N.Y. Public Health Law § 3326: Institutional research licenses

§ 3326. Institutional research licenses. 1. Subject to the provisions

of this title, the commissioner is authorized to license an institution,

which regularly engages in research, to approve specific projects

conducted under its immediate auspices.

2. An institution seeking a license pursuant to this section shall

make application in the same manner as an applicant for a license

pursuant to section 3325. However, such institution shall submit, in

lieu of a detailed protocol of a specific project, a statement

including:

(a) the qualifications and such other data as the commissioner may

require regarding each member of the committee within the institution

which will approve specific projects;

(b) a description of the system within the institution for approving,

supervising and evaluating such projects.

3. Upon approval of each specific project, such institution shall

forward to the commissioner a description of the project, the names and

qualifications of the individuals working thereon and of those

individuals designated to supervise the project. If administration or

dispensing to human subjects is contemplated, there shall also be

included a description of the provisions for safe administration or

dispensing.

4. Such institution shall forward to the commissioner periodic

progress reports and evaluations of, as well as amendments to each

project, in such manner and in such detail as the commissioner may

prescribe.