Benefit.

A positive or valued outcome of an action or event. Benefits resulting from research participation may be physical, psychological, or social.

Blinded.

A design feature of clinical trials in which information about whether research participants are in the experimental or control arm is withheld from participants only (single-blinded trials) or both participants and researchers (double-blinded trials).


Certificate of Confidentiality.

Certificates issued by the National Institutes of Health to research institutions to protect the privacy of research participants involved in sensitive research by protecting investigators and institutions from being compelled to release identifying information in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding.

Clinical research.

Commonly viewed as research that uses human participants to test the safety or effectiveness of medical interventions, especially drugs, or to study the diagnosis or pathophysiology of diseases, disorders, or injuries. More broadly conceived, it “includes all studies intended to produce knowledge valuable to the prevention, diagnosis, prognosis, treatment, or cure of human disease” which involve direct interactions with child participants in research (IOM, 1994a, p. 35). Disease, in this context, can be interpreted to include disorders and injuries.

Commensurate.

Reasonably similar to (procedures that prospective research participants ordinarily experience).

Common Rule.

The general term for Subpart A of federal regulations protecting human subjects in research as it applies to the U.S. Department of Health and Human Services (45 CFR 46) and 16 other federal agencies.

Compensation.

A payment for the time and inconvenience involved in research participation.

Condition.

A specific (or set of specific) physical, psychological, neurodevelopmental, or social characteristic(s) that an established body of scientific evidence or clinical knowledge has shown to negatively affect children’s health and well-being or their risk of developing a health problem in the future.

Conflict of interest.

Any financial or other personal interest in the outcome of a research study that may, in actuality or appearance, compromise the objectivity of a researcher and the integrity of the research being conducted.

Consent.

An autonomous decision made by an individual with the legal and cognitive capacity to choose voluntarily participate in research.



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