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Application for NICHD Certificate of Confidentiality

Welcome to the Application for Certificate of Confidentiality. Please note that this form must be filled out in its entirety as you will not have the ability to save an application in progress. To successfully submit your application you must complete ALL sections below. If a section does not apply to you, select the "Not Applicable" checkbox. When uploading files, the following types are allowed: Microsoft Word (.doc, .docx), Microsoft Excel (.xls, .xlsx), Word Perfect (.wpd), Images (.gif, .jpg, jpeg, .bmp, .tiff, and .tif), and Adobe Acrobat (.pdf).

Background: Confidentiality Certificates are issued by NIH Institutes pursuant to Section 301 (d) of the Public Health Service U.S.C. Section 241 (d) to afford special privacy protection to subjects enrolled in biomedical, behavioral, clinical, or other research within NIH mission areas. A Certificate helps the researcher avoid compelled 'involuntary disclosure' (e.g. subpoenas) of identifying information about a research subject. It does not prevent voluntary disclosures such as disclosure to protect the subject or others from serious harm, as in cases of child abuse. Also, a researcher may not rely on a Certificate to withhold data if the subject consents to the disclosure. For additional general information on Certificates of Confidentiality, please visit the NIH Certificate of Confidentiality Kiosk at http://grants.nih.gov/grants/policy/coc/.

Informing Subjects about Certificate: When a researcher obtains a Certificate of Confidentiality, the subjects must be told about the protections afforded by the Certificate, and any exceptions to that protection. This information is usually included in an 'informed consent'.

Need to adapt examples: Research subjects vary widely in their cultural and educational backgrounds. The language used should covers the basic points - privacy protection means that the subject will not be identified as participating in the study, unless the subject consents, or a disclosure is made to protect the subject or another from serious harm. Researchers may adapt the language to the special needs of their clientele, and to the subject matter of the study.

Researchers should also review the language about confidentiality which is routinely included in consent forms to be sure that it is consistent with Certificate of Confidentiality protections. For example, consent forms sometimes refer to state law reporting requirements. However, HHS General Counsel advises that such a disclosure would be voluntary, even though (otherwise) required by State law, because the Certificate protects the researcher from the compulsion of that law. Thus, researchers would simply state the circumstances in which disclosures would be made.
 
1. Institution Information
2. Research Sites
3. Research Project
4. Source of the Supporting Grant
5(a). Requirement
5(b). IRB
5(c). Federal Wide Assurance Number/Statement of Qualifications
6. Applicant Information
7. Project Date Range
8. Description of Study of Project Aims and Research Methods
9. Means Used to Protect Subjects' Identities
10. Reasons for Requesting a Certificate of Confidentiality
11. Informed Consent Forms for Human Subjects, as it Will Read if the Certificate of Confidentiality is Issued
12. Research Not Funded by NIH
13. All Research in which a Controlled Drug or Drugs will be Administered
14. Research Project in Testing for Reportable Communicable Diseases
 
A field with an asterisk (*) before it is required.
 
1. Institution Information
This is the institution with which the applicant is affiliated and the recipient of grant support for the research, if there is any. The principal investigator must be a faculty member of the institution. Individuals who are in a temporary status such as graduate students or post-doctoral fellows may only be co-investigators.
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2. Research Sites
Sites where the research will be conducted and a brief description of the facilities available for the conduct of the research. The lead site of a multi-site project should apply for a single Certificate to protect participants enrolled at all sites and should maintain a current listing of other sites.

Example of Description of facilities: Each facility has private examination rooms for study participants to answer questionnaires and will use trained staff to obtain study samples and input data. Study samples will be analyzed by qualified laboratory facilities. Genetic materials will be maintained at ---- repository..
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3. Research Project
Title of research project. If the project title on the IRB form (see item 5 below) is different from title given here, the applicant must document that the IRB approval pertains to this project.

Include all alternate titles in addition to the IRB approved title. Alternate titles may be found on the consent form, award letters, collaborative agreements, clinical trials registry listing, etc. When entering the titles below, put "also know as" between them.
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4. Source of the Supporting Grant
Source of the supporting grant, if applicable. (e.g., "supported by institutional funds" or "supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development".)

If the NIH funds the project, please provide the name of the funding Institute or Center.


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5(a). Requirement
A Certificate of Confidentiality will not be issued to an applicant conducting research involving human subjects unless the project has IRB approval. The approving IRB must be in compliance with applicable Federal requirements. If the applicant institution is receiving DHHS funding for research involving human subjects, an OHRP-approved IRB for that institution must approve the project for which a Certificate of Confidentiality is sought. For additional information on OHRP and IRB assurances, see http://www.hhs.gov/ohrp/assurances/

If the applicant institution has not received DHHS funding for this research involving human subjects but has an IRB that complies with the requirements for IRBs imposed by another Federal agency, that IRB must approve the research. If the applicant institution does not have an IRB, the project should be reviewed by an IRB in accordance with 45 CFR Part 46.
5(b). IRB
Documentation of IRB approval: Attach letter or form signed by an authorized IRB representative. Approval must be current and unconditional, or conditioned only upon the issuance of a Certificate of Confidentiality and documented by a letter or form signed by an authorized IRB representative. If this is a multi-site project, only the lead site IRB approval needs to be submitted, but the lead site must maintain a copy of the IRB approval from each site, which must be made available to the NIH upon request.
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5(c). Federal Wide Assurance (FWA) Number/Statement of Qualifications
Documentation of IRB qualifications: For all projects, submit for the IRB that reviewed the project the assurance number assigned by OHRP or a statement of qualifications that the IRB complies with the applicable Federal regulations governing research involving human subjects. If this is a multi-site project, only approval from the lead site IRB is required to issue a Certificate of Confidentiality.
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6. Applicant Information
Please complete all of the Applicant information as well as name and title of other key personnel. Also include a brief summary of the scientific training of the Applicant and key personnel. If this is a multi-site project, only information from the lead site should be submitted to the NIH. However, the lead site must collect and maintain this information from each site and make it available to the NIH upon request. If there are multiple investigators they can be added using the "Enter More Key Personnel" button. If the additional investigators are co-principal investigators, it can be noted in the summary of scientific training box. Alternatively a listing of key personnel can be uploaded and the additional co-principal investigators can be noted in that document.

Briefly, in no more than 2 or 3 sentences, state the qualifications of the Principal Investigator and in particular note the faculty affiliation with the submitting institution.

Example of Summary of Scientific Training
- PhD received from Green University in Clinical Psychology in 1978
- Academic Faculty full time at Orange University from 1981 until present



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Key Personnel
If you have more than one key person you would like to add, either add them individually by selecting the Enter More Key Personnel button or uploading a document containing a list of the key personnel by selecting the Browse button. If you intend to add more than 20 key personnel, we recommend that you upload a document.
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7. Project Date Range
Please enter the date the project began or will begin and the date the project is expected to end. The Certificate will state a date on which the research will begin, or if it is underway, it will state that it is underway. It will also state the date upon which the research is expected to end (expiration date). A Certificate of Confidentiality protects all information identifiable to any individual who participates as a research subject (i.e., about whom the investigation maintains identifying information in its research files) during any time the Certificate is in effect. The protection afforded by the Certificate is permanent. If the research is not completed by the expected (expiration) date, the Applicant must submit a written request for an extension three months prior to the date. Any such request must include a brief description of the reason for the extension, documentation of the most recent IRB, a copy of the consent form being used, and the expected date for completion of the research project.
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8. Description of Study of Project Aims and Research Methods
This section should include a description of the project to allow the NIH Coordinator to review the project for the Certificate as well as a 2 or 3 sentence brief summary of the project to be included in the Certificate.. If significant changes are made to the project aims or methods during the course of the study, the Applicant should contact the Certificate Coordinator who issued the Certificate. That person will determine if the Certificate can be modified or if the Applicant will need to submit an amended application.

Example of Description of Study:
The proposed study would investigate the occurrence of maternal depression, parenting attitudes and social support, and the effects of these on infant developmental risk in a group of rural, Native American mothers. The study also examines the detrimental effects of poverty and environmental deprivation on children as mediated through mothers' psychological and social well-being and parenting behavior in the early years In addition, the proposed study would determine prevalence rates of infant cognitive and developmental delay at one year as a developmental outcome measure. Finally the study will look at social support as a powerful moderator of maternal psychological functioning, and a buffer to risk for children.

The study has four main objectives:

1. To determine the relatedness of maternal depressive symptoms to maternal prenatal risk behaviors, ie., smoking, alcohol and drug abuse during pregnancy.
2. To determine the occurrence and relatedness of maternal depressive symptoms and poor parenting attitudes at infant age 2 days, 2 months, and at 1 year in this population.
3. To discover maternal perceptions of social support (extended family and partner),and test the hypothesis that social support alleviates maternal depressive symptoms and poor parenting attitudes.
4. To test the hypothesis that infant developmental delay at 1 year IS related to maternal depressive symptoms and attitudes, moderated by social support
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Example of Brief Summary:
This behavioral research study examines the relationship between maternal depressive symptoms, pre-natal risk behavior, perceived social support, and infant outcomes. Approximately 200 Native American mother-infant pairs will be recruited as subjects and evaluated at baseline and scheduled intervals for one year.


9. Means Used to Protect Subjects' Identities
Describe the procedures used for collection and storage of personally identifiable information.

For Example: Subjects are coded by numbers not names, linking information is kept in locked files, identifiers will be destroyed when the study is completed, etc.

10. Reasons for Requesting a Certificate of Confidentiality
Include a brief description of sensitive and identifying information to be collected.

Examples for Reason for Requesting Certificate of Confidentiality:
  • Sensitive information regarding drug and alcohol use, physical habits and dream content are being collected.

  • Genetic material is being collected in patients and their families who may be at risk of developing specified diseases.

  • Genome analysis will be performed to search for familial, disease-influencing genes and their alleles.

  • This information, if disclosed, could expose subjects or their families to adverse economic, legal, psychological or social consequences

    11. Informed Consent Forms for Human Subjects, as it Will Read if the Certificate of Confidentiality is Issued (Attach Copy)
    The informed consent form must include a description of the protections and limitations of the Certificate of Confidentiality, including the circumstances in which the investigators plan to disclose voluntarily identifying information about research participants (e.g., child abuse, harm to self or others, etc.). Sample language is provided below. 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 points.

    Researchers should 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 Certificate of Confidentiality.

    The researchers must include language regarding circumstances that could lead to voluntary disclosure, without consent of the participant, to authorities and appropriate professionals, such as information about child abuse, intent to hurt self or others, or other disclosures (including a description of the circumstances under which disclosures would be made).

    If this is a multi-site project, only the lead site must submit a consent form. If multiple consent forms are available (e.g. a consent form and an assent form), please merge them into a single document prior to uploading. When uploading your form(s), please note that only Word Processing based files will be accepted. No scanned images or other file types will be accepted. In addition, the lead site must indicate that it has on file a copy of the IRB approval and IRB-approved consent form from each site, which will be made available to the NIH upon request. The informed consent form for each site should contain appropriate language about the protections and limitations (voluntary disclosures) of the Certificate of Confidentiality.

    If significant changes are made to the informed consent form, the Applicant should contact the Certificate Coordinator who issued the Certificate and submit a copy of the revised consent form.

    Information for research projects with children: A Certificate of Confidentiality cannot be used to refuse to disclose identifiable research information about a minor if a parent or legal guardian requests it. The researchers may use other basis for a refusal to disclose information - after checking with their IRB about waivers of parental permission and other issues. In any case, researchers should discuss this possibility with their institution's officials.

    Please carefully read the suggested language, as some of it may not apply to your research project.

    Suggested Language to be Included in Consent Forms:

    We will do everything we can to keep others from learning about your participation in this study. To further help us protect your privacy, we have obtained a Certificate of Confidentiality from the United States Department of Health and Human Services (DHHS).

    With this Certificate, we cannot be forced (for example by court order or subpoena) to disclose information that may identify you in any federal, state, local, civil, criminal, legislative, administrative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you (or if applicable: "you or your child"), except to prevent serious harm to you or others, and as explained below.

    You should understand that a Certificate of Confidentiality does not prevent you, or a member of your family, from voluntarily releasing information about yourself, (and if applicable: "your child"), or your involvement in this study.

    If an insurer or employer learns about your participation, and obtains your consent to receive research information, then we may not use the Certificate of Confidentiality to withhold this information. This means that you and your family must also actively protect your own privacy.

    (Insert this sentence only if the study has DHHS funding): Disclosure will be necessary, however, upon request of DHHS for the purpose of audit or evaluation, and is limited only to DHHS employees involved in the review.

    You should understand that we will in all cases, take the necessary action, including reporting to authorities, to prevent serious harm to yourself, children, or others. For example, in the case of child abuse or neglect. Note: Researchers can also list other types of harm they may voluntarily report specific to the research project, (e.g., elder abuse, suicide, domestic abuse, etc.).

    (Insert this sentence only if the study does NOT have DHHS funding): A Certificate of Confidentiality does not represent an endorsement of the research study by the Department of Health and Human Services or the National Institutes of Health.

    Researchers may contact the Certificate Coordinator at the IC for which they are applying with questions or additional recommendations and suggestions on language to be included in consent and assent forms regarding the Certificate of Confidentiality.
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    12. Research Not Funded by NIH
    Research not funded by NIH in which drugs will be administered to human subjects must provide the following additional information:
    - Identification of drugs to be administered; e.g. Phenobarbital
    - Description of methods for administration of these drugs, including a statement of dosages; e.g. 50 to 100 mg 2 to 3 times daily.
    - Evidence that individuals who will receive the drugs are authorized to do so under applicable Federal and State law.
    e.g. Patients with Alzheimer's are allowed to use anti-epileptic medications in the State of Rhode Island.


    If you have more than one drug you would like to add, add them individually by selecting the Enter More Drugs button (limit 20 drugs).


     
     
    13. All Research in which a Controlled Drug or Drugs will be Administered (Attach Copy)
    All research in which a controlled drug or drugs will be administered must submit a copy of the Drug Enforcement Administration Certificate of Registration (BND Form 223) under which the research project will be conducted.



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    14. Research Project in Testing for Reportable Communicable Diseases
    If the research project is testing for reportable communicable diseases, the applicant must submit information relating to its plans for working with State and local authorities as specified in the August 9, 1991 memorandum from the Assistant Secretary for Health
    (http://grants.nih.gov/grants/policy/coc/cd_policy.htm).



    Assurances
    A paper copy on institutional letterhead of the assurances referencing the application with original signatures, identification of the signatories, and the date of signing must follow after this form is submitted.

    The following assurances are required and the following information should be inserted verbatim into the Certificate application letter. Both the PI and the Institutional Official must sign this letter:

    This institution agrees to use the Certificate of Confidentiality to protect against the compelled disclosure of personally identifiable information and to support and defend the authority of the Certificate against legal challenges.

    The institution and personnel involved in the conduct of the research will comply with the applicable Federal regulation for the protection of human subjects or, if no such Federal regulation is otherwise applicable, they will comply with 45 CFR Part 46.

    This Certificate of Confidentiality will not be represented as an endorsement of the project by the DHHS or NIH or used to coerce individuals to participate in the research project.

    All subjects will be informed that a Certificate has been issued, and they will be given a description of the protection provided by the Certificate.

    Any research participant entering the project after expiration or termination of the Certificate will be informed that the protection afforded by the Certificate does not apply to them.