Certificate of Confidentiality Effective June 11, 2017 the Certificate of Confidentiality (Certificate) issued for the database of Genotypes and Phenotypes (dbGaP) is subject to the requirements of section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)). Moreover, as of October 1, 2017 dbGaP is required to adhere to the NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109). Therefore, Approved Users of dbGaP, whether or not funded by the NIH, who access a copy of information protected by a Certificate held by dbGaP, are also subject to the requirements of the Certificate of Confidentiality and subsection 301(d) of the Public Health Service Act. Under Section 301(d) of the Public Health Service Act and the NIH Policy for Issuing Certificates of Confidentiality, recipients of a Certificate of Confidentiality shall not: • Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual whom the information, document, or biospecimen pertains; or • Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research. Disclosure is permitted only when: • Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding; • Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual; • Made with the consent of the individual to whom the information, document, or biospecimen pertains; or • Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.
