1. What is a Certificate of
Confidentiality?
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
February 25, 2003
2. When should an investigator seek a Certificate of
Confidentiality for a study?
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.
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3. Will an IRB require an investigator to obtain a Certificate
of Confidentiality?
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.
4. How does an investigator
apply for a Certificate of Confidentiality?
To apply for a Certificate, an investigator should submit an
application letter to the IRB, with the information required by
the specific federal agency. Detailed instructions for applying
for a NIH Certificate of Confidentiality are available at the
following website:
http://grants1.nih.gov/grants/policy/coc/. Applications for a
Certificate of Confidentiality require Institutional Signature
before submission. The application should be sent to the IRB
Office for signature by the Vice President for Research.
