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Revised: November 2015

The Â鶹ӳ»­ Human Research Protection Program (HRPP) was developed to ensure the rights, safety and welfare of all participants recruited or enrolled in research projects. The HRPP does this by serving as the advocate for the rights and welfare of persons who participate in research programs conducted by faculty, staff, students and Affiliate faculty. In accordance with university policy, all such research must not only be in compliance with state and federal regulations, but must also meet or exceed the standards of accreditation as set forth by the Association for Accreditation of Human Research Protection Programs (AAHRPP).

The University applies ethical standards and regulatory requirements to all human research in which university and affiliate faculty, students, and staff are engaged, regardless of funding source, type of research, or research site. The HRPP coordinates oversight by incorporating all aspects of compliance related to human subjects research. These include the

• Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referenced as the "Belmont Report");
• Department of Health and Human Services (DHHS) regulations at , Subpart A (also known as the "Common Rule"), and Subparts B, C, and D;
• Food and Drug Administration (FDA) regulations at , , , and ;
• Department of Veterans Affairs regulations at and related VHA handbooks;
• Health Insurance Portability and Accountability Act of 1996 (HIPAA), ;
• Department of Education regulations at and ; and
• other applicable federal regulations, and State and local laws.

The University exercises its responsibilities to protect the rights and welfare of human research participants through relationships with components of the university's HRPP including but not limited to the Office of the Vice President for Research and Innovation, the Research Integrity Office (RIO), Office of Sponsored Projects, the Institutional Review Board (IRB), departmental officials, Principal Investigators and research staff, and institutional safety committees; and external components including Affiliate Institutions, Sponsors, participants, and the community.

Authority of the Vice President for Research and Innovation for Human Research Protection

Under the authority of the university President, the Vice President for Research and Innovation (VPRI) has sufficient standing, authority, and independence to ensure implementation and maintenance of the university's HRPP. The VPRI ensures the university's HRPP has sufficient resources and its DHHS federal-wide assurance is appropriately executed (FWA00002306). As the designated Institutional Official for the University, the VPRI has the authority to assume on behalf of the institution the obligations imposed by the federal regulations pertaining to human research protection.

Authority of the Research Integrity Office for Human Research Protection

The VPRI recognized the RIO as the institutional component with primary responsibility for implementation and maintenance of the university IRB and coordination with other components of the university's HRPP. The HRPP is responsible for administrative and regulatory support to the University Institutional Review Board (IRB). In this capacity, the RIO has the authority and responsibility to

• determine when projects do not constitute human subject research;
• review and approve exempt research,
• require Expedited or Full Committee Review by the IRB, and
• assess complaints and problems in human research and dismiss the matter, require corrective actions, refer the matter to other institutional authorities, and fulfill reporting requirements.

With the support of the Institutional Official, the RIO has the authority to establish IRB agreements with individuals who wish to conduct human research under the authority of the University (i.e., Independent Investigators) and with external IRBs to minimize duplication of IRB review. The latter may occur when university or affiliate investigators conduct research at external sites or collaborate with researchers from external sites or institutions.

The RIO also has the authority to establish training requirements for university and affiliate faculty, staff, and students involved in the design, conduct, or reporting of research involving human participants.

Authority of the Institutional Review Boards for Human Research Protection

Under the direction of the RIO, the University grants its IRB the authority necessary to function independently to ensure the consistent and unbiased application of the requirements for human research protection.

The university IRB has the authority necessary to function independently but in coordination with other institutional components and regulatory committees to ensure the consistent and unbiased application of the requirements for human research protection.

• Approval by other institutional bodies cannot substitute for IRB approval.
• IRB disapprovals may not be superseded by other institutional authorities but institutional authorities may disallow studies approved by the IRB.

The university IRB has the authority to

• review, approve, require revisions to secure approval, and disapprove all human research activities overseen and conducted by the University and affiliate institutions;
• suspend or terminate approval of research that is not conducted in accordance with the IRB's requirements or that involves unexpected serious harm to participants or others;
• require researchers to obtain legally effective informed consent from each participant prior to her/his involvement in any research activities; and
• observe or have a third party observe the consent process or the conduct of the research.

During Full Committee and Expedited Review, the IRB ensures human research projects comply with the DHHS criteria for IRB approval of human research at and other applicable federal regulations and requirements, State and local laws, and University and affiliate institution policy.

Human Research Protection Policies and Procedures

The details the policies and procedures for the submission, review, and conduct of research with human subjects conducted by university and affiliate faculty, staff, and students. These policies and procedures, developed and administered by the Research Integrity Office apply to all research involving human subjects, regardless of sponsorship and performance site conducted under the auspices of the University or its affiliate Institutions. University policy requires departmental officials ensure the principal investigator possesses the necessary qualifications, credentials, and resources to conduct human research while protecting the rights and welfare of human participants.

The HRPP Manual provides details about

• roles and responsibilities of the HRPP components;
• ethical standards and federal regulations and requirements applicable to human research;
• enrollment of vulnerable populations in research;
• requirements for recruitment and consent, assessing research risks and benefits, and protecting participant privacy and data confidentiality;
• submission requirements;
• review and approval processes;
• requirements for record-keeping;
• requirements for reporting events or situations that suggest noncompliance or identify a unexpected problem that may involve risks to participants or others; and
• the RIO Quality Improvement Program.