. In parallel, we must also adhere to U.S. government regulations to protect our research data and intellectual property. To ens...

Researchers receiving or applying for Department of Energy (DOE) funding should be aware of a new mandatory Research Security training requirement. The DOE is now requiring all covered individuals inv...

There are new guidance documents for cannabis and hemp research. These guidance documents outline Penn State’s current capabilities and limitations on research, outreach, and other activities related ...

The federal government is expanding regulation of nucleic acid synthesis. Current regulation applies to sequences from organisms and toxins on the select agents list but will be expanded to include an...

Are you studying for the Certified Research Administrator (CRA) exam? Thinking about taking the exam? Wondering about professional development opportunities post-ACES? The Research Administrators Cert...

University Policy RP11: Use of Regulated and Biohazardous Materials in Research and Instruction has been updated to clarify when Institutional Biosafety Committee (IBC) review is required and to bette...

Announcements: New HRPP Executive Director: Jen Kucera, MS, CIP Jen Crossen promoted to Senior IRB Analyst. Backfill of her position will be hybrid role split between Reliance team and broader HRPP. ...

The Human Research Protection Program (HRPP) is pleased to announce Jen Kucera, MS, CIP, as the new executive director of the HRPP in the Office for Research Protections (ORP). Jen comes to Penn State...

With the faculty hiring season in process, programs at University Park and the Commonwealth Campuses are reminded to partner with the Office for Research Protections when recruiting new researchers to...

The Quality Assurance (QA) team is excited to announce the introduction of Proactive Audits for Continued Training (PACTs), designed to assist researchers in navigating the complexities of study imple...

Starting November 1, the "Confidentiality, Privacy, and Data Management" section of the IRB protocol will be revamped. There are not changes to the requirements around data use and storage. The goal o...

The NIH will implement several policies changes pertaining to Gene Drive (GD) and Gene Drive Modified Organisms (GDMO), effective September 30. Researchers modifying genetic codes (regardless of origi...

The Office for Research Protections is pleased to participate in the Provost Endorsement Program, which sets a new standard for professional development at Penn State. This Provost Endorsement looks t...

Inquiries sent to HRPP General Inbox: irb-orp@psu.edu Always: include CATS submission ID or PI's name read response carefully contact for PSU ID contact for PSU password: Contacting your analyst:...

The Office for Research Protections announces multiple, related structure changes to their leadership and programs.  In recent months, the ORP has taken on responsibility for two new programs: the Exp...

Penn State's AI Hub recently released AI guidelines for the University, including guidance specifically for researchers. This guidance lays out general principlesto consider when using AI for research...

Penn State’s IACUC program introduces a new website with resources on compassion fatigue for researchers, veterinarians, animal care staff, and others involved in animal care and research. Compassion ...

The Institutional Animal Care and Use Committee (IACUC) recently updated its University policy, RP04 Care and Use of Vertebrate Animals: the definition of animals in research now includes cephalopods....

Effective May 15, 2024, xylazine is considered a controlled substance in Pennsylvania.  On May 15, the Pennsylvania Governor signed House Bill 1661 into law, permanently adding xylazine to the list of...

NIH's Office for the Director has released a notice strongly encouraging the use of the ARRIVE Essential 10 Checklist for any publications involving NIH-supported research on vertebrate animals and ce...

The Office for Research Protections recently updated the oversight for research involving animal tissue to clarify that compliance review is under the oversight of the Institutional Biosafety Committe...

Following the detection of a case of poliovirus in New York in July 2022, the U.S. National Authority for Containment of Poliovirus (NAC), part of the CDC, has developed resources “to help reduce the ...

We are happy to share the results of the latest HRPP satisfaction survey, which was conducted in October 2023 and analyzed through the CTSI’s Biostatistics, Epidemiology, and Research Design Core. Thi...

For researchers, there's more to moving than just packing boxes. From managing sponsored funds to transferring compliance protocols, faculty members must ensure that the appropriate offices have been ...

The IACUC program at University Park announces the adoption of a new module in CITI for training researchers working with poultry. Moving forward, all personnel working with poultry on an IACUC protoc...

The ORP recently released guidance about who can serve as a Principal Investigator on a research protocol.  This guidance covers research, testing, or teaching activities involving human subjects, ani...

The Human Research Protection Program (HRPP) is now charging fees to serve as the reviewing IRB for multi-center and cooperative projects that designate Penn State as the reviewing IRB. The fee struct...