If the investigator obtains information from the study participant about a third party that is both private and individually identifiable, then the third party is considered a human subject.

IRB approval is required in order to collect data from, or use data about those subjects. In some cases, consent from third parties will be necessary. However, under certain circumstances, the IRB is permitted to grant a waiver of consent.

In order to grant a waiver of the requirement for consent, the IRB must find that all of the following are true:

  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver or alteration; and
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Contextual information, such as familial or social relationships identified only by that association, age, body build, ethnic or cultural background, marital status, social networks, or occupation, would not be considered private information and would not make a third party a human subject.