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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 4 / 23

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A1.0050

UK policy requires that all investigators/study personnel conducting research involving human subjects or clinical investigations successfully complete and periodically renew mandatory training in the protection of human subjects. This policy includes research exempt from federal regulations. Exemption reviewers may recommend revisions within an exempt project to enhance subjects’ protection. Investigators conducting research exempt from federal regulations may also incorporate consent and other procedures covered by human research protections. Finally, the sponsoring agency may require that proposed research receive full or expedited review even when the research activities otherwise qualify for exemption.

A1.0300 ORGANIZATIONAL STRUCTURE FOR HUMAN RESEARCH PROTECTION

Human research protection is a shared institutional responsibility which encompasses diverse units and designated personnel crossing three primary domains: (1) the institution, (2) the institutional review boards, and (3) the investigator/study personnel. Areas of responsibility for each with specific reference to the conduct of research are delineated in institutional policies and procedures appropriate to the particular unit mission and/or administrative position of the personnel involved.

A1.0350 INSTITUTIONAL LEADERSHIP AND HUMAN RESEARCH PROTECTION PROGRAM ADMINISTRATION

A1.0400 Vice President for Research

The key institutional leader responsible for oversight and management of all aspects of UK research is the Vice President for Research (VPR), who reports to the Provost who, in turn, reports to the University President. The VPR is the designated institutional official for human research protection in UK’s Federalwide Assurance with the DHHS and for all components of the institutional HRPP. The University authorizes the VPR to act on its behalf, specifically committing the University to compliance with all requirements of the Code of Federal Regulations, 45 CFR 46, and other applicable federal regulations (e.g., FDA 21 CFR 50 and 56), not only for all federally sponsored research but for all human research activity regardless of sponsorship. Specific institutional responsibilities in meeting HRPP requirements include: developing policies and procedures that ensure human research protections; establishing an appropriate number of IRBs sufficient to meet institutional research needs and appointing qualified members to serve on the IRBs; ensuring education of IRB members, staff, and study personnel; providing sufficient resources and staff support to implement the HRPP and to ensure the effective operation of the IRBs; supporting IRB decisions; implementing mechanisms for institutional oversight; ensuring effective institution-wide communication and access to human research information for all UK entities; ensuring submission of and sign-off on appropriate assurances and certifications for the institution and cooperating performance sites; and overseeing UK reporting to regulatory agencies.

A1.0450 Office of Research Integrity A1.0500 Coordination and Administration

The Office of Research Integrity (ORI), a research support unit reporting directly to the VPR, plays a significant role in the institutional HRPP, interacting with the IRB and all University constituencies engaged in the HRPP to facilitate effective human research protections. The ORI

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