Form 1 Certification of Confidentiality

1.0 CoC Screens
1.1 CoC User Interface, Question 1

1.2 Burden Statement

1.3 User Interface: Certification, Questions 2-6

Certificate of Confidentiality Request

1.3 User Interface, Certification Questions 7-16, Research, Institution, and Performance Sites
Project Details

7. Research Project Title*
8. Project Start Date*
9. Project End Date*
10. Project Description*
Institution and Performance Site Details

11. Name of Institution*

12. Institution Address:
Street Address*

City*
State*
Country*
Zip Code
13. Name of Institutional Official*
14. Email Address of Institutional Official*
15. Phone Number of Institutional Official
Peformance Site and Addresses

16.

Performance Site Name*

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1.3 User Interface: Certification, Questions 17-24, Performance Site, Principal Investigator, Other Person, Key Personnel
17.

Performance Site Address*
Street Address line 2
Street address line 3
City*
Country*
State*
Zip Code

Principal Investigator and Other Key Personnel

18. Name of Principal Investigator (PI):
Middle Name
First Name*

Last Name*

19. PI Phone
20. PI Email*
21. PI Degree*
22. PI Current Position*
23. Other Person to Receive CoC Communications and Certificate:
First Name
24.

Last Name

(New)

Email Address of Other Person

Other Key Personnel

First Name

Middle Name

Last Name

Other Key Personnel Degree
Other Key Personnel Current Position

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1.3 User Interface: Certification, Questions 25-26, Administration of Drugs
Administration of Drugs

25. List any drugs that will be administered in this study, including method of administration and dosage (e.g.
Phenobarbital 50 mg 2 times daily)
Name of Drug

Method of Administration

Dosage

26. Are all individuals administering drugs authorized to do so by Federal and State Law?
Yes

No

1.4 For Instructional Purposes Only
1.41 User Interface

Instructions Only
After the user completes questions 1-26, she/he will submit the CoC request.
• The user will click on the Submit for Verification button. Once the button is clicked, a message appears:
Confirmation Needed. The user will click Yes.
• If any of the drugs being administered are a controlled substance, the user will click on the Upload and
Submit for Verification button. The screen displays the following instructions: Please submit all
documents as a single PDF. If more than one Drug Enforcement Certification of Registration will be
submitted, please merge documents into a single file prior to submission. Once the button is clicked, a
message appears: Confirmation Needed. The user will click: Yes Proceed with Upload and will then
browse to select the upload the BND form 223.
The browser will display a success message:

If there are errors on the form, the form is not submitted and the user can scroll through the form to see the
errors in red and correct:

Once corrected, the user will repeat the steps above to submit the CoC request.
The request will trigger the system to send an email to the Institutional Official (IO) email addresses with a PDF
copy of the CoC request. The email will contain an encrypted link, with the following information: Verification
and submission is needed for the following CoC application. When the Institutional Official clicks on the link,
she/he will be redirected to the CoC form to review and verify the information is correct. The IO will make
corrections if necessary. At the bottom of the request is a section titled Assurance Statement

1.42 User Interface

Instructions Only
IO Assurance Statement questions
Assurance Statement

*This request is submitted by an institutional official who has signature or other authority to submit this request.
*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 understands that research information protected by a Certificate of Confidentiality is subject to the
protections and the disclosure requirements noted in 42 U.S.C 241 and 42 CFR Sect. 2a. Any investigator or institution
conducting research protected by a Certificate of Confidentiality SHALL NOT disclose or provide to any other person not
connected with the research the name of such an individual or any information, document, or biospecimen that contains
identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research
without the specific consent of the individual to whom the information pertains or as otherwise permitted in accordance with
42 U.S.C 241 and 42 CFR Sect. 2a.
*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.
*The institution and personnel involved in the conduct of the research will comply with the informed consent requirements
of the applicable Federal regulations, including 45 CFR Part 46.
*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 and disclosures that are outside the scope of coverage of the Certificate (e.g. public health
reporting as required by Federal, State, or local laws, or requirements for child or elder abuse reporting). 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.
The IO will read each institutional assurance statement and mark each checkbox if she/he agrees that the statement is true. When all
checkboxes are marked, the IO will click on the submit button.
The IO, PI, and other person will receive a confirmation email from the system, which includes a PDF attachment of all submitted
information.
NEW
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1.5 Burden Disclosure

When the Burden Disclosure link is selected on any system screen, the Burden Disclsoure pop-up
shown in section 1.5.1 will appear on the screen.

1.5.1 User Interface