Proposing and Communicating the Results of Evaluation Studies: Ethical, Legal, and Regulatory Issues - Evaluation Methods in Biomedical Informatics - page 338

1 Proposing and Communicating the
Results of Evaluation Studies:
Ethical, Legal, and Regulatory
Issues
This final chapter addresses a set of critical issues for evaluation. These
are the often “hidden” but important considerations that can determine
if a study receives the financial support that make its conduct possible,
if a study in progress encounters procedural difficulties, or if a completed
study leads to settled decisions that might involve the improvement
or adoption of an information resource. Whether a study is funded
depends on how well the study plan is represented in a proposal; whether
a study encounters procedural difficulties depends on the investigator's
adherence to general ethical standards as well as more specific stipula-
tions built into an evaluation contract; whether a study leads to settled
decisions depends on how well the study findings are represented in various
reports.
We will see in this chapter that studies can succeed or fail to make an
impact for reasons other than the technical soundness of the evaluation
design—the considerations that have occupied so much of this volume.
Conducting an evaluation study is a complex and time-consuming effort,
requiring negotiation skills and the ability to compromise between con-
flicting interests. The investigator conducting an evaluation must be a com-
municator, manager, and politician, in addition to a technician.
This chapter provides a glimpse into this nontechnical set of issues.
We focus on proposals that express study plans, the process of refereeing
other people's proposals and reports, how to communicate the study
results in reports and other formats, and a set of ethical and legal consid-
erations pertinent to evaluation. We are aware that the treatment of
each of these issues here includes just the rudiments of what a fully accom-
plished investigator must know and be able to do. We encourage the
reader to access additional resources to amplify what is presented here,
including the references and additional readings listed at the end of the
chapter.
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