59.05.050 Regulation of Biological Samples

(a) Any researcher who seeks to collect, acquire, or analyze any biological samples must agree and abide by the following conditions with regard to research with biological materials.

(b) The Tribe may, at any time, decide to withdraw from the research project or any portion thereof, and request the return of all biological samples. The researcher, and any other parties, must comply.

(c) When biological samples are collected, the PI must state how the samples will be used. If there is a desire to use the samples for purposes other than what is stated in the approved notice, the PI must submit a request to the RRB and TMBCI for approval.

(d) Upon completion of the research project, or termination or cancellation of the project at any time prior to completion, the biological samples must be completely and fully returned to the Tribe.

(e) No biological samples from this study may be released to, or used by, any other researcher(s), research institution, or any other entity, whether public or private, without the prior and fully-informed written approval of the Tribe.

(f) If the Tribe permits any biological samples to be stored in any other locations, the Tribe will maintain jurisdiction over the samples and the researcher shall maintain at all times a complete list thereof. The list shall include a description of the sample or data, source, specific use or purpose of each item, responsible person(s) at the location, and where the item is housed (e.g., in a "gene bank" or on a specific computer), and any relevant time lines with regard to use of, disposition, return, or destruction of the samples or data. The researcher shall provide an updated copy of the list to the Tribe whenever changes are made. The updated list shall include identification of changes made since the last copy of the list was provided to the Tribe.

(g) Any situation where biological samples will leave the possession or control of the researcher will require a separate agreement between the Tribe and the external party in accordance with this Act.

(h) No entity may seek to patent or commercialize any biological materials obtained from the Tribe, from the Tribe's jurisdiction, or under the authority of the Tribe including but not limited to, genetic samples, any copies of the original genetic samples, any cell lines derived from collected materials, and data derived from these samples.