6,510: Policy for Human Research w88 slot online
Revised: November 2015
The University of Nevada, Reno Human Research w88 slot online 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 w88 slot online Programs (AAHRPP).
The University applies ethical standards and regulatory requirements to all w88 slot online 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 w88 slot online subjects research. These include the
• Ethical Principles and Guidelines for the w88 slot online of Human Subjects of Research (often referenced as the "Belmont Report");
• Department of Health and w88 slot online Services (DHHS) regulations at Title 45 Code of Federal Regulations (CFR), Part 46), Subpart A (also known as the "Common Rule"), and Subparts B, C, and D;
• Food and Drug Administration (FDA) regulations at 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812;
• Department of Veterans Affairs regulations at 38 CFR 16 and related VHA handbooks;
• Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191;
• Department of Education regulations at 34 CFR 98 and 34 CFR 99; and
• other applicable federal regulations, and State and local laws.
The University exercises its responsibilities to protect the rights and welfare of w88 slot online 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 w88 slot online
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 w88 slot online.
Authority of the Research Integrity Office for Human Research w88 slot online
The VPRI recognized the RIO as the institutional component with primary responsibility for implementation and maintenance of the w88 slot online IRB and coordination with other components of the w88 slot online's HRPP. The HRPP is responsible for administrative and regulatory support to the w88 slot online Institutional Review Board (IRB). In this capacity, the RIO has the authority and responsibility to
• determine when projects do not constitute w88 slot online subject research;
• review and approve exempt w88 slot online,
• require Expedited or Full Committee Review by the w88 slot online, and
• assess complaints and problems in w88 slot online 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 w88 slot online 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 w88 slot online participants.
Authority of the Institutional Review Boards for Human Research w88 slot online
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 w88 slot online.
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 w88 slot online.
• Approval by other institutional bodies cannot substitute for w88 slot online approval.
• w88 slot online disapprovals may not be superseded by other institutional authorities but institutional authorities may disallow studies approved by the w88 slot online.
The w88 slot online IRB has the authority to
• review, approve, require revisions to secure approval, and disapprove all w88 slot online research activities overseen and conducted by the University and affiliate institutions;
• suspend or terminate approval of w88 slot online 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 w88 slot online activities; and
• observe or have a third party observe the consent process or the conduct of the w88 slot online.
During Full Committee and Expedited Review, the IRB ensures w88 slot online research projects comply with the DHHS criteria for IRB approval of w88 slot online research at 45 CFR 46.111 and other applicable federal regulations and requirements, State and local laws, and w88 slot online and affiliate institution policy.
Human Research w88 slot online Policies and Procedures
The Human Research w88 slot online Policy Manual details the policies and procedures for the submission, review, and conduct of research with w88 slot online 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 w88 slot online 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 w88 slot online research while protecting the rights and welfare of w88 slot online participants.
The HRPP Manual provides details about
• roles and responsibilities w88 slot online HRPP components;
• ethical standards and federal regulations and requirements applicable to w88 slot online research;
• enrollment of vulnerable populations in w88 slot online;
• requirements for recruitment and consent, assessing w88 slot online risks and benefits, and protecting participant privacy and data confidentiality;
• submission w88 slot online;
• review and approval processes;
• w88 slot online for record-keeping;
• w88 slot online 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.