Ethical Issues Encountered in Establishment of the Texas Birth Defect Research Center (TBDRC)

Abstract

The Texas Birth Defect Research Center (TBDRC) is funded by the Centers for Disease Control and Prevention and administered by the Birth Defects Monitoring Division of the Texas Department of Health. Texas is one of eight states in the National Birth Defects Prevention Study. As part of the Study, Texas contributes cases and controls to a composite database, performs interviews with mothers, and collects biological specimens. The cases are identified from the existing Texas Birth Defects Registry (TBDR) and use of these data in an interstate study required review by Institutional Review Boards at the state and federal level, as well as coordination with the IRBs of other states.

The TBDR is a legislated surveillance system and it is not intrinsically a research entity. Because the mission of the TBDR includes social services referral and birth defects prevention, the information collected is not anonymous. Confidentiality protocols have been established for use of the Registry data by researchers, but organization of the NBDPS required a more formal review of human subjects protections. The ethical questions addressed by Texas in coordinating with the NBDPS fall into 10 categories:

1) Informed consent; 2) Sensitivity to ethnic/cultural minorities; 3) Participation of minors in research; 4) Patient/parent confidentiality 5) Patient/parent right to refuse; 6) Patient/parent right to withdraw 7) Patient/parent privacy right vs public health need for data; 8) Compensation for participation; 9) Use of electronically transmitted data and; 10) What to do when Texas state law differs from that of other states.

In organization of the TBDRC, the two largest issues for Texas have been participation of minor parents who are not emancipated and translation of the questionnaire into a culturally sensitive version of spanish. As the study has progressed, the most difficulty has been balancing the need for subject participation with a non-coercive, non-harassing contact process.