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Informed Consent

Definition
AI-generated

Informed consent is the process by which a person voluntarily agrees to participate in research or clinical care after disclosure of material information—purpose, risks, benefits, alternatives, confidentiality, and rights such as withdrawal—at a level appropriate to the context.

Why it matters in GWAS

Broad genomic research often uses tiered or dynamic consent (e.g. return of results, data sharing, commercial use); mismatch between consent scope and secondary analyses (including biobank linkage to EHRs) creates ethical and legal risk and can undermine participant trust.

Example usage

"The protocol amendment required renewed informed consent before linking genotypes to pharmacy claims."

References

  • Grady C. (2015). Enduring and emerging challenges of informed consent. N Engl J Med.

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