CERTIFICATES OF
CONFIDENTIALITY
Certificates of Confidentiality
• Issued by the National Institutes of Health (NIH)
• Protect investigators and institutions from being compelled
to release information that could be used to identify
research study participants
• Allow the investigator and others who have access to
research records to refuse to disclose identifying
information in any
-
civil
criminal
administrative
legislative, or other proceeding, whether at the federal,
state, or local level
Statutory Authority
• Section 301(d) of the Public Health Service Act (42 U.S.C.
241(d))
• Secretary DHHS may authorize persons engaged in:
-
biomedical
behavioral
clinical
other research
to protect the privacy of individuals who are the subjects
of that research.
• Authority has been delegated to the NIH.
Identifying Information
• Broadly defined
• Not just name, address, social security number,
etc.
• Includes any item or combination of items that
could lead directly or indirectly to the
identification of a research participant.
Eligibility
• For IRB-approved research collecting identifying
information
• If disclosure could have adverse consequences
for subjects or damage:
- financial standing
- employability
- insurability, or
reputation
•
NIH or PHS funding not required
Examples of research with potential adverse
consequences for subjects
• Collecting genetic information
• Collecting information on psychological well-being of
subjects
• Collecting information on sexual attitudes, preferences or
practices
• Collecting data on substance abuse or other illegal risk
behaviors
• Studies where participants may be involved in litigation
related to exposures under study (e.g., breast implants,
environmental or occupational exposures)
Other issues
• Issued for single, well-defined research projects
• Certificates granted to Institutions based on PI’s
application
• Sometimes issued for cooperative multi-site
projects
- Must have a coordinating center or “lead” institution
- Lead institution can apply on behalf of all institutions
associated with the multi-site project.
- Lead institution must ensure that all participating
institutions conform to the application assurances
Projects Not Eligible for a
Certificate
• Not research
• Not collecting personally identifiable information
• Not reviewed and approved by the IRB as
required by these guidelines
• Collecting information, that if disclosed, would
not significantly harm or damage the subject
Requirements
• Must tell subjects that Certificate is in effect in
Informed Consent form
• Must provide fair and clear explanation of
Certificate’s protection, including
- limitations
- exceptions
• Must document IRB approval and IRB
qualifications
• Must provide a copy of the informed consent
forms approved by the IRB
• PI and Institutional Official must sign application
Assurances
• Agree to protect against compelled disclosure and to
support and defend the authority of the Certificate against
legal challenges
• Agree to comply with Federal regulations that protect
human subjects
• Agree to not represent Certificate as endorsement of
project by DHHS or NIH or use to coerce participation
• Agree to inform subjects about Certificate, its protections
and limitations
Boundaries of Protection
• Protects data collected between date of issuance
and date of expiration
• Protects those data in perpetuity
• Does not protect against voluntary disclosure:
-
child abuse
threat of harm to self or others
reportable communicable diseases
subject’s own disclosure
• Must disclose information about subjects for
DHHS audit or program evaluation or if required
by the Federal Food, Drug, and Cosmetic Act
An Important Caveat
• Certificates of Confidentiality do not obviate the
need for data security
• Data security is essential to the protection of
research participants’ privacy
• Researchers should safeguard research data and
findings.
• Unauthorized individuals must not access the
research data or learn the identity of research
participants
For Additional Information
• Go to the Certificates of Confidentiality Kiosk at
http://grants1.nih.gov/grants/policy/coc/index.htm
• Kiosk includes:
-
background information and Instructions
application information for extramural investigators
application information of intramural investigators
FAQs
contact list
reportable communicable diseases policy