Individuals who are placed at special risk by virtue of their socioeconomic and/or educational background. As research participants, these individuals may be vulnerable to coercion or undue influence.
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 months prior to the study).
Pertaining to that which relieves of a responsibility, obligation, or hardship; clearing from accusation or blame.
Review of proposed research by the IRB Chairperson or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
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…