Application for Extramural NICHD Certificate of Confidentiality

Not all clinical research studies qualify for a Certificate of Confidentiality. To determine if you should proceed with an application, please review the following statements and indicate that they apply to your study by checkng the box below. If you would just like to view an application without filling it out, you should also check the box below to proceed. If you have any questions, please contact your NIH Certificate of Confidentiality coordinator, listed at http://grants.nih.gov/grants/policy/coc/contacts.htm. 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.
	This study will collect personally identifiable information.
	This study will maintain consent forms with identifiable information other than names (e.g., social security numbers, addresses, etc.).
	This study can not be conducted anonymously—that is, the research itself relies on personally identifiable data to gather data.
	The study subject matter falls within the research mission of the NIH and its Institutes, Centers, and Offices.
By checking this box, I agree that all the above statements are true.

Application for NICHD Extramural Certificate of Confidentiality

Welcome to the Application for Extramural NIH Certificate of Confidentiality. To successfully submit this application the user 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), Microsoft Excel (.xls), 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

5(a). Requirement

5(b). IRB

5(c). Federal Wide Assurance Number/Statement of Qualifications

6. Applicant Information

7. Project Date Range

8. Brief Description 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.

Select the institute to which you are applying for a Certificate of Confidentiality:

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.

* Institution Name:

* City:

* Address 1:

* State:

Address 2:

* Postal Code:

Address 3:

* Country:

Address 4:

* Institute Official:

Address 5:

* Title:

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..

* Primary Site:

* Brief Description Of Facilities:

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.

* Title(s):

4. Source

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. If there is no support, type "None".

Select this checkbox if there is no funding support for this project:

* Source:

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/assurances_index.html

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.

* Name Of IRB:

* Letter Of Approval:

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.

* FWA Number:

* Statement Of Qualifications: