South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-4 - Controlled Substances
Part 1700 - Protection of Researchers and Research Subjects
Section 61-4.1700.1702 - Exemption from Prosecution for Researcher

Universal Citation: SC Code Regs 61-4.1700.1702

Current through Register Vol. 48, No. 9, September 27, 2024

(a) Upon registration of a practitioner to engage in research in controlled substances under the Act, the Bureau of Drug Control, DHEC, on its own motion or upon request in writing from the Director or from the practitioner, may exempt the registrant when acting within the scope of his or her registration, from prosecution under State or local laws for offenses relating to possession, distribution or dispensing of those controlled substances within the scope of his or her exemption. However, this exemption does not diminish any requirement of compliance with the Federal Food, Drug and Cosmetic Act ( 21 USC 301, et seq.) or with the Federal Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801, et seq.).

(b) All petitions for Grants of Exemption from Prosecution for the Researcher shall be addressed to the Director, Bureau of Drug Control, SCDHEC, 2600 Bull Street, Columbia, SC 29201, and shall contain the following:

(1) The researcher's registration number, if any, for the project;

(2) The location of the research of the research project;

(3) The qualifications of the principal investigator;

(4) A general description of the research or a copy of the research protocol;

(5) The source of funding for the research project;

(6) A statement as to the risks posed to the research subjects by the research procedures and what measures of protection will be afforded to the research subjects;

(7) A statement as to the risks posed to society in general by the research procedures and what measures will be taken to protect the interests of society;

(8) A specific request for exemption from prosecution by Federal, State, or local authorities for offenses related to the possession, distribution, and dispensing of controlled substances in accord with the procedures described in the research protocol;

(9) A statement establishing that a grant of exemption from prosecution is necessary to the successful completion of the research project;

(c) Any researcher or practitioner proposing to engage in research requesting both exemption from prosecution and confidentiality of identity of research subjects may submit a single petition incorporating the information required in §§ 1701 and 1702.

(d) The exemption shall consist of a letter issued by the Bureau Director, which shall include:

(1) The researcher's name and address;

(2) The researcher's registration number for the research project;

(3) The location of the research project;

(4) A concise statement of the scope of the researcher's registration; and

(5) The limits of the exemption;

(6) The exemption shall apply to all acts done in the scope of the exemption while the exemption is in effect. The exemption shall remain in effect until completion of the research project or until the registration of the researcher is either revoked or suspended or his or her removal of registration is denied. However, the protection afforded by the grant of exemption from prosecution during the research period shall be perpetual.

(e) Within 30 days of the date of completion of the research project, the researcher shall so notify the Bureau Director. The Bureau Director shall issue another letter including the information required in paragraph (d) of this section and stating the date on which the period of exemption concluded; upon receipt of this letter, the researcher shall return the original letter of exemption.

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