CTSI acts as an advocate for researchers navigating the following regulatory pathways, as well as other regulatory processes not mentioned here.
Clinical Oversight for Research Involving the Dead (CORID):
The University of Pittsburgh Committee which considers research studies involving recently deceased subjects who have donated their bodies for the purpose of research.
Federal law requires applicable clinical trials to register before enrollment of the first participant. This guide will provide instruction and useful websites to insure compliance. Please contact the University’s PRS administrator Susan Sandusky. to initiate the clinical trial registration process or for further assistance.
Conflict of Interest (COI):
The University of Pittsburgh's Conflict of Interest Policies and Resources.
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.
Genomic Data Sharing Plans (NIH):
To assist the University of Pittsburgh research community in developing data sharing plans that meet the requirements of the National Institutes of Health (NIH) Genomic Data Sharing Policy, some guidance documents have been developed.
These documents are located on the Office of Research website under "References and Resources".
Contact CTSI Research Facilitators for inquiries and assistance with NIH genomic data sharing plans.
Guide for the Care and Use of Laboratory Animals:
The University of Pittsburgh refers to The Guide as the primary reference when using animals for research.
Human Research Protection Office (HRPO):
The HRPO (formerly the IRB) maintains its position under the Research Conduct and Compliance Office (RCCO) and continues to oversee the functions of the IRB Committees and administrative review processes. This change does not affect the review process or services provided to the research community; rather it more accurately reflects the comprehensive services that have always been provided. The HRPO promotes the safety and protection of individuals involved in research by providing support, guidance and education to facilitate ethical and scientifically sound research.
Human Stem Cell Research Oversight Committee (hSCRO):
Oversight and information for investigators using human stem cells in research.
Internet-Based Studies in Education and Research:
Access to online research training and resources for human and animal studies, including: Research Integrity, Good Clinical Practice, Human Subjects, Biomedical Science, Social and Behavioral Science, and Use of Laboratory Animals in Research and Education
Institutional Animal Care and Use Committee (IACUC):
The University of Pittsburgh's main animal research website. Offers instructions on how to submit your animal subject research proposal to IACUC.
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 Data and Safety Monitoring Boards (DSMBs):
Information and submission process for DSMBs through the Office of Clinical Research.
Investigational Drug Services (IDS):
Coordinates the dispensing of research pharmaceuticals through UPMC Pharmacies. Contact at email@example.com
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.
Office of Research (OOR):
Support for all sponsored research at the University of Pittsburgh.
Office of Research, Health Sciences (OORHS):
Review of Grant Applications for Faculty in the School of Health Sciences: OORHS has scientific administrators available to review grant applications. Contact Jeremy Somers at firstname.lastname@example.org
Online Submission for Institutional Reviews (OSIRIS):
Online IRB submission form for all human subjects studies.
Pitt Data Use Agreements or Material Transfers Agreements (DUA/MTA):
Information on Data and Material Transfers from the University of Pittsburgh Office of Research. Links to additional resources and contact information.
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 askQRC@upmc.edu. The QRC reviews, refers, and approves QI projects at UPMC. These projects do not require IRB approval unless they involve human participant research, but are still subject to oversight.
Radiation Safety Office:
University of Pittsburgh Office responsible for ensuring that all sources of licensed radioactive material and ionizing radiation producing equipment, which fall under its responsibility, are used optimally and safely.
This brief video describes SMART IRB, one of several options for single IRB review.
United States Food and Drug Administration (FDA):
General information, additional resources, and contact information.
UPMC Office of Sponsored Programs and Research Support (OSPARS):
Oversight of industry-sponsored studies using a central IRB, and UPMC Fiscal Review. To contact, email at OSPARS@upmc.edu, or call at 412-647-4461.
Used to pay research subjects for their participation in a clinical research study.