N.Y. Comp. Codes R. & Regs. tit. 9 § 132.3

Current through Register Vol. 46, No. 43, October 23, 2024

Section 132.3 - Applying for a License

(a) All research license applications shall be approved by the Board and meet the requirements of this Part. To apply for a license, the applicant shall have at least one proposed research project to register under the license. Applicants shall submit the following information in a form and manner as determined by the Board:

(1) full name of the applicant;

(2) applicant contact information;

(3) street address of the intended research site, including the floor location or room number, if applicable;

(4) the mailing address of the applicant, if different from the research site;

(5) the name, address and telephone number of the attorney or representative of the applicant, if any;

(6) the following information regarding all cannabis research project(s) that the applicant wishes to engage in:

(i) projected goals and outcomes of the research project(s) covered by the license that the applicant intends to conduct within the next year following submission of the application, including project quality, study design, value, and impact;

(ii) information demonstrating the applicant has the appropriate key personnel, expertise, facilities and infrastructure, funding, and appropriate approvals, such as IRB or IACUC, to successfully conduct the project(s);

(iii) the name and curriculum vitae (CV) of key personnel participating in the research project(s);

(iv) the name and address of the licensee, permittee or registrant, including any cultivator, processor, manufacturer, dispensary facility, or laboratory associated with the research project(s), if applicable;

(v) disclosures of any contracts and agreements between the applicant and any licensee, permittee, or registrant approved by the Board involved in any aspect of the project(s);

(vi) disclosures of contracts and agreements, if any, between the applicant and an institution of higher education;

(vii) the IRB that will be utilized for ethics review of research involving human subjects including the status of approval, if applicable, and the contact information for the IRB;

(viii) the IACUC that will be utilized for ethics review of research involving animals, the current status of approval, if applicable, and the name of each licensed veterinary doctor in good standing, that will lead the research project(s) as principal investigator, co-principal investigator, sub-investigator, or monitor the participation of animals, if any, in the research project(s);

(ix) a description of the project(s) funding or resources that includes an attestation that the project(s) is/are adequately funded or resourced, the sources of the funding, and disclosure of any known conflicts of interest, if applicable;

(x) a description of the proposed human subjects, which includes, but is not limited to, demographic information, and details on those deemed vulnerable participants and any applicable safety precautions for those participants;

(xi) a description of proposed animals to be used in the research, if any;

(xii) attestation and/or certification of good clinical practice training, if applicable; and

(xiii) the quantity of investigational products anticipated to be needed over the duration of the research project(s) and information regarding:

(a) the proposed canopy size of the cultivation space, if applicable;

(b) justification for the amount of investigational products to be cultivated or purchased by the applicant and information detailing how the proposed canopy or purchased investigational products are consistent with the project's scope and goals;

(c) the laboratory where the investigational products will be tested, if applicable;

(d) the source of the investigational products, including the following for the source: licensee name, address and date of sale or donation to the research licensee; and

(e) a plan for the disposal or donation of investigational products at the conclusion of the research project.

(7) if working within an organization, the following information of such affiliated organization shall be submitted unless waived by prior written approval by the Board:

(i) the organization's name and address;

(ii) applicant's role in the organization;

(iii) documentation attesting to the following:

(a) the organization is aware that the applicant is applying for a research license;

(b) the organization has no objections to the research project(s) being proposed;

(c) the applicant is qualified to serve as the PI and has the organizational authority to oversee and make decisions regarding the research activities being performed;

(d) the researcher may use the organization's staff as key personnel in the research study, if applicable;

(e) the researcher may utilize the organization's facilities to perform the research; and

(f) the organization may be held responsible if:

(1) there is any undue harm to a human subject as a result of the research being performed;

(2) there is any adverse event that the research licensee is unable to contain or provide sufficient restitution; and

(3) there are any violations of the Cannabis Law or the regulations that the research licensee is unable to adequately compensate or that the organization should have reasonably known would have caused damages.

(b) The application fee for a research license shall be $250. The licensing fee shall be $500. The application and licensing fees may be waived by the Office:

(1) based on the size, scope, or duration of the proposed research project; or

(2) if the applicant can demonstrate financial hardship.

(c) The Board shall approve or deny a research application after an application review period as determined by the Board; all applications in review will be assessed for completion and accuracy.

(d) An application shall be denied for the following reasons:

(1) description of the project does not meet the requirements of Cannabis Law;

(2) proposed research poses a danger to public health or safety;

(3) proposed research poses a health or safety risk to the human subjects;

(4) applicant has not received approval or conditional approval from an IRB or IACUC, if applicable;

(5) applicant failed to be registered with the U.S. Department of Agriculture for a research project involving animals, if applicable;

(6) applicant has not provided sufficient justification for the scientific value or validity of the proposed research project;

(7) applicant is not qualified to conduct the proposed research project;

(8) applicant's research protocol, funding, or other resources are insufficient to perform the proposed research project;

(9) the application is incomplete;

(10) the information provided within the application is false or misleading;

(11) the applicant failed to supply information and/or documents requested by the Office within the deadline imposed by the Office;

(12) the application does not meet the requirements set forth by this Part; or

(13) any other reason as determined by the Board.

(e) The Board shall provide notice of denial in writing to the applicant and include the reason for the denial.

(f) The applicant may submit a new completed application for consideration if the reason for previous denial has been addressed.

(g) An application to renew a research license that was issued under this Part shall be filed with the Board not more than six months nor less than four months prior to the date of expiration. The license will be considered expired if a renewal application is not submitted to the Board within such time limits.

(1) The research license shall be renewed every two (2) years.

(2) The renewal fee for a research license shall be $200. The renewal fee may be waived based on financial hardship or the size, scope, or duration of the ongoing research project.

(3) The renewal application shall be in a form prescribed by the Board and include the following:

(i) a list of the research projects approved by the Board that are continuing or, if any of them are concluded, the dates they were concluded;

(ii) a report of the current status of active registered research projects being conducted by the research licensee, including preliminary findings, if applicable, and any anticipated future research projects over the course of the two years following the date of submission of the report;

(iii) a description of any new proposed research projects that the research licensee intends to register with the Office and conduct within the next licensing period following submission of the renewal application, including evidence of IRB approval or conditional approval for each research project, if applicable;

(iv) any updated contracts between the research licensee and other licensees, permittees, or registrants of the Board involved in the research project; and

(v) any other information deemed necessary by the Board.

(4) Additional research projects may be added or considered at the time of renewal. The Board shall evaluate the proposed research project activities to ensure that they meet the requirements of section 38(2) of Article 3 of the Cannabis Law as well as the requirements under this Part.

(5) The Board will not approve a renewal of a research license under this Part if the Board determines that the research licensee does not intend to begin any additional approved research projects within the first 6 months following the approval of its application for renewal.

(h) Any false statement made by the research licensee is punishable under section 210.45 of the Penal Law.

(i) Materials supplied to the Office in support of an application for a research license may be subject to release pursuant to the law or regulation, other compulsory legal process, or at the discretion of the Board, where legally permissible.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.3

Adopted New York State Register August 9, 2023/Volume XLV, Issue 32, eff. 8/9/2023