What must be done before I may contact people who agreed to be contacted for participation in a future study?

  • There are two oversight bodies whose regulations might affect this answer:
    1. HIPAA:if health information involved (privacy/confidentiality) and
    2. DHHS/IRB regulation (recruitment part of IC process)

HIPAA: doesn’t require researchers to have prior subject approval to make contact about future studies. If the researcher wants to keep a list of potential subjects for future studies that is not associated with an active approved protocol, they will need to obtain IRB approval for the list of names (“a database protocol”) before creating the list of names.

DHHS/IRB regulation: researcher must also obtain IRB approval for telephone script or text of letter PRIOR to contacting the potential subjects

    • Note: since the researcher already had permission from the subjects, this is not considered “cold contacting,” so the researcher does not need permission from each potential subject’s primary physician before making first contact about the new study