Statement of Authority and Purpose
Jurisdiction of the Avera Institutional Review Board applies to all biomedical or behavioral research, development or related activities or projects involving human subjects and carried out or conducted by individuals affiliated with Avera facilities.
The IRB has the authority to ensure that research is designed and conducted in such a manner that protects the rights and welfare of participating subjects. Specifically, the IRB:
- Will review all research projects involving human subjects before the involvement of human subjects may begin;
- May disapprove, modify or approve studies based upon consideration of human subject protection aspects;
- Reviews, and has the authority to approve, require modification in, or disapprove, all research activities that fall within its jurisdiction;
- Has a mechanism in place for prompt reporting of any planned changes in approved projects prior to the implementation of those changes;
- Has the authority to conduct continuing review as it deems necessary to protect the rights and welfare of research subjects, including requiring progress reports from the investigators and auditing the conduct of the study, and observing the informed consent process and/or auditing the progress of any study under its jurisdiction as it deems necessary to protect the rights and welfare of human subjects;
- May suspect or terminate approval of a study;
- May place restrictions on a study for the purpose of subject protection.
The IRB is established to review biomedical and behavioral research involving human subjects regardless of the source of funding and location of the study. Except for research in which the only involvement of humans is in one or more of the categories exempted or waived under 45 CFR 46 Section 101(b)(1-6) or 101(i), all research involving human subjects, and all other activities which even in part involve such research, regardless of sponsorship, are subject to these policies and procedures if one or more of the following apply
- The research is sponsored by institutional authorities and/or;
- The research is conducted by or under the direction of any employee, faculty, staff, student, or agent of the Institution in connection with his or her institutional responsibilities and/or;
- The research is conducted by or under the direction of any employee, faculty, staff, student, or agent of the Institution using any property or facility of the Institution and/or;
- The research involves the use of the Institution's nonpublic information to identify or contact human research subjects.
A. Governing Principles
1. IRB Review of Research
2. Failure to Submit a Project for IRB Review