1. Return of research results and incidental findings How, from whom, to whom, and when research results (both general and individual) should be communicated remains subject to debate. This includes incidental findings, which are unexpected findings discovered in the course of research that are beyond the aims of the study. No return “Due to the experimental nature of the planned analyses, it will not be possible to inform you, or the father of your child, or your own doctors, of the results of any tests, including genetic tests, on your samples” (case # 22) General/Aggregate “You will have access to the general results of the study including analyses of samples and data, as we will keep you informed of publications arising from the research” (case # 23) General/Aggregate + Individual “If the study finds the gene and specific gene mutation associated with your genetic condition, the study doctor would offer to discuss these findings with you. … You will be provided with a summary of the results at the conclusion of this study” (case # 26) Individual (including incidental findings) “If we find information by chance that relates to another condition or conditions besides the one under study and it is life threatening or very serious and there is a treatment available, we will re-contact you unless you indicate you do not wish to be contacted” (case # 20) Process for return There are various processes utilised by research studies for disseminating research results. Below are examples of just a few of the processes we found in the consent forms. “…there is a chance we may uncover health information (information we were not looking for) which would directly impact the care of you/your child during childhood (this is what we refer to as “incidental findings”). If the study identifies such information, the study doctor will inform you/your child. Should this happen, repeat testing might be recommended to confirm any research results and the benefits and risks as well as possible inconveniences will be discussed with you/your child” (case # 32) “You may communicate with the research team in order to obtain information concerning the progress of the study or general results of the research. The investigators will contact you if the research leads to the identification of genetic variations that could have an impact on the health of your child, your family or yourself. These results would be explained to you upon request from yourself in the context of a genetic clinic that is independent from the research team. A new blood sample would then be obtained to confirm the findings. These results would be included in your child's medical chart. At anytime during the course of this study, you can have a consultation with a genetic counsellor.” (case # 19) Who returns/contacts There is variation in who returns the research results or contacts the child or parent to disclose research results or incidental findings. Researchers “If a mutation is found that is believed to be the cause of your child’s condition, we will be glad to share this information with you after the study is complete and analyzed” (case # 29) Doctor “If this unlikely event [of incidental findings] occurs, the researchers will try to contact your doctor…and explain what the research test results might mean. … Your doctor may explain this unexpected finding with you” (case # 42) Geneticists/genetic counsellors (to discuss test results) “If you wish, you could meet a genetic counsellor to discuss these [incidental finding genetic test] results” (case # 30)