Attachment C_IRB Exemption for ACF-Sponsored Analysis of Performance Measures

IRB Review of Research Ethics Protocols for the Protection of Human Subjects
EXEMPTION FROM ON-GOING REVIEW
Project Title:

Building Usage, Improvement, and Learning with Data in Healthy
Marriage and Responsible Fatherhood Programs (BUILD HMRF)

HML IRB Review ID#:

837MATH21x

Principal Investigator:
Degree(s), address, email

Grace Roemer, M.S.,
Project Director
Mathematica
600 Alexander Park, Princeton, NJ 08540
[email protected]
Mathew Stange, deputy project director, Ph.D.

Other Key Personnel:
Title, degree(s):
Primary study site(s):

Administrative data only for human subjects participating in federal grant
programs from 4/1/2021-9/30/2025

Participation of Human Subjects
From – to dates

NA

Funding Source:
PO Number:
or other billing info required by your organization

Administration for Children and Families (ACF)
Purchase Order number 310369

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Date of IRB Request
Date(s) IRB Comments Returned
Date Final Documents Received
DATE OF IRB APPROVAL

28 January 2021
None
None
29 January 2021

Exemptions from IRB Review
Check all that apply
1. Research conducted in educational settings that involves educational practices not likely to adversely affect students'
opportunity to learn required content, or educators who provide instruction. This includes research on instructional
strategies, on the effectiveness or comparison of instructional techniques, curricula, or classroom management methods.

2. Research involving educational tests, survey procedures, interview procedures, or observations of public behavior, if at
least one of the following criteria is met:
a. Data are obtained in a way that identity of the subjects cannot be ascertained, directly or through identifiers linked to the
subjects; or
b. Disclosure of subjects' responses will not place them at risk of criminal or civil liability, or be damaging to their financial
standing, employability, education, or reputation; or
c. Data are obtained in a way that identity of the subjects can be ascertained, directly or through identifiers linked to the
subjects, and an IRB conducts a limited review to make the determination that confidentiality is maintained.
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Check
(X)
here

Page 3

3. Research involving benign behavioral interventions in conjunction with data collection from consenting adult subjects, if
at least one of the following criteria is met:
a. Data are recorded in a way that identity of the subjects cannot readily be ascertained, directly or through identifiers
linked to the subjects; or
b. Disclosure of subjects' responses will not place them at risk of criminal or civil liability, or be damaging to their financial
standing, employability, education, or reputation; or
c. Data are obtained in a way that identity of the subjects can be ascertained, directly or through identifiers linked to the
subjects, and an IRB conducts a limited review to make the determination that confidentiality is maintained.
Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a
significant adverse lasting impact on subjects, and the investigator has no reason to think subjects will find the interventions
offensive or embarrassing. Examples of benign behavioral interventions include having subjects play an online game, solve
puzzles under various noise conditions, or having them decide how to allocate cash between themselves and someone
else.
If the research involves deceiving subjects regarding the nature or purpose of the research, this exemption is not applicable
unless subjects authorize the deception through a pre-agreement to participate in research where they are informed that
they will be misled regarding the nature or purpose of the research.
X
4. Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following
criteria is met:
a. The identifiable private information or biospecimens are publicly available;
b. Data are recorded in a way that identity of subjects cannot readily be ascertained, directly or through identifiers linked to
subjects, investigators do not contact subjects, and investigators will not re-identify subjects; or
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c. The research involves only information collection and analysis involving the investigator's use of identifiable health
information when that use is a part of public health or medical surveillance.
d. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or
government-collected information obtained for non-research 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 storage and
privacy regulations of that department or agency.

5. Research and demonstration projects that are conducted or supported by a Federal department or agency, and are
designed to study, evaluate, improve, or examine public benefit or service programs, including procedures for obtaining
benefits or services under those programs, possible changes or alternatives to those programs, or possible changes in
methods or levels of payment for benefits or services under those programs. These projects include, but are not limited to,
internal studies by Federal employees, as well as studies under contracts or consulting arrangements, cooperative
agreements, or grants.
Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and
1115A of the Social Security Act, as amended.
Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a
publicly accessible Federal Web site or as the department or agency head may determine, a list of their research and
demonstration projects conducted or supported under this provision. The project must be published on this list prior to
commencing the research involving human subjects.

6. Taste and food quality evaluation and consumer acceptance studies:
a. If wholesome foods without additives are consumed, or

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b. If a food is consumed that contains an ingredient at or below the level found to be safe, or an agricultural chemical or
environmental contaminant at or below the level found to be safe by the FDA, or approved by the EPA or the Food Safety
and Inspection Service of the USDA.
X
7. Storage or maintenance for secondary research where broad consent is required:
Storage or maintenance of identifiable private information or biospecimens for potential secondary research use if an IRB
conducts a limited IRB review and makes the determinations that risks to subjects have been minimized, are reasonable in
relation to benefits, that subject selection is equitable, that informed consent is sought, and that monitoring and storage of
data is secure.
X
8. Secondary research where broad consent is required. Research involving the use of identifiable private information or
biospecimens for secondary research use, if the following criteria are met:
a. Consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable
biospecimens is obtained.
b. Documentation of informed consent or waiver of documentation of consent is obtained.
c. An IRB conducts a limited review and makes the determination that the research is within the scope of the consent; and
the investigator does not include returning individual research results to subjects as part of the study plan. This provision
does not prevent an investigator from abiding by any legal requirements to return individual research results.

HML IRB
1101 Connecticut Avenue, NW Suite 450
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+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
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→ PROCESS:

HML IRB will conduct a research ethics review of submitted materials and determination of
exemption status, and make comments below.
We will then return this template for responses from researchers.
Please reply in the right-side column, and we will issue a letter of approval or ask for further clarification.

Ethics Review Board
Criteria of Interest
Section

1.3

Research Risk: Do submitted materials address
potential risks to subjects?
Minimal Risk Only: The probability and magnitude of
anticipated harm or discomfort is not greater than
ordinarily encountered in daily life or during performance
of routine physical or psychological exams or tests
Research may be approved as exempt if it is not greater
than minimal risk and fits one of the exempt review
categories as defined by federal regulation 45 CFR 46,
above.
Exemption category or categories from above =

1.4

Comments, amendments, additions, or revisions

1
1.1

1.2

I.

IRB
OK

Section
II.

Reviewer Comments or
Requests for More Information
Researchers: Please respond to IRB’s red
comments in another color

NA

Please keep us informed of any subject protection protocol
or research design changes that need to take place in
adaptation to the COVID-19 pandemic

X

X
X

2
2.1
2.2
2.3

Research Design: Do submitted materials describe
the proposed research?
Background and rationale
Description of methodology
Are all documents final versions?

X
X
NA

2.4
2.5

Does study involve an intervention or treatment group?
Does study involve a comparison or control group?

X
X

Please respond.

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2.6

2.

2.8
2.9
2.10
Section

3
3.1

3.2

Type of data collection:
a. survey questionnaire…………………….……..
b. subject interview…………………………………
c. key informant interview (KII)…………..……….
d. focus group discussion (FGD)……………..…..
e. document review…………………..……………
f. on-site observation……………….…..………..
g. case study……………………………………….
h. physical measurements ……………………….
i. biological specimen ……………….….…….…
j. other..…………………………………..…...……
Secondary data analysis
Number of Data Collections:
a. one-time (no follow-up)………………………….
b. two or more (follow-up) ………………….……...
Sample size: Total n or approximate n =
Are any subjects children (<18 years old)?
13 – 17 yo
Comments, amendments, additions, or revisions
Recruitment: Do submitted materials describe
subjects and the recruitment process?
Subject identification:
a. subjects’ names are recorded ……………….
b. no names are recorded .…………………..….
c. other personally identifiable information (PII) is
recorded ………………………………….……
d. no PII is recorded …………………………..…
e. subjects are given a unique identifier...................X
If name or any other PII is recorded, are procedures

X

NR
X
X

X

X

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3.3
3.4
3.5
3.6

3.7

3.8

3.9

3.10
Section

4

4.1

included for how this info will be kept separate from
responses?
Are sampling strategy & subject recruitment procedures
adequately described?
Do recruitment procedures show any indication of
coercion, intimidation, compulsion, pressure, or force?
If subjects are children, do materials adequately describe
ages and why these ages are appropriate?
If subjects are children, are materials (e.g.: survey
instruments, focus group topics, etc.) appropriate based
upon age?
If subjects are children or other vulnerable groups, is
recruitment done in a manner sensitive to potential
vulnerabilities or weaknesses (real or perceived) subjects
may have?
If subjects are paid, compensated, or provided a gift for
participation, is the incentive described and justified as
being non-coercive?
If future contact with subjects is planned, does it provide
for subject safety and data security through the research
period and beyond?
Comments, amendments, additions, or revisions
Informed Consent: IC is a negotiation whereby
subjects are informed about the study and their
rights, and they agree to participate voluntarily. IC
must be sought from each subject or the subject's
authorized representative confirming this process.
Type of Informed Consent:
a. written & signed ………………………...……………
b. written not signed ……………………………..……X

X
X
X
X

X

X

X

X

X

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4.2
4.3
4.4

4.5

4.6
4.7

4.8
4.9
4.10

c. written & signed by authorized representative.……
d. verbal & signed or
recorded……………….………...
e. verbal & signed by authorized representative…..…
f. verbal not signed or recorded……………….………
g. active…………………………………………………..
h. passive…………………………………………………
i. other …………………………………………………..
Are procedures for obtaining IC adequately described?
Are written IC documents, using clear and simple
wording, included?
Does IC include the purpose of the research presented in
simple, age, education, and culturally appropriate local
language?
Does IC state that participation is voluntary, and subject
may choose to not respond to any or all questions, or
may withdraw without consequences?
Does IC include a description of any risks or benefits to
subjects?
Does IC include a statement describing how
confidentiality (or anonymity) of subjects and data will be
maintained, and any limitations to confidentiality?
Does IC include the expected duration of the subject's
participation (hours/minutes)?
Does IC provide identity and contact info of investigators?
Do IC materials advise subjects to keep focus group
discussions (FGD) confidential from anyone outside the
group?

X
X
X

X

X
X

X
X
NA

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4.11
4.12
4.13
4.14
4.15
4.16
Section

5
5.1
5.2
5.3

5.4

5.5
5.6
5.7

Where subjects differ by type (e.g.: age, sex, risk, status,
etc.), are IC documents specific for each type?
Where data collection differs by method (e.g.: survey,
FGD, interview), do IC materials cover each method?
For child subjects, is there provision for obtaining consent
from parent, guardian, caregiver, or responsible person?
For child subjects, is their role in the study described
adequately for them to provide written or verbal assent?
If IC is written, is a copy left with subjects or there is
explanation for not doing so?
Comments, amendments, additions, or revisions
Subject Protections: Do submitted materials clearly
identify protection against risk?
Do materials describe the use of information collected?

X

Are subjects given a clear indication of who will have
access to their responses and in what form?
If children or other vulnerable groups are subjects, do
materials clearly describe special considerations or
accommodations for their safety or protections?
If children or other vulnerable groups are subjects, have
personnel had experience working with these groups? If
not, what specialized instruction will they receive?
Have personnel collecting data from subjects had ethical
training specific to the target group?
Are personnel collecting data aware of ethical issues that
may arise and their mitigation strategies?
Comments, amendments, additions, or revisions

X

X
X
X
X
X

X

X

X

X
X
X

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Section

6

6.1
6.2
6.3

6.4

6.5
Section

7
7.1
7.2
7.3

7.4

7.5

Subject Risks: Are risks reasonable in relation to any
benefits to subjects and to the importance of
knowledge that may be expected to result from the
research?
Do study objectives show that risk is reasonable in
relationship to expected gains?
Does study deliver potential benefits to subjects through
provision of information or services?
In event of physical, psychological, social, or legal risk, do
protocols describe and outline clear strategies to mitigate
against these risks?
If a subject discloses or is suspected to be at risk outside
of the study, are procedures in place to address or report
risk?
Comments, amendments, additions, or revisions
Data Protection: Do data collection and storage
protocols adequately ensure subject & data safety?
Are data collection tools appropriate and constructed to
assure subject privacy, confidentiality, or anonymity?
Do data collection procedures and environment ensure
subject safety and data security?
Do procedures cover all data types (e.g., written, audio,
video, observation), & are protections described for each
type?
Is chain of custody of data, from collection, transfer,
analysis, de-identification, storage, to destruction, clearly
described?
Will a data set be created for storage, dissemination
and/or use either publicly or restricted at the completion
of this project? If yes, please describe the data set,

X
X
X

X

X

X
X
X

X

X

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7.6
7.7

where it will be stored, with whom it will be shared, and its
intended use.
Is future contact with subjects, if any, planned in a way
that ensures data security?
Comments, amendments, additions, or revisions

X
X

HML IRB
1101 Connecticut Avenue, NW Suite 450
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+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
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© 2021 HML IRB