===== page 1 ===== Page 1 of 1 WERTC Resolution IRB Code Approval WHITE EARTH RESERVATION TRIBAL COUNCIL A/K/A WHITE EARTH BUSINESS COMMITTEE WHITE EARTH BAND OF CHIPEWA INDIANS OO) "1 “DOK Resolution No. ____ WHEREAS, the White Earth Reservation Tribal Council is the duly elected governing body of the White Earth Reservation pursuant to Article IV, Section 1, of the revised constitution of the Minnesota Chippewa Tribe, as amended, and organized under Section 16, of the Act of June 18, 1934 (48 Stat. 984), and WHEREAS, the White Earth Reservation Tribal Council, also known as the White Earth Reservation Business Committee, is the duly authorized governing body of the White Earth Band, and WHEREAS, the White Earth Reservation Tribal Council has previously determined that a working group of the White Earth Band has drafted a proposed Institutional Review Board Ordinance in order to uniformly and effectively govern research and other academic proposals impacting or affecting the White Earth Band, its people, culture, history, or lands, and WHEREAS, a working group of the White Earth Band has drafted a proposed Institutional review Board Ordinance in order to uniformly and effectively govern research and other academic proposals impacting or affecting the White Earth Band, its people, culture, history, or lands, and WHEREAS, the comment period has expired and the working group has finalized the Institutional Review Board Ordinance, and recommends the White Earth Reservation Tribal Council also adopt the same, now THEREFORE BE IT RESOLVED, that the White Earth Reservation Tribal Council hereby adopts the Institutional Review Board Ordinance as presented in the attached format. We do hereby certify that the foregoing resolution was adopted by a vote of 3 for, 1 against, 0 silent, a quorum being present at a special meeting of the White Earth Reservation Tribal Council held on January 9, 2017 in Minnesota. Terrence "Terry" Tibbetts, Chairman / Tara Mason, Secretary/Treasurer ===== page 2 ===== WHITE EARTH NATION RESEARCH CODE 01. TITLE This code shall be known and cited as the White Earth Nation Research Code. 02. LEGISLATIVE FINDINGS AND POLICY The White Earth Tribal Council recognizes the value of medical, social, and physical science research to the White Earth people. The White Earth Tribal Council, as the governing body of the Tribe must also act to protect the safety and well-being of the individual members of the Tribe. The White Earth Tribe also has fundamental policy to protect and preserve the culture of the Nation and ensure that activities permitted on the Reservation are conducted in a way that does not harm to the people or culture of the White Earth Nation. The Tribal Council understands that when research has been conducted in ways that do not respect the safety and human dignity of subjects; and/or does not recognize the interests of the White Earth Nation that damages occur. The White Earth Tribal Council, through its Internal Review Board and Tribal Research Code, intends to ensure research is performed in a way that is of benefit to individual Tribal members and nation at large. 03. PURPOSE The purpose of this code is to define Tribal research policies and to establish how the research policies will be administered. It provides for procedures by which the White Earth Tribal Council will grant permission to researchers to conduct research on the White Earth Indian Reservation. The Code provides: A. An application and permitting procedure with which applicant researchers must comply in order to obtain permission to conduct research of any kind on the White Earth Reservation; B. Standards of conduct designed to protect individuals, communities and the Tribe from improper research procedures; C. Provisions to protect the rights of individuals and the Tribe in data and reporting; and D. Provisions to ensure appropriate Tribal and community participation in the design and evaluation of research, along with local opportunities for employment in research projects permitted on the White Earth Reservation. 04. SCOPE AND NATURE OF CODE A. This code is civil in nature and hereby amends any existing Tribal resolution or ordinance inconsistent with respect to research. B. This code shall apply within the exterior boundaries of the White Earth Reservation. It shall also be enforceable outside the boundaries of the Reservation as applicable law permits with respect to research conducted on the Reservation or research using materials as to which the Tribe has a claim of ownership; and with respect to White Earth Tribal members domiciled off the Reservation. C. This code shall apply to all persons subject to the civil jurisdiction of the White Earth Nation, including members and non-members, Indians and non-Indians and other corporate and institutional persons who might conduct research on the White Earth Reservation. ===== page 3 ===== D. This code is adopted pursuant to the Constitution and Bylaws of the Minnesota Chippewa Tribe in the exercise of Article VI. Specifically, this code asserts the Tribe's power to provide for the welfare and safety of the White Earth Band of Chippewa (Article I, Section 3.) and the Tribe's power to tax and regulate business conducted on the White Earth Reservation (Article VI, Section (d).) This code shall apply to all research, as defined elsewhere in this code, conducted on the White Earth Reservation, whether involving human subjects or not, and all research regarding materials wherever located as to which the White Earth Nation has a claim of intellectual, cultural, or other ownership; legal or equitable. 05. DEFINITIONS A. RESEARCH is the use of systematic methods to gather and analyze information for the purpose of proving or disproving a hypothesis, evaluating concepts or practices or otherwise adding to knowledge and insight in a particular discipline or field of knowledge or to demonstrate or investigate theories, techniques, or practices. For the purpose of this code, research includes: 1. Basic and clinical research; 2. Behavioral studies; 3. Anthropological and archaeological studies; or 4. Feasibility and other studies designed to evaluate or test programmatic techniques or to develop basic data in all phases of public administration. 06. UNLAWFUL ACTS It shall be unlawful for any person to conduct research on the White Earth Reservation, whether involving human subjects or not, or with respect to materials wherever located as to which the White Earth Nation has a legal or equitable claim of intellectual or cultural ownership unless the researcher has obtained a permit as specified in this code. Failure to obtain a permit or to abide by its terms shall result in the penalties and sanctions specified in this code. 07. ADMINISTRATION There is hereby established a Tribal Research Review Committee to approve research submitted pursuant to this code. The Committee shall be composed of 7 (seven) voting members, approved by the Tribal Council, including: A. A medical representative A Legal representative Behavioral Health representative Education representative Cultural representative Land/Natural Resources representative Community member at large ===== page 4 ===== 08. INFORMATION TO BE PROVIDED The code administrator shall prepare the appropriate application forms and develop a review process which adequately implements the intent of this code and which provides fundamental fairness to each applicant for a permit. At a minimum, the following information shall be provided by an applicant researcher in support of an application for a permit. A. Description of the nature of the research being proposed, including the goals and objectives and the type of information that will be sought from individuals or other participation involving individuals (including the donation of samples), the type of information concerning the culture, religion/spirituality, and customs and practices of the White Earth Tribe, either historical or contemporary. Description why the research should be done on the White Earth Reservation at this time. Expected benefits of the proposed research, including immediate and long range benefits to: the sum total of human and scientific knowledge, human subjects or participants; the Tribe; the Tribal members; and society generally. Identified Risks associated with or inherent in the research, including risks to the physical or psychological well-being of individual human subjects or participants and risks of harmful impact on the cultural, social, economic or political well-being of the community. The assessment of risk will also address the steps that are being taken to minimize the risks and the curative steps that will be taken in the event the research causes actual harm to participants or others. Assurances of confidentiality of data as appropriately applied to individuals and, where necessary, to families/communities/Tribe. The applicant shall provide assurances of confidentiality for the life of the project. The applicant shall indicate how confidentiality will be protected after the project and for how long. The applicant shall indicate where raw data and other materials will be deposited and stored at the completion of the project; and indicate the circumstances in which confidentiality may be breached by legal or contractual obligations of the researcher. Assurances that the White Earth Nation will own the data. It will establish what control the individual research participants have over the use of their own data. It will establish what control the Tribe has over the current and future use of the data, and how the control will be exercised. It will identify what control the Tribe will have over publication and other dissemination of results; where the information will be disseminated, and by whom. It will identify who will own specimens – human biological material – from the research. It will identify the degree of control the individual research participants have over the use of their own specimens. It will identify control the Tribe will have over the current and future use of the human biological material, and how the control will be exercised. Opportunities for the Tribe, individual subject communities and individuals to have the research project fully explained to them and opportunity to comment on the research; opportunities for the Tribe, communities, individuals, as appropriate, to receive periodic reports on the progress of the research and to comment on periodic and draft final reports, the burden under this code being on the researcher to show that Tribal, community, or individual input would be inappropriate. ===== page 5 ===== Provisions for Native and local preference in employment in all phases of the project, including both on and off-Reservation phases. The priorities in Native hiring preference shall be reflective of the Tribe's hiring preferences. 09. ENFORCEMENT The code shall be enforced in the following manner: A. No research shall be done on the White Earth Reservation or otherwise subject to this code unless the researcher has first received a permit from the Tribe according to the procedures specified herein. Any violation of this provision shall be subject to the sanctions provided in this section. Where circumstances indicate, particularly where off-reservation enforcement of Tribal rights and interests may be of special importance, the researcher, his/her sponsoring institution or funding source, may be required to sign a contract with the White Earth Nation specifying contractual Tribal rights to data or materials or with respect to ultimate publication. When such a contract is required, applicant researchers will have the burden to show that it is not necessary or that alternate acceptable mechanisms exist and are beneficial for Tribal purposes. Whenever it appears that a person has violated or is violating, or is threatening to violate any provision of this code, the Tribal Prosecutor may file a civil suit in Tribal Court to enforce this code. In any action brought for violation of this code, the court may grant injunctive relief, including a temporary restraining order, temporary injunction, and permanent injunction, financial fines, or banishment to restrain the person from continuing the violation or threat of violation. The court may order restitution, civil penalties, and such other relief that may be necessary to redress any injury suffered by and person, family, organization, or community resulting from the violation or threatened violation. Any action taken under this code does not prohibit an individual subject to the research, or the Tribe itself to undertake a civil suit for compensation of damages. 10. NOTICE TO OTHER PERSONS OR INSTITUTIONS A. If a petition is filed pursuant to this act, notice shall be given to the research project's sponsoring organization and/or funding source. If a judgement is entered against the person(s) conducting the research project subject to this code, notice of the judgement shall be given to the project's sponsoring organization and/or funding source as well as to the professional organization or licensing agency of the person conducting the research.