NCHS Determination: ERB Approval Not Required

Date received:

NCHS Protocol Determination Request Form
The purpose of this form is to guide investigators through a series of questions to help determine the required
level of review for submissions according to the HHS Policy for Protection of Human Subjects regulation (45
CFR 46) and the NCHS Practices and Procedures for the Protection of Human Subjects. In some instances, the
investigator will be asked to provide additional information to justify his/her response. Ultimately, this
information will be used to determine if the proposed activity is exempt research, non-exempt human
subjects research, is not considered research, not considered research involving identifiable human subjects
(e.g., surveillance), or is non-exempt human subject research in which NCHS is not engaged (e.g., an NCHS
investigator with solely an advisory role to a non-NCHS research project).
Which projects need to use this form?
• New Data Collection Projects involving NCHS investigators
• Amended Data Collection Projects involving NCHS investigators
• Non-NCHS Data Collection Projects involving NCHS investigators (Non-NCHS data collections in which
NCHS investigators solely serve in an advisory role)

Protocol Title: National Survey of Family Growth (2022-2029) (or should we start in 2021?)
NCHS Primary Contacts

Name and degrees

(First name Last name, Degrees)

Primary Contact Anjani Chandra, Ph.D.

User ID
ayc3

CITI Expiration Telephone#
Date
5/23/2024
301-458-4138

NCHS Division/Branch
DVS/RSB

Principal Investigator/
Project Advisors
Same as above

Section 1: Activity Classification
Yes
X

No
1. Does the activity involve obtaining information about living individuals? (If no, go to Section 4 to

provide a project summary and justification for your response. The activity does not involve
human subjects; however, it is subject to review by the Human Subjects Contact.)
X 2. Is the activity for administrative purposes only? (If yes, go to Section 4 to provide a project

summary and justification for your response. The activity does not involve human subjects;
however, it is subject to review by the Human Subjects Contact.)

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Yes

No

x

3. Is the activity conducted, supported, requested, ordered, required, or authorized by NCHS? (If no,
go to Section 4 to provide a project summary and justification for your response.)
x

4. Is the activity limited to the collection or study of data, documents, records, or biospecimens that
were collected for some other primary or initial activity? (If yes, this is solely a secondary data
collection; skip to Section 3 Question #1. If no, this activity includes primary data collection; go to
Section 2 Question #1. Projects with both primary and secondary collection should respond with
“no” and proceed to Section 2 Question #1.)

Section 2: Primary Data Collection
Yes
X

No
1. Does the activity involve intervention or interaction with the individual about whom the data are

collected, or with their legally authorized representative? (If yes, skip to Section 2 Question #4.)
2. Is the information individually identifiable and can the identity be readily ascertained by the
investigator or associated with the information? (If no, go to Section 4 to provide a project
summary and justification for your response. The activity does not involve human subjects;
however, it is subject to review by the Human Subjects Contact.)
3. Is the information private? Private information includes information about behavior that occurs in
a context in which an individual can reasonably expect that no observation or recording is taking
place, and information that has been provided for specific purposes by an individual and that the
individual can reasonably expect will not be made public (e.g., a medical record). (If no, go to
Section 4 to provide a project summary and justification for your response. The activity does not
involve human subjects; however, it is subject to review by the Human Subjects Contact.)
X

4. Is the activity considered to be public health surveillance? As defined by §46.102: Public health
surveillance activities [include] the collection and testing of information or biospecimens [and are]
conducted, supported, requested, ordered, required, or authorized by a public health authority.
Such activities are limited to those necessary to allow a public health authority to identify,
monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or
conditions of public health importance (including trends, signals, risk factors, patterns in diseases,
or increases in injuries from using consumer products). Such activities include those associated
with providing timely situational awareness and priority setting during the course of an event or
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crisis that threatens public health (including natural or man-made disasters. (If yes, go to Section 4
to provide a project summary and justification for your response that addresses the NCHS’ role in
the activity. The activity is excluded from the Common Rule. The NCHS Practices and Procedures
apply and NCHS ERB review is required.)
Yes

No
5. Is the activity a systematic investigation (an activity that is planned in advance and that uses data
collection and analysis to answer a question) designed to develop or contribute to generalizable
knowledge? (If no, go to Section 4 to provide a project summary and justification for your
response. The activity is excluded from the Common Rule. The NCHS Practices and Procedures
apply and NCHS ERB review is required.
6. Does the research involve only survey procedures, interview procedures, and/or benign
behavioral interventions? (If no, skip to Section 2 Question 8.)
7. Does the research involve children? (If no, go to Section 4 to provide a project summary and
justification for your response. The activity is research involving human subjects, but it is eligible
for exemption from the Common Rule. Complete and submit both the 1255x and 1379 forms in
support of an exemption request. The NCHS Practices and Procedures do apply and NCHS ERB
review is required.)
8. Is the research eligible for exemption under any other provisions of 45 CFR 46.104? (Exemption
categories are noted on page 9. If yes, go to Section 4 to provide a project summary and
justification for your response. The activity is research involving human subjects but is eligible for
exemption from the Common Rule. Complete and submit both the 1255x and 1379 forms in
support of an exemption request. The NCHS Practices and Procedures do apply and NCHS ERB
review is required. If no, the activity is research involving human subjects, and the research is not
eligible for exemption from the Common Rule, go to Section 4 to provide a project summary and
justification for your response. The research involves human subjects and requires IRB review
consistent with the HHS Policy for Protection of Human Subjects. Complete and submit both the
1255 and 1379 forms in support of an IRB Review. If this is a subsequent request for change,
rather than an initial review, use a 1257 form instead of the 1255.)

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Section 3: Secondary Use Activity
Yes

No

1. Are the data, documents, records, or biospecimens individually identifiable and can the identity
be readily ascertained by the investigator or associated with the information? (If no, go to Section
4 to provide a project summary and justification for your response. The activity does not involve
human subjects; however, it is subject to review by the Human Subjects Contact.)
2. Is the information private or does the activity involve identifiable biospecimens? Private
information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is taking place, and information that has
been provided for specific purposes by an individual and that the individual can reasonably expect
will not be made public (e.g., a medical record). (If no, go to Section 4 to provide a project
summary and justification for your response. The activity does not involve human subjects;
however, it is subject to review by the Human Subjects Contact.)
3. Is the activity considered to be public health surveillance? As defined by §46.102: Public health
surveillance activities [include] the collection and testing of information or biospecimens [and are]
conducted, supported, requested, ordered, required, or authorized by a public health authority.
Such activities are limited to those necessary to allow a public health authority to identify,
monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or
conditions of public health importance (including trends, signals, risk factors, patterns in diseases,
or increases in injuries from using consumer products). Such activities include those associated
with providing timely situational awareness and priority setting during the course of an event or
crisis that threatens public health (including natural or man-made disasters). (If yes, go to Section
4 to provide a project summary and justification for your response. The activity is excluded from
the Common Rule. The NCHS Practices and Procedures apply and NCHS ERB review is required.)
4. Is the activity a systematic investigation designed to develop or contribute to generalizable
knowledge? (If no, go to Section 4 to provide a project summary and justification for your
response. The activity is excluded from the Common Rule. The NCHS Practices and Procedures
apply and NCHS ERB review is required.
5. Does the research involve identifiable private information (not identifiable biospecimens) that
was generated or collected by the Federal government, and was the information originally
obtained for non-research activities (e.g., for public health surveillance or administrative
purposes)? (If yes, the activity is research involving human subjects, but is eligible for exemption
from the Common Rule. Go to Section 4 to provide a project summary and justification for your
response. Also, complete and submit both the 1255x and 1379 forms in support of an exemption
request.)
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Yes

No

6. Does the research involve the use of identifiable biospecimens, and was regulatory broad consent
obtained for the storage, maintenance, and secondary research use of the biospecimens? (If yes,
the activity is research involving human subjects, but is eligible for exemption from the Common
Rule. Go to Section 4 to provide a project summary and justification for your response. Also,
complete and submit both the 1255x and 1379 forms in support of an exemption request.)
7. Is the research eligible for exemption under any other provisions of 45 CFR 46.104? (Exemption
categories are noted on page 9. If yes, go to Section 4 to provide a project summary and
justification for your response. Also, complete and submit both the 1255x and 1379 forms in
support of an exemption request. If no, the activity is research involving human subjects, and the
research is not eligible for exemption from the Common Rule. Go to Section 4 to provide a project
summary and justification for your response. Also, complete and submit both the 1255 and 1379
forms in support of an IRB Review. If this is a subsequent request for change, rather than an initial
review, use a 1257 form instead of the 1255.)

Section 4: Protocol Summary and supporting justification (Please provide a summary of the
project below and attach copies of the complete protocol. Proposed surveillance projects
should include text with justifications that are consistent with the definition of public health
surveillance. Likewise, data collection efforts submitted as not meeting the definition of
human subjects research should provide text that would support that position. And finally,
projects claiming eligibility for exemption should document the basis for that conclusion.)
If NCHS staffers have a limited role in the activities captured in the attached protocol (for
example, only serving in an advisory capacity or only analyzing the data), please be sure to
document those distinctions both within this summary and the actual protocol.

This is a new protocol submission to conduct the National Survey of Family Growth
(NSFG) over its next 8 years of data collection, from January 2022 through December 2029 as a
surveillance project. As defined by §46.102: Public health surveillance activities [include] the
collection and testing of information or biospecimens [and are] conducted, supported,
requested, ordered, required, or authorized by a public health authority. Such activities are
limited to those necessary to allow a public health authority to identify, monitor, assess, or
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investigate potential public health signals, onsets of disease outbreaks, or conditions of public
health importance (including trends, signals, risk factors, patterns in diseases, or increases in
injuries from using consumer products).

Since 1973, NSFG has been conducted by the National Center for Health Statistics
(NCHS), part of the Centers for Disease Control and Prevention (CDC), with the collaboration
and support of several other groups within the Department of Health and Human Services
(DHHS). NCHS, under its duties specified in 42 U.S.C. 242k, Section 306(a and b)(1)(h) of the
Public Health Service Act, conducts the NSFG to collect and disseminate “statistics on family
formation, growth, and dissolution.” The NSFG supplements and complements the data from
birth and fetal death certificates on factors (such as sexual activity, contraception, marriage
and cohabitation, and infertility) that affect birth and pregnancy rates. In addition, the NSFG
serves a variety of data needs in public health programs and agencies in DHHS that sponsor
and depend on it. The data are used to track key indicators over time as well to conduct
generalizable research based on the U.S. household population. Throughout its history, NSFG
has been administered in person, in English and Spanish, with a self-administered portion
added in more recent survey periods. Under the plan laid out in this protocol, NSFG builds on
its past survey design and procedures and incorporates online administration into a multiphase, multi-mode design. About 5,000 people aged 15-49 are to be surveyed each year.

Section 5: Signatures
As the Principal Investigator, I hereby accept responsibility for conducting this project in an ethical manner,
consistent with the NCHS Practices and Procedures for the Protection of Human Subjects and to abide by the
principles outlined in federal policies for the protection of human subjects according to 45 CFR 46.
Principal Investigator’s Signature:
Date:

/

signed by Anjani Chandra -S
Anjani Chandra -S Digitally
Date: 2021.08.10 15:37:27 -04'00'

___________________

/

Remarks:

As the supervisor of the Principal Investigator, I hereby accept responsibility for conducting this project in an
ethical manner, consistent with the NCHS Practices and Procedures for the Protection of Human Subjects and
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to abide by the principles outlined in federal policies for the protection of human subjects according to 45 CFR
46.
signed by Isabelle L. Horon -S
Isabelle L. Horon -S Digitally
Date: 2021.08.11 07:15:14 -04'00'
__________________
Branch Chief’s Signature:

Date:

/

/

Remarks:

As the supervisor of the Principal Investigator, I hereby accept responsibility for conducting this project in an
ethical manner, consistent with the NCHS Practices and Procedures for the Protection of Human Subjects and
to abide by the principles outlined in federal policies for the protection of human subjects according to 45 CFR
46.
Division Director’s Signature:
Date:

/

signed by Steven Schwartz
Steven Schwartz Digitally
Date: 2021.08.10 17:36:27 -04'00'
_____________________

/

Remarks:

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Section 6: Supplemental Questions to be Completed by the HSC/ERB Chair
Yes

No
X 1. Does the activity involve only the use of identifiable private information that was shared (or will

be shared) with NCHS by another government agency? (If no, skip to Section 6 Question 3.)

2. Will the government-generated or government-collected information be linked to other NCHSgenerated or NCHS-collected data using direct identifiers?
X 3. Does NCHS currently have custody of the identifiable private information? (If yes, the ERB will

determine if the secondary use is within the scope of consent or data sharing agreement. If no, the
ERB will determine if the information to be provided to the data custodian is consistent with NCHS
Practices and Procedures for secondary use activities.)
Human Subject Contact Office Use Only
Proposed activity does NOT involve human subjects (No institutional Review Needed.)
Date:

HSC Signature:

Remarks:

X Proposed activity DOES involve human subjects but is EXCLUDED from the purview of 45 CFR 46, 2018
requirements (e.g., public health surveillance, per 46.102)
Date: 08/11/2021

HSC Signature: Verita C. Buie -S

Digitally signed by Verita C. Buie -S
Date: 2021.08.11 13:22:59 -04'00'

Remarks: The activities captured in this submission meet the definition for public health surveillance.

Proposed activity is human subjects research that is NOT EXCLUDED* from the purview of 45 CFR 46, 2018
requirements
Date:

HSC Signature:

Remarks:

* This proposed activity needs to be referred to the NCHS ERB for further determination and processing
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NCHS ERB Chair Use Only

NCHS’ Ethics Review Board Chair Determination
Yes

No

NCHS’ Ethics Review Board Chair has determined that this proposed activity is EXEMPT from the
full extent of 45 CFR 46, 2018 requirements.
(This proposed activity is subject to NCHS ERB review per internal Practices and Procedures for
the Protection of Human Subjects. This proposed activity may need certification from the
Confidentiality Officer and be subject to Limited Review under 45 CFR 46 and HRPO registration
and processing.)
Please check one or more applicable exempt categories under 45 CFR 46, below (see 46.104(D)
for full descriptions and additional, necessary criteria involving these):
Research conducted in educational settings that specifically involves normal educational practices
Research that only includes interactions involving educational tests, survey procedures, interview procedures, or
observation of public behavior

Research involving benign behavioral interventions in conjunction with the collection of information from an adult
subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively
agrees to the intervention and information collection
Secondary research uses of identifiable private information or identifiable biospecimens
The identifiable private information or identifiable biospecimens are publicly available
Information, which may include information about biospecimens, is recorded by the investigator in such a
manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers
linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify
subjects
The research involves only information collection and analysis involving the investigator's use of identifiable
health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the
purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public
health activities and purposes” as described under 45 CFR 164.512(b)
The research is conducted by, or on behalf of, a Federal department or agency using government-generated or
government-collected information obtained for nonresearch activities, if the research generates identifiable
private information that is or will be maintained on information technology that is subject to and in compliance
with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private
information collected, used, or generated as part of the activity will be maintained in systems of records subject
to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected
subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
Research and demonstration projects that are conducted or supported by a Federal department or agency that are
designed to study, evaluate, improve, or otherwise examine public benefit or service programs. Such projects include,
but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements,
cooperative agreements, or grants.
Taste and food quality evaluation and consumer acceptance studies
Storage or maintenance for secondary research for which broad consent is required
Research involving the use of identifiable private information or identifiable biospecimens for secondary research use
for which broad consent is required

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If the proposed activity is classified as EXEMPT research above, please indicate:
Yes

No

This exempt research requires that NCHS’ ERB refer the package to HRPO’s Lead Administrator
for IRB review under the provisions of Limited Review per 46.104(d) and 46.111(a)(7) or
46.111(a)(8).

Check below if the proposed activity is research (i.e., NOT EXCLUDED) and NOT EXEMPT:
Yes

No

This research requires that NCHS’ ERB refer the package to HRPO’s Lead Administrator for IRB
review under the full provisions of 45 CFR 46.

Check below if the proposed activity does not meet the definition of human subjects
research or is excluded from 45 CFR 46, 2018 requirements (for example, surveillance
projects):
Yes

No

Date:

This activity has been reviewed and approved by the NCHS’ ERB to be in compliance with NCHS
Practices and Procedures.
ERB Chair Signature:

Remarks:

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