Certificate of Confidentiality Application Instructions

Certificate of Confidentiality
Office of Scientific Integrity
Centers for Disease Control and Prevention
1600 Clifton Rd., MS D-74
Atlanta, GA 30333

• Name(s)
• Institutional affiliation(s)
• Complete mailing address(es)
• Telephone number(s)
• Fax numbers(s)
• Email address(es)

If the project name on the IRB form is different from the name given here, the applicant must document that the IRB approval pertains to this project.

Address retention time information will be kept in identifiable form.

Note: Often study ID numbers or codes are used, but generally a list linking Names with ID number must be maintained. If this is the case, identify those who will have access to this link.

List the Center, Institute, or Office within CDC, or Division within ATSDR providing the funding. Include the funding mechanism (grant, cooperative agreement, contract/task order), award number, and the name and telephone number of the CDC/ATSDR Project Officer, Program Official, or Project Coordinator.

The certificate must be written to last as long as data collection is expected to continue. CDC issues certificates for five years. Certificates may be extended after five years, if identifiable data is still being collected.

Note: If data collection has already begun, indicate the date that data collection began and briefly explain why data collection was begun before a Certificate was requested.

This will be included in the formal purpose statement within the certificate. It should be limited to one or two clear sentences.

This section should be at least 3-4 paragraphs in length.

Describe:

1) what the study is attempting to learn; incorporate the Purpose stated above, but expand;

2) the Method (e.g., “Five hundred women attending STD clinics will be recruited to participate, and half will receive educational interventions to increase their awareness of…”); and

3) how the subjects will be identified.

Describe in detail the sensitive information that is to be collected. Sensitive information is information that must be protected because it might cause perceivable damage to someone or something if revealed to persons not entitled to it. Sensitive information includes: Sexual attitudes, preferences, or practices; use of alcohol, drugs, other addictive products; illegal conduct; an individual’s psychological mental health; genetic information; information that if released could reasonably be damaging to an individual’s financial standing, employability, insurability or reputation; information normally recorded in a medical record, the disclosure of which could lead to social stigmatization.

Describe the safeguarding measures that will be in place to protect the data (e.g., locked cabinets, encryption of data, linking information stored in a different location from other data, access limited to small number of research staff).

Example: Individuals may not be willing to participate or may provide inaccurate information.

Example: Participants are on parole and their parole officers could subpoena information on illegal activities, such as drug use.

If reportable disease testing is not being done, state: “The project does not involve testing for communicable diseases.” If project is conducting testing, briefly describe the testing being conducted, and address how the project intends to comply with policies set out in the Notifiable Disease Reporting with Confidentiality Certificates memorandum.

State specifically that the project has been reviewed by an Institutional Review Board (IRB) or IRBs. For each IRB approval, list the name of the IRB, the dates of the approval period, and the site of the research. Address if CDC IRB review is needed.

If IRB approval has not yet been obtained, indicate the date of submission, whether any IRB report has been received, etc. Note: CDC IRB approval is not required for grants. It may be required for cooperative agreements.

[Include the following 2 paragraphs verbatim to indicate your agreement.]

The principal researcher(s) at each site involved in the collection of individually identified data for the project have agreed to add CDC’s preferred confidentiality advisement language (below) to consent documents when the Certificate approval has been obtained, and to return revised consent forms to their IRB(s) for approval:

“All answers that you give will be kept private. This is so because this study has been given a Certificate of Confidentiality. This means anything you tell us will not have to be given out to anyone, even if a court orders us to do so, unless you say it’s okay. But under the law, we must report to the proper authorities suspected cases of child abuse or if you tell us you are planning to cause serious harm to yourself or others.”

[End all applications with the following assurances and provide space for each person requesting authorization of 301(d) protection (PI and Co-PIs if applicable) to provide their signature and date below the assurances]

I assure: (1) that personnel involved in the conduct of the research will comply with all the requirements of 45 CFR Part 46 “Protection of Human Subjects” (Non-DHHS-supported projects must comply with 45 CFR 46 103 (c) and document legally informed consent in a manner consistent with the principles stated in 45 CFR 46); (2) that the Certificate of Confidentiality will not be represented as an endorsement of the project by the DHHS Secretary or used to coerce individuals to participate in the research project; (3) that the recipient of the Confidentiality Certificate will use the vested authority to protect the identity of research subjects; (4) that all subjects be informed that a certificate has been issued and that subjects will be provided with a description of the protection covered by the certificate; and (5) that subjects who enter the project after termination of the certificate will be informed of the termination.