Section 500.147 - Operational Requirements for Marijuana Research Facility Licensees and Research Permits(1) In addition to the security requirements provided in 935 C 500.110, Marijuana Research Facility Licensees shall comply with the operational requirements required under 935 CMR 500.147.(2)General Requirements(a) For each research project to be conducted on the Premises, a Marijuana Research Facility Licensee shall have a valid Research Permit issued by the Commission pursuant to 935 CMR 500.147(4) prior to beginning a research project. The Research Permit shall be renewed at least annually, or sooner depending on the nature and duration of the approved research project.(b) All individuals engaging in research at the Marijuana Research Facility shall be registered with the Commission as Marijuana Establishment Agents under 935 CMR 500.030.(c) A Marijuana Research Facility Licensee may submit an application for a Research Permit to conduct research in areas including, but not limited to, the following: 1. Chemical potency and composition levels of Marijuana and Marijuana Products;2. Clinical investigations of Marijuana Products, including dosage forms;3. Efficacy and safety of administering Marijuana or Marijuana Products as a component of medical treatment under the supervision of a Certifying Healthcare Provider;4. Genomic research on Marijuana;5. Horticultural research on Marijuana;6. Agricultural research on Marijuana; and7. Other research topics upon the approval of the Commission, provided however that research conducted under the Marijuana Research Facility License may not be a substitute for processes for drug approval established by the U.S. Food and Drug Administration (FDA) pursuant to 21 CFR 312; and the Commission may impose additional standards necessary to ensure the safety and efficacy of Marijuana and Marijuana-derived compounds for their intended research application.(d) Marijuana or Marijuana Products used in research conducted under a Marijuana Research Facility License shall be cultivated by, produced by or acquired from a licensed MTC or Marijuana Establishment authorized to cultivate, produce or sell Marijuana or Marijuana Products, which includes a Marijuana Cultivator, Marijuana Product Manufacturer, Marijuana Retailer, a Microbusiness or a Craft Marijuana Cooperative. A Marijuana Research Facility Licensee not authorized to cultivate its own Marijuana may enter into an agreement with a licensed MTC or Marijuana Cultivator, Microbusiness or Craft Marijuana Cooperative to grow Marijuana specifically for research.(e) Any Marijuana or Marijuana Product cultivated, produced or acquired for use in a Commission-approved research project shall be entered by the Marijuana Establishment providing it to the Marijuana Research Facility Licensee into the Seed-to-sale SOR in a form and manner to be determined by the Commission.(f) All Marijuana or Marijuana Products used in research and consumed by human or animal subjects shall comply with the following1. Be adequately described in the Informed Consent Form.2. Tested in accordance with 935 CMR 500.160 prior to consumption by human or animal subjects.(g) Any research project where human research subjects are participants shall include one or more licensed physicians in good standing to monitor the participants.(h) For any research project other than a survey-only research project, human participants in research conducted by a Marijuana Research Facility Licensee where consumption of Marijuana or Marijuana Products is a component of the research project design shall reside in the Commonwealth.(i) Any research project where animal research subjects are participants shall include one or more licensed veterinary doctors in good standing to monitor the participants.(j) For any research project other than a survey-only research project, research conducted pursuant to a license granted by the Commission shall be conducted solely within the boundaries of the Commonwealth.(k) A Marijuana Research Facility Licensee shall supply the Commission with copies of all final reports, findings or documentation regarding the outcomes of approved research projects receiving a Research Permit. Any records received by the Commission may be subject to release pursuant to the Public Records Law, M.G.L. c. 66, § 10 and M.G.L. c. 4, § 7, cl. 26, or other compulsory legal process, or at the Commission's discretion.(3)Marijuana Research Facility Licensee Activities and Premises. (a) A Marijuana Research Facility Licensee may conduct research at one or more than one Marijuana Research Facility so long as the facility is approved by the Commission.(b) A Marijuana Research Facility may be colocated with another Marijuana Establishment provided that the Marijuana Research Facility and other, colocated Marijuana Establishment(s) are commonly owned and physically separated. Physical separation shall include, but may not be limited to, separation by a permanent wall with a secure, locked entrance.(c) A Marijuana Research Facility Licensee shall only possess for research the amount of Marijuana or Marijuana Products approved by the Commission to be used in each research project receiving a Research Permit.(d) A Marijuana Research Facility Licensee with more than one Research Permit shall physically separate all Marijuana or Marijuana Products used in the Licensee's approved research projects according to Research Permit and in such a way that it is objectively clear what Marijuana or Marijuana Products are being used for each approved project.(e) One or more Marijuana Research Facility Licensees may enter into agreements to conduct research jointly on an identified research project, provided that research activities authorized under the Research Permit shall be conducted at one identified, licensed Marijuana Research Facility. The Marijuana Research Facility Licensee shall disclose to the Commission all contracts or agreements entered into with other Marijuana Research Facility Licensees in furtherance of a research project.(f) A Marijuana Research Facility Licensee may not permit the consumption of Marijuana or Marijuana Products on its licensed Premises, unless consumption of Marijuana is part of an approved research project holding a valid Research Permit and the Marijuana Research Facility is not co-located with another Marijuana Establishment.(4)Research Permits(a) To qualify for a Research Permit to conduct human based research, the research project shall have an Institutional Review Board ("IRB") which shall approve the proposed research project.(b) Applicants for a Research Permit to conduct research at a Marijuana Research Facility Licensee shall submit for each project the following information to the Commission in a form and manner determined by the Commission: 1. The name and curriculum vitae (CV) of each investigator, including the Principal Investigator who leads the research project and each sub-investigator;2. The name of each licensed physician in good standing that will lead the project as Principal Investigator, be a sub-investigator, or monitor the participation by human subjects, if any, in the research project;3. The name of each licensed veterinary doctor in good standing that will lead the project as Principal Investigator, be a sub-investigator, or monitor the participation by animal subjects, if any, in the research project;4. The IRB Institution, if applicable;5. A publication-ready summary of the research project to be conducted;6. A detailed research protocol, including safety protocols;7. Articulated goals of the research project;8. Start and end dates of the research project;9. A description of the project funding or resources, an attestation that the project is adequately funded or resourced, and the sources of funding or resources;10. Information about the human subject participants, if any, which shall include but not be limited to: a. The number of participants;b. The number of Registered Qualifying Patients, if any;c. Demographic information about the participants;d. The ages of the participants;e. Any cohort deemed "vulnerable" and applicable safety precautions (e.g. pregnant/breastfeeding women, minors, disable veterans, etc.);f. A copy of the Informed Consent Form or Waiver of Consent, if applicable; andg. Documentation that the process of obtaining Informed Consent complied with the Research Licensee's other IRB, institutional, industry, or professional standards.11. The quantity of Marijuana or Marijuana Products anticipated to be needed over the duration of the research project;12. The Independent Testing Laboratory where the Marijuana or Marijuana Products will be tested;13. The name and license number of the Marijuana Research Facility Licensee or facilities where the research project will take place, provided that if a license has not yet been granted to the Marijuana Research Facility, the Research Permit applicant will still identify the facility and provide its application number;14. The disposal protocol for Marijuana or Marijuana Products that are unused;15. Disclosures of any actual or apparent conflicts of interest between any Marijuana Research Facility Licensee or Agent and any member of the IRB required by 935 CMR 500.147(4)(b) iv; and(c) The information required in 935 CMR 500.147(4)(b) to qualify for a Research Permit may, but is not required to, be submitted with an application for licensure as a Marijuana Research Facility.(d) Prior to receiving a Research Permit for a research project that includes human or animal participants as subjects, the applicant shall submit evidence of approval of the project by the identified IRB. Evidence of IRB approval or exemption may be submitted separately from the information required in 935 CMR 500.147(4)(b), but shall be submitted to receive a Research Permit.(e) Materials submitted in support of an application for a permit that are received by the Commission may be subject to release pursuant to the Public Records Law, M.G.L. c. 66, § 10 and M.G.L. c. 4, § 7, cl. 26, or other compulsory legal process, or at the Commission's discretion.(5)Research Permit Approval.(a) When evaluating an application for a Research Permit to conduct a research project at a licensed Marijuana Research Facility the Commission or its delegee(s) shall consider: 1. Whether the research project is allowed under 935 CMR 500.147(2)(c);2. The adequacy of safety protocols detailed in 935 CMR 500.147(4)(b)6.3. The research project design;4. Whether the research project is adequately funded or resourced and the sources of the funding or resources;5. Whether the amount of Marijuana or Marijuana Products anticipated to for growth or use during the duration of the research project is consistent with the proposed research project's scope, goals, aims and the protocols for tracking the amount used;6. Disclosures of agreements between Marijuana Research Facility Licensees and the nature of those agreements; and7. Whether a required IRB is affiliated with an accredited academic institution, licensed healthcare institution or other licensed research institution and, if not, may require additional information regarding the sufficiency of the IRB as it relates to the proposed research project.8. Whether sufficient evidence of approval of the research project by the identified IRB has been provided.(b) Research Permits shall be approved by the Executive Director and shall not require a vote of the Commission prior to issuance.(c) As set forth in 935 CMR 500.840, the issuance of a Research Permit may not give immunity under federal law or poses an obstacle to federal enforcement of federal law.(6)Denial of Research Permits.(a) The Commission or its delegee may deny an application for a Research Permit for any of the following reasons, provided that a written denial including the reason for the denial shall be issued to the applicant(s):2. Failure to provide adequate information regarding the IRB;3. Proposed research poses a danger to public health or safety;4. Proposed research lacks scientific value or validity;5. The applicant for the Research Permit is not qualified to do the research;6. The Research Permit applicant's protocols or funding or other resources are insufficient to perform the research; or7. Proposed research is otherwise in consistent with the Commission's governing laws.(b) The applicant shall not be entitled to an administrative hearing under 935 CMR 500.500 for the denial of a research permit.(7)Inspections and Audits. (a) The Commission or its delegee(s) may at its discretion inspect a Marijuana Research Facility.(b) The Commission or its delegee may at its discretion require an audit of a research project granted a Research Permit. Reasons for an audit shall include, but are not limited to: 1. The Commission has reasonable grounds to believe that the Marijuana Research Facility Licensee is in violation of one or more of the requirements set forth in these regulations or present a danger to the public health, safety or welfare;2. The Commission has reasonable grounds to believe that the activities of the Marijuana Research Facility Licensee or a Marijuana Establishment Agent present a danger to the public health, safety or welfare; or3. The Commission has reasonable grounds to believe that the Marijuana Research Facility Licensee has been or is engaged in research activities that have not been approved or permitted by the Commission.Adopted by Mass Register Issue 1434, eff. 1/8/2021.Amended by Mass Register Issue 1441, eff. 1/8/2021.