Serious Adverse Event (AE) or Serious Problem – Defined as an adverse event that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect.
1) A serious problem in research is one that results in:
(a) Substantive harm or damage (or risk of substantive harm or damage) to the rights, or welfare of research subjects, research staff, or others; or
(b) Substantive harm or damage (or risk of substantive harm or damage) to the safety or welfare of laboratory animals.
2) An adverse event or problem in research is also considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent preceding subparagraphs.
SOP: Standard Operating Procedures – Detailed, written procedures for the uniform performance of a function. These must be consistent with the “Common Rule” and federal regulations and policies pertaining to research compliance and protection of human subjects. (Federal regulations tell “what” to do, but not “how” to do it. individual institutions SOP outline the “how” to do research at that institution.)
Suspended Protocols: Suspension of IRB approval. An action taken by the IRB to temporarily or permanently withdraw approval for some or all research activities short of permanently withdrawing approval for all research activities.