Human Research Protections
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Observational Study:

A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).

Off-Label Use:

A drug used for conditions other than those approved by the FDA.

Office for Human Research Protections (OHRP):

A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.

Open-Label (Open-Label Trial):

Describes a clinical trial in which masking is not used. This means that all parties involved with the trial know which participants have been assigned which interventions.

Orphan Drugs:

An FDA category of medication used to treat rare diseases and conditions.

Weill Cornell Medicine Human Research Protections 575 Lexington Avenue New York, NY 10022 Phone: (646) 962-8200