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Controlled Substances in Research

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Policy Statement

Certain research protocols conducted by faculty of the University may require the use of controlled substances. As part of the planning for the use of such substances in research, the research protocol must be reviewed by the Assistant Vice President for Research and authorization given for the use of the specific substances.

In conducting research with controlled substances, all authorized personnel must comply with University policies, federal and state laws and regulations regarding background checks, use, licensure; storage requirements, inventory maintenance, substance disposal, reporting and record keeping in accordance with Title 21, Part 1300-1308 of the Code of Federal Regulations (CFR).

All matters related to the University Drug Enforcement Administration (DEA) Controlled Substances Registration Certificate are a function of the Office of Research and Community Collaboration (ORCC) and the Assistant Vice President for Research.

The Assistant Vice President for Research will assist researchers in complying with applicable rules and regulations and provide information regarding University procedures.

Definitions

Controlled Substance - Section 802 (6) of Title 21, United States Code (USC) provides the legal definition of a controlled substance. The term means a drug or other substance included in schedule I, II, III, IV or V of part B of this subchapter. http://www.usdoj.gov/dea/pubs/csa.html
Authorized Personnel - An individual working on a research protocol authorized by the Assistant Vice President for Research


Related Committees

Institutional Review Board for the Protection of Human Participants


History

03/02/09 - Approved by the President of the University as recommended by the Policy Committee of the University


Mary T. Gardier Paterson, Esquire | Secretary of the University | paterson@marywood.edu