A newborn.
An application submitted by the manufacturer of a drug to the FDA, after the clinical trial has been completed, for a license to market the drug for a specified indication.
A federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers. It is responsible for carrying out and supporting biomedical and behavioral research.
Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).
Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with the research plan as approved by a designated IRB, or federal regulations or institutional policies governing such research. Noncompliance may range from minor to serious, be unintentional or willful, and may occur once or several times.
Noncompliance includes deviations to the protocol made in the interest of a single participant such as to coordinate study visits. Noncompliance may result from the action of a participant, investigator or staff and may or may not impact the rights and welfare of research participants or others, or the integrity of the study. Complaints or reports of noncompliance from someone other than the research investigator are handled as allegations of noncompliance until such time that the allegation is validated or found to be invalid and dismissed.
Related terms:
A non-inferiority trial compares a test treatment to a control treatment of established effectiveness and seeks to show that the test treatment is not materially worse than or inferior to the control treatment. A non-inferiority trial seeks to show that any difference between the two treatments is small enough to allow a conclusion that the test treatment has at least some effect or, in many cases, an effect that is not significantly less than the active control. A non-inferiority trial may proceed under 21 CFR 50.24 if it meets the requirements of the regulation.
For a non-inferiority trial to be informative, there would need to be clear data about the effectiveness of the control treatment (to make the non-inferiority study interpretable) and about known safety or other problems associated with the control treatment. Non-inferiority trials are generally used in situations where a placebo-controlled trial would be unethical and where there are no data to suggest the new treatment would be more effective than the standard treatment.
An investigational medical device that does not present significant risk to the research subject (e.g., tongue depressor, or swab).
Research that has no likelihood or intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.
An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific determination as to viability must be made by a physician in each instance. (See also: Viable Infant.)
Not Human Subjects Research (NHSR) means that the research activity is not regulated by the IRB in any way because the activity is not considered human subjects research. A study would not be considered human subjects research if the answer to the questions “is it research as defined by the federal regulations?” or “is it human subjects research as defined by the federal regulations?” is no. Answering “no” to either of those questions means the IRB does not have jurisdiction to review the project and no IRB approval is necessary. Note, this determination is different from a study reviewed and determined to be Exempt.
A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
