N.Y. Comp. Codes R. & Regs. tit. 9 § 132.2

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

Section 132.2 - General Provisions

(a) A research license shall:

(1) be required in order to conduct research studies with investigational product, or on populations that use investigational product.

(2) be issued in the name of the applicant who will serve as the PI of the research project.

The applicant shall register all research projects they lead, as PI, under the same research license. A PI may serve as a co-principal investigator or sub-investigator on other research projects under a different research license.

(b) A research license shall not be required for:

(1) research and development activities conducted by licensees, permittees, or registrants approved by the Board, provided that the research activities are within the scope of their existing license type;

(2) data only studies that do not directly involve human subjects or use of investigational product directly or in any whole or processed form; or

(3) studies conducted using federally sourced cannabis supplied by the National Institute on Drug Abuse Drug Supply Program, provided that the researcher supplies the Office with documentation of such federal approvals once received.

(c) Investigational products provided for research purposes shall not enter the medical or adult-use supply chain for use by a cannabis consumer for adult-use purposes or a medically certified patient for medical purposes, unless it is being provided to human subjects or key personnel in accordance with an approved research project.

(d) A research licensee may:

(1) deliver, transport, or provide investigational products to:

(i) a licensee or permittee approved by the Board under Article 4 and 6 of the Cannabis Law;

(ii) a cannabis testing laboratory permitted by the Board;

(iii) a registered organization;

(iv) another research licensee;

(v) key personnel or a human subject, as part of, and in compliance with, the conditions of an approved research project; or

(vi) individuals or entities as approved by the Board.

(2) in accordance with the authorizations of their research project(s), produce, process, purchase, and/or possess investigational products for the purpose of conducting cannabis research.

(3) conduct research involving investigational products for the following limited research purposes:

(i) to conduct agricultural research;

(ii) to conduct genomic research;

(iii) to test chemical potency and composition levels;

(iv) to conduct clinical investigations with investigational products, including human observational studies;

(v) to conduct research on the efficacy and safety of administering investigational products as a component of medical treatment; or

(vi) other research topics approved by the Board that comply with Cannabis Law section 38.

(4) contract with a licensee, permittee or registrant approved by the Board to assist with the testing, cultivating, processing, or the dispensing of investigational products for research purposes.

(5) share premises with another licensee, permittee or registrant approved by the Board provided that:

(i) the research licensee receives prior written approval from the Board;

(ii) all investigational products used for research purposes are physically segregated and designated as such; and

(iii) inventory records pertaining to research can be distinguished from other records.

(6) contract with an institution of higher education, including but not limited to, a hospital within the State University of New York, to perform research in conjunction with such institution. An institution of higher education may also apply for a research license.

(e) A research licensee shall not, for the purposes of fulfilling the authorizations under this license:

(1) obtain or transport investigational products outside of New York State;

(2) acquire investigational products from a person other than a licensee, permittee or registrant approved by the Board, unless approved by the Board; or

(3) employ, or permit to be employed, or allow to work, any persons under 18 years of age, on any research project.

(f) An applicant shall demonstrate to the Board that there are effective procedures to safeguard against diversion, theft or loss of investigational products, including proving that the security measures are adequate for storing the quantity of investigational products the research licensee may have in possession.

(g) All human subjects shall be 21 years of age or older unless they are certified patients in the Medical Cannabis Program.

(h) Access to stored investigational products, whether ambient or refrigerated, must be restricted to the principal investigator and key personnel.

(i) A research licensee shall:

(1) maintain a record of all key personnel involved with the research project.

(2) abide by the worker health and safety standards as set forth in any applicable law, or regulation.

(j) The issuance of a research license to a research licensee shall not convey upon the research licensee, or any of the research studies authorized to be conducted by the research licensee, that the:

(1) opinions, points of view, research methods, or conclusions expressed in such research studies represent the Office;

(2) investigational products discussed in such research studies constitutes product approval or endorsement by the Office; and

(3) Office:

(i) controls or guarantees the accuracy, legality, relevance, timeliness or completeness of the information contained in the research study;

(ii) endorses such research licensee's:

(a) expressed views or opinions,

(b) research studies;

(c) methods of research;

(d) conclusions in such research studies; or

(e) the investigational products or cannabis plants in such research studies; and

(iii) authorizes the use of copyrighted materials, if any, used in such research study.

(k) Publication. All publications that result from research studies associated with research licenses issued by the Board shall include the following statement: "The content herein is solely the responsibility of the authors and does not necessarily represent the official views of the Office of Cannabis Management."

N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.2

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