Confidentiality (also Certificates of Confidentiality) 

Consent Form Template: Confidentiality section                         

  • General Guidance

    Describe how identifiable data will be stored, who will have access, how long it will be kept, and measures to be taken to ensure confidentiality of electronically stored/transmitted data (e.g. "All records will be stored in locked files and will be kept confidential to the extent permitted by law"). Update per revised Common Rule: A statement about whether subject's private information or biospecimens could be used for future research studies or distributed to another investigator for future research studies, with or without identifiers.

    Also include our standard language regarding confidentiality:

    Records will be available to research staff, and to Federal, State and Institutional regulatory personnel (who may review records as part of routine audits).

    Describe measures to be taken to ensure confidentiality of electronically stored/transmitted data.

  • The following are required when appropriate to the study:

    Update per revised Common Rule:
    When appropriate to the study, include a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.

    For individuals recruited and seen at NYSPI, include the following electronic medical record disclosure: "Your name and other personal identifying information will be stored in an electronically secure database at New York Psychiatric Institute."

    If it is a drug company sponsored study, indicate that drug company personnel may also review the research records.

  • Clinical Trials

    If your study needs to register in ClinicalTrials.gov, the following language is required:

    A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you.  At most, the Web site will include a summary of the results. You can search this Web site at any time.

    Update per revised Common Rule:
    [Note: Posting of clinical trial consent form: For each clinical trial conducted or supported by a federal agency that has signed the revised Common Rule, one IRB approved consent form used to enroll subjects must be posted on a publicly available federal website that is established as a repository for such consent forms. This is the responsibility of the research or the federal agency. These repositories are to be announced.]

  • Certificate of Confidentiality

    For any other applicable limitations to confidentiality, or if your study involves genetics, of if you have a Certificate of Confidentiality, please see below.

    If the study is covered by a Certificate of Confidentiality, describe the protections and limitations afforded by the certificate. Although required language may vary, depending on which agency will be granting the Certificate, the essential point is that it protects the researchers from having to release any research data - including the names of participants, even under court order or subpoena. The following template language is suggested by NIH as of May 2019:

    This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that the researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.

    There are some important things that you need to know. The Certificate DOES NOT stop the reporting [requirements] that federal, state, or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT pervent your information from being used for other research if allowe4d by federal regulations.

    Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.
  • MRI

    The PSF confidentiality section should describe where scans, associated clinical and identifying data, and clinical readings will be stored and how confidentiality will be maintained. If results are to be maintained on a widely available database (e.g. Webcis) this information should be noted and described in the consent form.

    Your MRI will be interpreted and the results will be shared with you or a physician who you may designate.  Your MRI report will be maintained as part of the clinical database at the New York State Psychiatric Institute or the Columbia University Medical Center along with your name and will be accessible to clinicians at the Medical Center.  Your psychiatric diagnosis will not be a part of the report.  [delete last sentence for controls]

    Depending on the location of scanning and interpretation, one of the following statements should be included:

    A. The results of your MRI scan will be maintained in an electronically secure database at NYSPI or CUMC and accessible only to the members of the research team. or,

    B. The results of your MRI scan will be maintained on the clinical information system at Columbia University Medical Center and will be accessible to hospital clinicians.

  • For research involving biospecimens

    Update per revised Common Rule: Include a statement that the subject's biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit. Address whether the research will (or might) include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

  • Genetic Information Nondiscrimination Act (GINA)

    Genetic studies require a Certificate of Confidentiality

    Consent forms for genetic studies must describe new protections under the Genetic Information Nondiscrimination Act (GINA). Please review the Genetics CF template available on the IRB website. Consent forms for existing studies may be revised at the time that they are submitted for continuing review or modification.

    In addition to the confidentiality protections described in this consent form, a federal law called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information.  GINA does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance or by adoption agencies. GINA also does not protect you against discrimination based on an already diagnosed genetic condition or disease. If you would like to know more about it you can discuss this with the principal investigator of this study or you can go to the following website www.genome.gov/10002328

  • Suspected abuse or threatened violence

    Suspected or known neglect or sexual or physical abuse of a child, or threatened violence to self or others will be reported to the appropriate authorities.

  • Focus Groups

    Because you will take part in a group interview, the other people in the group interview will also hear your responses.  We ask that everyone respect the confidentiality of the other participants....