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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 10 / 23

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A1.0050

A1.1150 INVESTIGATOR/RESEARCH PERSONNEL

Direct responsibility for ethical conduct of human research and protection of research subjects lies with each investigator and the study personnel engaged in human research activities. Investigators hold the following key responsibilities: to design and implement ethical research within sound study designs according to the Belmont ethical principles and the standards of the discipline; involve study personnel qualified by training and experience for their research responsibilities; obtain IRB approval prior to initiating human research activity; comply with federal and state regulations, institutional and IRB requirements, and requirements of the Health Insurance Portability and Accountability Act pertaining to research; implement research as approved and in compliance with all IRB decisions, conditions, and requirements; maintain appropriate project and personnel oversight and appropriately delegate research responsibilities; conduct recruitment of subjects fairly and equitably while assessing risks/benefits to research subjects; obtain and document informed consent/assent/authorization when applicable and provide a mechanism for receiving and responding to subjects’ complaints or requests for information; monitor data integrity as well as the rights and welfare of human subjects; submit progress reports; report unanticipated problems/adverse events; obtain prior approval for modifications to research protocols—including promotional materials; maintain written documentation of activities; and retain records. A detailed list of responsibilities is included in IRB/ORI Standard Operating Procedures (SOPs) and in the document A Principal Investigator’s Guide to Responsibilities, Qualifications, Records and the Documentation of Human Subjects Research.

To enable researchers to perform their responsibilities appropriately, UK has established mandatory education requirements regarding human research protection for investigators and their study personnel. Additional mandatory training is required, to ensure investigators who assume the role of sponsor for an FDA regulated product are knowledgeable about applicable regulatory and institutional requirements. The ORI documents completion of education requirements.

In designing the human subject protections specific to the project, the principal investigator (PI) shall consider any and all conflicts of interest as defined in AR 7:2 and, in cooperation with the appropriate associate dean for research or other appropriate University official, identify and develop a plan to manage conflicts of interest.

The PI shall make a determination before conducting the study that the appropriate resources to protect human subjects are or will be in place, including resources to address adverse events and possible research-related injuries. For research protocols involving greater than minimal risk, the PI shall specifically detail plans for data safety and monitoring (i.e., for determining harm to research subjects and mitigating potential injuries).

If applicable to the research, the PI and study personnel must also comply with policy, procedures, and mandatory education requirements specified by other University administrative units such as the Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), Markey Cancer Center, Corporate Compliance, and the RDRC.

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