N.Y. Comp. Codes R. & Regs. tit. 9 § 132.1

Current through Register Vol. 46, No. 25, June 18, 2024

Section 132.1 - Definitions

For purposes of this Part, the following terms shall have the following meanings:

(a)Adverse event means any untoward or unfavorable medical occurrence associated with the use of a drug in human subjects, whether or not considered drug related, or damage, or any other serious important medical events.

(b)Applicant means an individual applying for a research license issued by the Board pursuant to Article 3 section 38 of the Cannabis Law, who shall also be the principal investigator.

(c)Board means the New York State Cannabis Control Board as defined in Article 1 of the Cannabis Law.

(d)Cannabis-derived product means concentrated cannabis or cannabis-infused products for use by a cannabis consumer or research participant.

(e)Cannabis-related product means a product that may be synthetically produced to mimic or produce similar effects to cannabis.

(f)Canopy means an area to be calculated in square feet and measured using clearly identifiable boundaries of all areas that will contain non-immature cannabis, which shall be vegetative or flowering plants, excluding seedlings or small clones, including the space(s) within the boundaries. Canopy may be noncontiguous, but each unique area included in the total canopy calculations shall be separated by an identifiable boundary including, but not limited to: interior walls, shelves, greenhouse walls, hoop house walls, garden benches, hedge rows, fencing, garden beds, or garden plots.

(g)Co-principal investigator or Co-PI means an individual whose role is similar to that of the principal investigator in determining the intellectual content, direction, and conduct of the research project or project activities.

(h) Curriculum vitae or CV means a detailed document highlighting academic and professional accomplishments.

(i)Double-blind trial means neither the participants of the research project nor the principal investigator and those administering the intervention or treatment know what intervention or treatment the participants are receiving.

(j)Electronic data capture or EDC means software used to collect and manage research project data.

(k)Good clinical practice means an ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of humans as subjects; assurance that the rights, safety, and well-being of trial subjects are protected.

(l)Human subject or research participant means an individual participating in a research project whose data or biospecimens may be collected through intervention or interaction with the individual.

(m)Informed consent means the legally effective knowing permission and agreement of an individual or their legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion, to engage in licensed research activities as a human subject.

(n)Informed consent form or ICF means a document to explain to the individual giving informed consent of the procedures to be followed, and their purposes, including identification of any procedures which are experimental, a description of any attendant discomforts and risks reasonably to be expected, a description of any benefits reasonably to be expected, a disclosure of any appropriate alternative procedures that might be advantageous for the individual, an offer to answer any inquiries by the individual concerning the procedures, and an instruction that the individual is free to withdraw their consent and to discontinue participation in the research project at any time without prejudice.

(o)Institutional review board or IRB means a human research review committee established and approved under the provisions of article twenty-four-A of the public health law, or an institutional review board established and approved under the provisions of Title 45 of the Code of Federal Regulations Part 46 or Title 42 of the US Code section 289(a), for the purpose of reviewing and monitoring research.

(p)Institutional animal care and use committee or IACUC means an independent committee that oversees all research with animals. The IACUC requires researchers to give reason to their need for animals in research, ensure they select appropriate species for the research, and use of the fewest number of animals in the research to reach their desired outcome.

(q)Investigational product means the cannabis, cannabis-derived product, or cannabis-related product being studied or used in an approved research project.

(r)Key personnel means staff, other than the PI, participating in a research project who is delegated to perform research tasks.

(s)Medical Cannabis Program means the administration of Article 3 of the Cannabis Law by the Office.

(t)Office means the Office of Cannabis Management.

(u)Principal investigator or PI means the applicant or research licensee who shall also be the primary individual who leads and oversees a research project and is responsible for all activities conducted under the research license.

(v)Protected health information or PHI means information in a medical, or other type of record, related to health care diagnosis or treatment that can be used to identify an individual. It may be transmitted or maintained electronically or in any other form or medium.

(w)Research means a systematic investigation, including but not limited to, research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

(x)Research project or study means a formulated plan of action to perform research and the execution of such plan.

(y)Research and development or R&D means activities that lead to the innovation of new products, processes, or services, or improvements to those that already exist in support of a business.

(z)Research contract means a written agreement between an applicant or research licensee and another licensee, permittee or registrant approved by the Board, that contains the responsibilities and duties of each party with respect to the research project or research study that the approved research licensee and the licensee, permittee or registrant intend to conduct under this Part.

(aa)Research protocol means a written procedure for conducting a research project or study.

(ab)Serious adverse event means an adverse event that results in death, requires hospitalization or prolongation of hospitalization, is life threatening, results in a permanent disability or damage, results in congenital abnormality/birth defect, or requires intervention to prevent permanent impairment.

(ac)Single-blind trial means a trial in which participants of a research project do not know what treatment or intervention they are receiving, but key personnel administering the treatment or intervention do.

(ad)Sub-investigator or Sub-I means an individual delegated by the principal investigator to perform critical study procedures and assist with making key decisions.

(ae)Vulnerable participant means an individual whose willingness to volunteer in a research project may be unduly influenced by the expectation, whether justified or not, of the benefits associated with participation, or of a retaliatory response from research staff if they refuse to participate. A vulnerable participant may include, but not be limited to, prisoners, minors, and those incapable of giving consent.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.1

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