OMB control number

Electronic Application for NIH Certificates of Confidentiality (CoC E-application System)

OMB 0925-0689 · HHS/NIH.

OMB 0925-0689

NIH is requesting a reinstatement without change to continue use the online Certificate of Confidentiality (CoC) application system for the next three years. In 2015, NIH launched an online application system for researchers to request a discretionary CoC from NIH. In 2020, NIH launched a new CoC online request system with fewer data fields than the 2015 system, to decrease burden on the requester and NIH staff. Information is collected to allow confirmation of eligibility for a CoC and to issue a Certificate. Eligible requesters receive an electronic Certificate once approved. In 2022, NIH received OMB approval for the revision to the CoC system data fields to add an optional data field that allows the researcher to identify another person to receive CoC system communication and the approved CoC. Since then, there has been several non-substantial change memo requests to make minor updates to the system. For this request, NIH does not request any revisions and requests a reinstatement without change. CoCs protect research participants by prohibiting disclosure of identifying information about participants to persons not connected to the research, with limited exceptions. NIH, through its funding Institutes, Centers, and Offices (ICOs), has issued CoC since 1997 to researchers who request this protection. Since 2016, NIH-funded researchers are deemed issued a Certificate upon award of NIH funding and do not need to request a Certificate through the system. Non-NIH funded researchers may continue to request a CoC through the online system.

The latest form for Electronic Application for NIH Certificates of Confidentiality (CoC E-application System) expires 2028-08-31 and is listed under ICR 202507-0925-001.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form 1 FormForm
Form 1 ApplicationForm
Form 1 Private sectorForm
30-day Comment Tracking Log_0925-0689_FINAL.docxSupplementary Document
Public Comment_Certificates of Confidentiality Submission System.pdf (document unavailable)Public Comments
PC_202507-0925-001_080825_054810_1.pdf (document unavailable)Public Comments
Public Comment RE NIH CoC_2025.08.07.docx (document unavailable)Public Comments
PC_202507-0925-001_080725_051338_1.pdfPublic Comments
UC Comments on NIH CoC Notice_final_7.22.25.pdfPublic Comments
PC_202507-0925-001_072225_120655_1.pdfPublic Comments
PC_202507-0925-001_071425_122131_1.pdfPublic Comments
30day FRN.pdfSupplementary Document
30day FRN.pdf Supplementary Document
NIH CoC Support Statement A.docxSupporting Statement A
Attachment 2 - List of DHHS CoC Coordinators.docxSupplementary Document
Attachment 2 - List of DHHS CoC Coordinators.docx Supplementary Document
Attachment 4 - NIH Privacy Act Memo Applicability of the Privacy Act_CoC_FEB 2022.pdfSupplementary Document
Attachment 4 - NIH Privacy Act Memo Applicability of the Privacy Act_CoC_FEB 2022.pdf Supplementary Document
Attachment 3 - Privacy Impact Assessment (PIA).pdfSupplementary Document
Attachment 3 - Privacy Impact Assessment (PIA).pdf Supplementary Document
Private sector Form
Private sector Form
Private sector Form