Appl Clin Inform 2010; 01(03): 244-255
DOI: 10.4338/ACI-2010-02-CR-0014
Case Report
Schattauer GmbH

Confronting and Resolving an Ethical Dilemma Associated with a Practice Based Evaluation Using Observational Methodology of Health Information Technology

P.S. Sockolow
1  College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania
,
H.A. Taylor
2  Department of Health Policy and Management
3  Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland
› Author Affiliations
Further Information

Publication History

received: 28 February 2010

accepted: 02 July 2010

Publication Date:
16 December 2017 (online)

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.