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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]
In research of human subjects, a survey is a list of questions aimed for extracting specific data from a particular group of people. Surveys may be conducted by phone, mail, via the internet, and also in person in public spaces. Surveys are used to gather or gain knowledge in fields such as social research and demography.
In social science research, snowball sampling is a similar technique, where existing study subjects are used to recruit more subjects into the sample. Some variants of snowball sampling, such as respondent driven sampling, allow calculation of selection probabilities and are probability sampling methods under certain conditions.
A probability-based survey sample is created by constructing a list of the target population, called the sampling frame, a randomized process for selecting units from the sample frame, called a selection procedure, and a method of contacting selected units to enable them to complete the survey, called a data collection method or mode. [10]
Studies with poor allocation concealment (or none at all) are prone to selection bias. [1] Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization. [2]
A research design that involves multiple measures of the same variable taken on the same or matched subjects either under different conditions or over two or more time periods. [1] Paired t-test, Wilcoxon signed-rank test