F1.0100
Medical IRB Research Description
5
Date of admissions/ discharge and operation procedures
Results of physical exams done by healthcare professionals
Complications including date of death
Postop visits and status at visits
Resources: Describe what resources/facilities are available to perform the research (i.e., staff, space, equipment).
Such resources may include a) staffing and personnel, in terms of availability, number, expertise, and experience;
b) psychological, social, or medical services, including counseling or social support services that may be required
because of research participation; c) psychological, social, or medical monitoring, ancillary care, equipment needed
to protect subjects; d) resources for subject communication, such as language translation services, and e)
computer or other technological resources, mobile or otherwise, required or created during the conduct of the
research. Please note: Some mobile apps may be considered mobile medical devices under FDA regulations
(see FDA Guidance). Proximity or availability of other resources should also be taken into consideration, for
example, the proximity of an emergency facility for care of subject injury, or availability of psychological support
after participation.
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky,
at sites that are geographically separate from UK, or at sites that do not fall under the UK IRB’s authority, are
subject to special procedures for coordination of research review. Additional information is required (see ORI's Off-
Site Research web page); supportive documentation can be attached in the E-IRB "Additional Information" section.
Provide a written description of the role of the non-UK site(s) or non-UK personnel who will be participating in
your research. The other site may need to complete its own IRB review, or a cooperative review arrangement may
need to be established. Contact the Office of Research Integrity at (859) 257-9428 if you have questions about the
participation of non-UK sites/personnel.
If the University of Kentucky is the lead site in a multi-site study, or the UK investigator is the lead investigator,
describe the plan for managing the reporting of unanticipated problems, noncompliance and submission of
protocol modifications and interim results from the non-UK sites.
Medical records will be reviewed by Cardiothoracic Surgery study personnel at the University of
Kentucky Medical Center Cardiothoracic Surgery Offices and data will be analyzed by the PI.
Both paper and electronic medical records will be reviewed; but, collected data will only be
stored electronically (in REDCap/in an encrypted database/spreadsheet).
Potential Risks: If applicable, describe any potential risks--physical, psychological, social, legal or other.
The only risk is the breach of confidentiality. This will be avoided by the procedures described in
the Confidentiality section.
Research Materials, Records and Privacy: Identify the sources of research material obtained from individually
identifiable living human subjects. Indicate what information (specimens, records, data, genetic information, etc.)
will be recorded and whether use will be made of existing specimens, records or data. Explain why this information
is needed to conduct the study.
Return of Research Results or Incidental Findings (if applicable):
If research has the potential to identify individual results or discover incidental findings that could affect the health
of a subject, describe plans to assess, manage, and if applicable disclose findings with individual subjects or provide