Certificates of Confidentiality
(CoC) External User Guide
March 15, 2024
NOTE: This user guide is an identical PDF version of the online help.
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Contact Us
Additional Help Needed?Please contact the eRA Service Desk (https://www.era.ni-
h.gov/need-help).
Toll-free: 1-866-504-9552; Phone:301-402-7469
Hours: Mon-Fri, 7:00 a.m. to 8:00 p.m. Eastern Time
Feedback on the user guide? Please email the eRA Communications Office (era-
[email protected]).
Disclaimer STATEMENT
No data shown in illustrations represents any real account, project, or individual. Any
resemblance to actual accounts, projects, or individuals is purely coincidental.
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Table ofContents
Table ofContents 4
Latest Updates 6
Welcome to Certificates of Confidentiality (CoC) for External Users Online
Help 7
Help Icon in Module Leads to Online Help 7
Table of Contents Pane 7
Contacting the eRA Service Desk 8
Viewing all Online Help in a PDF Version 9
Showing Hidden Text or Images 9
Tools for Navigating Topics, Showing Hidden Material, and Printing 10
Search Field 11
Finding Related Topics 11
Providing Feedback on the Online Help or PDF 12
About Certificates of Confidentiality 14
Frequently Asked Questions (FAQs) 14
Other Sources of Information 16
Overview of Requesting a Certificate of Confidentiality 17
Starting a Certificate of Confidentiality Request 19
Details on Certificate of Confidentiality Eligibility Questions 21
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Requesting a Certificate of Confidentiality 25
Project Details 25
Institution and Performance Site Details 26
Principal Investigator and Other Key Personnel 30
Administration of Drugs 33
Methods to Submit the CoC Request 34
Verifying a Certificate of Confidentiality 37
Verification Email 37
Confirmation Email 39
Next Steps... 39
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Latest Updates
Updates and new features in Certificates of Confidentiality:
December 4, 2023
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New Look and Feel for Online Help and User Guide
o
The online help and user guide have been updated to the new look and feel,
consistent with the new look and feel of eRA Modules. There are no changes
to the organization or function of the help topics.
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New Confirmation dialog box during verification process.
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Welcome to Certificates of Confidentiality (CoC) for External Users
Online Help
This help system provides online information about the functionality of the Certificates
of Confidentiality (CoC) for External Users module. This topic illustrates the use of this
online help system.
Help Icon in Module Leads to Online Help
Access online help by clicking the Help icon, which is a blue circle containing a white
question mark, from any screen within the Certificates of Confidentiality (CoC) for
External Users module.
Table of Contents Pane
Use the table of contents pane at the left of a help system to navigate through topics. If a
topic name has a down arrow next to it, click it to reveal subheadings.
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When the browser window is narrow, the table of contents pane is hidden. To view a hid-
den table of contents, click the three-horizontal-line icon at right top to toggle the table
of contents between onscreen and hidden.
Contacting the eRA Service Desk
Online help pages contain a link to the eRA Service Desk at top. Contact the service desk
for help with error messages, system questions, and help solving problems in
eRAmodules. The link is located above the page title on all online help pages.
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Viewing all Online Help in a PDF Version
All online help is available in PDF format. The PDF contains identical information as the
online help. The PDF is linked at the top right of every online help page with a link
named PDF Version.
Showing Hidden Text or Images
You might encounter dropdown text or toggled images in online help. Sometimes, to
save screen space and let you focus on the information important to you, online help
hides text or images behind linked text.
For instance, click the following heading to see the hidden dropdown text showing steps
of a procedure:
Creating a New File
1. Click the New button.
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2. Enter a name for the file.
3. Click the Save button.
Images can also be toggled. In the example below, click the words "Access the Edit
action by clicking the three-dot ellipis icon" to see the hidden image.
Tools for Navigating Topics, Showing Hidden Material, and Print-
ing
Click the left and right arrow icons at top right to go to the previous or next topic in the
table of contents:
Click the print icon, below, to print:
Click the expand icon, below, to expand all material that is hidden in a topic.
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Click the collapse icon, below, to collapse all material. The collapse icon appears only
after clicking the expand icon.
Search Field
Type text into the search field to find all topics that contain matching text. Then either
press the Enter key or click the magnifying glass icon to search.
If you type multiple words in the search field, the search assumes an 'AND' between each
word. For example, if you search for system requirements, the search does this: Find all
topics that contain both system AND requirements, not necessarily adjacent to each
other in text. It counts variations of words as a match; for example; require or required
are deemed to be matches for requirements.
If you want only topics that contain an exact phrase, enclose it in double quotation marks
like this:
"system requirements"
The search field searches ONLY the current help system for the Certificates of Con-
fidentiality (CoC) for External Users module. To search all help systems, go to the eRA
website and use the search field at the top of the page.
Finding Related Topics
Most topics contain a Related Topics section, which show links to a list of topics that are
related to the one you are viewing.
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Providing Feedback on the Online Help or PDF
All topics contain a green feedback footer with an email link to the eRACommunications
Office, which creates and updates online help and PDFs. The eRACommunication Office
does not provide technical support but is happy to accept feedback on how we might
make the online help better meet your needs.
For tech support, contact the eRAService Desk instead of the Communication Office.
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About Certificates of Confidentiality
Researchers working on eligible human subjects research projects can use the Online Cer-
tificate of Confidentiality System to request a Certificate of Confidentiality (CoC) from
NIH. A series of questions at the start of the system determines initial eligibility. To learn
about Certificates of Confidentiality, see the NIHCertificates of Confidentiality website
and FAQs, and read below.
Frequently Asked Questions (FAQs)
Below is an abbreviated FAQ on Certificates of Confidentiality. For a comprehensive
policy FAQ, see https://grants.nih.gov/faqs#/certificates-of-confidentiality.htm.
What is a Certificate of Confidentiality?
A Certificate of Confidentiality (Certificate) protects the privacy of research participants
enrolled in biomedical, behavioral, clinical or other types of health-related research that
collect or use identifiable, sensitive information. With limited exceptions, researchers
may not disclose names or any information, documents or biospecimens containing iden-
tifiable, sensitive information. The Certificate prohibits disclosure in response to legal
demands, such as a subpoena.
How do I start a Certificate of Confidentiality request?
See Starting a Certificate of Confidentiality Request.
IMPORTANT: You must know your funding source to determine if and how you obtain a
CoC.
Where do I access the Online Certificate of Confidentiality System?
Go to https://public.era.nih.gov/commonsplus/public/coc/request/init.era OR click the
Get your CoC button from the How to Get a Certificate of Confidentiality? page.
Where can I get help on the eligibility questions?
See Details on Certificate of Confidentiality Eligibility Questions.
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How do I know my request was submitted?
When you first submit the request, you see a message in the browser that it was sub-
mitted for verification:
After the initial CoC request is submitted for verification, the institutional official (IO)
receives an email titled "Verification and submission..." from NIH-CoC-Coordin-
[email protected] with a link. The IO needs to click the link in the email, which opens a
browser page to the submitted request. The IO needs to review the CoC request, correct
any data fields as needed, and then affirm the institutional assurance statements. Once
the IO affirms these statements and submits the request to NIH, the IO will receive a suc-
cess message in the browser:
In a few minutes, the IO and the PI will receive a confirmation email:
Also see Next Stepsfor what happens after a request is received by NIH.
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What if I Experience Problems?
If you have technical problems with the CoC system, contact the eRA Service Desk or
email [email protected].
If you have process or policy-related questions about a CoC request, contact NIH-CoC-
[email protected].
TIP: eRA recommends using Internet Explorer, Mozilla Firefox, or Google Chrome
browsers (Windows) or Safari (Mac).
What Are My Responsibilities if I have a CoC?
To learn about your legal responsibilities and rights regarding data from a research pro-
ject covered by a CoC, go to CoC FAQs and scroll to the following questions under A.
General Information about Certificates:
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What are the recipient’s responsibilities under a Certificate?
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What is the researcher's responsibility to inform participants of a Certificate?
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Is it possible to share information protected by a Certificate with other researchers?
Can such information be shared openly (e.g., on a public website without any
requirements for download)?
Also, see NIH's policy for Issuing Certificates of Confidentiality, located here:https://-
grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html
Other Sources of Information
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Certificates of Confidentiality (CoC) - Human Subjects
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Definition of Human Subjects Research
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NIH's policy for Issuing Certificates of Confidentiality
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Overview of Requesting a Certificate of Confidentiality
This topic is a very general overview of steps to use the Online Certificate of Con-
fidentiality (CoC) System to request a CoC. To learn more about Certificates of Con-
fidentiality and this system, see About Certificates of Confidentiality on page 14.
General steps to use the Online Certificate of Confidentiality System to request a CoC
(For detailed steps, click the linked topics below):
1. First, specify the funding source for your research. Some federal agencies have
their own CoC processes and indicating one of those agencies as a source of fund-
ing directs you to more information for CoCs for those agencies. If the funding
source is covered by the Online Certificate of Confidentiality System, continue to
the eligibility questions.
See Starting a Certificate of Confidentiality Request on page 19
2. Next, answer a set of eligibility questions. The eligibility questions are based on
applicable U.S. law and regulations.
See Details on Certificate of Confidentiality Eligibility Questions on page 21.
3. If the eligibility answers indicate your research is eligible for a CoC, you are shown
the next screen, where you enter the details of your research such as research title,
institution, institutional official, principal investigator, physical and email addresses,
etc. You also specify drugs administered for the study and attach a DEA certificate
for any controlled substances.
See Requesting a Certificate of Confidentiality on page 25.
4. Then you submit the CoC request for verification, after which an email is auto-
matically sent to the institutional official's email address with a link to verify the
request. The email is from [email protected].
See Methods to Submit the CoC Request on page 34.
5. Finally, the institutional official clicks the link in the email, which opens all the data
from the original request in a web page. The institutional official reviews the data,
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makes corrections if necessary, confirms the institutional assurance statements,
and then submits the CoC request to NIH. Both the institutional official and prin-
cipal investigator receive a confirmation email from NIH.
See Verifying a Certificate of Confidentiality on page 37.
NOTE: Using the Online Certificate of Confidentiality System is NOT necessary for NIH-
funded projects, as applicable NIH-funded research studies are automatically deemed
issued a CoC.
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Starting a Certificate of Confidentiality Request
Use the Online Certificate of Confidentiality System to request a Certificate of Con-
fidentiality (CoC), issued by NIH. First, determine your eligibility by answering questions.
Then, if the answers indicate eligibility, enter information about your research and your
institution to complete the request.
A Certificate of Confidentiality request must be completed in its entirety in one Internet
browser session; you cannot save and finish it later. Because of this, you might want to
review the information that you will be asked to provide in the online Certificate of Con-
fidentiality (CoC) system before you begin.
NOTE: At any time during the CoC request process, click the Print button at the right of
the page to display a printer-friendly form with all questions and answers entered thus
far. The browser's print dialog also opens.
To start the CoC request:
1. Go to the How to Get a Certificate of Confidentiality? page.
2. Click the AccessNIHCertificate of Confidentiality System button to open the
Online Certificate of Confidentiality System.
Figure 1: AccessNIHCertificate of Confidentiality System button
3. Select the source of funding from Select Funding Source and click the Next but-
ton. If you select this option:
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National Institutes of Health, your CoC request stops. Research covered by
the NIH CoC Policy is automatically deemed issued a Certificate of Con-
fidentiality. You do not need to use this system to request a CoC.
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Other DHHS agency, then select an option from the Select DHHS Agency
that appears, which lists some Department of Health and Human Services
agencies. For all selections listed, except Other, your CoC request stops. You
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will see a window that directs you to agency-specific directions on NIH's web-
site. Choose Other if your funding agency is within HHS and is not listed in
the drop-down list. Choosing Other continues to eligibility questions.
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Other federal agency, then select an option from the Select Federal
Agency that appears, which lists DOJ (Department of Justice) and Other. If
your funding agency is DOJ, your funding request stops. You will see a win-
dow that directs you to agency-specific directions on NIH's website. Choose
Other if your funding agency is a non-HHS federal agency other than DOJ.
Choosing Other continues to eligibility questions.
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Non-federal, this indicates you are doing research not funded by any federal
department or agency. Choosing Non-federal continues to eligibility ques-
tions. Requestors who have applied but not received funding from NIH may
designate their request as non-Federal. NOTE:You do not need to apply for
a CoC if your research project will not begin until after award.
4. Answer all eligibility questions. These appear only if you choose one of the fol-
lowing:
Other DHHS agency --> Other
Other federal agency --> Other
Non-federal
For specific details on these questions, see Details on Certificate of Confidentiality
Questions.
5. Click the Next button, which takes you to the intake form, where you enter inform-
ation about your research. See Requesting a Certificate of Confidentiality for details
on the next screen.
NOTE: Answering No on question 2, 3, 4, or 5 disqualifies the research project from pro-
ceeding with the CoC request. Answering Yes on question 6, and No on the subsequent
question that appears under question 6 also disqualifies. Contact NIH-CoC-Coordin-
[email protected] with questions related to eligibility for a CoC.
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Details on Certificate of Confidentiality Eligibility Questions
The Online Certificate of Confidentiality System includes questions to determine if a
research project may be eligible to receive a Certificate of Confidentiality (CoC) issued by
NIH. The questions asked are partly derived from United States Code (laws) or the Code
of Federal Regulations (explanations of how agencies carry out laws).
NOTE:
- Non-federally-funded research might also qualify to receive a CoC from NIH.
- The NIH Guide Notice for NIHPolicy for Issuing Certificates of Confidentiality discusses
identifiable, sensitive information, as well as human subject research, in detail.
See the questions below to find out more about each question:
1. Select Funding Source(s) / Select Federal Agency
The only answers to this question that will continue the Online CoC request are Other
DHHS agency --> Other, Other federal agency --> Other, or Non-federal.
DO NOT use the Online Certificate of Confidentiality System if your research is funded by
the NIH. NIH-funded research studies that are within the scope of the NIH CoC Policy are
automatically deemed issued a CoC
In addition, the Online Certificate of Confidentiality System is not the method used to
request a CoC for all federal agencies. If your research is funded by any of the following,
the Online Certificate of Confidentiality System will display an alert message that directs
you to CoC information for the respective agency.
Agencies that have their own process for issuing a Certificate of Confidentiality:
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AHRQ - Agency for Healthcare Research & Quality
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CDC - Centers for Disease Control and Prevention
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FDA - Food and Drug Administration
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HRSA - Health Resources and Services Administration
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IHS - Indian Health Service
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SAMHSA - Substance Abuse and Mental Health Services Administration
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DOJ - Department of Justice
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For research funded by agencies listed above, see the How to Get a Certificate of Con-
fidentiality page on the NIH website for CoC Coordinator contact information at the
applicable funding agency.
2. Does the activity meet the definition of research as defined in 42 cfr§2a.2?
Clicking Yes on this question is consistent with eligibility for a CoC.
This refers to the Title 42 of the Code of Federal Regulations (Public Health), located
here:
https://www.ecfr.gov/cgi-bin/text-idx?SID-
=90791b67270aeed31a19094a24309963&-
&mc=true&node=pt42.1.2a&rgn=div5#se42.1.2a_12
The relevant definition from the code is:
Research means systematic study directed toward new or fuller knowledge and under-
standing of the subject studied. The term includes, but is not limited to, behavioral science
studies, surveys, evaluations, and clinical investigations.
3. Does the activity involve collection or use of identifiable, sensitive information
as defined by 42 U.S.C 241(D)(4)?
Clicking Yes on this question is consistent with eligibility for a CoC.
This refers to Title 42 of the United States Code (Public Health and Welfare) and is loc-
ated at the following website: https://www.ecfr.gov/current/title-42/chapter-
I/subchapter-A/part-2a/section-2a.2
The relevant definition from the code is:
(4) For purposes of this subsection, the term "identifiable, sensitive information" means
information that is about an individual and that is gathered or used during the course of
research described in paragraph (1)(A) an
(A) through which an individual is identified; or
(B) for which there is at least a very small risk, as determined by current scientific
practices or statistical methods, that some combination of the information, a
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request for the information, and other available data sources could be used to
deduce the identity of an individual.
4. Will the activity be conducted in accordance with all applicable federal, state,
and local laws and regulations, including, but not limited to, 45 CFR 46?
Clicking Yes on this question is consistent with eligibility for a CoC.
This question asks you to verify that the research activity complies with all federal, state,
and local laws and regulations, including Title 45 (Public Welfare) Part 46 (Protection of
Human Subjects) of the Code of Federal Regulations, located at the following website:
https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
5. Do all personnel with major responsibilities in the research project have appro-
priate scientific and other training?
Clicking Yes on this question is consistent with eligibility for a CoC.
This question ascertains if personnel who have major research responsibilities also pos-
sess the training necessary to perform the research.
6. Is a waiver or alteration of informed consent under 45 CFR 46 to be used?
Clicking No on this question is consistent with eligibility for a CoC. However, clicking Yes
results in a follow up question to further determine eligibility.
This question asks if you are using the informed consent as described in Title 45 (Public
Welfare) Part 46 (Protection of Human Subjects) of the Code of Federal Regulations. If
you are not using a waiver or alteration to the informed consent described, answer No
to this question.
See section §46.116 at the following website for a description of informed consent:
https://www.ecfr.gov/current/title-45/section-46.116
If you are using a waiver or alteration, answer Yes and another question appears:
If yes, has the waiver or alteration been approved by the IRB in accordance with
45 CFR 46?
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Clicking Yes on this question is consistent with eligibility for a CoC. Clicking Yes means
the waiver or alteration of informed consent has been approved by the reviewing Insti-
tutional Review Board (IRB).
This question appears only if you answered Yes to question 6. Details on obtaining a
waiver or alteration of consent are contained in Title 45 (Public Welfare) Part 46 (Pro-
tection of Human Subjects) of the Code of Federal Regulations, section §46.116.
US Code §46.116, sections (e) and (f), titled, Waiver or alteration of consent in research
involving public benefit and service programs conducted by or subject to the approval of
state or local officials, and General waiver or alteration of consent, provide details on waiv-
ing the requirement to obtain informed consent or altering or omitting some or all of the
elements of informed consent, including IRB findings and approval. See section §46.116
at the following link and scroll to section (e) and (f):
https://www.ecfr.gov/cgi-bin/text-idx?SID-
=57fa58676e7c82a-
aed9f3adb5bb52e7ca&mc=true&node=pt45.1.46&rgn=div5#se45.1.46_1116
After answering all questions, click the Next button to continue.
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Requesting a Certificate of Confidentiality
If your answers to eligibility questions determine that your research is eligible for a Cer-
tificate of Confidentiality (CoC), you will see a data entry screen after answering eligibility
questions and clicking the Next button. Here, you enter the details of your research pro-
ject, contact info, and drug administration details.
All fields with a red asterisk are required. Toggle the sections on the page to expand or
collapse by clicking the View All / Hide All toggle button at the right. Click the Print but-
ton at the right of the page to display a printer-friendly form with all questions and
answers entered thus far.
There are four main sections to the Certificate of Confidentiality Request screen, and two
ways to submit:
Project Details
You must enter the project details before completing other sections of this
form; otherwise you won't be able to save performance sites, key personnel,
or drugs later in the form.
In the top section titled Project Details, enter the following:
Figure 2: Certificate of Confidentiality Project Details screen
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7. Research Project Title.
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8. Project Start Date. This date must be in the future. If the research
has already begun, enter today's date plus one business day. If the
research has not yet begun, enter its future start date.
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9. Project End Date.
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10. Project Description. Include enough detail to show that the
research project falls within the health-related missions of NIH or HHS.
This field is limited to 1000 characters.
Institution and Performance Site Details
If the requesting institution is not in the United States, then at least one of
the performance sites must be in the United States to proceed. If you have
questions about this requirement, contact the NIH CoC Coordinator at NIH-
[email protected].
You will also receive a warning if the institutional official (IO) and the principal
investigator (PI) are the same person or share the same email address. Go to
the Institutional Official definition question in the FAQ . If this information is
accurate, you may proceed through this warning.
In the Institution and Performance Site Details section, complete the fol-
lowing fields:
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Figure 3: Certificate of Confidentiality Institute and Performance Site
Details section
11. Name of Institution — The institution that will be conducting the
research project. For multisite projects in which the coordinating center
or lead site is requesting a Certificate on behalf of all member insti-
tutions (e.g., participating sites), enter the requesting institution name.
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12. Institution Address
TIP: The State field is disabled unless "UNITED STATES" or other applic-
able country is entered as the country. Also, you must use the drop-
down menu to specify State and Country rather than typing the state
or country. Not doing so can result in a submission error.
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13. Name of Institutional Official — The authorized institutional offi-
cial (IO) is the individual named by the requesting institution who is
authorized to act for that institution and assumes on behalf of the insti-
tution the obligations imposed by the Certificate of Confidentiality as
well as obligations imposed by the Federal laws, regulations, and other
requirements. The IO must have signature or other authority to submit
the request.
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14. Email Address of Institutional Official — After you submit the
CoC request, the email address you enter for the IO will receive an email
with a link to the original request. The IO clicks the link, reviews the
request, and agrees to a set of legal obligations imposed by the CoC.
This email address will receive all further communications on this CoC,
so be sure that this email address is correct and routinely monitored.
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15. Phone Number of Institutional Official
Add one or more performance sites. If there is only one performance site, and
it is the same as the institution requesting the CoC, then you can skip enter-
ing information in this field. Click the Add Performance Site & Address but-
ton to display fields for entering performance site data. Then enter the
following:
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Figure 4: Performance Site & Address section
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16. Performance Site Name — Name of institution or other identifier
where the research will mainly take place. For multisite projects, enter
the name(s) of all member institution(s) (e.g., participating sites).
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17. Performance Site Address — Physical address where research will
mainly take place. For multisite projects, enter the physical address(es)
of all member institution(s) (e.g., participating sites).
NOTE: The State field is disabled unless "UNITED STATES" or other applicable
country is entered as the country. Also, you must use the dropdown menu to
specify State and Country rather than typing the state or country. Not doing
so might result in a submittal error.
Click the Save Performance Site button when finished. For multisite pro-
jects, click the Add Performance Site & Address repeatedly to enter the
name(s) of all member institution(s) (e.g., participating sites). A table displays,
listing the performance sites that you have added. You can edit or delete indi-
vidual performance site information by clicking the Edit and Delete buttons
in the Action column of the table:
Figure 5: Table of Performance Sites
Principal Investigator and Other Key Personnel
In the Principal Investigator and Other Key Personnel section, complete the
following fields:
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Figure 6: Certificate of Confidentiality Principal Investigator and Key Per-
sonnel section
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18. Name of Principal Investigator (PI) — The person leading the
research team.
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19. PIPhone
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20. PI Email — The PI will receive a notification when the IO submits
the CoC request to NIH. See Confirmation Email on page 39.
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21. PI Degree — Enter the terminal degree of the PI.
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22. PI Current Position — List the PI's title at the institution.
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23. Other Person to Receive CoC Communications and
Certificate— List another individual who should receive CoC inform-
ation related to your research project. The purpose of this item is to des-
ignate a person in addition to the IO and PI to receive CoC notifications
and correspondence.
If you list the same name for this section as either the IO or the PI, a
same-name warning appears.
Figure 7: IO/PI and Other Person to Receive CoC Communication Same-
Name Warning
If you list the same email address for this section as either the IO or
the PI, a same-email warning appears.
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Figure 8: IO/PI and Other Person to Receive CoC Communications
same-email warning
NOTE: Item 23 is optional, but if you choose to list another person, you
must complete all three fields (First Name, Last Name, Email
Address).
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24. Other Key Personnel
o
Click the Add Key Personnel button to display fields where you
can record key personnel name, degree, and position. Key Per-
sonnel are individuals who contribute to the scientific development
or execution of a project in a substantive, measurable way, whether
or not they receive salaries or compensation.
o
Click the Save Key Personnel button when finished. Click Add
Key Personnel again to add additional individuals if necessary. A
table displays, listing key personnel you have added. You can edit
or delete individual key personnel information by clicking the Edit
or Delete buttons in the Action column of the table:
Figure 9: Other Key Personnel table
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Administration of Drugs
If drugs will be administered as part of the research, complete the following
in the Administration of Drugs section:
Figure 10: Certificate of Confidentiality Project Details screen
1. Click the Add Drug button and enter the following:
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Name of Drug — Example: ibuprofen
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Method of Administration — Example: oral administration
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Dosage — Example:600 mg 2x/day
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2. After entering a drug, click the Save Drug button. Click Add Drug addi-
tional times to enter each drug that will be administered in the study. A
table appears, listing drugs that you have added. You can edit or delete
individual drug information by clicking the Edit or Delete buttons in
the Action column of the table.
3. After you are done adding drug(s), answer Yes or No to "Are all indi-
viduals administering drugs authorized to do so by Federal and State
law?" Answering No will result in a message indicating ineligibility for a
CoC.
4. For item 27, if one or more drugs being administered in your study are
a controlled drug, you must include a PDF copy of the Drug Enforce-
ment Certification of Registration (BND Form 223) under which the
research project will be conducted. If you need to upload multiple cer-
tification forms, merge them into one PDF file. This file must be under 6
MB in size. Merging and compression can be done with Adobe Acrobat.
Do not upload until you are ready to submit the request; see Methods to
Submit the CoC Request on page 34.
Methods to Submit the CoC Request
There are two ways to submit the CoC request: The Upload and Submit Veri-
fication button or Submit for Verification button:
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Use the Upload and Submit for Verification button if there are one
or more controlled drugs that will be administered in your research pro-
ject, which lets you upload your drug enforcement certification of regis-
tration form(s).
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Use the Submit for Verification button if there are no controlled
drugs that will be administered in your research project.
To Submit the CoC Request for Verification:
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1. Before you click on a Submit for Verification button, carefully check
the information you have entered and make corrections, if needed.
2. Print the CoC request for your records using the Print button on the
top right of the web page.
3. Click a Submit button:
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If you don't need to upload a Certification, click the Submit for
Verification button at the bottom of the page:
Figure 11: Submit for Verification button
In the Confirmation Needed dialog, click the Yes button.
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If you need to upload a Certification, click the Upload and Sub-
mit for Verification button (found under the Administration of
Drugs section):
Figure 12: DEA Certification Upload and Submit button
In the Confirmation Needed dialog, click the Yes Proceed with
Upload button, then browse to select the Certification PDF.
4. In the browser, you will see a success message:
Figure 13: Success message
If there are errors on the form, the form is not submitted, and you can scroll
through the form to see the errors in red and correct:
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Figure 14: Example of errors on form
IMPORTANT: After submitting for verification, the CoC request is NOT final.
The individual identified as the institutional official will receive an email with a
link to the requestor's submitted data and must verify the data and confirm
legal obligations imposed by the CoC. Once this is done, the institutional offi-
cial must click the button to submit the CoC request to NIH. See Verifying a
Certificate of Confidentiality on page 37 for details on the institutional official
verification process.
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Verifying a Certificate of Confidentiality
After the initial request is submitted, there is a verification process.
Verification Email
Once the request to apply for a Certificate of Confidentiality (CoC) has been completed
by clicking a Submit for Verification button, the CoC system sends an automated mes-
sage to the email address entered for the institutional official. (see sample email below)
The email is from [email protected].gov with a Subject of: Verification and
submission of COC Application.
Figure 15: CoC verification email
IMPORTANT: The NIH CoC Coordinator is not able to access or view your request until
after the institutional official verifies and submits the request. If you have questions
about your CoC request before the institutional official has taken action, contact the eRA
Service Desk.
1.
At this point, the institutional official (IO) must take the following steps to verify
and submit the CoC request to NIH:
2.
Click the link in the Verification and submission email.
The browser opens to a page that contains the original CoC request.
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3.
Review the information in the request and verify it is correct. Edit and make cor-
rections if necessary.
See Requesting a Certificate of Confidentiality on page 25 for details on fields.
4.
At the bottom of the request, a section titled Assurance Statement appears.
Figure 16: Verification Assurance Statement showing checkbox confirmations for
each statement
5.
Carefully read each institutional assurance statement and mark each checkbox if
you agree that the statement is true.
6.
After selecing all checkboxes, click Submit.
7.
A pop-up confirmation message appears. Click ICertify to verify that the state-
ments are true and complete the submission.
Figure 17: Confirmation messaage for assurance statements with "I Certify" button
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Confirmation Email
Both the IO and the PI will receive a confirmation email such as this, which includes a PDF
of all submitted information:
Figure 18: Success submit email
This email serves as confirmation that NIH received your request. Reference the Request
ID number if you need to contact the eRA service desk regarding this request. Contact
[email protected] if you have CoC policy questions.
Next Steps...
Once the IO verifies and submits the CoC request, the NIH CoC Coordinator can view and
process the request. If NIH has questions about the request, the NIHCoC Coordinator
will contact the PI and IO via email. Typically, NIH processes CoC requests within one
week after receiving the request. After submission, if you don't receive NIH com-
munications regarding the CoC request within a week, contact NIH-CoC-Coordin-
[email protected] to request a status update. When the request is approved, the IO and
PI will receive an email from the NIH CoC Coordinator with a PDF copy of the Certificate.