2016 Tennessee Code
Title 53 - Food, Drugs and Cosmetics
Chapter 14 - Legend Drug and Controlled Substance Research Act of 1984
§ 53-14-109. Institutional applicants for licenses.

(a) Any institution that regularly engages in research, instruction or chemical analysis may apply for a license authorizing internal approval of specific projects conducted under the institution's immediate auspices. The application shall be accompanied by the fee and materials specified in § 53-14-104; provided, that in lieu of a detailed protocol, the institutional applicant may submit a written statement containing:

(1) The qualifications of each member of the committee within the institution that will approve specific projects;

(2) A description of the system within the institution for approving, supervising and evaluating the projects; and

(3) Other information the commissioner may require.

(b) Any institution licensed pursuant to subsection (a) shall maintain for review by the board:

(1) A description of the project, including the names and qualifications of the individuals assigned to work on and supervise the project;

(2) A description of the provisions for safe administration or dispensing of drugs to human subjects, if contemplated; and

(3) Upon request of the commissioner, progress reports, evaluations and revisions, if any, of the project, in a form the commissioner prescribes.