Regulatory & Bioethics Support
Overview
The Regulatory and Bioethics Support program aims to provide centralized and accessible advice, guidance, and resources for investigators on issues related to human research protections, new drug and device authorizations, animal care and use, biosafety and other considerations relevant to the ethical conduct of research across the translational spectrum.
Our team advises investigators on regulatory requirements, documents, and processes as well as ethical considerations for designing and implementing research. This core also serves as a liaison between the Office of Human Research Protections and the UIC IRBs, investigators, research staff and CCTS partner organizations.
We are available to answer a quick question, review materials to check for completeness, clarity, and consistency prior to submission, or provide in-depth consultation on a challenging issue.
Our Impact at UIC Heading link
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↓ 18 days IRB turnaround time reduction for applications supported by regulatory specialists
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ETHICAL protocol development and consultative advice
Meet the Team Heading link
Emily Anderson
Email:
Rachel Olech
Phone:
Email:
Alison Santiago
Phone:
Email:
Terry Vanden Hoek
Phone:
Email:
Support by Project Stage Heading link
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Planning
Relevant Support:
- Submissions to Institutional Review Board, Institutional Biosafety Committee, Animal Care Committee, Food and Drug Administration (investigational new drugs and medical devices)
- General questions related to the submission process
- Review of entire protocol/application prior to initial submission
- Responding to requests for changes or additional information
- Protocol Development: Guidance regarding ethical and regulatory issues associated with:
- Research design
- Subject selection and recruitment
- Informed consent
- Privacy, confidentiality, and data management and storage
- Recruitment and Informed Consent Documents and Procedures
- Developing materials
- Reviewing materials for compliance with regulations and best practices
- eConsent
- Waivers of consent
- Establishing Data and Safety Monitoring Boards/Committees (DSMB/C)
- Working with non-UIC sites and investigators:
- Single IRB Review: WIRB, NCI CIRB, NIH single IRB review requirements, reliance agreements
- Reporting and documentation requirements for the UIC IRB
- Conflicts of Commitment & Interest
- Investigator training requirements
- Submissions to Institutional Review Board, Institutional Biosafety Committee, Animal Care Committee, Food and Drug Administration (investigational new drugs and medical devices)
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Data Collection
Relevant Support:
- Guidance on IRB requirements:
- Adverse Events and Unanticipated Problem Reporting
- Amendments
- Continuing Review
- Study close-out and Final Reports
- Consultation on ethical issues that arise in the field
- Recruitment and informed consent
- Participant withdrawal
- Privacy & confidentiality
- Competing studies
- Guidance on IRB requirements:
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conclusion
Relevant Support:
- Conflict of Interest Disclosures
- Authorship
- Maintaining participant confidentiality in publication
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dissemination
Relevant Support:
- Ethical issues related to dissemination and publication
- ClinicalTrials.gov
