Participants’ identities are kept private. The information in this study is confidential. All records are kept under lock and key. Identifying information is removed from computer files, which are password protected. Mothers' names, fathers' names, or children’s names are never used in any report or publication. Answers to interview questions and results of genetic tests are not seen by or given to anyone outside the study, including insurance companies or other government agencies, even if requested by a court of law.

What is informed consent?

When the interviewer called to begin a telephone interview, they gave more details about the study, including potential risks and benefits of participating. They asked each participant to provide verbal consent (permission) to use her answers in our study to understand the causes of birth defects. When participants completed the interview, they received a cheek cell collection kit in the mail that contained a written consent form specific to the collection of DNA samples. This form explained more details about providing DNA samples, including the potential risks and benefits of participating. The signed consent form was returned with the cheek cell samples. Participants also had the opportunity to call the researchers with any questions about participating in the study.

What will the researchers do with the genetic information?

The genetic information that researchers collected from the DNA samples will be used only to study birth defects and for no other reason. To protect confidentiality, no names or other personal information will be attached to the samples. Genetic information may be shared with other participating sites and other researchers when and if it has been approved by research review committees. The shared data will not contain any information that could identify any individual.