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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 21 / 23

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A1.0050

requirements. In addition, the ORI documents completion of training for investigators conducting human research. Specific University requirements call for all study personnel involved in human research to complete one of the following two training courses: Collaborative Investigator Training Initiative (CITI) or Protecting Study Volunteers in Research (Dunn & Chadwick). Both are available through the ORI and include web-based testing to document successful completion of training. In order to continue human research activities, study personnel must complete continuing education every three years. Personnel may choose from a number of web-based training options or attendance at a human research protection conference such as UK’s annual regional HRP conference. UK also requires training for investigators who assume the sponsor role for a FDA regulated research study. Web-based modules and exam are maintained by ORI to ensure and document that the sponsor-investigator is informed regarding additional regulatory and institutional responsibilities.

Additional training falling under the purview of Corporate Compliance and the Committee on Safety and Environmental Health and its subcommittees is also mandatory for investigators.

A1.2350 Quality Improvement Program

The ORI and the UK IRB provide a Quality Improvement Program to strengthen human research protections at UK and to demonstrate UK’s commitment to continuous improvement in compliance. The QIP Coordinator evaluates human research protections at varying levels (e.g., federal, state, institutional, and Good Clinical Practice); increases awareness of existing processes, operating procedures, and educational programs; and acquires information necessary to enhance protections. Components of the program focus on educating UK investigators on the mechanisms by which human subjects are protected and regular assessment of current HRPP practices in relation to AAHRPP standards. QIP components present the opportunity for researchers, ORI staff, and IRB members to continually improve human research protections performance and excel beyond federal and state standards for protections.

The QIP provides useful information for identifying educational/training initiatives for researchers and their staff, ORI staff, and IRB members. The QIP also plays a significant role in preparing the AAHRPP application and annual reports and in assessment of the UK HRPP as required by AAHRPP standards.

The QIP consists of three main components which examine the entire research process and may focus on the researcher, the IRB’s review process, the IRB records maintained by the ORI, and/or the HRPP as a whole.

Directed on-site reviews are initiated by IRB or ORI request due to unusual circumstances or significant risks to subjects, routine failure of an investigator to comply with federal and/or institutional requirements, allegations or concerns about the conduct of the study brought to the IRB’s attention, or any case requiring further scrutiny, as deemed appropriate by the IRB.

Principal Investigator Self-assessment reviews are voluntarily performed by the investigator or his/her study personnel. However, the IRB or the ORI may also directly invite an investigator to perform a self-assessment review. The ORI provides a web-based self-assessment form (also available electronically or in paper copy) to be completed by the investigator and/or study personnel.

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