Institutional Review Board

Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC)

Purpose

�鶹�� recognizes that the Oglala people, and many other peoples in North America and on other continents who have been subject to colonization, have been subjected to research practices that are ethically and morally reprehensible. The review process at �鶹�� is informed by an appreciation for that historical background in addition to federal law and generally acceptable ethical principles.

In order to comply with ethical principles and with federal guidelines concerning the protection of human and animal subjects, research conducted under the auspices of �鶹�� is subject to a review process in order to insure that it meets required legal and ethical standards. �鶹��'s Institutional Review Board must review all clinical and behavioral research involving human subjects conducted at or through �鶹�� in order to assure that the research complies with ethical standards and federal law.

�鶹��'s Institutional Animal Care and Use Committee (IACUC) must review all research involving animal subjects in order to comply with ethical standards and federal law. The IACUC?s overall task is to determine whether a project?s societal benefit justifies any animal pain and suffering that it might cause, and whether whatever animal pain or suffering occurs will be kept to a minimum.

Nothing in this Policy or statement of Purpose should be construed as creating an impediment to research. �鶹�� encourages research. This policy is designed to support research and to insure that research is conducted with due regard for protection of human and animal subjects.

Part I: Protection of Human Subjects ? the Institutional Review Board (IRB)

A. Definition of Research

�鶹�� adopts, for the purposes of human subjects' protection, the federal definition of research:

"A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities."

45 CFR 46.102

B. Covering Regulations:

45CFR46 Protection of Human Subjects

C. Ethical principles:

Ethical principles reflect cultural and social bases for the goal of protecting human subjects. The Lakota values of respect and generosity are foundation stones and they overlap substantially with the internationally recognized principles that formed a basis for legal regulation of research. Those include 1, respect for persons: individuals are autonomous agents, and persons of diminished autonomy are entitled to protection; 2, Beneficence: Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being (do no harm, maximize benefits, minimize potential harm); 3, Justice: Who ought to receive the benefits of research and bear its burdens? An injustice occurs when some benefit is denied without good reason or when some burden is imposed unduly (cf. Belmont Report, 1979 US Dept. H.E.W.)

D. Scope: What is subject to IRB Review

1. Generally, any �鶹�� research that uses humans, human tissue, surveys of human subjects, or human subjects' records requires IRB review, irrespective of its funding source. The IRB's charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.

2. Specifically, IRB review and approval is required for any research involving human subjects that meets any of the following criteria:

a) research is conducted by University faculty, adjunct faculty, staff, students;
b) research is performed on the premises of the �鶹��, including Piya Wiconi, college centers, and He Sapa Learning center;
c) research is performed with or involves the use of facilities or equipment belonging to �鶹��;
d) research involves �鶹�� students, staff, or faculty
e) research satisfies a requirement imposed by �鶹�� for a degree program or for completion of a course of study
f) research is certified by a college administrator to satisfy an obligation of a faculty or consultant appointment at �鶹��, including clinical or adjunct appointments
g) research is conducted by or under the direction of any employee or agent of �鶹��, in connection with his or her institutional responsibilities;
h) research using data on human subjects gathered in earlier projects require IRB review.

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