Ala. Admin. Code r. 420-7-4-.08

Current through Register Vol. 43, No. 02, November 27, 2024

Section 420-7-4-.08 - Access To Information For Research Purposes

(1) The AHSCIR may release statistical data only to a person or agency for the following purposes:

(a) medical research or education;

(b) epidemiologic studies;

(c) health education;

(d) health planning or administration;

(e) required statistical reports necessary for publication of an annual report;

(f) publication of the AHSCIR annual report; and

(g) other statistical reports not previously produced and/or published by written request for research, information or education.

(2) A medical researcher may request the release of clinical records from the AHSCIR by the submission of a written research proposal to the registry containing the following information:

(a) purpose of the research;

(b) research design;

(c) proposed benefits to be derived from such research;

(d) a statement of compliance with all applicable state and federal requirements regarding the confidentiality of patient records;

(e) a completed application to the ADPH Institutional Review Board for release of confidential data; and

(f) If the research is to be credited toward a degree to the researcher, or if the research is being otherwise conducted by an institution of higher learning the proposal shall contain a statement, signed by the dean of the school, or designee, declaring that the proposed research is in compliance with all applicable research standards of the institution.

(3) The clinical records or reports of the individual patient may be disclosed to research staff for the purpose of medical research, provided that the registry has determined that:

(a) disclosure of this information is deemed necessary to accomplish the purposes of the research;

(b) the research warrants the risk to the individual patient of the potential disclosure of their medical records;

(c) adequate safeguards to protect the clinical records or identifying information are established and maintained.

(4) For the purposes of these rules, research is defined as any systematic investigation designed to answer a defined scientific question that requires collection and analysis of data in order to develop or contribute to generalizable knowledge. A researcher is defined as the primary investigator or project director.

(5) The AHSCIR shall submit all research proposals to the AHSCIR Research Review Committee in determining whether to release information as provided in this Rule. The consideration of all research proposals shall conform to the established Department of Public Health research policy.

(6) Any copies of reports or records provided to the researcher remain under the ownership of the AHSCIR and shall be returned to the AHSCIR upon termination of the research to be destroyed. Upon completion of the study, the researcher shall submit one copy of the completed research paper to the AHSCIR. The AHSCIR shall transmit the paper to the AHSCIR Research Review Committee for review, to be returned to the AHSCIR for file. If the committee deems the research to be of importance to the practicing physicians of the state, then the committee may recommend, with the concurrence of the researcher, the research agency or institution, that the abstract of the research be published.

Author: Teresa S. Pells, M.P.H.

Ala. Admin. Code r. 420-7-4-.08

New Rule: Filed November 18, 1998; effective December 23, 1998.

Statutory Authority:Code of Ala. 1975, § 22-11C-1, etseq.