REGULATORY RESOURCES


CTSI Research Facilitators can help investigators navigate the research pathway and connect them with resources.

Submit a request for assistance or to schedule a consultation.

Here are some research and regulatory resources:

Human Research Protection Office (HRPO)


The HRPO (formerly the IRB) oversees the IRB Committees and administrative review processes. It promotes the safety and protection of individuals involved in research by providing support, guidance, and education to facilitate ethical and scientifically sound research.

Office of Research (OR)


Supports all sponsored research at the University of Pittsburgh including grants, subcontracts, and DUA/MTAs. OR reviews, negotiates, endorses, and provides administrative oversight related to proposals and awards.

CITI (Collaborative Institutional Training Initiative)


Access to online research training and resources for human subjects research, including: Responsible Conduct of Research, Good Clinical Practice, Human Subjects, Biomedical Science, Social and Behavioral Science, and Privacy & Information Security.

Environmental Health and Safety (EH&S):


University of Pittsburgh resources for Workplace Health and Safety, Biological Safety, Laboratory Safety, Chemical Hygiene, Research Support, and Emergencies.

Health Sciences Library System (HSLS)


HSLS supports teaching, research and clinical care in the health sciences for University of Pittsburgh faculty, students and staff, and University of Pittsburgh Medical Center residents and fellows. It can also help with Data Management Sharing Plans.

Computing Services and Systems Development (CSSD)


CSSD provides security services, tools and education to protect your computer, safeguard personal information, and secure sensitive University data. They also assist University administration with adhering to state and federal regulations regarding technology.

Radiation Safety Office


Responsible for ensuring that all sources of licensed radioactive material and ionizing radiation producing equipment are used optimally and safely.

Conflict of Interest (COI) Office


Information on the University of Pittsburgh's COI policies and resources.

Online Submission for Institutional Reviews (OSIRIS)


A web-based system for submitting a HRPO (formerly the IRB) protocol. 

* OSIRIS will be transitioning to PittPRO starting 10/15/2018. Click on OSIRIS link to learn more.

Reliance Agreements/Single IRB Review


Reliance agreements are required to enable single IRB oversight for multi-center studies.

Office of Research, Health Sciences (OORHS)


OORHS has scientific administrators available to review grant applications for faculty in the Schools of the Health Sciences. Contact Jeremy Somers.

Institutional Data and Safety Monitoring Boards (IDSMBs)


CTSI oversees DSMBs for clinical trials that require oversight, and assists in ensuring safe conduct of the study. To request services please complete the IDSMB request form.

A DSMB training manual has been developed through a collaborative effort across several academic institutions with CTSA awards. The purpose of this manual is to serve as a training and reference resource for individuals asked to serve on a DSMB or some other capacity of safety oversight for clinical research studies. It contains a comprehensive collection of the regulatory framework for DSMBs as well as best practices. 

UPMC Office of Sponsored Programs and Research Support (OSPARS)


Oversight of industry-initiated studies using a central IRB, and UPMC Fiscal Review. E-mail OSPARS@upmc.edu, or call 412-647-4461.

Human Stem Cell Research Oversight Committee (hSCRO)


Conducts reviews to ensure compliance with all federal and Commonwealth of Pennsylvania regulations governing the conduct of human stem cell research.

Internet-Based Studies in Education and Research


Access to online research training and resources for animal studies, including Use of Laboratory Animals in Research and Education.

Quality Assurance and Quality Improvement Projects (QA/QI)


Projects addressing issues of Quality Assurance and Quality Improvement in UPMC facilities should contact the Quality Improvement Review Committee (QRC) at UPMC. These projects do not require IRB approval unless they involve human participant research, but are still subject to oversight.

ClinicalTrials.gov


Federal law requires applicable clinical trials to be registered before enrollment of the first participant. Contact the University’s Protocol Registration System (PRS) administrator at CTgov@pitt.edu to initiate the clinical trial registration process or for further assistance.

Data Use and Material Transfers Agreements (DUA/MTA)


Information on Data and/or Material Transfers from the University of Pittsburgh Office of Research.

Investigational Drug Services (IDS)


Evaluates plans for ordering, receipt, storage, preparation, dispensing, and billing of drugs used in research studies to ensure compliance. Contact pharm-ids@upmc.edu.

Office of Investigator-Sponsored IND and IDE Support (O3IS)


Investigational New Drug (IND) applications and Investigational Device Exemptions (IDE) applications for acceptance by the U.S. Food and Drug Administration (FDA) must be filed through this office.

Genomic Data Sharing Plans (NIH)


Guidance on data sharing plans that meet the requirements of the National Institutes of Health (NIH) Genomic Data Sharing Policy.

Committee for Oversight of Research and Clinical Training Involving Decedents (CORID)


CORID is the University of Pittsburgh Committee which is responsible for review and approval of research studies involving recently deceased subjects who have donated their bodies for the purpose of research.

Institutional Biosafety Committee (IBC)


University of Pittsburgh Committee responsible for maintaining compliance with the NIH Guidelines on all research that involves recombinant DNA (rDNA).

Institutional Animal Care and Use Committee (IACUC)


Oversees animal subject research and provides instructions for protocol submission.

National Institute of Health (NIH)


NIH is the largest biomedical research agency in the world.