Glossary | Human Research Protections

Baseline:

The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. At this reference point, measurable values such as physical exam, laboratory tests, and outcome assessments are recorded.

Belmont Report:

A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978. Read the Belmont Report here

Beneficence:

An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
Benefit: A benefit is a valued or desired outcome; an advantage.

Benign essential blepharospasm (for testing purposes):

A rare disorder in which the muscles of the eyelids (orbiculares oculi) do not function properly, and that includes intermittent and involuntary contractions or spasms of the muscles around the eyes. Although the eyes themselves are unaffected, the patient may eventually become functionally blind because of an inability to open the eyelids. Benign essential blepharospasm is a form of dystonia, which is a group of neuromuscular disorders characterized by muscle spasms. More about dystonia.

Bias:

When objectivity is impaired by personal gain or personal judgment. In clinical studies, bias is minimized by blinding and randomization.

Biologic:

Any therapeutic serum, toxin, anti-toxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

Biological Product:

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), used for the prevention, treatment, or cure of a disease or condition of human beings. Biological products include bacterial vaccines, allergenic extracts, gene therapy products, growth factors, cytokines, monoclonal antibodies, and recombinant DNA. Biological products may be considered drugs.

Blinded Study Designs:

Study designs comparing two or more interventions in which the investigators, subjects, or some combination thereof do not know group assignments.

Broad Consent:

Broad consent involves asking participants for permission to store identifiable data and/or biospecimens for future research on a specific disease or condition, but where the nature of the future research is not yet known.