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INTRODUCTION

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We will complete our conceptual framework of clinical research by discussing ethical issues related to the conduct of human studies. We ask people to participate as subjects in studies for the purpose of gaining new knowledge that may or may not have an impact on their lives. Clinical research is conducted because we have questions and do not have the answers; therefore, participation in research may come with some risk to the health and well-being of the subjects. In this society, we recognize a responsibility to research subjects for assuring their rights as individuals. Since the middle of the 20th century, the rules of conducting research have been and continue to be discussed, legislated and codified.

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The purpose of this chapter is to present the principles and practices that have become standards in the planning and implementation of research involving human subjects. These principles elucidate the ethical obligation of researchers to engage in meaningful research and to acknowledge the participation of not only the subjects under study but also professional colleagues who contribute substantially to a research project. We will cite the major documents that define public policy.

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INTEGRITY OF THE RESEARCHER

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Researchers have a responsibility for honesty and integrity in all phases of the research process, beginning with choice of a research question. Researchers who are health professionals must set priorities and pursue questions that are relevant to important health care issues. Today, for example, we see an emphasis on research to examine the outcomes of emerging health care strategies. Changes in the population profile, public health problems and scientific or technological advances have stimulated research in specific areas, such as geriatrics, acquired immune deficiency syndrome (AIDS) and stem cell research. External forces such as the priorities of private and governmental funding agencies affect the research direction of most clinical scientists. These complex factors influence the selection of ongoing research efforts.

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Researchers also have an ethical responsibility to do clinical research that is meaningful. We should be able to justify a project based on the potential scientific value of its results. This implies an obligation to base our research on rational theoretical principles and to carry it out according to a sound research design with an appropriate sample. It also suggests that research should be conducted by competent investigators who have the expertise to do reliable and valid work. It is not ethical to involve patients in a study, with potential risks to them, when the study has little chance of making a scientific contribution.

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During data collection researchers must be careful to minimize the effect of personal bias in measurement. Rosenthal1 has described several types of experimenter bias that can have significant effects on experimental outcomes. These include unconscious or purposeful inaccuracies in measurement that will tend to support the research hypothesis and influential interactions between researcher and subject that alter the subject's ...

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