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

34 Pediatric Research and Informatics 443
is the unit of analysis?” or what is the entity from which data is being collected.
In traditional clinical research, it is the patient (or human subject) who is the unit
of analysis. In quality improvement research, it may be a clinical practice or care
unit (such as a hospital). In public health research it may be a subpopulation of a
community. In the evaluation of clinical information technology, it is the provider
(the clinical user of IT) who is the unit of analysis (and sometimes the clinic or
workplace). 22 Formalization of a study involves:
Identification of a principal investigator and research team
Definition of the purpose and methodology of the study
Development of the protocol that defines subject eligibility, recruitment, enrollment,
allocation, and reimbursements. Protocols also define all data, forms, and
analyses that are to be collected or completed, all budgets related to the protocol
and nonstandard procedures (for halting a study early, for example).
34.2.4 Obtaining Institutional Review Board Approval
The assurance of sound study design and adherence to shared principles of research
ethics is the purpose of institutional review board (IRB) of a study project. The
protocol submission and review process is typically complex, with multiple
sources of information, participants, and steps to assure that the design and implementation
of pediatric research protocols protects the population being studied. The
complexity of the process has led to a number of Web-based protocol management
tools to assure these steps. 23
34.2.5 Executing the Protocol
Once IRB approval has been obtained, the processes of subject recruitment and
enrollment, data collection and recording, and study management and budget tracking
may be executed. Although many generic business IT and business applications
that incorporate database and spreadsheet applications exist, the most important
component in successful protocol execution is a competent research project
manager.
34.2.5.1 Subject Recruitment and Enrollment
Subject recruitment, enrollment, registration, and group assignment depends on
the number of eligible subjects. Recruitment activities may be explicitly specified,
especially for children, to assure the ethical principles of autonomy, beneficence,
justice, respect, non-malfeasance, and honesty. In the case of low prevalence of