Certificates of Confidentiality
Standard Operating Procedure Table of Contents
|
|
Purpose
To protect investigators and institutions from being forced to release information that would identify research participants.
Procedure
Certificates of Confidentiality can be used for biomedical, behavioral, clinical, or other types of research that is considered sensitive, i.e., disclosing identifying information could have adverse consequences for subjects.
Sensitive research activities include collecting the following:
- Genetic information.
- Information on psychological well-being of subjects.
- Data on substance abuse or other illegal risk behaviors.
Some projects are ineligible for a Certificate of Confidentiality, e.g., those that do not collect personally identifiable information; those that collect information which, if disclosed, would not significantly harm or damage the participant.
Anyone collecting sensitive information from human subjects may apply for a Certificate of Confidentiality.
Applicants
- Get the certificate before you start to collect information from subjects.
- Go to Application for Certificate of Confidentiality to fill out an application form.
- Once you get a Certificate of Confidentiality, you must inform research subjects about the protections covered by the certificate and any exceptions.
- Review language about confidentiality and data security that is routinely included in consent forms. Make sure it is consistent with the protections of the Certificate of Confidentiality.
Contacts
NIAID inquiries, niaidcertificates@mail.nih.gov
If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.
Links
Certificates of Confidentiality: Background Information
Certificates of Confidentiality Kiosk |
