An environment in which students learn. Educational settings include preschool, elementary, secondary, and higher educational facilities and programs; and alternative settings where educational services or activities are provided such as home instruction, electronic or web-based courses and schools, and after-school programs when these involve tutoring or homework help.
Indication that the clinical trial intervention produces a desired therapeutic effect on the disease or condition under investigation.
List of criteria guiding enrollment of participants into a study. The criteria describe both inclusionary and exclusionary factors, (e.g. inclusion criterion - participants must be between 55 and 85 years old; exclusion criterion – must not take drug X three month prior to the study).
The FDA defines “emergency use” as the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21CFR 56.102 (d)].
An institution is considered engaged in a particular human subjects research project when its employees or agents for the purposes of a non-exempt research project obtain:
An institution is also considered engaged when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor.
An individual is considered engaged in human research when he/she for the purposes of the non-exempt research project, obtains:
The fair or just selection of study subjects (principle of justice) to assure that the benefits and burdens of research are equally distributed.
Exempt research is Human Subjects Research that meets one of the minimal risk categories in the federal regulations. Research studies determined Exempt from the regulations are considered research with human subjects. An Exemption determination means that not all of the regulations in 45 CFR 46 must be applied to the individual study and the WCM IRB office may instead choose to apply or not apply some standards. Studies reviewed at this level may be required to undergo a limited IRB review. Limited IRB review considers data protection and, where appropriate, broad consent.
A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs, devices, or test articles to patients with serious diseases or conditions who cannot participate in a clinical trial.
A study involving research with human subjects that is both minimal risk and fits into one of the “Expedited Review Categories” is eligible for expedited review. Every Expedited level study is subject to the regulations outlined in 45 CFR 46.110. Studies reviewed at the Expedited level must have all informed consent requirements at 45 CFR 46.116 (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111.
A drug that has an Investigational New Drug (IND) application filed with the FDA, but has yet to be licensed.
When a continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the informed consent document. No activities can occur on the expiration date or after.
