Confidentiality; research – Ohio Admin. Code 3701-57-04

Information, data and reports with respect to a birth defects case that is furnished to, or obtained by, the birth defects information system or by the director is for the confidential use of the department, but may be disclosed for the following purposes:

• To inform parents, guardians and custodians of children with birth defects of medical care and other services available for the child and family;
• To provide data regarding birth defects in Ohio to the “National Birth Defects Prevention Network”; 
• To distribute reports of information as required;
• With the written consent  of the parent or legal guardian of the child;
• To the birth defects registry of another state, if the other state has entered into a written reciprocal agreement with the department providing that the state will comply with confidentiality provisions, and that information identifying a child will not be released to any person without the written consent of the individual’s parent or legal guardian;
• For medical research studies including demographic, epidemiologic, teratologic, or similar studies related to health and health care provision, if the study meets the following standards and conditions:
  • The person requesting to access the data initially meets with the birth defects program administrator or other staff to discuss the proposed study concept and programmatic data elements requested;
  • Following the outcome of this meeting, the person conducting the study submits a complete application to the department’s institutional review board and provides written information about:
    • The purpose of the study;
    • The nature of the data to be collected;
    • How the researcher intends to analyze it;
    • The records the researcher seeks to review, and;
    • The safeguards the researcher will take to protect the identity of the patients.
  • The person or entity signs an agreement to maintain the confidentiality of the information and the study meets the following standards:
    • The study had clearly defined goals that pertain to birth defects diagnosis, prevention, treatment or service coordination;
    • For case control studies, the research design will involve a sufficiently large sample size that any meaningful difference between cases and controls will be statistically significant;
    • For other projects, the study will provide enough cases for meaningful analysis of the data for identification of potential risk factors and intervention strategies for birth defects treatment and prevention; and
    • The study will be conducted by researchers who have the ability to analyze and interpret data.

Information assembled by the birth defects information system may be released in summary, statistical or other form that does not identify particular individuals or individual sources of information.