Pubdate: Fri, 16 Mar 2018
Source: Morning Call (Allentown, PA)
Copyright: 2018 The Morning Call Inc.
Author: Andrew Wagaman


The 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

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

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.
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