Change Request Memo CoC System

DEPARTMENT OF HEALTH&, HUMAN SERVICES

Public Health Service
National Institutes of Health
National Institute of
General Medical Sciences
Bethesda, Maryland 20892-6200
http://www.nigms.nih.gov

Febuary 27, 2020
TO:

Office of Management and Budget (0MB)
Through:
Debbie Kramer, Reports Clearance Officer, DHHS _____
Mikia Currie, Project Clearance Chief, NIH _____

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: 02/28/2023)

We are writing to request approval of some non-substantial changes to data collection
instruments scheduled for use as part of the Electronic Application for NIH Certificates
of Confidentiality (CoC E-application System) (OMB# 0925-0689). The proposed
modifications are wording changes to add clarity for respondents. They 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.
For clarification purposes, we have modified the wording of the two questions below: 1)
Question 6, to further specify what is meant by the term "modification of informed
consent" and to be consistent with regulatory language; and 2) the last item in Question
1.6.1., to clarify language about disclosures outside the scope of coverage of the
Certificate; and expand on and clarify the examples of such disclosures. Proposed
wording changes are highlighted in YELLOW below. No questions have been added or
removed to the data collection instrument.
Oriainal Question
6. Is a modification of informed consent
under 45 CFR46 to be used?

Proposed Change
6. Is a waiver or alteration of informed
consent under 45 CFR46 to be used?

If yes, has the modification been approved by
the IRB in accordance with 45 CFR46?

If yes, has the waiveF or alteration been
approved by the IRB in accordance with 45
CFR46?

1.6.1. 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 outside the
scope of coverage of the Certificate (e.g.
infectious disease child or elder abuse
reporting as required by Federal, State, or
local laws). 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.

1.6.1. 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
reP.orting). 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.

Pamela R. Kearney, M.D.
Attachments:
Screenshots of Proposed Electronic Application for NIH Certificates of Confidentiality (CoC £­
application System)