(a) An application for access to any confidential data elements for individual patients identified as part of the operation of the central registry must contain a protocol and be submitted to the program manager. The protocol shall explain the applicant's "valid scientific interest" by describing, at length:(1) the name and qualifications of the principal investigator, professional staff, and every person who will review, analyze, or access the data;(2) the background justification for the study;(3) the goals and aims of the proposed study;(4) the health outcomes of interest;(5) the methodology for measuring exposures;(6) the methodology for measuring and adjusting for confounding variables;(7) the precise statistical techniques to be used in the analysis of data, including power and methods to address biases inherent in the study design and data;(8) the time tables and feasibility for completion of the study;(9) the level and sources of funding for the study;(10) an explanation of the potential benefits and disadvantages involving human subjects;(11) the plans to maintain the confidentiality of the information provided by the department; and(12) a discussion of the project's pertinence to the fields of medical research, medical care, public health, epidemiology, biostatistics, or maternal and child health(b) After the program manager receives the completed request for information, the protocol will be reviewed by a program review panel. The panel shall consist of the program manager, the unit manager, and a departmental epidemiologist. Upon approval by the program panel, the protocol shall be evaluated and judged by the department's institutional review board. Final approval of the protocol shall require the approval of both the program panel and the institutional review board and shall be based on an evaluation of the criteria listed in subsection (c) of this section. The department's institutional review board shall evaluate the research based on federal regulations found in