N.Y. Comp. Codes R. & Regs. tit. 9 § 132.6

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

Section 132.6 - Research Involving Human Subjects

(a) Prior to receiving a research license for a research project that includes human subjects, the following shall be required:

(1) one or more licensed practitioners in good standing to monitor participants shall be included, if required by the IRB of record;

(2) for any research project involving the consumption of investigational products by human subjects:

(i) all products shall be tested in accordance with Part 130 of this Title;

(ii) research participants shall be subject to all applicable laws and regulations; and

(3) for any multi-site research projects involving the consumption of investigational products by human subjects, all research sites shall be located in New York State.

(b) Prior to receiving a research license for a research project that includes human subjects, the applicant shall submit evidence of approval or exemption of the project by the identified IRB. Evidence of IRB approval or exemption may be submitted separately from the information required in this part but shall be submitted to receive a final research license.

(c) Advertisements used to recruit human subjects must be reviewed and approved by the IRB of record.

(d) An applicant or research licensee shall be prohibited from conducting any research involving human subjects unless:

(1) all aspects of its proposed research project have been reviewed and approved by an IRB that is registered and in good standing with the Office for Human Research and Protections, U.S. Department of Health and Human Services;

(2) the applicant provides copies to the Office of the IRB's determination that:

(i) the research project has been conditionally approved and is pending final approval;

(ii) the research project has been approved; or

(iii) the research project has been exempted from IRB review.

(e) A research licensee shall at all times comply with requirements for protection of human subjects, including additional safeguards necessary for vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, Title 45 of the Code of Federal Regulations Part 46, and all other relevant federal and/or state laws and regulations regarding research on human subjects, as well as all prevailing ethical standards and requirements for research involving human subjects.

(f) A research licensee shall abide by the following conditions when utilizing an informed consent form in research involving human subjects:

(1) A research licensee shall ensure informed consent from any individual participating in such research is obtained prior to the individual's participation in the research project. For studies involving minors, the research licensee shall also ensure assent from minors is obtained, as determined by the IRB of record.

(2) A research licensee shall comply with requirements for informed consent, specifically the safeguards for children in clinical investigations, under Title 21 of the Code of Federal Regulations Part 50, as part of approval and ongoing oversight and review by an IRB, including, but not limited to:

(i) sufficient opportunity to consider whether or not to participate;

(ii) information given to the participant is in a language and reading level understandable to the participant or their representative; and

(iii) the ICF shall not include any language that waives or appears to waive the participant's legal rights, nor appears to release the PI or the research licensee from liability for negligence.

(3) A copy of the signed ICF and documentation showing that the process of obtaining informed consent complied with the research licensee's IRB standards shall be available to the Office upon request.

(g) A research licensee may serve as a designated caregiver, or a designated caregiver facility, provided that:

(i) the research licensee registers as a designated caregiver or designated caregiver facility, as applicable, in accordance with Part 113 of this Title; and

(ii) the investigational products are purchased exclusively from a registered organization.

(h) PHI may be used or reported in an aggregated, nonidentifiable form.

(i) A research licensee shall not disclose the PHI of human subjects participating in the research project. Participant records shall be confidential and shall not be subject to disclosure under the Freedom of Information Law. If necessary, and upon written request to the Office, reasonable access to participant records obtained under this part may be provided to:

(1) the Office and local law enforcement agencies for purposes of investigating and enforcing what is set forth in any applicable regulation;

(2) licensed practitioners, advanced practice registered nurses, pharmacists or other dispensaries for the purpose of providing patient care and drug therapy management;

(3) the human subject participating in the research project, but only with respect to information related to the human subject, themselves;

(4) third party payors who pay claims for a qualifying patient's medical cannabis or who have a formal agreement or contract to audit any records or information in connection with such claims;

(5) any person, the state or federal government, or any agency thereof pursuant to an order of a court of competent jurisdiction or pursuant to a search warrant; and

(6) any person upon the express written consent of the human subject and only with respect to information related to such human subject. Such written consent shall clearly identify the specific human subject and purpose for which consent is being granted, but in no event shall such information be disclosed for data capture into an EDC system.

(j) No electronic equipment utilized by a dispensary shall collect a research participant's PHI for use outside of the research project unless:

(1) the patient has consented to the release of PHI by informed consent; or

(2) the Office has requested PHI be disclosed for purposes of an inspection or investigation.

(k) No electronic equipment utilized by an approved research project shall collect PHI specific to human subjects for use outside of the research project, except that such data shall be disclosed to the Office or law enforcement for purposes of an inspection or investigation.

(l) A research licensee, key personnel, or research participant who is acting within the scope of his or her involvement in an approved research project shall not be subject to arrest or prosecution, penalized in any manner, including, but not limited to, being subject to any civil penalty or denied any right or privilege, including, but not limited to, being subject to any disciplinary action by a professional licensing board, for the use of investigational products.

(m) The provisions of subdivision (l) of this section shall not apply to:

(1) any use of investigational products that endangers the health or well-being of a person other than the research subject or a research project employee; or

(2) the use or consumption of investigational products:

(i) in a motor bus or a school bus or in any other moving vehicle;

(ii) on any school grounds unless it is the site of a research project and such use is pursuant to the terms of the approved research project; or

(iii) in any public place, unless required by an approved research project.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.6

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