| Policy |
Certificate of Confidentiality |
| DEPARTMENT: |
OFFICE FOR HUMAN RESEARCH PROTECTION |
| POLICY NUMBER: |
IX.C |
| SECTION: |
PRIVACY AND CONFIDENTIALITY |
| REVIEW: |
IRB POLICY AND PROCEDURE COMMITTEES |
| EFFECTIVE DATE: |
March 19, 2007 |
| ASSOCIATED PROCEDURE: |
Certificate of Confidentiality Procedure |
Subject: Certificate of Confidentiality
Policy:
It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to assure that the privacy and confidentiality protections are adequate for all research participants, which may include securing a Certificate of Confidentiality.
- The Secretary of DHHS may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or Local civil, criminal, administrative, legislative, or other proceedings to identify such individuals. [1]
- When a Certificate of Confidentiality has been obtained for a research study, a statement describing the protection must be added to the consent form to comply with IRB Policy IV.A. [2]
[1] 42 USC 241 (d)
[2] IRB Policy IV.A
