§1301.18 Research protocols.
(a) A protocol to conduct research with controlled substances listed in Schedule I shall be in the following form and contain the following information where applicable:
(1) Investigator:
(i) Name, address, and DEA registration number; if any.
(ii) Institutional affiliation.
(iii) Qualifications, including a curriculum vitae and an appropriate bibliography (list of publications).
(2) Research project:
(i) Title of project.
(ii) Statement of the purpose.
(iii) Name of the controlled substances or substances involved and the amount of each needed.
(iv) Description of the research to be conducted, including the number and species of research subjects, the dosage to be administered, the route and method of administration, and the duration of the project.
(v) Location where the research will be conducted.
(vi) Statement of the security provisions for storing the controlled substances (in accordance with Sec. 1301.75) and for dispensing the controlled substances in order to prevent diversion.
(vii) If the investigator desires to manufacture or import any controlled substance listed in paragraph (a)(2)(iii) of this section, a statement of the quantity to be manufactured or imported and the sources of the chemicals to be used or the substance to be imported.
(3) Authority:
(i) Institutional approval.
(ii) Approval of a Human Research Committee for human studies.
(iii) Indication of an approved active Notice of Claimed Investigational Exemption for a New Drug (number).
(iv) Indication of an approved funded grant (number), if any.
(b) In the case of a clinical investigation with controlled substances listed in Schedule I, the applicant shall submit three copies of a Notice of Claimed Investigational Exemption for a New Drug (IND) together with a statement of the security provisions (as proscribed in paragraph (a)(2)(vi) of this section for a research protocol) to, and have such submission approved by, the Food and Drug Administration as required in 21 U.S.C. 355(i) and Sec. 130.3 of this title. Submission of this Notice and statement to the Food and Drug Administration shall be in lieu of a research protocol to the Administration as required in paragraph (a) of this section. The applicant, when applying for registration with the Administration, shall indicate that such notice has been submitted to the Food and Drug Administration by submitting to the Administration with his/her DEA Form 225 three copies of the following certificate:...