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The Belmont Report summarizes ethical principles and guidelines for human subject research. Three core principles are identified: respect for persons, Beneficence, and Justice. The three primary areas of application were stated as informed consent, assessment of risks and benefits, and selection of human subjects in research.
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. [1]
Random assignment or random placement is an experimental technique for assigning human participants or animal subjects to different groups in an experiment (e.g., a treatment group versus a control group) using randomization, such as by a chance procedure (e.g., flipping a coin) or a random number generator. [1]
Randomization is a statistical process in which a random mechanism is employed to select a sample from a population or assign subjects to different groups. [1] [2] [3] The process is crucial in ensuring the random allocation of experimental units or treatment protocols, thereby minimizing selection bias and enhancing the statistical validity. [4]
The most commonly recognized source for drawing attention to the importance of justice is the Belmont Report, [1] which used the term "justice" to describe a set of guidelines for the selection of research subjects. [2] This is a critical safeguard to making clinical research ethical. [3]
Attrition bias is a kind of selection bias caused by attrition (loss of participants), [13] discounting trial subjects/tests that did not run to completion. It is closely related to the survivorship bias , where only the subjects that "survived" a process are included in the analysis or the failure bias , where only the subjects that "failed" a ...
During the selection step of the research study, if an unequal number of test subjects have similar subject-related variables there is a threat to the internal validity. For example, a researcher created two test groups, the experimental and the control groups.
Without the use of allocation concealment, researchers may (consciously or unconsciously) place subjects expected to have good outcomes in the treatment group, and those expected to have poor outcomes in the control group. This introduces considerable bias in favor of treatment.