Glossary

ethical principles and guidelines for the protection of human subjects of research.

something that promotes or protects well-being, an advantage. Compensation cannot be considered a benefit.

Just as there are a range of harms: physical, social, economic, psychological, and legal, there can also be a range of benefits: physical benefit is clinically beneficial - as with standard-of-care procedures known to be helpful in guiding the subject's care when plans include using them as such (experimental procedures or procedures that must be verified by an approved device might not result in this benefit), notwithstanding that the subjects could have received the benefit without being in the study (this information comes to light in the alternatives description); psychological benefit of educational, informational, counseling or other resources provided in the study or empowerment. These can be directed at the individual (direct benefit, secondary benefit, monitoring benefit), the community or a general knowledge gained benefit (philanthropic on behalf of the individual). Only certain anticipated benefits may be considered appropriate for consideration to weigh against the probability of harm in certain populations and circumstances.

interventions which are: brief in duration; harmless, painless, not physically invasive; not likely to have a significant adverse lasting impact on the subjects; no reason to believe the subject will find the intervention offensive or embarrassing; or may include incomplete disclosure.

The risk of making clinical billing errors.

Depending on the nature of the study, the clinical services can be billed to either the participant’s healthcare insurance or must be paid by the research.  It is important to determine the appropriate payor for each study procedure before the study begins to avoid making clinical billing errors (i.e., “billing risk”).

a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

removal of a piece of tissue from a live animal.

the abdominal, thoracic, cranial, synovial, or bone marrow cavities, i.e. those chambers not immediately associated with the outside world.

payments tied to the rate or timing of recruitment or performance or other aspects of a clinical study. Does not include compensation for recruitment services as long as the compensation is unrelated to whether the participant ultimately enrolls in or completes the research study.

a protocol in which animals are only bred for use in other protocols.