Specialized consent for studies involving genetic or genomic analysis. Includes detailed sections on genetic privacy, incidental findings, and family implications.
The Genomic Research Consent template addresses the specialized considerations of research involving genetic sequencing, genotyping, or other genomic analyses. It provides comprehensive coverage of genetic privacy, the potential for incidental findings, and implications for biological relatives.
With eleven sections, this template covers introduction, study purpose, genetic procedures, what will be learned, incidental findings policy, genetic privacy and GINA protections, data sharing and repositories, risks specific to genetic research, benefits, family implications, and contact information.
The incidental findings section is particularly detailed, explaining what types of findings may be discovered, whether and how they will be communicated, and participants' options regarding receiving this information. This addresses one of the most complex ethical issues in genomic research.
This template is essential for whole genome sequencing studies, GWAS research, pharmacogenomics trials, and any study where genetic results may have implications beyond the research questions being investigated.
This is a preview of the complete consent form experience participants will see.
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This template includes specific provisions for managing incidental findings - genetic variants discovered that are unrelated to the study but may be medically significant.
Federal law (GINA) protects participants from genetic discrimination by health insurers and employers. This template clearly explains these protections.