he Pennsylvania Department of Health has issued new regulations for medical marijuana clinical research programs.
The regulations, released Friday, outline the process for an accredited medical school with an acute care hospital to become an approved “Academic Clinical Research Center” that can engage in medical marijuana-related research projects with “clinical registrants,” an entity that can grow, process and dispense medical marijuana.
The regulations also detail the application process for prospective clinical registrants, how research studies are reviewed and approved and how researchers may interact with the commercial medical marijuana market. The health department will approve a maximum of eight clinical registrants.
According to Rachel Levine, acting health secretary and physician general, Pennsylvania is the first and only state in the nation to institute such a program. State legislators who supported the 2016 medical marijuana law envisioned the state as a national leader in medical marijuana research.
Businesses that have already been issued a grower/processor permit or a dispensary permit can apply to convert to an approved clinical registrant if they enter into a research contract with an accredited medical school. Medical schools must also file an application with the Department to be to participate in these research projects.
Approved clinical registrants must begin approved research projects within six months of being deemed operational.
According to the health department, any description of research projects provided to the department through the application process will not be subject to disclosure under Pennsylvania’s open records law. Neither will research contracts or any intellectual property.
The dispensary of an approved clinical registrant must identify to the health department the patients enrolled in an approved research project. Researchers must provide a written report of their findings within a year of the completion of a research project.
More than 24,000 patients have registered to participate in the medical marijuana program, with more than 8,400 certified by a physician and 7,000 who have received their identification cards. According to the health department. Nearly 5,000 patients have already received medical marijuana at a dispensary.
Physicians continue to register to participate in the program. To date, 844 have registered and of those, 433 have competed the training to become certified practitioners.