Ala. Admin. Code r. 420-2-1-.03
Current through Register Vol. 43, No. 02, November 27, 2024
Section 420-2-1-.03 - Research And Data(1) Records and data may be released as needed to the principal investigators associated with a valid scientific study provided that the protocols for release and handling of such records and data shall be approved in advance by a duly constituted institutional review board for the protection of human subjects.(2) All data requests shall be made to the OEMS by submitting a Data Request application.(3) All approved data requests or studies involving any information collected through the OEMS shall require that the published results contain a statement acknowledging the efforts and cooperation by the OEMS.(4) All published results of a data request shall be submitted to the OEMS within a reasonable time.(5) Any licensee who is, or contemplates being, engaged in a bona fide research program which may be in conflict with one or more specific provisions of these rules may make application for a variance of the specific provisions in conflict. Application for a variance shall be made to the OEMS which shall, upon completion of its investigation and recommendation of the SEMCC, send its findings, conclusions, and recommendations to the State Health Officer for final action.Ala. Admin. Code r. 420-2-1-.03
New Rule: Filed April 20, 2011; effective May 25, 2011.Amended by Alabama Administrative Monthly Volume XXXV, Issue No. 06, March 31, 2017, eff. 4/30/2017.Adopted by Alabama Administrative Monthly Volume XXXVII, Issue No. 05, February 28, 2019, eff. 4/7/2019.Adopted by Alabama Administrative Monthly Volume XXXVIII, Issue No. 07, April 30, 2020, eff. 6/14/2020.Adopted by Alabama Administrative Monthly Volume XL, Issue No. 05, February 28, 2022, eff. 4/14/2022.Rule 420-2-1-.32 was renumbered 420-2-1-.03 as per certification Filed February 20, 2019; effective April 7, 2019.
Authors: William Crawford, M.D.; Jamie Gray
Statutory Authority:Code of Ala. 1975, § 22-18-1, et seq.