Answer: The document that provides protection for the privacy of study participants in alcohol and drug abuse research studies is called a Certificate of Confidentiality.
Explanation: A Certificate of Confidentiality is a document issued by the National Institutes of Health (NIH) or other federal agencies that protects identifiable research information from forced or compelled disclosure by legal authorities or third parties. A Certificate of Confidentiality allows researchers and institutions to refuse to disclose the names or other identifying characteristics of research participants in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings.
A Certificate of Confidentiality is intended to protect the privacy of research participants who are involved in sensitive or stigmatized research topics, such as alcohol and drug abuse, mental health, sexual behavior, genetic diseases, or criminal activities. By providing this protection, a Certificate of Confidentiality aims to encourage participation in research, enhance the validity and reliability of data, and facilitate ethical and responsible research conduct.
A Certificate of Confidentiality can be obtained by researchers who are conducting biomedical, behavioral, clinical, or other types of research that collect identifiable information that could have adverse consequences for participants if disclosed. The research can be funded by the federal government or by other sources. The researchers must apply for a Certificate of Confidentiality before or during the course of the research and must follow the requirements and procedures specified by the issuing agency.
A Certificate of Confidentiality does not eliminate the need for informed consent or compliance with other ethical and legal standards for research. It also does not prevent researchers from voluntarily disclosing information about participants with their consent or for certain purposes, such as reporting child abuse, preventing imminent harm, or complying with federal audits. A Certificate of Confidentiality also does not protect researchers from liability for negligence or misconduct.