IRB policy allows studies to be approved and recruitment to begin once the investigator has applied for a Certificate of Confidentiality.
All new studies that require a Certificate of Confidentiality will be approved for enrollment once you have informed us that you have applied for the certificate (i.e., while the application is pending). The IRB approval notice will continue to reflect that a Certificate of Confidentiality is pending, but we will provide you with stamped approved consent forms.
To be approved, consent forms must include the language required of studies covered by a certificate, but must now read "We have applied for…” a Certificate of Confidentiality instead of “We have obtained…”
- Once the Certificate has been obtained, you will forward a copy to the IRB Office.
- At the time of the next continuing review or any other required consent form modification (whichever comes first), you will update the consent forms to reflect that the Certificate has been obtained.
This procedure enables investigators to initiate recruitment sooner while providing confidentiality protections.
When a researcher obtains a Certificate of Confidentiality, the research subjects must be told about the protections afforded by the certificate and any exceptions to that protection. That information should be included in the informed consent form. Examples of appropriate language follow. Researchers may adapt the language to the needs of the research participants and to the subject matter of the study. However, the language used must cover the basic points
Researchers should also review the language about confidentiality and data security that is routinely included in consent forms to be certain that it is consistent with the protections of the Certificate of Confidentiality.
Sample consent form language
This research is covered by a Certificate of Confidentiality issued by the [AGENCY NAME HERE (e.g., Department of Health and Human Services (DHHS))]. With this Certificate, the researchers cannot be forced to release any research data in which you are identified, even under a court order or subpoena, without your written consent. The Certificate does not prevent the researchers from reporting suspected or known neglect or sexual or physical abuse of a child, or threatened violence to self or others. Such information will be reported to the appropriate authorities.
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.
Records will be available to research staff, and State and Institutional regulatory personnel (who may review records as part of the routine audits).”
[If the study receives federal support, revise to read] “...and Federal, State and Institutional personnel ...
For more information on the Certificate of Confidentiality, click on the following link
NIH Certificates of Confidentiality Kiosk (grants1.nih.gov)