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)
Digitally signed by Pamela R.

Pamela R. Kearney S

SUBJECT:

Kearney -S
Date: 2024.05.21 13:08:06 -04'00'

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 two
nonsubstantive changes to the currently approved collection on October 12, 2023. The
proposed modification is a minor edit to the Institutional Assurance statement #5, to
clarify the institutions’ responsibility to conduct research in compliance with 45 CFR 46,
including the relevant subparts. The modification does 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.
For the proposed modification in the Institutional Assurance statement #5, we are
clarifying NIH’s expectation that institutions submitting a CoC request will comply with
the entirety of 45 CFR Part 46, including the informed consent requirements and the
relevant subparts (i.e., Subparts B, C, and D). The current language in statement 5 is as
follows: “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.” In addition, question 4 in the CoC application, which is completed by a
staff member (e.g., investigator, study coordinator) states: “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?” The question 4 requirement is not
included in the current Institutional Assurance statement. We revised the Institutional
Assurance statement #5 language to include the requirement from question 4, so the
Institutional Official will attest that the research will be conducted in accordance with 45
CFR Part 46 and relevant subparts (even if not specifically required by regulation) as
well as all applicable federal, state, and local laws and regulations throughout the life of
the study.
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
Institutional Assurance Statement 5:

Proposed Change
Institutional Assurance Statement 5:

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.

The research will be conducted in
accordance with 45 CFR 46 and relevant
Subparts (even if not specifically required
by regulation), as well as all applicable
federal, state, and local laws and
regulations throughout the life of the
study.

Pamela R. Kearney, M.D.
Attachment 1:
Screenshot of Proposed Change to Electronic Application Institutional Assurance
Statement for NIH Certificates of Confidentiality (CoC E-application System)