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A new generation of genomic technologies permits the increased collection of data on large study populations.1,2 New methods in informatics facilitate the integration of diverse types of information with genomic data in disease research. As a result, researchers are learning more about the genetic bases of disease and response to drugs.3–6 Genetic tests, including many that are offered directly to the consumer, are growing in number and clinical relevance. Genomic knowledge and technologies are also being adopted in areas distant from human health. Here, I describe evolving policies pertinent to genetic and genomic research, the integration of genetics into clinical care, and the broader issues raised by genetic technologies and information.
Controversies in Genomic and Genetic Research
Although genetic and genomic research do not raise wholly new ethical issues in the context of general biomedical research, they cast these issues in a fresh light. First, research using collections of biologic specimens, genomic data, and information from medical records has amplified the long-standing yet unresolved issue about consent for future research that is unanticipated at the time of specimen collection. Second, the push for broad access to research data sets has raised privacy concerns. Third, as researchers seek to share data with colleagues, the issue of whether and how to share research results with study participants remains vexing, particularly in the absence of explicit prior consent from participants.
Consent and Confidentiality
Consent documents provide a means of communicating the risks of a study (including informational risks) to participants. Narrow consent documents describe the benefits and risks of a specific study, whereas a broad consent may ask participants to agree to any number of future studies that will use their samples or data. Research participants may vary in their views and preferences about consent and in whether they wish to undergo a reconsenting process for every specific study that may be conducted with their specimens or information. They may also vary in their views about being notified of the results and implications of such studies. Broad consent is often obtained for future research on stored specimens and medical records because such research is considered to be of low risk to participants. Having the option of giving broad consent for future studies...