Before you prepare your consent document, please review the information below and carefully review the Consent Requirements, Consent Templates, and other helpful resources.
The ethical principle of respect for persons requires that subjects be given the opportunity to choose what shall and shall not happen to them. Valid informed consent requires: Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other federal agencies to protect the privacy of research subjects. The certificates provide protection against compelled disclosure of identifiable sensitive biomedical, behavioral, clinical or other research information provided by individuals participating in a research study. Identifying information which, if revealed, could harm the financial standing, employability, insurability, or reputation of a research subject, may be protected through the Certificate of Confidentiality. Thus, the Certificates “help minimize risks to subjects by adding an additional level of protection for maintaining confidentiality of private information.” The protection is not limited to federally funded research.
Once an investigator acquires a Certificate of Confidentiality, the investigator may refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other legal proceedings, whether federal, state or local.
Certificates of Confidentiality do not protect research subjects against the voluntary disclosure by the investigator of identifying information, such as evidence of child abuse or a subject’s threatened violence to self or others. However, “if a researcher intends to make such voluntary disclosures, the consent form should clearly indicate this [fact].” OHRP Guidance on Certificates of Confidentiality; 02/25/03
Before submitting a new application to the IRB, investigators should consider whether a Certificate of Confidentiality is needed for their study. If the investigator seeks to obtain identifying information of a sensitive nature from research participants, and the disclosure of such information could harm the participant as described above, then the investigator should state in the application to the IRB that they will seek a Certificate of Confidentiality after the IRB has reviewed the application.
The IRB may also request that an investigator apply for a Certificate of Confidentiality if the IRB determines that the data collected from participants should have the protections provided by a Certificate. For projects that involve extremely sensitive data, the Full IRB may request that an investigator refrain from recruitment and consenting until the Certificate has actually been obtained. However, in most cases, the investigator will be permitted to begin recruitment while the Certificate of Confidentiality application is under review by the agency.
To apply for a Certificate, an investigator should submit an application letter to the Office of Research Integrity with the information required by the specific federal agency. Detailed instructions for applying for a NIH Certificate of Confidentiality are available at the Certificates of Confidentiality Kiosk.
Investigators are required to use the FIU formatted Certificate of Confidentiality Assurance Template as part of the Certificate of Confidentiality application process.
As part of the application process, the investigator will need to include additional language in the Consent Form to outline the protections of the Certificate of Confidentiality. Template language is provided below.
(Include this paragraph in your Informed Consent Form if you have successfully obtained the Certificate or if you do not plan to begin recruitment and consenting until after you have obtained the Certificate):
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.
(Include this paragraph in your Informed Consent Form if you wish to begin subject recruiting and consenting before you have actually obtained the Certificate):
To help us protect your privacy, we have asked for a Certificate of Confidentiality from the National Institutes of Health. We will let you know right away if we do not get it. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.
(Include these remaining paragraphs in your Informed Consent Form for all projects seeking a Certificate):
The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of Federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).
[The researchers should include language such as the following if they intend to make voluntary disclosure about things such as child abuse, intent to hurt self or others, or other voluntary disclosures.] The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information that would identify you as a participant in the research project under the following circumstances. [The researchers should state here the conditions under which voluntary disclosure would be made. If no voluntary disclosures will be made, the researchers should so state.]
(Include this entire paragraph below if the nature of the study makes it likely for participants to reveal reportable information):
If we learn about serious harm to you or someone else, we will take steps to protect the person endangered even if it requires telling the authorities without your permission. If we have reason to believe that your child is being abused, we will report this to the Florida Abuse hotline. In these instances, we would only disclose information to the extent necessary to prevent harm.
A Certificate of Confidentiality enables the researchers to refuse to make disclosures that would otherwise be legally required. Therefore, please do not add any additional language to your Consent Form that references the reporting of events as required by law. Please only use the template “Reporting Language” that is provided in the above paragraph.
Applications for a Certificate of Confidentiality require an Institutional Signature before submission. The application should be sent to the FIU Office of Research Integrity (MARC 414) for signature by the Vice President for Research. More information about obtaining Certificates of Confidentiality can be accessed that the following web page: https://humansubjects.nih.gov/coc/index.