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In addition to the intervention trials, there are also three natural history studies for T1D that are ongoing in the US. These include DAISY (Diabetes Autoimmunity in the Young Study) in Colorado, PANDA (Prospective Assessment in Newborn of Diabetes Autoimmunity) in Florida, and DEW-IT (the Diabetes Evaluation in Washington). All are based on newborn genetic screening in the general population, and therefore, concerns have been raised about proper informed consent. Similar concerns have been raised for the DIPP study in Finland, which is also screening the general population.
Parents of babies who carry high risk DQB1 alleles receive a letter informing then that their infant is at ‘high’ or ‘moderate’ risk of developing the disease. The likelihood that these children will develop T1D before they are 35 years of age is actually only about 6%. Moreover, approximately half of the children who actually will develop T1D come from the ‘low’ risk group, which is not eligible to participate.
The final report of the Task Force on Genetic Testing recently noted that “‘a knowledge base on genetics and genetic testing should be developed for the general public. Without a sound knowledge base, informed decision are impossible and claims of autonomy and informed consent are suspect”. Because genetic testing for T1D is currently being conducted, it is essential that we begin to address these issues now. We developed this Module with the hope that it will begin to fulfill the need for health professionals who work with families with diabetes. Module 3 will cover informed consent, psychosocial and ethical issues that are related to diabetes and the actual process of genetic testing.