10A NCAC 41A .0104      RELEASE OF COMMUNICABLE DISEASE RECORDS: RESEARCH PURPOSES

(a)  A person may request, for bona fide research purposes, the release of records which pertain to a communicable disease or communicable condition and which identify individuals. The request shall be in writing and shall contain the following information:

(1)           Name of organization requesting the data;

(2)           Names of principal investigators;

(3)           Name of project;

(4)           Purpose of project;

(5)           Description of the proposed use of the data, including protocols for contacting patients, relatives, and service providers;

(6)           Descriptions of measures to protect the security of the data;

(7)           An assurance that the data will not be used for purposes other than those described in the protocol;

(8)           An assurance that the data will be properly disposed of upon completion of the project; and

(9)           An assurance that the results of the project will be provided to the custodian of the records.

(b)  The request for release of the records shall be granted or denied in writing based upon the following considerations:

(1)           Whether the objectives of the project require patient identifying information;

(2)           Whether the objective of the project can be reached with the use of the data;

(3)           Whether the project has a reasonable chance of answering a legitimate research question;

(4)           Whether the project might jeopardize the ability of the Epidemiology Division to obtain reports and information regarding communicable diseases and communicable conditions;

(5)           Whether the patient's right to privacy would be adequately protected.

History Note:        Authority G.S. 130A‑143(9);

Temporary Rule Eff. February 1, 1988, for a period of 180 days to expire on July 29, 1988;

Eff. March 1, 1988;

Amended Eff. September 1, 1991;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. January 9, 2018.