Investigators are responsible to discuss the research with subjects, and to document the subjects’ consent to participate. The consent process must be adapted to the decision-making needs of the subject. Different studies--depending on degree of therapeutic benefit and risk--require different emphasis during the consent discussion. The consent form is an important part of this process and is intended to guide the investigator and subject in the consent process. Please note changes for the CF Template Confidentiality section were made to comply with the revised Common Rule that went into effect January 21, 2019. All revisions are in green Times New Roman text below.
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"). 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: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.
- 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:
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.
[You may use the following language as applicable] The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by [THE AGENCY] which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.
[Language such as the following should be included if researcher intends to disclose information covered by a Certificate, such as potential child abuse, or intent to hurt self or others in response to specific federal, state, or local laws.] The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of [list what will be reported, such as child abuse and neglect, or harm to self or others].
[Language such as the following should be included if researcher intends to disclose information covered by a Certificate, with the consent of research participants.] The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document [restate what will be disclosed, such as including research data in the medical record].
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
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....