Effective September 20, 2016
OREGON LIQUOR CONTROL COMMISSION
Application for Marijuana Research Certificate
(1) The Commission shall issue Marijuana Research Certificates to qualifying public and private researchers who present research proposals that demonstrate:
(a) The proposed research would benefit the state’s cannabis industry, medical research or public health and safety; and
(b) The proposed operation and methodology complies with all applicable laws and administrative rules governing marijuana licensees and licensee representatives.
(2) The process for applying for, receiving and renewing a certificate shall be the same as the process for applying for, receiving and renewing a marijuana license under OAR 845-025-1030 to 845-025-1115 except that an applicant for a Marijuana Research Certificate is not subject to the residency requirements in OAR 845-025-1045(2)(b).
(3) In addition to the application requirements in OAR-025-1030 the applicant must also provide:
(a) A clear description of the research proposal;
(b) A description of the researchers' expertise in the scientific substance and methods of the proposed research;
(c) An explanation of the scientific merit of the research plan, including a clear statement of the overall benefit of the applicant’s proposed research to Oregon’s cannabis industry, medical research, or to public health and safety;
(d) Descriptions of key personnel, including clinicians, scientists, or epidemiologists and support personnel who would be involved in the research, demonstrating they are adequately trained to conduct this research;
(e) A clear statement of the applicant’s access to funding and the estimated cost of the proposed research;
(f) A disclosure of any specific conflicts of interest that the researcher or other key personnel have regarding the research proposal;
(g) A description of the research methods demonstrating an unbiased approach to the proposed research;
(h) A description of the quantities of marijuana items, if any, that are proposed be transferred to licensees; and
(i) If the applicant intends to research the use of pesticides, an experimental use permit issued by Oregon Department of Agriculture pursuant to OAR 603-057-0160.
(4) Research certificates will be granted for up to a three-year term.
(5) The Commission may request that the research certificate holder submit information and fingerprints required for a criminal background check at any time within the research certificate term.
(6) A certificate holder may, in writing, request that the Commission waive one or more of these rules. The request must include the following information:
(a) The specific rule and subsection of a rule that is requested to be waived;
(b) The reason for the waiver;
(c) A description of an alternative safeguard the licensee can put in place in lieu of the requirement that is the subject of the waiver, or why such a safeguard is not necessary; and
(d) An explanation of how and why the alternative safeguard or waiver of the rule protects public health and safety, prevents diversion of marijuana, and provides for accountability.
(7) The Commission may, in its discretion, and on a case-by-case basis, grant the waiver in whole or in part if it finds:
(a) The reason the certificate holder is requesting the waiver is because another state or local law prohibits compliance; or
(b) The certificate holder cannot comply with the particular rule, for reasons beyond the certificate holder’s control or compliance with the rule is cost prohibitive; or
(c) Because of the nature of the research, the Commissions finds that compliance with a particular rule is not necessary and that even with the waiver public health and safety can be protected, there is no increased opportunity for diversion of marijuana, and the certificate holder remains accountable.
(8) The Commission must notify the certificate holder in writing whether the request has been approved. If the request is approved the notice must specifically describe any alternate safeguards that are required and, if the waiver is time limited, must state the time period the waiver is in effect.
(9) The Commission may withdraw approval of the waiver at any time upon a finding that the previously approved waiver is not protecting public health and safety or the research certificate holder has other issues with compliance. If the Commission withdraws its approval of the waiver the certificate holder will be given a reasonable period of time to come into compliance with the requirement that was waived.
Stat. Auth.: ORS 475B.235
Stats. Implemented: ORS 475B.235 & Sections 12 & 65, Chapter 24, Oregon Laws 2016
Marijuana Research Certificate Privileges; Prohibitions
(1) A certificate holder may receive marijuana items from a licensee or a registrant under ORS 475B.400 to 475B.525.
(2) A certificate holder:
(a) May not:
(A) Sell or otherwise transfer marijuana items to any other person except when disposing of waste pursuant to OAR 845-025-7750, transferring to another certificate holder or transferring to another licensee.
(B) Transfer more to another licensee than is permitted in the Commission’s order granting the research certificate.
(b) Must comply with the testing rules in OAR 333-007-0300 to 333-007-0490 applicable to a producer or processor prior to transferring marijuana items to a licensee.
(3) A certificate holder may not conduct any human subject research related to marijuana unless the certificate holder has received approval from an institutional review board that has adopted the Common Rule, 45 CFR Part 46.
(4) All administrative rules adopted by Commission for the purpose of administering and enforcing ORS Chapter; and any rules adopted thereunder with respect to licensees and licensee representatives apply to certificate holders except for those which are inconsistent with this rule.
Stat. Auth.: ORS 475B.235
Stats. Implemented ORS 475B.235 & Sections 12 & 65, Chapter 24, Oregon Laws 2016