1. (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 Texas Department of Health's (department) director of the Texas Birth Defects Monitoring Division. The protocol shall explain the applicant's "valid scientific interest" by describing, at length:

   1. (1) the name and qualifications of the principal investigator, professional staff, and every person who will review, analyze, or access the data;
   2. (2) the background justification for the study;
   3. (3) the goals and aims of the proposed study;
   4. (4) the health outcomes of interest;
   5. (5) the methodology for measuring exposures;
   6. (6) the methodology for measuring and adjusting for confounding variables;
   7. (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. (8) the time tables and feasibility for completion of the study;
   9. (9) the level and sources of funding for the study;
   10. (10) an explanation of the potential benefits and disadvantages involving human subjects;
   11. (11) the plans to maintain the confidentiality of the information provided by the department; and
   12. (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.
2. (b) After the director of the Texas Birth Defects Monitoring Division receives the completed request for information, the protocol will be reviewed by a divisional review panel. The panel shall consist of the director of the Texas Birth Defects Monitoring Program, the chief of the Bureau of Epidemiology, and a senior departmental epidemiologist. Upon approval by the divisional 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 divisional panel and the institutional review board and shall be based on an evaluation of the criteria listed in subsection (c) of this section.

3. (c) The evaluation criteria for approval shall include the following.

   1. (1) The key investigators shall have significant training and experience in biomedical research as demonstrated by a history of prior research and publication of results in peer-reviewed journals. For bona fide student proposals, faculty committee members should possess these qualifications.
   2. (2) The background reasons for conduct of the proposed study shall be compelling, as judged by the importance of the scientific question being asked, relative to the fields of epidemiology, medicine, public health or other medical research.
   3. (3) The goals and aims shall be clearly stated, consistent with the scientific question, and relevant to the field.
   4. (4) If appropriate, the methods for measuring or estimating exposure shall be scientifically valid.
   5. (5) The roles of other factors (that might be related to both the exposures and the birth defects studied) shall be considered, and the methods for measuring and adjusting for these factors shall be clear and scientifically valid.
   6. (6) If appropriate, power calculations shall indicate a reasonable chance of identifying expected differences between groups.
   7. (7) The statistical techniques to be used in data analysis, including methods to address biases in the study design shall be clear and appropriately used.
   8. (8) The potential benefits and disadvantages of working with human subjects must be clearly described.
   9. (9) Plans of how the investigators propose to maintain the confidentiality and integrity of the information provided by the department shall be clearly detailed.
   10. (10) The hypothesis or topic to be studied must not already be under investigation.
4. (d) Modification to the protocol or other terms and conditions may be required before releasing any data.
5. (e) If the applicant intends to contact individuals whose names were provided by the Texas Birth Defects Monitoring Division, the protocol must contain strong methodologic support for the need for such contact.
6. (f) If the protocol is approved by both the divisional panel and the institutional review board, then the researcher shall be considered to have established a valid scientific interest as required. The Director of the Texas Birth Defects Monitoring Division shall so advise the Commissioner of the Texas Department of Health (Commissioner). The researcher will be required to comply with the conditions of subsections (g) and (h) of this section before any data will be released.
7. (g) If permission is granted, the applicant shall be responsible for all reasonable and necessary costs incurred by the Texas Birth Defects Division in making the data available. The applicant shall incur the cost of the Texas Birth Defects Monitoring Division to monitor all contact with human subjects. The date of delivery of data shall be determined by the Director of the Texas Birth Defects Monitoring Division based on workload and the nature of the request.

8. (h) Prior to release of any data, the director of the Texas Birth Defects Monitoring Division shall receive from all applicants, including the principal investigators, staff, and consultants who will receive access to any confidential central registry data, a signed written statement guaranteeing that:

   1. (1) the applicant shall not allow any person other than those identified in the protocol, to access, use, or otherwise review the data supplied by the Texas Birth Defects Monitoring Division;
   2. (2) there shall be no deviation from the protocol without explicit advance review and approval by the Texas Birth Defects Monitoring Division panel, the department's institutional review board, and the Commissioner;
   3. (3) information obtained in the course of activities undertaken or supported using the data from the Texas Birth Defects Monitoring Program shall not be used for any purpose other than the exact purpose for which it was supplied;
   4. (4) all data, data tapes and disks, hard copy output, interview questionnaires or other materials provided by the Texas Birth Defects Monitoring Division are considered the property of the Texas Department of Health and shall be returned to the department at the completion of the study. Any confidential information which is copied or otherwise transferred, electronically or through other means, shall be destroyed at the completion of the research unless otherwise stated in the research protocol;
   5. (5) the Texas Birth Defects Monitoring Division, Texas Department of Health shall be acknowledged as a source of birth defects or other data in all written reports, data tabulations or publications that are produced by use of these data;
   6. (6) the applicant agrees to notify the director of the Texas Birth Defects Monitoring Division immediately upon receiving any request for access to data in the applicant's possession;
   7. (7) the applicant shall notify the director of the Texas Birth Defects Monitoring Division on receiving notice of any legal action that might affect disclosure of the data, either by subpoena, discovery, or other means; and
   8. (8) the applicant must agree to reimburse the Texas Birth Defects Monitoring Division for reasonable costs it incurs in protecting patient information from legal disclosure.
9. (i) While the Texas Birth Defects Monitoring Division utilizes vital records information, that information is the responsibility and property of the department's Bureau of Vital Statistics (bureau). Investigators who request vital records information from the bureau must obtain approval according to the policies of the bureau.

Source Note:The provisions of this §37.306 adopted to be effective October 20, 1994, 19 TexReg 8032.