Ethical Challenges in Obtaining Informed Consent for Genetic/Genomic Research
Obtaining informed consent (IC) for genetic/genomic research is complicated because most of the ethical issues associated with genetic research are considerations to be disclosed by researchers and weighed by prospective participants during the consent process. These include complicated questions associated with return of results, management of incidental findings (results beyond the aims of the study that are of potential significance to individual participants), and responsibility for reinterpretation of findings. Moreover, some research designs and contexts—such as recruitment based on genotype, or research with direct-to-consumer testing company data or among indigenous peoples—present distinct IC challenges. Sharing samples and data to address a wide range of research questions, combining population-based cohorts to create ancestrally diverse study populations, and NIH data sharing requirements have prompted suggestions that traditional, study-specific IC be replaced by broad consent and dynamic consent. This shift, as well as practicalities of conducting research during the COVID19 pandemic, accelerated the use—and calls for evaluation—of interactive digital interfaces…
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