Conducting the Study - Protecting Subjects and Others From Harm

In some cases, disclosure of confidential information without consent may be unavoidable. This may occur when an investigator has unexpectedly become aware of information that he/she must report to protect the subject or a close contact from harm, or because it is mandated by law. Examples of information that must be disclosed by law include child abuse or neglect, elder abuse, and certain communicable diseases. Links to state of Connecticut mandatory reporting requirements on several of these issues can be found in the Applicable Regulations and/or Guidance From Professional Associations section of this module.

In other cases, disclosure may be required to provide the subject with needed professional services, obtain appropriate professional consultations, or protect the subject or a third party from harm. In these cases disclosure should be limited to only what is necessary to achieve these aims or the purposes of the consultation. It is important for investigators to try and “over anticipate” potential disclosures during the study design phase so they can be discussed with potential subjects during the informed-consent process.