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From a certain point onward there is no longer any turning back. That is the point that must be reached.
—Franz Kafka
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LEARNING OUTCOMES
The information provided in this chapter will assist the reader to:
Understand the Institutional Review Board (IRB) process.
Acknowledge the many facets of healthcare ethics and professional behavior.
Identify if inquiry should include a pilot study or survey.
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IMPORTANT PREPARATIONS
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You are now almost ready to engage in the inquiry and evidence-based practice process. Just two more items need to be dealt with before you begin. First, you must gain permission from the relevant human participants committee(s). Second, you must double-check to make sure that you have everything needed to complete the inquiry process. For example, make sure that all components (i.e., required equipment, access to meeting rooms, or permission to utilize an evaluation tool) are granted before you begin your project. Before going further, it is important to note that the level or type of evidence-based practice process you are engaging in will determine whether or not you need to complete the human participants or Institutional Review Board (IRB) process. This chapter will also inform the researcher about the process, benefits, and limitations of conducting a pilot study. From this point on, the chapter will refer to research, but the same policies and procedures may need to be followed for an evidence-based practice inquiry.
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HUMAN PARTICIPANTS COMMITTEE PROCEDURES
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Before you implement your research study, you must submit a proposal describing your study to the human participants committee, the group responsible for safeguarding the rights of the individuals or groups you will be studying. (These committees may be known by other names, such as Institutional Review Board or research protocol review committee.) If you are a student, you will address the committee within your university; if you are a healthcare practitioner, you will approach the committee within or connected to your facility. Students planning to conduct research with patients frequently need consent from the human participants committees of both the university and the treating facility.
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The purpose of the human participants committee is to ensure that individuals who are participating in a research study are protected and that ethical research standards are employed. This concern for the welfare of human participants in medical research studies was organized into a worldwide system in 1964, at the 18th World Medical Assembly in Helsinki, Finland. At that meeting, the Declaration of Helsinki was adopted by the assembly and has since provided the guiding principles for human subject research.
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Before conducting research, you must present a proposal to the appropriate human participants committee(s) outlining the purpose, hypotheses, background, definitions of terms, and methodology of the study. The proposal should also ...