We will develop and evaluate a decision aid that helps research participants choose the type of genetic research results they want to learn from studies that offer to return results from genome sequencing. The decision aid can be used during informed consent and any time before research participants are actually told the results. There are three major types of results possible from genomic research; primary, incidental and secondary. When researchers find the cause of the disorder they are studying, the finding is called a primary result. When hunting for the primary cause, sometimes researchers “stumble upon” gene differences that could impact a person’s health. These are called incidental findings or results. In some studies, differences in certain genes may be looked at even though researchers know the genes are not related to a research participant’s health condition. When differences are found that could impact a person’s health the differences are called secondary findings or results. Incidental or secondary findings could be associated with unexpected and perhaps unwelcome information that has medical consequences for the research participants and their family members. To help researchers feel comfortable discussing incidental and secondary findings, we will also create “just-in-time” (JIT) resources for members of the research team to use when they administer the decision aid. The JIT resources will include educational resources about genome sequencing and incidental and secondary findings, and will help study team members answer research participants’ questions.
The decision aid and JIT resources will contribute to a best practice model that facilitates shared decision making about return of incidental or secondary findings from genome sequencing studies. In addition, the creation and use of the decision aid and JIT resources will help to establish Cincinnati Children's Hospital Medical Center as a leader in shared decision making regarding return of genome sequencing results and strengthen Cincinnati Children's competitiveness for future funding or other collaboratives .