81-666. Approved researcher; application; contents; Department of Health and Human Services; powers.

The department may approve an individual or entity to be an approved researcher upon application and proof satisfactory to the department that the applicant is a qualified researcher, that the data will be used for bona fide scientific or medical research for prevention, cure, or control of certain diseases or injuries, and that the applicant will maintain the confidentiality and security of data obtained. The application shall contain, but not be limited to, the following information:

(1) The qualifications of the applicant and of the principal investigator, if other than the applicant, including education, experience, prior publications, and recommendations of professional colleagues who have knowledge and experience of scientific or medical research;

(2) The purpose of the research project, a summary of the project, and the anticipated time of completion of such project;

(3) The location where the research project will be conducted and the equipment, personnel, and other resources available to the applicant to carry out the project;

(4) The identity of the individual or entity funding the research project, a description of the availability of funds for the research project, and any conditions on the receipt or continuation of such funding;

(5) The specific data requested and a description of the use to be made of such data and, if patient-identifying data is requested, a substantiation of the need for access to such patient-identifying data;

(6) A description of the measures to be taken to secure the data and maintain the confidentiality of such data during the research project, for disposal of the data upon completion of the study, and to assure that the results of the study will not divulge or make public information that will disclose the identity of any individual patient;

(7) If contact with a patient or patient's family is planned or expected, substantiation of the need for such contact and a description of the method to be used to obtain permission from such patient or patient's family for such contact; and

(8) Such additional information as the department determines to be necessary to assure that release of data to the applicant is appropriate and will further the purpose of sections 81-663 to 81-675 or the laws governing the specific registry.

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