Developing a conceptual framework to assess surrogate decision maker (SDM) insight into critical illness gene variation research (CIGVR)

Background Critical illness gene variation research (CIGVR) is challenging. Diseases studied are acute and treatment rendered highly technological; patients are incapacitated with surrogate decision makers (SDMs) providing judgment. The timeframe for research enrollment is brief. Ethical conduct of CIGVR requires that SDMs understand the implications of such studies. We present a framework that may be useful to guide research enrollment that focus on 3 domains: (1) SDM knowledge/attitudes regarding genomics; (2) SDM knowledge/attitudes regarding clinical investigation; (3) complexity of SDM role (e.g., difficulty in making decisions, emotional stress, severity of patient's illness, etc.). We present findings related to the first domain and its relationship to SDM receptivity to research enrollment.

Methods We invited SDMs for ICU patients at 2 tertiary care hospitals to participate in focus groups/interviews exploring attitudes about genomics. Session transcripts were coded and analyzed (Atlas.ti software) to identify common themes and inter-theme relationships.

Results We screened 524 adult ICU admissions to identify 224 eligible patients (43%); 53 SDMs (22%) participated. Genomic knowledge varied with TV their primary source of information. . Participants responded that genomics could be used for forensic purposes, to establish paternity, or to enable cloning; many were unaware that genomics accounted for familial diseases. SDMs voiced concern regarding potential for employment/insurance discrimination, and were reluctant to permit CIGVR if use of the genetic sample was not well described.

Conclusions Genomic knowledge was limited and shaped by mass media. Pertinent to consent processes, SDMs were interested in knowing intended sample usage and safeguards against discrimination.