Common use of Certificate of Confidentiality Clause in Contracts

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.

Certificate of Confidentiality. 2 The project anniversary date can be found in “My Projects” after logging in to the dbGaP authorized-access portal. 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.

Certificate of Confidentiality. Effective June 11March 15, 2017 the Certificate of Confidentiality (Certificate) issued for the database NIA Genetics of Genotypes and Phenotypes Alzheimer’s Disease Data Storage Site (dbGaPNIAGADS) 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 NIAGADS is required to adhere to the NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109). Therefore, Approved Users of dbGaPNIAGADS, whether or not funded by the NIH, who access a copy of information protected by a Certificate held by dbGaPNIAGADS, 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.

Certificate of Confidentiality. Effective June 11, 2017 the RADxSM datasets are protected by a Certificate of Confidentiality (Certificate) issued for the database of Genotypes and Phenotypes (dbGaP) is subject to the requirements of under 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 RADxSM datasets are subject to the NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109). Therefore, Approved Users of dbGaPthe RADxSM Data Hub, whether or not funded by the NIH, who access a copy of information protected by a Certificate held by dbGaPthe RADxSM Data Hub, 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: • o 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 • o 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: • o 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; • o Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual; • o Made with the consent of the individual to whom the information, document, or biospecimen pertains; or • o Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

Certificate of Confidentiality. Effective June 11, 2017 the The CRADA Data collected under a Protocol conducted under this CRADA are covered under a Certificate of Confidentiality (Certificate) that has been issued for by the database of Genotypes and Phenotypes (dbGaP) is subject NIH pursuant to the requirements of section 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 Under this 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 the Collaborator may not: • : a) 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 to whom the information, document, or biospecimen pertains; or • or b) 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 Provided that Collaborator will be permitted only when: • Required to disclose the information described in the points set forth above as follows: a) If 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 ; b) If 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 ; c) If made with the consent of the individual to whom the information, document, or biospecimen pertains; or • Made or d) If made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects Human Subjects in research.