Other terms
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
- Investigational New Drug Application
- Investigational New Drug Application (IND)
- IRT (Interactive Response technology)
- itRECIST
- JAK inhibitor
- Keloids
- Keratoconus
- Lactose Intolerance
- Liver cirrhosis
- Lysosomal Storage Disorders
- Macula
Informed Consent Form
The informed consent form is a document that provides the details of the study.
The form should be approved by an IRB/IEC and includes:
- That the trial involved research
- Purpose and duration of participation
- Approximate number of subjects involved in the trial
- Trial procedures and treatments
- Potential risks and discomforts
- Feasible alternative procedures or treatments
- Possible benefits to the subject
- Measures to preserve the confidentiality of records
- Information regarding compensation for injuries
- Point of contact to answer questions the subject or family may have and to report any injuries
- Volunteer’s rights regarding withdrawal from the clinical trial, without losing treatment benefits
- Subject’s diagnosis, probability of success if known, and prognosis
Source: FDA Protection of Human Subjects, 21 C.F.R. § 50.25 (2021).