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 one non-substantial change 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). OMB approved one
nonsubstantive change to the currently approved collection on May 31, 2024. The
proposed modification is minor edits to the Institutional Assurance statement #6. The
modifications clarify when the investigator will inform individual participants about the
Certificate protections and limitations and when there are any changes to those
protections and limitations. For consistency, the terms used when referring to the
person that provided informed consent were modified. The modifications do not change
the scope of the inquiry, the method of collection, the population of participants outlined
in the original application, or the estimated burden of the collection.
For the proposed modifications to the Institutional Assurance statement #6, we are
clarifying NIH’s expectation of whom will be informed of the Certificate protections and
limitations to the Certificate protections and when there is a change to the protections
and limitations. The current language in statement 6 is as follows: “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 current language
asserts that all participants will be informed of the Certificate protections and limitations.
It would be burdensome for an investigator to inform participants of the Certificate
protections and limitations when consent is not otherwise required, such as when
research is being conducted on existing information and materials (i.e., secondary
research) or when the IRB waived the requirement to obtain informed consent from
individuals. Note the applicable regulations at 45 CFR 46 do not require investigators to
obtain informed consent when the study meets certain conditions, such as in secondary
research. Furthermore, the current statement is silent on informing individuals who

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

previously provided informed consent that the Certificate may not cover data collected
after the Certificate expires or is terminated. It is important to provide participants
updated, relevant information about changes to the Certificate protections, since such a
change may affect the participant’s willingness to continue participating in the research
study. Lastly, for consistency throughout Statement 6, we updated the language
referencing “subjects” and “research participants” to “individuals from whom informed
consent will be obtained”. Modifying these terms encompasses all persons from whom
the investigator obtains informed consent, including research participants, parents (who
provide parental permission/informed consent for their child to be enrolled in the
research) and legally authorized representatives (who provide informed consent for
individuals who are unable to give their own consent, such as an unconscious
individual).
Proposed wording changes are highlighted in YELLOW below. No other questions or
statements have been added or removed to the data collection instrument.
Original Question
Institutional Assurance Statement 5:

Proposed Change
Institutional Assurance Statement 5:

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.

All individuals from whom informed consent
will be obtained 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 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). Individuals who
give informed consent and continue study
participation after the expiration or
termination of the Certificate will be informed
that the protections of the Certificate may not
cover any new data that is collected after the
expiration or termination. Any individual
entering the project after expiration or
termination of the Certificate from whom
informed consent will be obtained will be
informed that the protection afforded by the
Certificate does not apply to them.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Pamela R. Kearney, M.D.

Pamela R.
Kearney -S

Digitally signed by Pamela
R. Kearney -S
Date: 2024.11.04 14:22:41
-05'00'

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