Harms

What is a harm?

Any harm (including death) experienced by a participant or other individual that, in the opinion of the investigator, is unexpected and at least probably related to the research procedures.

  1. A harm is "unexpected" when its specificity or severity is inconsistent with risk information previously reviewed and approved by the IRB in terms of nature, severity, frequency, and characteristics of the study population.
  2. A harm is "probably related" to the research procedures if, in the opinion of the investigator, the research procedures more likely than not caused the harm.

Examples of Harms include, but are not limited to, the following:

  • An investigator finds out that the study involves a currently approved drug that may cause renal failure according to newly published literature. An interim analysis or safety monitoring report that indicates that frequency or magnitude of harms or benefits may be different than those initially presented to the IRB.
  • Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol
  • An investigator realizes participants have accidentally been given study drug at a higher dose than was approved by the IRB. While no side effects were reported, the increase in dosage placed the subjects at potential risk of harm.
  • A subject at a non-NU site has experienced a severe and unexpected reaction to the study drug. The sponsor thinks this may be related to the study drug. As such, PIs are informed to promptly lower the drug dosage prior to obtaining IRB approval in order to eliminate an immediate hazard to subjects.
  • Four weeks into the study of a new asthma drug, the subject informs the research staff that she is pregnant although the pregnancy test done at screening was negative. Pregnancy is an exclusion factor in the study.