A Certificate of Confidentiality should be obtained for a research study when subjects’ participation, if it became known outside of the research, could place subjects at risk of criminal or civil liability or be damaging to their financial standing, health care, insurability, employment, employability or reputation. Certificates of Confidentiality help to minimize risks to subjects by adding an additional level of protection for maintaining confidentiality of private information.
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local. Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects, such as damage to their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects,
Certificates of Confidentiality protect subjects from compelled disclosure of identifying information but do not prevent the voluntary disclosure of identifying characteristics of research subjects. Researchers, therefore, are not prevented from voluntarily disclosing certain information about research subjects, such as evidence of child abuse or a subject's threatened violence to self or others.
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