By current federal and University policies, subjects in research give their informed consent to participate. In the informed consent procedure, subjects are often given assurances of protection against loss of confidentiality or for total anonymity. Despite the assurances and subsequent efforts, subjects may yet be identifiable. Two legal conditions are at stake:
- Loss of confidentiality can occur when a court requires that research files be submitted as evidence in a legal matter. The court decides who has access to the files and whose identity will be revealed.
- Loss of confidentiality can occur under the Freedom of Information Act. Under this Act, citizens can gain access to files of federal agencies, except as provided by law.
The University is obligated to protect subjects' identities when the promise of protection is made in obtaining their consent to participate. This obligation can be fulfilled in the following ways:
- If the research files are arranged so that the investigators cannot know the identity of participants, then loss of confidentiality cannot occur by court order. This can be accomplished by routinely destroying master code lists. Confidentiality may not be preserved by locating the master code lists outside the jurisdiction of the court, i.e., in another country. Anonymity may be assured when there are no identifiers whatsoever on project materials which could link the data with individual subjects.
Investigators can be held in contempt of court for failing to submit the research files or for destroying the master code lists only because of knowledge of the intent of the court. Investigators will not be held in contempt of court for not revealing the identity of the subjects when they routinely take steps to keep the identity of subjects unknown to themselves (i.e., subject responses are anonymous).
- If identifying information is not sent to a federal agency, then loss of confidentiality cannot occur under the Freedom of Information Act. Federal files are subject to the Act. University files are not subject to the Act. Participants should be informed if identifying information will be sent to a federal agency.
