Office of Research & Development |
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Although VA does not issue certificates of confidentiality, these FAQs will explain when a certificate might be needed and where to apply for one.
1. What is a Certificate of Confidentiality?
2. What types of CSR&D studies are eligible for a Certificate of Confidentiality?
3. How do I know if I need to apply for a Certificate of Confidentiality for my CSR&D Study?
5. When should I apply for a Certificate of Confidentiality?
6. How do I apply for a Certificate of Confidentiality?
7. What language about a Certificate of Confidentiality should be in the consent form?
8. How long is a Certificate of Confidentiality valid?
9. For multicenter studies, does each site have to apply for its own Certificate of Confidentiality?
10. Under what circumstances might a Certificate of Confidentiality need to be amended?
1. What is a Certificate of Confidentiality?
A Certificate of Confidentiality (CoC) is issued for applicable Department of Veterans Affairs (VA) research by several Department of Health and Human Services (DHHS) agencies to protect research subjects by preventing investigators and institutions from being forced or compelled to release identifiable information on research subjects. It allows the investigator and others who have access to research records to refuse to disclose identifying information on research subjects in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. The CoC helps to minimize risks by adding an additional level of protection for maintaining the privacy and confidentiality of research subjects in a VA study. Please note that the Department of Veterans Affairs does not issue CoCs.
2. What types of CSR&D studies are eligible for a Certificate of Confidentiality?
Generally, a CSR&D human subjects research project that collects personally identifiable, sensitive information and that has been approved by an IRB is eligible for a Certificate of Confidentiality (CoC). Sensitive information for purposes of a CoC is not synonymous with the definition of sensitive information in VA and Veterans Health Administration (VHA) Handbooks. Examples of sensitive information for purposes of evaluating whether or not a CSR&D study is eligible for a CoC include:
3. How do I know if I need to apply for a Certificate of Confidentiality for my CSR&D study?
As Principal Investigator, you may decide that a Certificate of Confidentiality (CoC) is appropriate for a study because sensitive information is being collected from research subjects. Or, your Institutional Review Board may also ask you to apply for a CoC. In some cases, after a funding decision has been made, you may be contacted by a CSR&D staff member, who will discuss whether a CoC application should be sent and to which Department of Health and Human Services agency it should be sent.
4. Who applies for the Certificate of Confidentiality (CoC) and to whom is the approved CoC issued for CSR&D studies?
5. When should I apply for a Certificate of Confidentiality?
An application for a Certificate of Confidentiality (CoC) is submitted after the Institutional Review Board (IRB) responsible for review of your CSR&D study approves it or issues an IRB approval conditioned upon issuance of a CoC.
6. How do I apply for a Certificate of Confidentiality?
7. What language about a Certificate of Confidentiality should be in the consent form?
8. How long is a Certificate of Confidentiality valid?
Individuals who participate as research subjects in the specified research project during any time the Certificate of Confidentiality (CoC) is in effect are protected permanently even if the subject gave the researcher data before the CoC was issued.
9. For multicenter studies, does each site have to apply for its own Certificate of Confidentiality?
10. Under what circumstances might a Certificate of Confidentiality need to be amended?
REFERENCES:
Section 301(d) of the Public Health Service Act (42 U.S.C. 241(d))
VHA Handbook 1200.05, Requirements for the Protection of Human Subjects in Research, May 2, 2012.
NIH FAQs on Certificates of Confidentiality: http://grants.nih.gov/grants/policy/coc/faqs.htm
NIH Certificates of Confidentiality: Background Information: http://grants.nih.gov/grants/policy/coc/background.htm
Detailed Application Instructions for Certificate of Confidentiality: Extramural Research Projects:http://grants.nih.gov/grants/policy/coc/appl_extramural.htm