Additional Requirement – 36: Certificates of Confidentiality

Section 301(d) of the Public Health Service (PHS) Act, as amended by Section 2012 of the 21st Century Cures Act, P.L. 114-255 (42 U.S.C. 241(d)), states that the Secretary shall issue Certificates of Confidentiality (Certificates) to persons engaged in biomedical, behavioral, clinical, or other research activities in which identifiable, sensitive information is collected. In furtherance of this provision, CDC supported research commenced or ongoing after December 13, 2016 and in which identifiable, sensitive information is collected, as defined by Section 301(d), is deemed issued a Certificate and therefore required to protect the privacy of individuals who are subjects of such research in accordance with Section 301(d) of the PHS Act.

Institutions and investigators are responsible for determining whether research they conduct is subject to subsection 301(d) of the PHS Act. Certificates issued in this manner will not be issued as a separate document, but are issued by application of this term and condition to this award.

Consistent with the statute, CDC considers research in which identifiable, sensitive information is collected or used, to include:

• Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt research except for human subjects research that is determined to be exempt from all or some of the requirements of 45 CFR 46 if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
• Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;
• Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or
• Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

Recipient Responsibilities

To determine if a Certificate of Confidentiality applies to research conducted or supported by CDC, investigators will need to ask, and answer the following question:

• Is the activity biomedical, behavioral, clinical, or other research?

If the answer to this question is no, then the activity is not issued a Certificate of Confidentiality. If the answer is yes, then investigators will need to answer the following questions:

• Does the research involve Human Subjects as defined by 45 CFR Part 46?
• Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
• If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
• Does the research involve the generation of individual level, human genomic data?

If the answer to any one of these questions is yes, then a Certificate of Confidentiality will apply to the research and therefore, in accordance with subsection 301(d) of the Public Health Service Act, the recipient of the Certificate 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 to 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.

Consistent with applicable grant regulations and the terms of this award, recipients conducting CDC supported research are required to establish and maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal statutes, regulations, and the terms and conditions of this award. As this requirement attaches to the funds provided under the award, recipients are also required to ensure: 1) that any investigator or institution not funded by CDC who receives a copy of identifiable, sensitive information protected by a Certificate, understands  that it is also subject to the requirements of subsection 301(d) of the PHS Act; and 2) that any subrecipient that receives funds to carry out part of this CDC award involving a copy of identifiable, sensitive information protected by a Certificate understands that it is  subject to subsection 301(d) of the PHS Act.

For studies in which informed consent is sought, CDC expects investigators to inform research participants of the protections and the limits to protections provided by a Certificate issued by this term and condition.

For more additional information about the Certificate of Confidentiality and the requirements associated with this protection, please contact:

Privacy and Confidentiality Unit

Office of Scientific Integrity

Email: [email protected]

Phone: (404) 639-4642