§ 1211a.29. Practices and procedures of research programs, projects or studies.
(a) Medical marijuana dispensed as part of a research program shall be dispensed only in a form permitted by the act or this part and only from a dispensary to a patient or to a caregiver.
(b) Marijuana dispensed under a research project or study may be dispensed, in any form deemed medically safe by an IRB, from a clinical registrant dispensary directly to an ACRC.
(c) A RAC or IRB shall adopt research procedures and shall review and approve each research program in accordance with the RAC or IRB established practices and procedures.
(d) An IRB shall review each proposed research project or study in accordance with the IRB’s practices, procedures and protocols.
(e) A RAC or IRB shall ensure that each research program, project or study addresses all of the following:
(1) Protecting the rights and welfare of patients involved ia)(2.1))n research programs conducted under this chapter.
(2) Minimizing the risk to patients by using procedures that are consistent with sound research design and that do not unnecessarily expose patients to risk being performed on subjects for diagnosis or treatment purposes.
(3) Determining that the risks to patients involved in research programs are reasonable in relation to the anticipated benefits (if any) to the patients, and the importance of the knowledge that may be expected to result from the research program.
(4) Guaranteeing that informed consent will be sought from each prospective patient or the patient’s legally authorized representative and is properly documented.
(5) Protecting the privacy of every patient.
No part of the information on this site may be reproduced for profit or sold for profit.
This material has been drawn directly from the official Pennsylvania Code full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
