S.C. Code Regs. § § 61-4.1700.1701

Current through Register Vol. 48, 12, December 27, 2024

Section 61-4.1700.1701 - Confidentiality of Research Subjects

(a) Any person registered to conduct a bona fide research project with controlled substances under the Act who intends to maintain the confidentiality of those persons who are the subjects of such research, shall, upon registration or within a reasonable time thereafter, submit to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201, a separate request for each research project involving controlled substances, which shall contain the following:

(1) The researcher's registration number for that project;

(2) The location of the research project;

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

(4) A specific request to withhold the names and/or any other identifying characteristics of the research subjects; and

(5) The reasons supporting the request.

(b) Within 60 days from the date of receipt of the request, the Bureau Director shall issue a letter, either granting confidentiality, requesting additional information or denying confidentiality, in which case the reasons for the denial shall be included. A grant of confidentiality shall be limited solely to the specific research project indicated in the request.

(c) Within 30 days after the date of completion of the research project, the researcher shall so notify the Bureau Director.

(d) In addition to the requirements set forth in paragraphs (a), (b), and (c) of this Section, the person requesting confidentiality of research subjects shall also provide the Bureau of Drug Control with a copy of the petition to the Attorney General of the United States required pursuant to the provisions of 21 CFR §1316.23. In the event that the federal petition for confidentiality is not granted, or is withdrawn by the Attorney General of the United States, the Bureau of Drug Control shall, after notice to the researcher, remove its grant of confidentiality, if previously granted.

S.C. Code Regs. § 61-4.1700.1701

Replaced and Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013.