Principal Investigators Guide
Research Compliance
Institutional Review Board (IRB) for the Protection of Human Subjects
All projects involving human subjects conducted by faculty, staff and students of the University of Denver require IRB review and approval. An IRB application must be completed and submitted electronically via eProtocol, along with additional attachments, before research begins and by the submission deadline. Please see ORSP Calendar for monthly deadlines and visit www.du.edu/orsp/research_compliance.html. Additionally, you may need to include one or more attachments if the project involves protected health information, anonymous or confidential consent forms and/or international research.
Please see the IRB Application and Checklist, found on the website, for links to these attachments.
NOTE: Some research studies are exempt from the Code of Federal Regulations. In these cases, an abbreviated “Exemption Application” may be completed and submitted to ORSP for review by the IRB chair. However, the IRB, not the PI, must determine that research is exempt. For information:
www.du.edu/orsp/irb.html or send an email to du-irb@du.edu.
Institutional Animal Care and Use Committee (IACUC)
Any individual proposing to use animals in research is required to obtain approval from the University of Denver IACUC. “Animal” is defined as “any live, vertebrate animal used or intended for use in research, research training, teaching, experimentation or biological testing or for related purposes.” Please visit www.du.edu/orsp/research_compliance.html for access to electronic submissions via eProtocol. For information and forms: www.du.edu/orsp/animal.html or send an email to du-iacuc@du.edu
Institutional Biosafety Committee (IBC)
The IBC is responsible for ensuring that research involving recombinant DNA or select agents and other biological hazards at the University of Denver is in compliance with established NIH Guidelines. To carry out this oversight, the IBC has three main tasks: review research proposals involving biological hazards, develop emergency plans for accidental biohazard spills, and provide consultation to PI’s on biosafety issues.
Please visit www.du.edu/orsp/research_compliance.html for access to electronic submissions via eProtocol.
For information and forms:
www.du.edu/orsp/biosafety.html or send an email to du-ibc@du.edu.
www.du.edu/orsp/meetingdates.html
Beginning October 1, 1995, federal regulations require that the University manage, reduce, or eliminate actual or potential conflicts of interest with financial interests of a principal investigator (PI), project director, or others. Accordingly, the University must require that the investigators/project directors disclose any significant financial interest that creates an actual or potential conflict of interest in relation to a sponsored project. These federal regulations also require that such disclosure occur prior to the submission of a sponsored project proposal as well as after proposal submission and issuance of award as significant financial interests arise. In order to comply with these federal requirements, the University requires Certification of Compliance: www.du.edu/orsp/conflict.html
The University’s Conflict of Interest (3.20.060) and Faculty Professional Service Activities and Conflict of Interest (3.01.005) Policies apply to all University personnel under all circumstances.
Please see the website for additional information regarding the following:
Certification and Training
COI - Conflicts of Interest
Contact Information
Data Security
Definitions
Education
FAQ’s
HIPAA (Privacy Act)
Informed Consent
Mission Statement
Policies and Procedures
Research Compliance Newsletter
Research Misconduct Policies
