New York Codes, Rules and Regulations › Title 9 - EXECUTIVE DEPARTMENT › Subtitle C - Division of the Budget › Part 132 - Cannabis Research License › Section 132.1 - Definitions

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