In fields such as epidemiology, social sciences, psychology and statistics, an observational study draws inferences from a sample to a population where the independent variable is not under the control of the researcher because of ethical concerns or logistical constraints. One common observational study is about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator. This is in contrast with experiments, such as randomized controlled trials, where each subject is randomly assigned to a treated group or a control group. Observational studies, for lacking an assignment mechanism, naturally present difficulties for inferential analysis.
The independent variable may be beyond the control of the investigator for a variety of reasons:
A randomized experiment would violate ethical standards. Suppose one wanted to investigate the abortion – breast cancer hypothesis, which postulates a causal link between induced abortion and the incidence of breast cancer. In a hypothetical controlled experiment, one would start with a large subject pool of pregnant women and divide them randomly into a treatment group (receiving induced abortions) and a control group (not receiving abortions), and then conduct regular cancer screenings for women from both groups. Needless to say, such an experiment would run counter to common ethical principles. (It would also suffer from various confounds and sources of bias, e.g. it would be impossible to conduct it as a blind experiment.) The published studies investigating the abortion–breast cancer hypothesis generally start with a group of women who already have received abortions. Membership in this "treated" group is not controlled by the investigator: the group is formed after the "treatment" has been assigned.
The investigator may simply lack the requisite influence. Suppose a scientist wants to study the public health effects of a community-wide ban on smoking in public indoor areas.
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