FDA Certificates of Confidentiality Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff

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Certificates of Confidentiality Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff[附网盘链接]由FDA于过去发布，适用于美国。

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CERTIFICATES OF CONFIDENTIALITY Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction 1

This guidance describes FDA implementation of the revised provisions applicable to the request st

for, and issuance of, a Certificate of Confidentiality (CoC). The 21 Century Cures Act (Cures Act) (Public Law 114-255) amended the Public Health Service Act (PHS Act), section 301(d) (42 U.S.C. 241(d)) relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is 2

being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled to disclose identifiable, sensitive information about the research participant, created or compiled for purposes of the human subject research. As amended, the statute broadened the protections by affirmatively prohibiting holders of CoCs from disclosing such information unless a specific exception applies. The Cures Act simplified certain aspects of the issuance of CoCs by requiring that CoCs be issued for federally-funded human subject research that collects or uses identifiable, sensitive information (referred to in this guidance as mandatory CoCs). For non-federally funded research, issuance of CoCs is not required but may be issued at the discretion of FDA (referred to in this guidance as discretionary CoCs). FDA intends to continue receiving and considering such requests and will issue discretionary CoCs as appropriate. This guidance is intended to provide information on how to request a discretionary CoC, the statutory requirements for requesting such a CoC, and the statutory responsibilities associated with possessing a CoC. Although the mandatory CoC and the discretionary CoC are issued under different processes, the protections 1

This guidance has been prepared by the Office of Policy in cooperation with the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, the Center for Tobacco Products, the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the Office of Chief Scientist at the Food and Drug Administration. 2

There are additional statutes and regulations that protect the privacy of human subject research participants. These are outside the scope of this guidance. 1

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