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1 I This Code of Research Ethics model was developed for the purpose of guiding policies and procedures for collaborative research projects between academic institutions and Native American tribal communities. For further information contact: Blakely Brown, PhD, RD Department of Health and Human Performance The University of Montana Missoula, Montana

2 <Name of Project> Code of Research Ethics <Brief description of proposed project, study design, targeted population (age, gender, location, etc), funding mechanism.> This document will provide the framework for setting principles and procedures to guide the project partners to achieve the goals and objectives of the <name of project>. The Code of Research Ethics ( also called "the Agreement") was developed by the project <Tribal partner names>,<principal Investigator name>, <Co-Investigators names>, <Legal counsel, academic institutions, tribal colleges names, etc> 1

3 <Name of Project> Code of Research Ethics <Date Adopted> INTRODUCTION <Description of Project - study design, communities involved, participants, etc> The <Project Name> is a partnership ofthe people of the <name of reservation> community (referred to as "community partners"), community based researchers at <name of reservation community and/or tribal college, tribal health department, etc> referred to as "community researchers), and academic researchers at <name of academic institution>. *Note: The Advisory Council membership is discussed during the study design phase. Our project engaged two reservation communities; other projects may have one community, or multiple communities. The actual makeup of the Council is discussed and agreed upon during the beginning phase of developing the protocol, grant proposal, etc. Our project is a health program for American Indian youth on two Northern Plains reservations, thus we have tribal educators and Indian youth as part of the advisory council. An Advisory Council of <number> members for the <name of project> will be assembled during year 1 of the program. *Example* Members will be chosen to represent <name of reservations/tribes> members (2), <name of reservations> Elementary Education System (2); these are referred to in this document as "community partners" and <name of reservations> Tribal Health Clinic (2), referred to as "community researchers". A tribal council member (1) and a member from the <name of reservation> Youth <name of tribal organization> (1) will also be on the Advisory Council. Two (2) <name of academic institution> project investigators will be on the Advisory Council, referred to in this document as "academic researchers". Collectively, the Advisory Council members ultimately represent the three community partners involved in this project(s), which are the <name of reservation community>, <name of reservation community> and <name of academic institution> Montana community. The three partners will work collectively and collaboratively in the design, implementation, analysis, interpretation, conclusion, reporting and publication of the experiences of the project. PURPOSE OF THE CODE OF ETHICS The purpose of this code of ethics is to establish a set of principles and procedures to guide the three partners to achieve the goals and objectives ofthe <name of project>. The Code outlines the obligations of each of the three community partners and the members of the Advisory Council through all phases of the project from the design of the research through to the publication and communication of the experiences of the project. POLICY STATEMENT The sovereignty of the American Indians of the <name of partnering reservations> to make decisions about research in their communities is recognized and respected. The benefits to the communities as a whole and to the individual community volunteers should be maximized by 2

4 the researchers. Research should empower the community to support community goals of health and wellness, to promote health lifestyles, improve its self-esteem and to fulfill its traditional responsibility of caring for the children of the next generation. PRINCIPLES 1. The reservation communities must be involved as a full partner in all aspects of the research. Continuous consultation and collaboration should characterize the partnership. 2. The strengths and culture of the community, including community researchers and staff as well as material resources must be respected and utilized whenever possible. 3. Permission from individual children and their parents must be obtained prior to collecting personal information. 4. The confidentiality of students, parents and teachers and other individuals must be respected. If necessary, <names of reservations> may choose to remain anonymous when reporting the results (page 6-7). 5. All research results, analyses and interpretations must first be reported to the three partners, via the Advisory Council, to ensure accuracy and avoid misunderstanding (page 6-7). 6. Under NIH policy the grantee institution (e.g. <name of academic institution» owns the data; however the <name of partnering reservations> will also own all data. The research partners <name of academic institution and reservation communities> will work jointly in the dissemination and publication of all project results (page 6-7). 7. At the conclusion of the project(s) the project data will be stored at the <name of reservations> community sites, as well as at <name of academic institution>. 8. The three partners must all be involved in making decisions about the publication and the distribution of all or parts of the research results. 9. Any disagreement among the partners about publication or distribution of research results will be settled by a majority vote, except for graduate student research papers, theses and dissertations, and oral theses and dissertation defenses (see the section below entitled, "Graduate Student Research Papers, Theses or Dissertation Work," for special procedures for graduate student communications). In the case of disagreement the partner who disagrees must be invited to communicate their own interpretation of the same data in an addition to the main communication, be it oral or written. All partners agree to withhold any information if the alternative interpretation cannot be added and distributed at the same time, provided that the disagreeing partner(s) do not unduly delay the distribution process (page 6-7). Nothing in this Agreement shall interfere with the ability of students involved in the project to complete the requirements of their degree programs, including publication of their thesis, dissertation, or research paper in the university library and presentation of an oral thesis/dissertation defense. OBLIGATIONS OF THE ADVISORY COUNCIL MEMBERS A. OBLIGATIONS OF THE ACADEMIC RESEARCHERS 1. To do no harm to the community(s). 2. To involve the community(s) in active participation rather than passive acceptance. 3

5 3. To ensure the design, implementation, analysis, interpretation, reporting, publication and distribution of the research are culturally relevant to the community and in agreement with the standards of competent research in which the research is being conducted. 4. To impart new skills to community members, e.g. data collection, community partnerships for research, etc. 5. To help to address any health or social issues that are raised as a result of the research. 6. To provide expertise to scientifically answer questions that emerges from the community(s). 7. To share in translating the <name of project> strategies and outcomes to the <name of reservation> communities. 8. To promote academic diffusion of knowledge through written publications and oral presentations. This includes the documentation of the undertaking of the project and of the results. 9. To share all project data outcomes with the community(s). 10. To be involved in any future analysis of the data after the project(s) have ended. 11. To inform graduate students working on the project as part of their research for their degree of their rights and responsibilities under this Agreement. B. OBLIGATIONS OF THE COMMUNITY RESEARCHERS Community researchers are employed within the community and are regarded as the <name of reservation> Tribal Health Clinic and <name of reservation> Tribal Health proj ect personnel such as co-investigators, project coordinators, staff and expert consultants. In addition to the obligations listed for academic researchers, the community researcher is obligated: 1. To maintain a long term relationship of trust in the dual role of health caregiver/educator and researcher: this will only be possible if the needs of the community are always considered as first priority in any decision. 2. To communicate with the academic researchers during all phases of the project. 3. To arrange for academic researchers to meet with Elementary School Committee, Hospital Directors and any other local organization necessary to implement and promote the project. *Note - this is part of our project since it is for American Indian health in children and adolescents* 4. To promote the intervention objectives ofthe project by working closely with the staffs of the schools, community advisory board, community recreation, sports organizations and food service outlets. 5. <Name of reservation, name of tribal health program> staffwill share their knowledge with the <name of reservation, name of tribal health program> staff to develop similar <name of disease> prevention programs for <age, targeted population> tribe(s) at the end of the project. C. OBLIGATIONS OF THE COMMUNITY MEMBERS 1. To represent <name of reservation> community through their respective organizations. To promote the objectives of daily physical activity, health eating habits and positive attitudes to the community. 4

6 2. To be updated by the <name of project> staff on a determined basis to support the development and offer analysis of the school and community activities to ensure compatibility with the project goals and objectives. 3. To meet with project academic investigators to maintain an awareness and to offer recommendations concerning the research aspect of the project. 4. To communicate with representatives of other communities to share ideas and program development for benefit and involvement. 5. To share guardianship of all evaluation data after the completion of the project. 6. To approve of or write a disagreement to the interpretation of the data analysis. <Name of Project> Authorship Guidelines INTRODUCTION The purpose of the <name of proj ect> is to investigate the research questions described in the protocol. This community based program has been developed to promote a positive attitude towards health and community support regarding health eating, daily physical activity, and behaviors to prevent the development of <name of disease> in American Indian <children, adults, etc>. Since this project is unique, the results will be of interest to those who wish to prevent <name of disease> in their communities. For this reason it is necessary to share the experience of this project with the largest audience who might benefit from it. Part of the research process includes the communication of research results to other people and organizations in similar areas of research. AUDIENCE Communications will be directed at four general audiences: 1. Health and Education officials 2. Scientists and Researchers 3. The <names of partnering reservations Tribal Council, Legislative Council, etc> 4. The <name of reservation> community(s) at large Health and education officials are those people working on programming and planning community health, and specifically minority health, projects. They will be interested in how this <name of disease> prevention program was developed and implemented as well as the outcome of the program efforts. Scientists and researchers will be interested in the project methods, the process ofthe program, the impacts measured, and the answers provided to the research questions. The <name of reservation> community(s) at large includes everyone who participated in the project as well as those who are generally interested in preventing <name of disease> in future generations of American Indians. These communities will want to know how well they are doing with respect to preventing diabetes and what they can continue to do to keep on a wellness path. PRINCIPLES All aspects of the <name of project> can be considered worthy of communication. All communication pertaining to the project will follow generally accepted ethical standards. The principles include: 1. Anonymity: Results to be presented in a grouped, not individual manner. 5

7 2. Confidentiality: All personal information provided by individuals will be made anonymous whenever possible and remain confidential. 3. Priority of Communities Involved: The communities participating will be the first to receive results and the first invited to provide input and feedback on the results. 4. Respect: Consideration for the <name of reservation communities> must be observed in all communications. PROCESS Results from research projects are usually presented in the following ways: 1. Articles in scientific journals, referred to as "a paper". 2. Oral presentation of "a paper" at a scientific conference or meeting. 3. Oral presentation to the community at large. 4. Written document to the community at large. 5. Teaching examples. 6. Graduate student research papers, theses, and dissertations. 7. Graduate student theses and dissertation defenses. For scientific journals and oral presentations at scientific conferences and meetings there is a standard process involved. It is therefore possible to outline the steps from idea to final communication and outline the responsibilities for those involved with the authorship. However, these points should also apply to communications to the community. From here on the word "communication" will be used to describe both oral presentations and written papers. DATA SHARING AND PUBLICATION PROCEDURES The Parties involved in the project «names of partnering reservations, academic institution» are encouraged to make publicly available the results of their research. To ensure that Proprietary/Confidential Information is protected and that sensitive issues are addressed to the satisfaction of all parties the following guidelines are proposed and will be discussed, modified if necessary and adapted by the Advisory Council during year 1 of the project. Any disagreement among the partners about publication or communication of research results will be settled by a majority vote, except for graduate student research papers, theses and dissertations, and oral theses and dissertation defenses (see the section below entitled, "Graduate Student Research Papers, Theses or Dissertation Work," for special procedures for graduate student communications). Such students will be able to include data that they generate for research papers, theses, and dissertations required by their degree programs. In the case of disagreement the party who disagrees must be invited to communicate their own interpretation of the same data in an addition to the main communication, be it oral or written. All parties agree to withhold any information if the alternative interpretation cannot be added and distributed at the same time, provided that the disagreeing partner(s) do not unduly delay the distribution process. The process for releasing information will include: a. Request by an author or group of authors (hereafter referred to as author) shall use a "Request for Publication" form to request the authority to prepare a information for release to the public (scientific manuscript, press release, news article or any other public release of research data). The request form will include a list of the specific 6

8 variables that will be reported and the focus (purpose) ofthe document. By completing the request form the proposed author agrees to use the data within implied purpose of the request. This request will be reviewed by all members of the Advisory Council. b. The Advisory Council will have thirty days to respond. All members have to agree to release the data. In the case of dissent by a minority it is expected that the Council will work (either via electronic methods or in a meeting) to come to a compromise to allow the information release in a sensitive manner. c. If the request is approved or approved with modifications. The author will be notified and the requested data variables will be released for analysis. It is understood that all reports of the data will include only group means and no individual identification. Furthermore, the Advisory Council shall have the right to regulate how the study population is identified (American Native American, Montana Native American, Northern Plains Indians, Chippewa-Cree, Blackfeet, Crow, Northern Cheyenne, Pima, Salish, etc.). d. The author shall sign a letter agreeing to submit any proposed documents to the Advisory Council for approval prior to publication. e. When manuscripts or articles are completed they shall be submitted to the Advisory Council for review. Before a manuscript or article may be published there must be unanimous consent by the Council. All Council members may suggest revisions or suggest that the manuscript or article not be published. However, before rejecting a manuscript or article, the Council will work (either via electronic methods or in a meeting) to come to a compromise to allow the information release in a sensitive manner. Manuscripts or papers may be rejected for other reasons such as quality of writing, accuracy of materials, research methods or as determined by the Council. The Council has thirty days to respond to the author. f. If revisions are required or requested, the author may have adequate time to make the necessary changes and resubmit the manuscript or article to the Council. g. The Council will again review the final manuscript before allowing the author to submit for publication. h. Once an article is submitted the author will keep the Council advised as to the progress of the article or manuscript and provide the Council with a copy of the published work. 1. Graduate Student Research Papers, Theses or Dissertation Work: It is anticipated that several Native and non-native students will work on various aspects of the project(s) and use the data towards their degree requirement (e.g. research papers, theses or dissertations). It is understood and agreed by both parties that graduate students must be able to publish their research in the university library and present an oral defense of their thesis or dissertation in order to complete their degree requirements. It is also understood that the restrictions outlined in this Agreement concerning release of data and approval of all communications do not apply to communications required as part of the university's requirements for completion of a graduate degree. This includes oral presentation of the research at the thesis/dissertation defense, and publication of the research paper, thesis or dissertation in the university library. It is the inherent responsibility of the student's academic advisor and the project principal investigators to: (1) only approve graduate research paper, thesis or dissertation proposals that are not controversial and focus on the primary intent of the overall project, (2) make sure that drafts of the graduate student's research paper, thesis or dissertation are provided to the Advisory Council for review 7

9 and comment, and (3) that the student makes a good faith effort to incorporate the Council's comments in the final version of the research paper, thesis or dissertation, and in the oral thesis/research defense. Nothing in this Agreement will be construed to limit graduate students working on the project from completing the requirements of their degree program, including the requirements for oral defense of their work and publication of a research paper, thesis or dissertation in the university library. Additional Guidelines for Publications and Communications 1. Preparing the Communication. The first author of an article will assume the major responsibility for preparing the article. The first author will assume most of the writing responsibility. Other authors contributing to the communication will appear in descending order. This order will depend on the contribution made to the subject of the communication and the preparation and writing of the communication. All project investigators will have the option of being on the publication. 2. Submitting a Communication. All authors on the paper must approve of the final version before the paper is submitted to the journal, conference, etc. Furthermore, final versions of all papers must be approved by the principal investigators before submission. Any disagreement about approval of a communication will be settled by a majority vote by these investigators. 3. Peer Review. Once a communication is submitted to a journal it will be reviewed by people considered experts in the subject of the communication. This peer review process results in suggested changes of the communication in order for publishing the article in the journal of interest. Any changes made in the review must be approved by all authors of the communication. This will be done by a letter to the editor signed by all authors. 4. Abstracts. An abstract is a short summary of the content of a communication. When someone wants to present a paper at a conference an abstract will be sent to the conference organizers. The abstract will then be used to decide if the communication will be accepted for publication. In case of a late call for an abstract, the Principal Investigators should be contacted as soon as possible. If there are no objections the abstract should be sent immediately. The preparation of the communication will proceed following the steps outlined previously. 5. Responsibility of Communication by the Principal Investigators. It is part of the shared responsibility of the principal investigators to prepare communications for the <name of reservations> communities and the scientific community. Communications for the reservation communities would appropriately be prepared by those who have more of an interest in them; likewise for communication to the scientific community. This should not limit the authors to one or the other. DATA COLLECTION AND EVALUATION GUIDELINES 1. The activities organized by the <name of project> should ensure that the data collection process is in accord with the host community cultures, values and norms and competent scientific practice. 2. Participation in evaluation activities is voluntary for the people in both communities and those who express a desire to withdraw will be able to do so at any time. 8

10 3. All information and data collected on individuals will be kept strictly confidential and will be obtained following explanation and signing of a <name of academic institution> IRB-approved consent form. An identification number will be given and the names of participants will be removed (e.g. "de-identified data"). A locked file containing names and identification numbers will be kept for future follow-up. Only the principal investigators will have access to this file. This computer will be maintained by a neutral party whose duty would be to put together data sets (e.g. requested variables from the study that are needed to write the communication as previously outlined in the communication approval process). 4. All de-identified data will be maintained on a secure, dedicated computer (without internet access) with back up files kept by the principal investigators. 5. For reasons of confidentiality, the person responsible for coding the collected information should not have access to the names of the participants. The names of the participants will be removed prior to data coding. 6. A project coordinator will be responsible for the quality control of the data coding and entry. 9

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