What Is a Marijuana Research Facility in Massachusetts?
A marijuana research facility is an academic institution, not-for-profit company, domestic corporation, or other organization allowed to conduct studies involving cannabis and cannabis products in Massachusetts. A marijuana research facility may cultivate, purchase, or otherwise acquire marijuana to research marijuana and marijuana products under the terms of an approved research permit.
Note that any human subject study conducted by a marijuana research facility must be approved by an Institutional Review Board (IRB). An Institutional Review Board means a specially formed administrative body established or designated by a marijuana research facility licensee to review and supervise the design and methods of a research project and, where human or animal subjects are used in the research, to protect the rights and welfare of individuals recruited to participate in the research. A marijuana research facility may also be a marijuana treatment center or other marijuana establishments in Massachusetts licensed to conduct research.
Collocation of a marijuana research facility with another licensed marijuana establishment or MTC is permitted if the marijuana research facility and the collocated licensed marijuana establishment or MTC are physically separated and commonly owned.
A marijuana research facility is not permitted to transfer marijuana or marijuana products to another marijuana establishment, except for testing purposes, or to sell marijuana or marijuana products to a consumer, registered qualifying patient, or caregiver that has been acquired for a research project under the terms of the marijuana research facility license.
A marijuana research facility in Massachusetts may not sell marijuana that it has cultivated to consumers, marijuana treatment centers, or other marijuana establishments.
Does Massachusetts License Independent Marijuana Testing Facilities?
Per the Adult Use Regulations, 935 CMR 500, persons or entities seeking to conduct research using marijuana must receive approvals from the Massachusetts Cannabis Control Commission (CCC). If such individuals or entities meet the set criteria, they may obtain marijuana research facility licenses from the CCC. Note that a license to operate a marijuana research facility is different from a research permit.
Each licensee of a marijuana research facility is required to acquire a research permit for each research endeavor. Research permits are certifications issued by the CCC authorizing the conduct of a particular research endeavor during a defined and limited period. Separate application and application requirements apply to each research permit. The research permit must be renewed at least yearly or sooner if the nature and length of the authorized research project require it.
A marijuana research facility may submit an application for a research permit to conduct research in areas including but not limited to:
- Genomic research on marijuana
- Agricultural research on marijuana
- Composition levels and chemical potency of marijuana and marijuana products
- Efficacy and safety of administering marijuana and marijuana products as a component of medical treatment under the supervision of a certifying healthcare provider
- Clinical investigations of marijuana products
- Horticultural research on marijuana
- Any other research topics approved by the CCC, provided that the research conducted by the research facility may not be a substitute for processes for drug approval established in accordance with the United States Food and Drug Administration (FDA) pursuant to 21 CFR 312.
How to Get a Marijuana Research Facility License in Massachusetts
An establishment seeking to enter the Massachusetts marijuana market must complete various application stages before commencing operations. The first step is to visit the Massachusetts Cannabis Industry Portal (MassCIP) and submit the license application fee and all three licensing application components in one application. The application of intent (AOI), the background check, and the management and operations profile are the three components of a research facility license application.
APPLICATION OF INTENT
The Application of Intent (AOI) requires the applicant to identify any individuals or organizations that have a direct or indirect influence in their license application. These categories include, but are not limited to, any individual or entity that owns a controlling interest in an applicant's indirect holding or parent company, the applicant's CEO or Executive Director, and any individual or entity in any position that may have an indirect influence on the research facility’s decision-making process.
- An entity or person who qualifies as holding a direct or indirect influence in a license application must satisfy one or more of the following conditions:
- An owner who has a financial stake in the research facility in the form of 10% or more equity.
- A person or organization with a voting stake of 10% or more in the research facility or the ability to veto important occurrences.
- An associate
- A person or entity that has the right to control, through contract or otherwise, or authority, including but not limited to:
- making decisions about operations and strategic planning, capital allocations, acquisitions, and divestments
- appointing more than half of the directors
- appointing or removing corporate-level officials;
- making major production, marketing, and financial decisions
- executing significant or exclusive contracts
- earning more than 10% of the dividends or at least 10% of the profits
- a court appointee
- a third-party technology provider having a financial interest in a delivery licensee
- Disclosure of In-State Interest: Applicants must disclose if any of the persons or organizations listed in the application have been disclosed in any other marijuana establishment license application or are otherwise linked with any other active license in Massachusetts. This information provided should not be misleading or fraudulent, nor should it include any information that may give a wrong impression.
- Disclosure of Out-of-State Interest: Applicants must disclose if any individual or organization included on their application has had or currently has marijuana-related business interests in other states, as well as provide evidence of such interests. This section may require submitting a business license, articles of organization, bylaws, operating agreements, or an affidavit attesting to the disclosure's correctness and truthfulness.
- Capital Resources: The applicant must disclose the amounts and sources of money available from each individual or organization providing funds to create or operate the research facility. The applicant may use loans or equity investments to raise funds. \
Additionally, the applicant must provide evidence of capital, such as a financial institution record dated within 60 days of filing the application. When a person or organization provides money for a loan, a formal loan agreement is needed. \
If the person or organization supplying the funds is also an individual or entity exercising direct or indirect influence over the proposed research facility, the applicants must disclose them. Additionally, the applicant must establish via an oath or notarized document that any money used to invest in or finance the company was earned or obtained lawfully.
- Bond or Escrow Account: All applicants are required to acquire a bond or establish an escrow account to pay the expenses of dismantling and closing the research facility. The funds must be sufficient to cover any outstanding state or local sales taxes, secure the licensee's premises, and destroy any marijuana and inventory on the licensee's premises.
- Property Identification and Interest Documentation: Each application must provide the planned research facility's location. Following the selection of the proposed site, the applicant must establish ownership of the land via one of the following methods:
- a legal title to the proposed site
- a legally binding agreement allowing the transfer of such title
- an option to buy the site
- paperwork from the owner granting permission to use the property
- Host Community Agreement Certification: Each application must include a one-page certification signed by the contracting authority of the host community and the applicant attesting to the applicant's completion of a Host Community Agreement. Additional information on the rules governing Host Community Agreements is available on the CCC website. It is important to note that the CCC will not accept a fully executed Host Community Agreement in lieu of the single-page certification form.
- Community Outreach Meeting Attestation and Documentation: The purpose of the Community Outreach Meeting is to educate the host community about the proposed research facility, provide information on the planned establishment, and answer public queries. It is recommended that the Community Outreach Meeting take place prior to signing a Host Community Agreement since the meeting is intended to educate participants on establishing a Host Community Agreement.
- Plan to Remain Compliant with Local Ordinances: Each applicant must describe plans to ensure that the research facility complies with all relevant municipal rules, ordinances, and bylaws applicable to its physical location, including, but not limited to, identifying any local requirements for the sale of marijuana for medical use. \
This plan should include all contacts with municipal agencies or authorities about local laws and permitting requirements. The plan should include the following:
- Identification of the prospective address's zoning district
- Identification of any necessary permits and Identification of the time and frequency of the renewals of the permits.
- Plan to Positively Impact Disproportionately Harmed People: This plan must be submitted with the application for a research facility license and must be designed to help the CCC-identified groups of disproportionately affected individuals as follows:
In the Background Check section, the applicant must list all relevant individuals and organizations and any background disclosures and authorization papers. The applicant must also include each individual or organization named in the Applicant of Intent section in the Background Check section. Persons and organizations will be subjected to a comprehensive background check, including fingerprinting of individuals.
- Background Check Information: The Commission is required to assess the suitability of each individual and organization named on a license application, which may involve performing background checks. Background checks will include the following, but will not be limited to:
- Records from Massachusetts and national crime databases
- Civil database records for Massachusetts and the United States, including professional and occupational records
- Other marijuana-related enterprises in which the person or organization is involved
- Any action taken against the person or entity's license or registration
Each applicant and organization must identify any ongoing legal proceedings in Massachusetts or another state. Applicants are not obliged to disclose any convictions sealed or erased according to a court order.
- Background Authorization Forms: Every applicant must submit to a background check. The Commission uses a third-party partner to perform background checks. To ensure that the partner obtains the required information, the applicant must provide three permission papers and an unexpired government-issued picture identification card for each person named on the application. This package includes the CORI Acknowledgement Form, the Disclosure and Acknowledgement Form, and the Release Authorization Form.
MANAGEMENT AND OPERATIONS PROFILE
The Management and Operations Profile section outlines the applicants' plan for operating the research facility to the Commission. This section shows that the applicant understands the legal requirements for running a research facility, including the Commission's regulations, and that the applicant has plans that are specific to the license type, location, and size of the applicant and will be permitted to operate lawfully.
- Business Information, Articles of Organization, and Bylaws: All applicants must demonstrate that their proposed business is registered in the Commonwealth as a domestic business corporation or equivalent domestic business organization. There will be a need for the following items:
- Business name
- Articles of Organization
- Massachusetts Business Identification number
- Certificates of Good Standing: All applicants must provide certificates of good standing from the Massachusetts State Secretary, the Massachusetts Department of Revenue, and the Massachusetts Department of Unemployment Assistance. All certifications must be dated within 90 days of the license application's filing date. \
An applicant must have employees in order to register with the Department of Unemployment Assistance and obtain a certificate of good standing. If an applicant is currently jobless, an attestation to that effect will suffice in place of a current Department of Unemployment Assistance certification.
- Business Plan, Liability Insurance Plan, & Proposed Timeline: All applications must contain insurance coverage, an implementation timeline, and a comprehensive business plan for the research facility's operation. The plan may include revenue and expense forecasts, a description of the business, and an operating strategy. \
While insurance policies are not needed until after licensing, applicants must show in their plans that they will get policies covering general liability and product liability in the amount of at least $1 million per occurrence and $2 million in aggregate once licensed. Each insurance coverage should have a $5,000 per-incident deductible.
- Summary of Operating Plans, Policies, and Procedures: The applicant must provide plans, rules, and procedures for the operation of the research facility. These papers must be compliant with the CCC's criteria and specifications. Documents such as the following are required:
- Security Plan
- Prevention of Diversion Plan
- Storage Plan
- Transportation Plan
- Inventory Plan
- Quality Control and Testing Procedures
- Personnel Policies
- Recordkeeping Procedures
- Maintenance of Financial Records
- Detailed Description of Qualifications and Intended Training for Agents
- Energy Compliance Plan
- Diversity Plan: As part of their Management and Operations Profile, applicants seeking a research facility license must present a Diversity Plan. The applicants must create diversity plans to guarantee that the facility is fair to people of color, including Black, African American, Hispanic, Latinx, Indigenous people and women, veterans, disabled individuals, and LGBTQ+ individuals. This plan must contain the research facility's goals, initiatives, and measurements after the issuance of a provisional license to the company. Licensees will subsequently be required to show the development or effectiveness of such initiatives in order to maintain their licenses.
When the Commission receives a license application, it conducts a thorough examination to verify that it complies with the Commission's rules and regulations. If any portion of the application is found to violate the Commission's regulations, the applicant will be issued a request for further information or RFI (Request for Information). The CCC will address any detected deficiencies or non-compliance problems in a narrative accompanying the RFI notice.
Applicants may resubmit their license applications after correcting any mistakes or non-compliance issues and submitting all required documents and information. When the Commission gets the new material, it will expedite its review of the case's merits. The application will be considered complete if it is determined to conform with the Commission's rules at this stage. If the application has not conformed with the rules, another notice of a request for information (RFI) will be issued after another round of supplementary review.
Following the completion of an application in its entirety, it is queued for review based on the date and time of submission and the application's priority, expedited, or general status, among other criteria. After confirming that the application is complete, the CCC will notify the applicant of the outcome. The notice will contain the following information:
- Payment instructions for background checks to be performed
- Fingerprint instructions for all required individuals
- Notification that the application, to the extent permitted by law, has been sent to the municipality (in which the research facility will be located) requesting a response concerning the marijuana establishment’s compliance with local ordinances or bylaws within 60 days
- Notification that the CCC will consider the application for a provisional license within 90 days.
The CCC will grant a provisional license provided the applicant and other relevant government bodies provide the commission with the required information. The Cannabis Control Commission's Adult-Use of Marijuana Regulations offer more information about obtaining a research facility license. Additionally, you may contact the Cannabis Control Commission at (774) 415-0200 or Commission@CCCMass.com for additional information about applying for a Massachusetts research facility license.
How to Get a Research Permit in Massachusetts
Applicants for a research permit to conduct research at a marijuana research facility must provide to the CCC, in the form and manner specified by the Commission, the following information for each project:
- Each investigator's name and curriculum vitae (CV), including the Principal Investigator who oversees the research study and each sub-investigator
- The name of each licensed physician in good standing who will lead the study as Principal Investigator, serve as a sub-investigator, or oversee the research project's involvement of human subjects, if any
- The name of each licensed veterinary physician in good standing who will direct the study as Principal Investigator, serve as a sub-investigator, or supervise the research project's animal subject involvement, if any
- If appropriate, the IRB (Institutional Review Board) institution
- A synopsis of the research study that will be performed that is suitable for publishing
- A comprehensive research protocol, including precautions
- Specific objectives for the research study
- The study project's start and finish dates
- A description of the funding or resources allocated to the project, an attestation that the project is appropriately financed or resourced, and the financing or resource sources
- Information on human subject participants, if any, including but not limited to:
- The total number of participants
- The total number of registered qualifying patients, if any
- Participants’ demographic information
- The participants' ages
- Any cohort considered as "vulnerable" and any applicable safety precautions (for instance, minors, pregnant or breastfeeding women, and disabled veterans)
- A copy of the Informed Consent Form or Waiver of Consent, if applicable
- Documentation that the procedure for getting Informed Consent adhered to any other IRB, institutional, industrial, or professional requirements applicable to the research licensee.
- The anticipated quantity of marijuana or marijuana products required for the period of the research project
- The testing laboratory where the marijuana or marijuana products will be tested
- The license number and name of the marijuana research facility licensee or facilities where the research project will be conducted, provided that if the marijuana research facility has not yet been granted a license, the research permit applicant will.
- The procedure for disposing of leftover marijuana or marijuana products
- Disclosures of real or perceived conflicts of interest between a licensee or agent of a marijuana research facility and a member of the IRB as required by 935 CMR 500.147(4)(b)iv
- Fee for the application.
How Much Does a Marijuana Research Facility License Cost in Massachusetts?
A marijuana research facility license costs $1,000. An application fee of $300 also applies while submitting the licensing application. To obtain a research permit for a specific marijuana research project, the application fee is $1,000, while the permit fee is also $1,000. Both licenses are renewable annually for $1,000 each.
Can Marijuana Research Facility Licensees Hold Other Cannabis Licenses in Massachusetts?
Per the Massachusetts Guide on Licensure, the Cannabis Control Commission places no restriction on the other types of licenses that marijuana research facility licensees may obtain. Hence, research facility licensees may obtain cultivator, product manufacturer, retailer, craft cooperative, and microbusiness licenses. However, no person or entity having direct or indirect control in a marijuana research facility may hold more than three research facility licenses.