Confronting and resolving an ethical dilemma associated with a practice based evaluation using observational methodology of health information technology.

SUMMARY: As the adoption of health information technology (HIT) has escalated, efforts to evaluate its uptake have increased. The evaluation of HIT often requires direct observation of health care practitioners interacting with the system. When in the field, the evaluator who is not a trained health care provider may observe suboptimal use of the technology. If evaluators have plans to share the results of the evaluation at the conclusion of the study, they face a decision point about whether to disclose interim results and the implications of doing so. To provide HIT evaluators with guidance about what issues to weigh when observing the implementation of HIT, this paper presents a study of an actual case and discusses the following considerations: (1) whether the evaluation of HIT is considered to be human subject research; (2) if the evaluation is human subject research, whether the Institutional Review Board will consider it exempt from review or subjected to expedited or full review; and (3) how interim disclosure to the clinic management impacts the research study. The recommendations to evaluators include use of a protocol for interim disclosures to patients, clinicians, and/or clinical management for both quality assurance initiatives and human subjects research.