Pediatric Informatics: Computer Applications in Child Health (Health ...

440 H.P. Lehmann et al.
Information technology and informatics provide new opportunities to extend
research boundaries by creating:
Improved methods for data collection and validation
“High-throughput” computing for processing large amounts of data quickly for
complex research models
Expanded technologies for quickly exploring very large data sets for prediction,
visualization, and hypothesis generation
New models for participation that include children and families as partners (as
well as subjects)
With these new opportunities and power of data also come new responsibilities to
assure the safety and rights of subjects and their families:
To assure the protections and rights of human subjects
To prevent the unauthorized or unintended use of personal health information
To assure the integrity of the research process, its intent, design, validity, execution,
and the representation of its findings
34.2 The Research Process and Informatics
The formalization of research has evolved to assure validity of the results of clinical
studies and trials and to protect the safety and rights of human subjects. 1 Even if
studies do not involve human subjects directly, they may involve protected health
information (PHI) of individuals which require special procedures to assure patient/
subject privacy. Formalization of research projects requires a clear statement of the
plan of research (its goals, objectives, and steps), an informed review of its scientific
validity and ethical base (systematic literature review, preliminary data, conflict
disclosures, expected risks and benefits), determination of a budget, resources, and
schedule and agreement on deliverables (a report, a product or process change)
between the researcher and the research funder. A framework for research formalization
in the context of informatics support is presented in Table 34.1.
34.2.1 Generating a Research Question or Hypothesis
Research begins with questions and observations not previously noted. Pasteur
noted that “Chance favors only the prepared mind.” With the incorporation of large
data sets and data mining 2 techniques, “chance” becomes a probability of detecting
previously unrecognized patterns or recurrences that can suggest hypotheses
for further testing. In drug research, such an approach has been used to economize
costs by suggesting likely avenues for research. In clinical medicine, physicians
have shown interest in using these techniques 3 for critiquing care and forecasting
needs.