8.0 Confidentiality of Records

Every effort will be made to strictly safeguard the confidentiality of all participants. Despite this, privacy cannot be guaranteed. Data collected from each participant will be identified only by the participant's initials on the source document and by a randomly generated numeric code on all secondary documents and databases. Informed consent for pre-screening measures will be kept in a locked file cabinet in the Medical Oncology department in the Lahey Clinic, and copies of the pre-screening informed consent will be maintained in a locked file drawer in a locked office of the Biological Psychiatry Laboratory at McLean Hospital. All measures, records, and videotapes will be kept in a locked file drawer in a locked office of the Biological Psychiatry Laboratory. Access to measures will be limited to regulatory agencies and researchers assessing the participant for changes in symptoms and individuals analyzing data. Researchers with access to data will not be provided with any information that would identify participants by name or by other means, such as social security number. If necessary, identifying information may be erased or otherwise removed from videotaped material. Storage and access to all records will remain fully adherent with HIPAA regulations. Participants will sign forms for the release of information to any of the individuals who will need to obtain this information. Interested parties might include the prescribing physician or psychiatrist.

Removing identifying information from data and restricting access to researchers directly involved in assessing the participants should prevent the dissemination of confidential data, with or without identifying information. Maintaining data in a secure environment will prevent the accidental or deliberate examination or removal of data. While it is possible that individuals may be identified on videotape through means other than their names, restricting access to videotaped material greatly reduces the opportunity for identification.