1. P R E V E N T I N G F O R C E D D I S C L O S UR E
CERTIFICATES OF
CONFIDENTIALITY

2. WHAT ARE THEY?
• Authorizations that allow investigators to protect the
privacy of participants taking part in research
activities that involve disclosures about sensitive
topics
• Protects against compulsory disclosure of identifying
information about or identifying characteristics of
research participants
• Exceptions

3. STATUTORY AUTHORITY
Under section 301(d) of the Public Health Service Act
(42 U.S.C. 241(d)) the Secretary of Health and Human
Services may authorize persons engaged in
biomedical, behavioral, clinical or other research to
protect the privacy of individuals who are the subject
of that research. This authority has been delegated
to the National Institutes of Health.

4. WHAT IS MEANT BY SENSITIVE
INFORMATION?
• Disclosure of identifying information could have adverse
consequences
• Includes but not limited to:
• Sexual attitudes, preferences, or practices
• Use of alcohol, drugs or other addictive products
• Information pertaining to illegal conduct
• Information that if released, could damage an individual’s
financial standing, employability, or reputation
• Information that if released, might lead to social stigmatization
or discrimination
• Information pertaining to an individual’s psychological well-
being or mental health
• Genetic information, tissue samples, genetic susceptibility or
family pedigree

5. INELIGIBILITY FOR CERTIFICATES OF
CONFIDENTIALITY
• Not research
• Not collecting personally identifiable information
• Not reviewed and approved by the IRB
• Collecting information that if disclosed would not
significantly harm or damage the participant

7. HOW TO APPLY FOR A CERTIFICATE OF
CONFIDENTIALITY
• Certificates of Confidentiality are issued by NIH
• Research must be within NIH mission area
• NIH funding is not a condition of application for and receipt
of a Certificate of Confidentiality
• Applications must have
• IRB approval and letter signed by authorized representative
from IRB holding an FWA with applicable assurance
number
• Application Letter
• Informed consent document containing information about
Certificate of Confidentiality and its safeguards
• PI and Institutional Official signatures

8. APPLICATION LETTER
• On institutional letterhead
• Name and address of institution which granted IRB
approval of research
• Sites where research will be conducted and brief
description of facilities
• Title of the research project
• Source and number of supporting grant, if
applicable
• Name, title, mailing and email addresses, telephone
and fax numbers of PI and other key personnel

9. APPLICATION CONTINUED
• Brief summary of scientific training of PI and key
personnel
• Beginning and expected end dates of the project
• Concise description of project aims and research
methods
• Description of data security and storage
• Number of subjects to be included in the study
• Description of population
• Source of recruitment
• Methods for protecting subjects’ identities

10. APPLICATION CONTINUED
• Reason for requesting a Certificate of
Confidentiality
• brief description of sensitive and identifying information to
be collected
• Specific assurances to be inserted verbatim in application
letter

11. DURATION OF CERTIFICATES OF
CONFIDENTIALITY
• Issued with a specific effective date and expiration
date
• Protection afforded is permanent
• Written requests must be submitted for extensions