Guidance and Resources
Guidelines
FDA Regulated Studies
NIH Sponsored/Funded Studies
UIC Sponsored Studies
- UIC encourages that internally funded studies follow the same guidelines as required for NIH-sponsored studies.
Glossary of terms
Conflict of Interest: Conflicts of interest in research involve situations in which financial, professional, or other personal considerations may compromise, or have the appearance of compromising an individual’s judgment in the design, conduct, or reporting of research.
Conflict of Commitment: A Conflict of Commitment refers to a situation where an individual engages in external activities, either paid or unpaid, that interferes with his/her primary obligation and commitment to the University.
De-Identified Data or Specimens: De-identified health information neither identifies nor provides a reasonable basis to identify an individual. There are two ways to de-identify information; (1) a formal determination by a qualified statistician; or (2) the removal of specified identifiers of the individual and of the individual’s relatives, household members, and employers is required, and is adequate only if the covered entity has no actual knowledge that the remaining information could be used to identify the individual.
Directed Monitoring: Monitoring activities conducted on a “for-cause” basis which include, but are not limited to, reported complaints and request by the IRB due to anomalies related to a protocol.
Focused Monitoring: Review of an IRB approved study where the monitoring focuses only on one aspect of the study; for example, review of only the consent documents and process, review of only inclusion/exclusion criteria, etc.
HIPAA Privacy Rule: Standards that address the use and disclosure by “covered entities” of individuals’ health information (Protected Health Information or PHI). For help in determining whether you are covered, use the decision tool at: http://www.cms.hhs.gov/hipaa/hipaa2/support/tools/decisionsupport/default.asp
HIPAA Security Rule: standards for protecting certain health information that is held or transferred in electronic form. This information is called electronic protected health information, or e-PHI.
Human Subject (As defined by Federal Policy for the Protection of Human Research Subjects):
A living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Interaction: includes communication or interpersonal contact between investigator and subject.
Intervention: includes both physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Key Study Personnel (sub-investigators, study coordinators, faculty mentors, other study team members) involved in supervising, managing, or conducting study-related activities are responsible for following the protocol and any SOPs as well as executing tasks as delegated in compliance with regulatory requirements and institutional policies.
Post-IRB Approval Monitoring: Overseeing the progress of a clinical trial after it has been approved by the IRB.
Post IRB-Approval Monitoring Team is responsible for coordination of monitoring activities including but not limited to:
- Routine monitoring of selected IRB approved studies;
- Conduct directed (for-cause) monitoring as indicated;
- Report findings from monitoring to the appropriate party(ies); and
- Development of educational and training programs for investigators and research staff
Principal Investigator is ultimately responsible for the overall conduct of the research, appropriate delegation of roles, responsibilities, and tasks, as well as compliance with applicable laws and policies.
Protected Health Information (PHI): individually identifiable information held or transmitted by a covered entity, in any form or media, whether electronic, paper, or oral. See Attachment A for full PHI listing.
Routine Post-IRB Approval Monitoring: Monitoring of a clinical trial selected without bias based on specific, objective criteria including but not limited to those studies which are federally funded, internally funded, investigator-initiated greater than minimal risk, where UIC is relying on an external IRB for review and approval, or where the principal investigator is new or inexperienced. Routine monitoring may also be requested by the Principal Investigator (PI) and/or study team.