SECTION 475:10-1-11. Operational protocols

(a)   An operational protocol to conduct scientific research, analytical laboratory activities, or institutional instructional activities with controlled dangerous substances listed in Schedules I through V shall be in the following form and contain the following information where applicable:

(1)   Scientific research, analytical laboratory activities, or institutional instructional activities.

(A)   Name, business address, and if any, the Federal Drug Enforcement Administration (DEA) registration number.

(B)   Institutional affiliation, if any.

(C)   Qualifications, including an academic vita and an appropriate bibliography (listing publications).

(i)   Applicants shall be required affirmatively to establish (by documentation or suitable references or other appropriate means) their good moral character and high ethical professional standing.

(ii)   Applicants for scientific research shall possess at least an earned bachelor's degree in natural science, medicine, or other appropriate field from institution(s) accredited by bodies recognized by the designated authority of the University of Oklahoma Health Sciences Center.

(iii)   Applicants for scientific research proposing studies involving human subjects should minimally possess an earned doctorate in medicine or natural sciences or other appropriate field from accredited institution(s).

(iv)   Applicants for analytical laboratory activities who propose studies involving chemical analysis or other chemical, physical, or biological scientific activities with Schedule I-V substances shall be required to have satisfactorily completed a minimum of thirty-two (32) semester hours, or the equivalent, of acceptable courses in chemistry, with one (1) or more accredited courses in analytical chemistry.

(v)   Institutional instructional activities or institutions of higher learning requesting registration of an agent of such institution shall be an institution accredited by the Oklahoma State Regents for Higher Education, or such agent of an institution shall be required to have satisfactorily completed a minimum of thirty-two (32) semester hours, or their equivalent, of acceptable courses in chemistry from an institution(s) accredited by bodies recognized by the United States Department of Education or theUnited States Department of Health and Human Services.

(vi)   All said applicants shall further be required to document at least one (1) year of recent suitable, professional experience for the activities to be undertaken for a Schedule I registration. This may consist of formal participation in established and recognized analytical laboratory analysis of controlled dangerous substances, research programs, institutional instructional activities, or other evidence of appropriate background approved by the Director (post-doctoral training, applicable laboratory experience, etc.).

(2)   Research project.

(A)   Title of project.

(B)   Statement of purpose.

(C)   Name of controlled dangerous substance or substances involved and the amount of each substance for use.

(D)   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.

(E)   Location where the research will be conducted.

(F)   Statement of the security provisions for storing the controlled dangerous substances and for dispensing the controlled dangerous substances in order to prevent diversion.

(G)   If the researcher or investigator desires to manufacture any controlled dangerous substances listed in this part, a statement of the quantity to be manufactured and the sources of the chemicals to be used.

(3)   Authority.

(A)   Institutional approval.

(B)   Approval of Institutional Review Board.

(C)   Indication of an approval for new DEA registration number if additional registration is required by DEA.

(D)   Indication of an approved funded grant (number), if any.

(4)   Adequate environment and facilities. All said applicants shall be required to establish that they have access to and beneficial use of an institutional (or other) environment appropriate to the type of activities contemplated, and that they possess the necessary facilities (inclusive of proper laboratory facilities and equipment, etc.). This requirement shall be interpreted as requiring that overall environment, facilities, and equipment meet generally recognized standards for the activities proposed.

(5)   Confidentiality of research subjects.

(A)   Any registrant under the Uniform Controlled Dangerous Substances Act who intends to maintain the confidentiality of those persons who are the subjects of such research shall, pursuant to Title 63 Okl.St.Ann. § 2-106, upon registration or within a reasonable time thereafter, submit to the Director a separate request for each research project involving controlled dangerous substances, which shall contain the following:

(i)   The researcher's registration number with the OBN and/or DEA registration number(s) for that project.

(ii)   The location of the research project.

(iii)   A general description of the research or a copy of the research protocol as required in this Chapter.

(iv)   A specific request to withhold the names and/or any identifying characteristics of the research subjects.

(v)   The reasons supporting the request.

(B)   Within thirty (30) days from the receipt of the request, the 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.

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

[Source: Amended at 29 Ok Reg 1312, eff 6-25-12; Amended at 36 Ok Reg 981, eff 7-25-19]