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

OMB 0925-0689

NIH is requesting a revision for three years. In 2015, NIH launched an on-line application system for researchers to request a Certificate of Confidentiality (CoC) from NIH. Information is collected to allow confirmation of eligibility for a CoC and to issue a Certificate. Eligible requestors will receive an electronic Certificate once approved. Certificates of Confidentiality (CoCs) protect research participants, researchers, and institutions by prohibiting disclosure of identifying information about participants to persons not connected to the research, with limited exceptions. NIH, through its 24 funding Institutes and Centers (ICs), has issued Certificates of Confidentiality since 1997 to researchers who request this protection. NIH-funded researchers are now deemed issued a Certificate upon award of NIH funding and no longer 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 2023-02-28 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 1 Private sector Form and Instruction
Revised assurance statement SEP2023.clean.docx Supplementary Document
Markup assurance statement SEP2023.pdf Supplementary Document
OMB change request SEP 2023.1signed.pdf Justification for No Material/Nonsubstantive Change
Updated assurance statement 06022023.pdf Supplementary Document
OMB change request JUN 2023.pk.pdf Justification for No Material/Nonsubstantive Change
Change Request Memo.docx Justification for No Material/Nonsubstantive Change
pub 30day FRN2022-05474.pdf Supplementary Document
Attachment 2 - List of DHHS CoC Coordinators.docx Supplementary Document
CoC Support_StatementA_FINAL_MAR2022.docx Supporting Statement A
Attachment 3 - Privacy Impact Assessment (PIA) NOV 2021.pdf Supplementary Document
Attachment 4 - NIH Privacy Act Memo Applicability of the Privacy Act_CoC_FEB 2022.pdf Supplementary Document
Private sector Form and Instruction

All Historical Document Collections

202310-0925-001 Approved without change	No material or nonsubstantive change to a currently approved collection	2023-10-05
202306-0925-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2023-06-15
202210-0925-006 Approved without change	No material or nonsubstantive change to a currently approved collection	2022-10-13
202203-0925-001 Approved without change	Revision of a currently approved collection	2022-03-16
202003-0925-001 Approved without change	No material or nonsubstantive change to a currently approved collection	2020-03-05
201912-0925-001 Approved with change	Revision of a currently approved collection	2019-12-23
201610-0925-002 Approved without change	Extension without change of a currently approved collection	2016-11-08
201312-0925-001 Approved without change	New collection (Request for a new OMB Control Number)	2013-12-06

OMB Details

CoC Applications - Private

Federal Enterprise Architecture: Health - Health Care Services

Form 1

NIH Certificates of Confidentiality Request Form Screenshot

Fillable Fileable

Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.