Glossary

Glossary
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  • Helsinki Declaration
    See: Declaration of Helsinki.

    Historical Controls
    Control participants (followed at some time in the past or for whom data are available through records) who are used for comparison with participants being treated concurrently. The study is considered historically controlled when the present condition of participants is compared with their own condition on a prior regimen or treatment.

    Human In Vitro Fertilization
    Any fertilization involving human sperm and ova that occurs outside the human body.

    Human Subjects
    Participants whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information [Federal Policy §___.102(f)].

    The Institute of Medicine, the National Bioethics Advisory Committee, and many others prefer participants for a generic term. They suggest using subjects, volunteers, and other such terms if necessary to refer to specific subsets of participants in a study.