04 October 2011


A perspective on the Washington Declaration on Intellectual Property and the Public Interest (see here) and the New Zealand Ko Aotearoa Tēnei report is provided in the 32 page 'Conducting Research with Tribal Communities: Sovereignty, Ethics and Data-Sharing Issues' (Seattle University School of Law Research Paper No. 11-24) by Anna Harding, Barbara Harper, Dave Stone, Catherine O'Neill, Patricia Berger, Stuart Harris & Jamie Donatuto.

It states that -
When conducting research with American Indian tribes, informed consent beyond conventional Institutional Review Board (IRB) review is needed because there may be potential for adverse consequences at a community or governmental level that are unrecognized by academic researchers.

This paper reviews sovereignty, research ethics, and data-sharing considerations when doing community-based participatory health-related or natural resource-related research with American Indian nations and presents a model material and data-sharing agreement that meets tribal and university requirements.

Only tribal nations themselves can identify potential adverse outcomes, and they can do this only if they understand the assumptions and methods of the proposed research. Tribes much be truly equal partners in study design, data collection, interpretation, and publication. Advances in protection of intellectual property rights are also applicable to IRB reviews, as are principles of sovereignty and indigenous rights, all of which affect data ownership and control.

Academic researchers engaged in tribal projects should become familiar with all three areas: sovereignty, ethics and informed consent, and intellectual
While respecting autonomy and conscious of past academic abuses (including indifference) one might question whether "Only tribal nations themselves can identify potential adverse outcomes".

The authors comment -
University-Tribal Material and Data-Sharing Agreement (MDSA)

To date, an appropriate MDSA between tribal communities and outside researchers has not been published in the literature. Such an agreement can provide and enforce equitable exchanges of information that benefit the community without infringing on the privacy of the study participants or on the sovereign rights of the tribe.

Table 1 summarizes current references to tribal codes of ethics related to research and IPR. The references cited in Table 1 formed the foundation for the initial MDSA of an NIEHS-funded university-tribal collaborative study between CTUIR and OSU .... In addition to conventional items, the MDSA addresses data ownership and publication processes. This document incorporates input from the team of OSU and CTUIR researchers, the project’s Tribal Advisory Committee, OSU’s IRB and Research Contracts offices, the CTUIR Health Commission, and the Portland Area Indian Health Board. The MDSA was reviewed and approved by each organization's legal officials. The final agreement has the following components:
• General project scope and collaborator: States the purpose of the project, the identity of the organizations participating in the agreement, the length of the agreement, procedures for its amendment or termination, and basic definitions.
• Types of material and data collected: States the types of material and data to be collected and the general collection method. This includes data, such as analytical sampling results and demographic attributes, as well as collected organic material, transcripts of focus group discussions, and project-specific questionnaires.
• Constraints on material and data use: Assures that materials and data supplied by the tribe to researchers, or collected by researchers on behalf of the tribe, are and remain tribal property and are not to be shared with third parties without the written permission of tribal authorities. It includes procedures for publication and post-completion return of all materials and data.
• Data access and security: Details the procedures for maintaining the physical security of the data, such as providing locked storage areas for paper documents and encrypting electronic media. Restricts data access to approved project researchers who require it for a specific task.
• Risks and benefits of research to the tribal community: Summarizes the risks and benefits to be expected from participation in the research project, for both the individual and the tribal community.
• Agreed-on mutual review processes: As a two-way document, the CTUIR agreed that it has equal responsibility for timely completion of research tasks and reports.
Developed in tandem with the MDSA were informed consent forms and confidentiality agreements. While the focus of this paper is on informed consent at the tribal government level, individual informed consent is equally imperative if the research involves human subjects.

Whether researchers plan to attend a community gathering such as a pow-wow and survey participants, or hold focus-groups with tribal elders, individual informed consent is necessary for the same reasons as informed consent in a government context. Extra time and care must be taken to ensure that individuals know what they are consenting to, including clear and concise descriptions of the purpose of the research, use and storage of the information collected, and issues of anonymity. Moreover, many tribal organizations have their own IRBs, or require researchers to obtain IRB approval from an organization such as the Indian Health Service, in addition to any academic IRB review. Tribally-affiliated IRBs are necessary to ensure against potential adverse impacts to tribal individuals or governments that may be overlooked by academic IRBs and therefore are not redundant review processes.

The informed consent form provides potential tribal participants with straightforward information on the risks and rewards of project participation. The confidentiality agreements are required to be signed by university research personnel who have access to project material and data. These forms are held by the tribal researchers under secured conditions so that they know who has access to the data and for what purpose.

The MDSA between CTUIR and OSU explicitly states agreed-on processes for the purposes of transparency for the benefit of university researchers and tribal governmental officials and other reviewers, and newer investigators and students. Mutually accommodating, the MDSA includes provisions such that both entities share equal responsibility for meeting project schedules and timely review of publications and grant reports. As tribes build scientific capacity, the collaboration model has moved from collecting data from tribes and reporting information back to them, to one of an equal tribal-university partnership in the research and in the dissemination of results to federal, community, and academic constituencies