Change Request Memo

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
National Institutes of Health
Bethesda, Maryland 20892
www.nih.gov

TO:

Office of Management and Budget (OMB)
Through:
Reports Clearance Officer, DHHS __________
Project Clearance Chief, NIH Mikia Currie

FROM:

Dr. Pamela Kearney, Director, Division of Human Subjects Research
Office of Extramural Research (OER)

SUBJECT:

Non-substantial Change Request to Electronic Application for NIH
Certificates of Confidentiality (CoC E-application System) (OMB# 09250689); (Expiration Date: 04/30/2025)

We are writing to request approval of some non-substantial changes to the data
collection instrument for use as part of the Electronic Application for NIH Certificates of
Confidentiality (CoC E-application System) (OMB# 0925-0689). The proposed
modifications are the addition of language to address the institutions’ protection of
personally identifiable information when using any third-party product or entity in the
research study. These modifications do not change the scope of the inquiry, the method
of collection or the population of participants outlined in the original application, or the
estimated burden of the collection.
We became aware that many research studies are utilizing third-party platforms to
collect and or store data, and the end user agreement may state that the data collected
on their platform can be disclosed upon subpoena, which is contrary to the protection of
the CoC. The current Institutional Official (IO) Statement #2 does not include any
language that addresses the research institution’s responsibility to ensure that
personally identifiable information which is collected and or stored for the research
project using a third-party product or entity will be protected against compelled
disclosure. To ensure the institution’s agreement to the protection of participants’
information that is collected and or stored using a third-party product or entity, we have
added the following sentence to the current IO Statement #2: “In addition, this institution
will ensure any third-party product or entity utilized for this project (e.g., contractors,
online platform vendors) to collect or store information can and will protect against the
compelled disclosure of the personally identifiable information.” We also split the current
Statement 2 into two separate sentences. Proposed wording changes are highlighted in
YELLOW below. No other questions or statements have been added or removed to the
data collection instrument.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
National Institutes of Health
Bethesda, Maryland 20892
www.nih.gov

Original Question
IO Statement 2:

Proposed Change
IO statement 2:

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.

This institution agrees to use the
Certificate of Confidentiality to protect
against the compelled disclosure of
personally identifiable information. In
addition, this institution will ensure any
third-party product or entity utilized for
this project (e.g., contractors, online
platform vendors) to collect or store
information can and will protect against
the compelled disclosure of the
personally identifiable information. The
institution agrees to support and defend
the authority of the Certificate against
legal challenges.

Pamela R. Kearney, M.D.

signed by
Pamela R. Digitally
Pamela R. Kearney -S
2023.06.02
Kearney -S Date:
13:46:47 -04'00'

Attachment 1:
Screenshot of Proposed Change to Electronic Application Institutional Assurance
Statement for NIH Certificates of Confidentiality (CoC E-application System)