Certificates of Confidentiality (CoC) are issued by the National Institutes of Health (NIH) or the Food and Drug Administration (FDA) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. CoC may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, CoC help achieve the research objectives and promote participation in studies by assuring confidentiality and privacy to participants.
CHOP-Approved Certificate of Confidentiality Language
The NIH's CoC language is written at Grade 20+ and will therefore, not be understandable to all but a few individuals. The CHOP IRB has revised the CoC language so that it is more approachable (Grade 8.4 - 10.4 depending on the reading assessment tool). The CHOP IRB encourages investigators to use its version of the CoC in consent forms. An MS Word version of the CoC can be downloaded from the Informed Consent page or by using the following link: CHOP CoC Text.
CHOP Certificate of Confidentiality Language
A Certificate of Confidentiality (CoC) issued by the NIH covers this research. A CoC helps protect your identifiable information and biological samples.
A CoC protects your private information from all legal proceedings. Unless you consent, information from this research study that identifies you will not be shared outside this research.
- No one can be forced to share your identifiable information or biological samples for a lawsuit.
- Your information can't be used as evidence even if there is a court subpoena.
If you consent, your information or biological samples could be shared for: (restate what will be disclosed if there are other purposes listed in the consent form)
- other scientific research;
- (Explain the other purposes) not connected with this research;
- your medical treatment (Since CHOP Policy requires all clinically relevant data to be stored in EPIC, this statement will rarely be applicable).
The CoC does not prevent some disclosures.
- (Only include the next statement if a US federal or state government agency is funding the research) The researchers can't refuse requests for information from those funding this research. The [Funding Agency] may need information to assess this project. (if applicable add) Also, the US Food and Drug Administration (FDA) may need information.
- You can still share information about yourself. You can also freely discuss your involvement in this research.
- The researchers must disclose things required by law. This includes suspected child abuse and neglect, harm to self or others, or communicable diseases.
As of October 1, 2017, all studies funded by the NIH that involve human subjects research will automatically be issued a CoC. The change is the result of the 21st Century Cures Act, passed in 2016. All investigators who receive funding for human subjects research should familiarize themselves with the new policy and must ensure that all consent forms include a CoC section.
Sources for additional information
- Certificates constitute an important tool to protect the privacy of research study participants. Information can be obtained at the National Institute of Health.
- For more information legal issues and challenges related to the validity of CoC see Wolfe et al. Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice.
Tools and Information Provided by the NIH
For more information and tools related to Certificates of Confidentiality:
- NIH CoC Kiosk
- NIH Suggested Consent Language Describing the CoC Protections Note: this version is written at a very high grade level and investigators are encouraged to use the CHOP version (above).
NIH is making information widely available to investigators working on sensitive biomedical, behavioral, clinical or other types of research.
Examples of such studies include (but are not limited to) research on HIV, AIDS, and other STDs; studies on the use of alcohol, drugs, or other addictive products; studies that collect information on illegal conduct; research on participants' psychological well being or mental health; and genetic studies, including those that collect and store biological samples for future use.
Procedures for Obtaining a CoC from the NIH for non-NIH funded studies at CHOP
Studies that are NIH-funded automatically receive a CoC. For non-NIH funded studies, follow the procedures outlined below.
Start at the NIH's page, How to Get a Certificate of Confidentiality?
Go to Step 2 and follow the instructions to request a CoC. To request a CoC, you will need to following information:
Project details, including research title, start date, projected end date, and description.
Institution and performance site (if applicable) details, including institution and performance sites(s) names and addresses, and institution offical name, email address, and phone number.
The Institutional Official (IO) at CHOP, Bryan Wolf MD, PhD, has delegated signature authority to CR Matthew Hodgson, VP Research Compliance and Regulatory Affairs. The address for the IO's designee must be included with the signature line: Roberts Center for Pediatric Research; 2716 South Street, Room 17121; Philadelphia, PA 19146. Phone 267-426-8723. Email hodgsonm [at] email.chop.edu.
Principal Investigator name, phone number, email address, degree, position.
If applicable, Name(s) of drugs that will be administered, route of administration, and dosage.
If applicable, a copy of the DEA certificate(s)/registration for studies in which a controlled drug will be administered.
After you submit the information above, an email is sent to Matthew Hodgson, the IO's designee. The designee of the IO will need to review the CoC request information for accuracy, affirm the online Institutional Assurance Statement, and submit the CoC request.
The PI will receive an email notification when the designee of the IO submits the Assurance Statement and when the NIH approves the CoC.
An application for a CoC requires an IRB-approved study. Please note that while the IRB will issue approval of a study with a pending certificate of confidentiality application, the IRB will not release the consent including the CoC template language until the certificate has been obtained.
When a researcher obtains a CoC, the research subjects must be told about the protections afforded by the certificate and any exceptions to that protection. That information must be included in the informed consent form. The NIH provides examples of appropriate language. Researchers may adapt the language to the needs of the research participants and to the subject matter of the study. However, the language used must cover the basic concepts of a CoC and be substantially similar to the language provided by the NIH and provided below.
Researchers should also review the language about confidentiality and data security that is routinely included in consent forms to be certain that it is consistent with the protections of the CoC.
Contact Matthew Hodgson at hodgsonm [at] email.chop.edu with questions about the CoC submission process.
Obtaining a CoC from the FDA
The FDA is authorized to issue a CoC for studies with an IND or IDE that do not have any other HHS funding.
For all investigational new drug products associated with an IND :
Food and Drug Administration
CDER Compliance Enforcement Branch
10903 New Hampshire Avenue
White Oak, Building 51, Room 5333
Silver Spring, MD 20993
Phone: (301) 796-3724- Direct line
Main Line: (301)796-3150
Email: kimberly.price [at] fda.hhs.gov (Kimberly Price, Office of Compliance, CDER)
Email: CDER-COC-Request [at] fda.hhs.gov (CDER CoC Request email)
For all investigational new drug products associated with an IDE:
Consumer Safety Officer
Food and Drug Administration
CBER/Office of Compliance and Biologics Quality
10903 New Hampshire Avenue, Building 71, Room 5132
Silver Spring, MD 20993-0002
Phone: 240-402-8950 or 240-402-9159
Email: anthony.hawkins [at] fda.hhs.gov (Anthony Hawkins, Office of Compliance and Biologics Quality, CBER)
or CBERBIMONotification [at] fda.hhs.gov
Download instructions for CBER CoC: Certificate of Confidentiality Instructions (CBER)