New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 132 - Cannabis Research License › Section 132.3 - Applying for a License

Current through Register Vol. 46, No. 28, July 10, 2024
(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.