Appendix F2 Institutional Review Board Approval

Page 1

Research Ethics Protocols for the Protection of Human Subjects
EXPEDITED REVIEW
Project Title:

Integrating Financial Capability into Employment Services (InFin)

HML IRB Review ID#:

1013MEFA21

Initiating Official:
Name & Organization
Principal Investigator:
Degree(s), address, email

Sam Elkin. Principal Associate, MEF Associates
[email protected]
Mary Farrell, MPPM and Signe-Mary McKernan, PhD
MEF Associates
1330 Braddock Pl, Suite 220
Alexandria, Virginia 22314
from MEF Associates:
Sam Elkin, Principal Associate, MPP
Valerie Benson, Senior Research Associate, MPP
Riley Webster, Research Analyst, MPP
Lorraine Perales, Research Analyst, MPP, MSW
Eunice Yau, Research Assistant, BA

Other Key Personnel:
Title, degree(s):

from Urban Institute:
Heather Hahn, Senior Fellow, PhD
William J. Congdon, Principal Research Associate, PhD
Mark Treskon, PhD
HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
US Department of Health & Human Services, Office for Human Research Protections, IRB #00001211, FWA #00001102
© 2021 HML IRB

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Kassandra Martinchek, MPA
Primary study site(s):
The location(s) of your subjects
Duration of Study:
& completion date
Participation of Subjects:
From – to dates
Funding Source:
Primary funder

United States
May 1, 2021 to January 31, 2024
February 2022 to October 2022
Office of Planning, Research, and Evaluation (OPRE) at the US Department of Health and
Human Services (HHS)

Billing: IRB approval cannot be provided without completing this section.
Billing Information
Please provide all billing information
required by your organization,
including PO or contract numbers
we will need to invoice you.
Billing Contact
Please provide email address of
invoice recipients.

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

15 October 2021
None
15 October 2021
18 October 2021

HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
US Department of Health & Human Services, Office for Human Research Protections, IRB #00001211, FWA #00001102
© 2021 HML IRB

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→ PROCESS: HML IRB will conduct a research ethics review of submitted materials 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
1.1

1.2

1.3
1.4

1.5

I.

Section
II.

2
2.1
2.2
2.3

Research Risk: Do submitted materials address
potential risks of participation?
Minimal Risk Only: Where 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 that may involve greater than minimal risk, but
where risks are justified by anticipated benefits; where the
relation of the anticipated benefits to risks is at least as
favorable as available alternative approaches; and where
the intervention or procedure is likely to yield generalizable
knowledge.
If there is potential for greater than minimal risk, are
mitigating procedures described?
Has (or will) approval for this study been obtained by any
other research ethics committee or any other type of
national or local entity? Urban Institute Institutional
Review Board
Comments, amendments, additions, or revisions
Research Design: Do submitted materials describe
the proposed research?
Background and rationale
Description of methodology
Are all documents final versions?

IRB
OK

Reviewer Comments or
Requests for More Information

IRB
use

Researchers: Please respond under IRB’s red
comments in another color

X

Please keep us informed of any subject protection
protocol or research design changes that need to occur in
adaptation to the COVID-19 pandemic in the sites of your
study.

X

X
X

X

X
X
X

HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
US Department of Health & Human Services, Office for Human Research Protections, IRB #00001211, FWA #00001102
© 2021 HML IRB

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2.4
2.5
2.6

2.7

2.8
2.9
2.10
Section

3
3.1

Does study involve an intervention or treatment group?
Does study involve a comparison or control group?
Type of data collection:
a. survey questionnaire………………………….…..…X
b. subject interview…………………………..…………X
c. key informant interview (KII)…………..………….
d. focus group discussion (FGD)…………………..…X
e. document review…………………..………………
f. on-site observation……………….…..………..……
g. case study………………………………………….
h. secondary data analysis….…………………….…
i. physical measurements ………………………….
j. biological specimen ……………….….…………..
k. other..…………………………………..…...………
Number of Data Collections:
a. one-time (no follow-up)………………………..……X
b. two or more (follow-up) ………………….………....X
A subset of survey respondents may be included in
more than one of the data collection activities (e.g.,
survey, interviews, and administrator FGD).
Sample size: Total n or approximate n = 163

X
X
X

Are any subjects children (<18 years old)?
None
Comments, amendments, additions, or revisions
Recruitment: Do submitted materials describe
subjects and the recruitment process?
Subject identification:
a. subjects’ names are recorded with responses……X
online surveys
b. names recorded separate from responses…….…X
phone interviews and remote FGDs
c. no names are recorded .…………………..………

NA

X

.

X

X

X

HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
US Department of Health & Human Services, Office for Human Research Protections, IRB #00001211, FWA #00001102
© 2021 HML IRB

Page 5

3.2

3.3
3.4
3.5
3.6

3.7

3.8

3.9

3.10

d. other personally identifiable information (PII) is
recorded ………………………………….……….…X
online surveys
e. no PII is recorded …………………………..………
f. subjects are given a unique identifier....................X
If name or any other PII is recorded, are procedures
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

X

X
X
NA
NA

NA

X

X

X

HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
US Department of Health & Human Services, Office for Human Research Protections, IRB #00001211, FWA #00001102
© 2021 HML IRB

Page 6
Section

4

4.1

4.2
4.3
4.4

4.5

4.6
4.7

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
survey
c. written & signed by authorized representative.….
d. verbal & signed or recorded……………….……….
e. verbal & signed by authorized representative……
f. verbal not signed……………..……………….…….X
interviews and FGDs
g. active………………………………………………….
h. passive……………………………………………….
i. other ………………………………………………….
Are written IC documents, using clear and simple wording,
included?
Are procedures for obtaining IC adequately described?
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?

X

X
X
X

X

X
X

HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
US Department of Health & Human Services, Office for Human Research Protections, IRB #00001211, FWA #00001102
© 2021 HML IRB

Page 7
4.8
4.9
4.10

4.11
4.12
4.13
4.14
4.15
4.16
Section

5
5.1
5.2
5.3

5.4

5.5

Does IC include the expected duration of the subject's
participation (hours/minutes)?
Does IC provide identity and contact info of investigators?

X

Do IC materials advise subjects to keep focus group
discussions (FGD) confidential from anyone outside the
group?
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?

X

X
X
NA
NA
X
X

X
X
NA

NA

X

HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
US Department of Health & Human Services, Office for Human Research Protections, IRB #00001211, FWA #00001102
© 2021 HML IRB

Page 8
5.6
5.7
Section

6

6.1
6.2
6.3

6.4

6.5
Section

7
7.1
7.2
7.3

7.4

7.5

Are personnel collecting data aware of ethical issues that
may arise and their mitigation strategies?
Comments, amendments, additions, or revisions
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
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, where it

X
X

X
X
X

X

X

X
X
X

X

X

HML IRB
1101 Connecticut Avenue, NW Suite 450
Washington, DC 20036 USA
+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
US Department of Health & Human Services, Office for Human Research Protections, IRB #00001211, FWA #00001102
© 2021 HML IRB

Page 9

7.6
7.7

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
Washington, DC 20036 USA
+1.202.246.8504 +1 202.549.1982 direct
[email protected] www.HMLIRB.com
US Department of Health & Human Services, Office for Human Research Protections, IRB #00001211, FWA #00001102
© 2021 HML IRB