Attachment D - IRB-Guidance

Guidance for Institutional Review
Board (IRB) Approval of Healthy
Marriage and Responsible
Fatherhood Grantee Activities
April 20, 2016

Submitted to:
Administration for Children and Families
7th Fl., 901 D St., SW
Washington, DC 20024
(202) 260-2242
seth.chamberlain@acf.hhs.gov
Project Officer: Seth Chamberlain
Contract Number: HHSP23320095642WC/HHSP23337050T
Submitted by:
Mathematica Policy Research
1100 1st Street, NE
12th Floor
Washington, DC 20002-4221
Telephone: (202) 484-9220
Facsimile: (202) 863-1763
Project Director: Sarah Avellar
Reference Number: 40286.F65

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CONTENTS

BACKGROUND: READ THIS FIRST ............................................................................................................ 1

1.  Background ......................................................................................................................... 1

2.  Organization of this document ............................................................................................ 2

A. PURPOSE AND PROCESS OF AN IRB REVIEW .................................................................................. 3

B. OBTAINING INFORMED CONSENT FROM RESEARCH SUBJECTS .................................................. 5

1.  Elements of a consent form ................................................................................................ 6

2.  Best practices for obtaining consent ................................................................................... 7

3.  Parental/guardian consent and youth assent ..................................................................... 7

4.  Waivers of consent.............................................................................................................. 9

C. SPECIAL CONSIDERATIONS FOR WORKING WITH VULNERABLE POPULATIONS ..................... 10

D. DATA SECURITY ................................................................................................................................... 12

E. FEDERALWIDE ASSURANCE .............................................................................................................. 13

F. ADDITIONAL INFORMATION ABOUT IRBS AND THE CONSENT PROCESS................................... 14

APPENDIX A: SAMPLE CONSENT FORM............................................................................................... A.1

APPENDIX B: NEIRB APPROVAL OF FaMLE CROSS-SITE PROJECT ................................................ B.1

APPENDIX C: PERFORMANCE MEASURE AND DATA COLLECTION LOGISTICS.............................C.1

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BACKGROUND: READ THIS FIRST

This guidance provides an overview of the IRB process, informed consent, and data security
for grantees who are required to pursue IRB review of their HMRF program activities.
1.

Background

What is an IRB? IRBs, or Institutional Review Boards, are administrative bodies or
committees whose function is to conduct an ethical review of proposed research to assure the
protection of the rights and welfare of human research subjects. They independently review
research projects prior to projects beginning. The purpose of an IRB review is to ensure that
human research subjects are not harmed – that is, to protect the rights and welfare of humans.
What is IRB approval? When an IRB determines that the research, as designed, will not
harm human research subjects, the IRB approves the project to begin. In order to obtain
approval, some IRBs will require researchers to demonstrate stronger protections for human
research subjects.
DHHS IRB determination regarding performance measures. Each Office of Family
Assistance (OFA) Healthy Marriage and Responsible Fatherhood (HMRF) grantee is required to
collect, store, and report data on standardized performance measures using a management
information system called nFORM (Information, Family Outcomes, Reporting, and
Management). The Department of Health and Human Services (DHHS) considered whether IRB
review was necessary for collecting performance measures using nFORM. Because HMRF
grantees will use these performance measures for program management, DHHS determined that
the data collection and reporting activities associated with the performance measures are not
subject to the federal regulations governing IRB review and approval. DHHS is therefore not
requiring HMRF grantees to obtain approval from an IRB for these activities.
Requirement for all grantees to review rules of their governing bodies to determine
whether IRB approval is necessary. Even though DHHS has determined that performance
measures collected using nFORM do not require IRB review, all HMRF grantees must still
review the rules of their governing bodies to determine whether they are otherwise required to
obtain IRB approval to enroll clients in their programs and/or to collect client data, including
performance measures.
In some cases, governing bodies such as universities or local governments may still
require IRB review and approval even though DHHS is not requiring it.1 In addition, some
grantees will be conducting their own local evaluations of their grant programs; these grantees
will almost certainly be required to obtain IRB approval for local evaluation activities, including
obtaining informed consent from their program clients to participate in the local evaluation.

1

A subset of HMRF grantees have been selected for participation in one of two federal evaluations; these
evaluations are called Building Bridges and Bonds (B3) and Strengthening Relationship Education and Marriage
Services (STREAMS). Grantees selected for B3 and STREAMS will still collect performance measures data; those
grantees will work with the B3 and STREAMS contractors on IRB review procedures.

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IRB approval already obtained for cross-site analyses. As part of a contract directed by
ACF, Mathematica Policy Research (Mathematica) will conduct cross-site analyses of the 90
HMRF grantees using the data stored in nFORM for the Fatherhood and Marriage Local
Evaluation (FaMLE) and Cross-Site Project. Mathematica has received approval from an IRB,
the New England Independent Review Board (NEIRB), to conduct these analyses. There are two
other salient points:


Waiver of consent. NEIRB also gave Mathematica a “waiver of consent”: this means the
IRB has approved Mathematica to access client data in nFORM without client consent.



Materials related to this IRB approval are available for grantees. Mathematica’s role and its
waiver of consent are described in this document (see section B.4 and Appendix A) so that
grantees can incorporate relevant information into their IRB applications, as needed.

The remainder of this document provides guidance for grantees that have determined
that they must obtain IRB approval.
2. Organization of this document
This document has the following sections:


Section A describes the purpose and process of an IRB review.



Section B describes the purpose and process of obtaining informed consent from research
subjects.



Section C describes the special considerations that grantees serving youth and incarcerated
individuals may need to follow.



Section D includes information about data security measures to protect the privacy of
grantee research subjects.



Section E outlines the process for obtaining a Federalwide Assurance, if applicable.



Section F lists specific sources that grantees can consult for additional information about
IRBs and the consent process.

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A. PURPOSE AND PROCESS OF AN IRB REVIEW

The regulations governing research funded or supported by DHHS, including the DHHS
Policy for the Protection of Human Research Subjects, are found in the Code of Federal
Regulations (CFR), specifically at 45 CFR Part 46 (see
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html). These regulations, otherwise
known as the “Common Rule”, require IRB review of all research activities covered by the
DHHS policy. As mentioned, DHHS has determined that HMRF grantee collection of
performance measures in nFORM is not subject to the Common Rule.
If grantees determine that their governing body requires them to obtain IRB approval for
their HMRF program activities the grantee must work with an IRB that will review its research
plans, IRBs often operate within public or private non-profit institutions, such as universities,
state agencies, and hospitals. If the HMRF grantee is conducting a local evaluation, the local
evaluator might have an existing relationship with an IRB. Grantees should confer with their
local evaluators, if applicable, to determine whether a relationship with an IRB is already in
place and whether it is possible to work with the local evaluator’s IRB. In some cases, it might
also be necessary for grantees to secure IRB clearance through the state’s IRB or research review
board in addition to the evaluator’s IRB. If a grantee needs to locate an IRB to work with, they
can refer to a national list of registered IRBs online at: http://ohrp.cit.nih.gov/search.
If grantees determine that they are required to obtain IRB approval for their HMRF program
activities, they should consult with their IRB to determine what materials must be submitted.
In general, most IRB submissions include:
a) A description of the proposed research, which typically includes descriptions of the scope
of work, funding level for the research, use of respondent incentives, and ways in which data
will be used or reported. Most IRBs have protocol forms that require specific data elements.
Consult with your IRB to obtain the necessary forms.
b) A consent form for research subjects to sign or affirm explaining what it means to
participate in the study (see Section B of this document). The form should contain specific
consent language as required by the IRB.
c) Data collection materials for data collection activities, such as surveys, interview
protocols, and focus group protocols.
d) Information about the proposed research subjects, including whether they are from
vulnerable populations.2 For example, some HMRF grantees may provide services to
pregnant women, youth, or incarcerated individuals.

2

Vulnerable populations include children and minors; decisionally-impaired persons; elderly and aged persons;
international research subjects; minorities (including women); pregnant women, fetuses, and neonates; incarcerated
individuals; students and employees; terminally ill patients; and traumatized and comatose patients.

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Some IRBs also require the following:
e) Resumes or CVs of staff involved in research activities.
f) Conflict of interest forms disclosing potential conflicts of interest among research staff.
g) A data security plan detailing how the study will protect any personally identifiable
information (PII) gathered.
h) Proof of training in human subjects research for the principal investigator leading the
project. Free training in human subjects research is available through the National Institutes
of Health (see https://phrp.nihtraining.com/users/login.php). Your organization may also be
a part of the Collaborative Institutional Training Initiative (CITI), which provides online
training materials for a fee (see https://www.citiprogram.org/).

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B. OBTAINING INFORMED CONSENT FROM RESEARCH SUBJECTS

“Informed consent” is the process by which appropriate information is provided to a
potential research subject so that he or she can decide whether to take part in the research.
Human research subjects must voluntarily provide consent to be involved in the research.
Obtaining informed consent is a legal requirement for federally funded research involving human
subjects unless the study is exempt or an IRB issues a waiver of informed consent.
DHHS has determined that collecting performance measures in nFORM is not subject to the
Common Rule, but grantee governing bodies may still require IRB approval. Because grantees
will have varied requirements, or no requirements, regarding informed consent, nFORM does not
include a process for consent or documentation of consent. As applicable, grantees will need to
develop their own consent and documentation procedures outside of nFORM.
A consent form explains the nature of the potential research subject’s involvement in the
study and ensures that his or her rights are explained and respected. It describes the potential
risks and benefits of participation, the option of declining to participate, and the ability to
withdraw from the study at any time.
The IRB will review the draft consent form as part of the IRB submission package and
provide feedback to ensure that the language accurately represents the study procedures, clearly
explains what is expected of research subjects, and can be easily understood by potential
research subjects.
Consent is usually obtained in one of two ways—in writing or verbally. Written consent is
the default form of consent. The IRB may waive the need to obtain a written, signed consent, but
may still require study participants to be informed about the study, if: (1) the study presents no
more than minimal risk to research subjects and involves no procedures for which written
consent is normally required outside of the research context; and (2) the study cannot feasibly be
carried out without a waiver because extremely sensitive information is collected, and the only
paperwork that links the subject to the research study is the consent document. Under these
conditions, the research subject receives the same information required in a written consent form,
but his or her signature is not required by the IRB.
For written consent, at a minimum, the consent form should contain spaces for the research
subject’s signature and printed name; it may also have spaces for the research subject’s address,
phone numbers, and date of birth, if needed. After reading (or being read) the consent form,
research subjects fill in the required information and sign their name as an indication of their
willingness to participate in the study. The signed portion is usually retained by study staff, and
research subjects are given a copy of the information on the consent form.
Verbal consent follows the same requirements as written consent. Verbal consent is often
used for data collection by phone, with the interviewer using a computer to enter the potential
research subject’s data or recording data on a paper form. In these cases, the interviewer reads
the consent statement to the potential research subject and asks, “Do you have any questions
about anything I just told you?” After answering any questions, the interviewer may say, “Can
we start now?” or “Let’s get started.” Typically, the interviewer records the time and date the

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research subject consented, as well as the research subject’s name or ID number if that
information has not already been collected. Sometimes interviewers will tape record the consent.
Both written and verbal consent are active consent processes because they require the
research subject to explicitly agree to be part of the research. But sometimes researchers use
implied/passive consent, requiring research subjects to explicitly refuse to be a part of the study
rather than actively give their consent. Implied/passive consent means that the research subject
agrees to participate, if he or she does not explicitly refuse to participate, but does not waive any
of his or her rights as a research subject. This type of consent is usually reserved for studies that
are found to be completely innocuous by the IRB. It is often used in schools that send forms to
parents asking them to allow their students to participate in various activities. Typically these are
consent processes where parents who do not respond are considered as consenting.
1. Elements of a consent form
Each grantee’s consent form may vary depending on its specific study goals and data
collection efforts. Information on the consent form may depend, for instance, on who is
collecting data, the timing of collection, and whether consent is being obtained for those
participating in the program or from members of a comparison group (who are not participating
in the program being studied). Consent forms should also reflect the specific requirements of the
grantee’s IRB and applicable state laws.
Typically, IRBs require the following elements on consent forms:


Name of the study’s sponsor.



The purpose of the study.



Specific information on all activities included under the consent request for the duration of
the study, such as surveys, focus groups, and interviews; the collection of administrative
records; and any other data collection activities.



A confidentiality statement and explanation of how the research subject’s personally
identifiable information will be protected. This would include a description of the federal
Certificate of Confidentiality, if one has been obtained by the researchers.3



Potential risks, harm, discomfort, or inconvenience caused by participation in the study.



Possible benefits of participation.



A description of the voluntary nature of the study and the right of the research subject to
withdraw at any time. This description should indicate that research subject data provided
prior to withdrawal can still be used by the study.



A description of any compensation, such as incentives.



The information for a contact person or people who can answer questions about the study or
the rights of research subjects; ideally, this would include a toll-free number for research

3

The Certificate of Confidentiality prevents researchers from being compelled to disclose confidential information
about research subjects. For more information please see http://www.hhs.gov/ohrp/policy/certconf.html.

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subjects to call to obtain more information. A contact person from the local evaluator might
also be listed. Grantees should consult with their IRBs about the specific contacts to include
on the consent form.


Documentation that consent was given; for example, space for the research subject’s printed
name, signature, and the date that consent was obtained.
An example of a consent form from a recent Mathematica study is attached in Appendix A.

2. Best practices for obtaining consent
The following best practices can help ensure that the research subject fully understands the
request for consent, IRB requirements are followed, and privacy is maintained:


Make the document clear and concise by using simple, clear wording that research
subjects will be able to understand. Use informative language to describe the study, and aim
to minimize the burden on research subjects by keeping the consent form short, generally
one to two pages.



Write the document in the primary language and reading level of the target
population. In cases where grantees are serving non-English speaking research subjects,
grantees will need to translate the consent forms into the necessary language(s). Grantees
can also use the Flesch Kincaid scale, which is included as a component of Microsoft Word,
to assess the reading level of the consent forms.



Describe the study, the sponsor, and how the research is expected to help the research
subjects and community. Examples include:
-

A frequently asked questions document

-

The link to a study website

-

A study-specific brochure

-

Supporting statements from key stakeholders or community leaders



Use only IRB-approved materials when interacting with study research subjects.



Provide research subjects with a copy of the consent form for their own records.



Store completed consent forms in a locked and secure location so that the identity of
research subjects is not revealed to anyone outside the research team; ensure that research
subjects’ identities are protected when forms are collected and/or transmitted. Appropriate
storage of completed consent forms is important if IRBs require submitting completed
consent forms at the conclusion of the study.

3. Parental/guardian consent and youth assent
For many youth-serving programs, parents/legal guardians must provide consent, and youth
must provide assent.

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The age of consent is the age of majority, which is 18 years old in most states, but can vary.
Grantees should follow the guidance provided by their state. When working with youth who
cannot provide consent because they have not yet reached the age of majority, parents or legal
guardians must typically provide consent for them. Which adults may consent on behalf of a
child is also a matter of state and child welfare agency policy and varies across states. The
process of obtaining consent may be simple in some states, but very complicated in others.
Grantees should confer with their state child welfare agencies to determine the rules and
regulations related to consent, specifically:


Who can provide consent for the minor? It depends on who has legal authority for the
youth. It could be a parent, a caregiver, a casework supervisor or area manager, a legal
guardian, or a judge. Foster parents often are not able to provide consent for youth in their
care; however; their ability to do so varies based on the state and specific circumstances of
the request.



Does the court need to be involved in the consent process? Some states require judicial
involvement for youth in state care.



Do the rules for consent change depending on whether or not the youth is currently in
state custody? Some states and IRBs have special precautions in place for youth with an
open child welfare case, even if the youth is over age 18.



Are homeless minors allowed to provide their own consent? Some states allow homeless
minors to provide their own consent under some circumstances, while others do not.

After appropriate consent is obtained for a youth to participate in the study, the minor must
also provide assent, or agreement, to participate in the study. Simply securing parental or
guardian consent is not sufficient for youth participation in the study. Likewise, securing youth
assent without having parental or guardian consent does not grant the youth permission to
participate in the study.
Consider the following tips when developing a youth assent form:


Use age-appropriate language that clearly conveys the major elements of consent
described above and is written at an appropriate reading level.



Ask youth to assent actively to help them understand the research and make an active
decision to agree to participate.



Request contact information for tracking when the youth are filling out the assent form so
they can be located for subsequent data collection efforts, if this will be needed for the
grantee’s local evaluation.



Assure confidentiality of their identity and their responses and remind youth that they
can skip questions in the data collection as they wish. Indicate that they can stop their
participation in the study at any time if they feel uncomfortable.

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Waivers of consent
IRBs can waive informed consent requirements if the research meets four conditions:

1. It involves no more than minimal risk to the research subjects.
2. The waiver will not adversely affect the rights and welfare of the research subjects.
3. The research could not practicably be carried out without the waiver or alteration of consent.
4. Whenever appropriate, the research subjects will be given additional pertinent information
after participation.
Grantees who would like to receive a waiver of consent must apply for it from the IRB;
waivers are not automatically granted by IRBs. The likelihood of being granted a waiver depends
on the research protocol and the requirements of the IRB. Grantees should consult with their IRB
and local evaluators to determine whether a waiver is an option.
Waivers of parental consent can in some circumstances be granted if the IRB determines
that, due to the study conditions or target population, permission is not a reasonable requirement
to protect the research subjects—for example, for studies of homeless youth. In these rare
circumstances, parental consent may be waived.
As noted, Mathematica received a waiver of informed consent from NEIRB for the FaMLE
Cross-Site Project. This waiver means that Mathematica can access each grantee’s client data in
nFORM without consent from the grantee’s clients. A copy of the NEIRB approval letter is
attached in Appendix B.

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C. SPECIAL CONSIDERATIONS FOR WORKING WITH VULNERABLE
POPULATIONS

The Common Rule regulations on human subjects research, specified at 45 CFR Part 46,
require special considerations when working with vulnerable populations. Vulnerable
populations are defined in the Common Rule as children and minors; decisionally-impaired
persons; elderly and aged persons; international research subjects; minorities (including women);
pregnant women, fetuses, and neonates; incarcerated individuals; students and employees;
terminally ill patients; and traumatized and comatose patients. Because many HMRF grantees
will serve clients from vulnerable populations, and may conduct research involving these clients,
grantees and their local evaluators should carefully consider whether and how research would
need to be designed to protect the rights and welfare of these vulnerable populations. Grantees
need to consider the following issues:


Ensure that participation is not coerced by making sure potential research subjects
understand that taking part in the study is voluntary. Further, it is important to understand
that coercion can take many forms. For example, incentives can be too high, thus
incentivizing potential research subjects to say yes to the study not because they want to
participate, but because the cost of not participating is too high. The environment could also
be coercive. For example, if potential research subjects are not allowed to decline to
participate privately, and instead are asked to do so in front of other people, that
environment may be coercive.



Protect research subjects’ confidentiality, which is perhaps one of the most vital
requirements of any study. Researchers must protect research subjects’ personallyidentifiable information (PII) unless disclosure is required by law. For example, state laws
regarding the mandatory reporting of child abuse vary. Grantees/local evaluators must notify
research subjects in the consent form about any circumstance in which the grantees/local
evaluators would be required to disclose their research subjects’ PII. Grantees should be
aware of all applicable local and state regulations regarding any mandatory reporting
obligations that so that these do not conflict with the confidentiality assurances given to
study subjects.



Consider whether waivers of parental consent are necessary. Some youth may not be
able to identify an adult who can provide consent for their participation in the study. In this
case, grantees should work closely with their IRB and local evaluator (if applicable) to
determine if parental consent can be waived or if nonparental adults, such as foster parents
or other relatives, can provide consent. Youth may also identify themselves as emancipated
minors who can lawfully consent for themselves. Grantees should develop a plan for
documenting emancipation and seek guidance from their IRBs on the documentation an
emancipated youth is required to provide.



Develop data collection protocols for incarcerated research subjects that adhere to
prison regulations. Prisons may restrict the way incarcerated individuals can participate in a
study. For example, it may not be possible to bring written materials or electronic devices
(laptops or tablets) into a prison facility. In such a situation, the grantee and its local
evaluator must devise alternative options for obtaining consent and collecting data from
incarcerated individuals. These might include allowing incarcerated individuals to consent to
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participate and provide data by telephone with a grantee staff person. Further, the IRB may
require that the consent language clearly indicate that study participation will not affect the
treatment or parole of incarcerated individuals. Grantees serving incarcerated individuals
should consult with their IRBs about the specific requirements for obtaining consent and
collecting data from incarcerated individuals.

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D. DATA SECURITY

Some IRBs may also require grantees to describe the security of the nFORM system which
grantees will use for collecting, storing, and reporting on performance measures and service data.
A formal data sharing and user agreement established between each grantee and Mathematica
describes the data that grantees will capture in nFORM and provide to Mathematica for cross-site
analysis, as well as how Mathematica will protect the grantee data in nFORM throughout the
grant.
Grantees should consider when and how information will be collected, and ensure that no
one outside their own HMRF grant team can access personally-identifiable information (PII) in
any form. All authorized grantee and/or local evaluator staff should receive training on data
security best practices before collecting client data.
Grantees should store all study materials, including paper records and computer systems, in
a locked office or room that only authorized staff are able to access. Paper materials containing
PII should be stored in locked filing cabinets. Likewise, laptops, tablets, and desktop computers
used to collect and store information about clients should be password protected and stored in
locked locations.
Please also see Appendix C in this document for further ways to protect PII.
After all data collection and analysis under the HMRF grants is complete, grantees should
cross-shred all paper documents containing PII. All electronic documents should be deleted
using a security tool such as Eraser, which completely removes sensitive data from the user’s
hard drive. Some IRBs might mandate a specific amount of time for which data collection
materials should be kept. Grantees should be sure to abide by the requirements of their IRB and
keep data secure until it can be destroyed.
To protect data security, nFORM is hosted and maintained by Mathematica and all data are
stored on secure servers behind Mathematica’s firewalls. Safeguards used to protect sensitive
data stored within the nFORM system are consistent with the Privacy Act, the Health Insurance
Portability and Accountability Act, the Federal Information Security Management Act, and
National Institute of Standards and Technology security and privacy standards. Identifiable data
will be encrypted at all times (in transit and at rest) using cryptographic modules that are
compliant with Federal Information Processing Standard 140-2, and will be securely deleted
from the system when no longer needed. Access to the nFORM system will be controlled via
multifactor authentication mechanisms and will be limited for both grantee and Mathematica
staff. A grantee will only be able to view and report data for its own program.

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E. FEDERALWIDE ASSURANCE

Grantees may determine that they must obtain a Federalwide Assurance (FWA). Through
an FWA, an institution commits that it will comply with the Common Rule. An FWA through
the Office for Human Research Protections (OHRP) is required for all research that DHHS
conducts or supports.
After completing the process to obtain an FWA, an organization will receive a unique FWA
number from OHRP. IRBs may require the FWA number for their review process. More
information is available online at http://www.hhs.gov/ohrp/assurances/assurances/index.html#.

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F. ADDITIONAL INFORMATION ABOUT IRBS AND THE CONSENT PROCESS

For more information on IRB procedures and informed consent, grantees may refer to the
following sources:


The U.S. Department of Health and Human Services (DHHS). “Informed Consent FAQs.”
This site provides answers to frequently asked questions about informed consent.
(http://www.hhs.gov/ohrp/policy/faq/informed-consent/index.html).



The U.S. Department of Health and Human Services (DHHS). “Tips on Informed Consent.”
This site also provides tips on obtaining informed consent.
(http://www.hhs.gov/ohrp/policy/ictips.html).



The National Science Foundation. “Human Subjects.” This website provides information
about human subjects protection and IRB review.
(http://www.nsf.gov/bfa/dias/policy/human.jsp).



Social Innovation Fund. “Working with Institutional Review Boards” includes tips for
selecting an IRB, when to consult with one, and suggestions for working together.
(http://www.famlecross-site.info/pdfs/SIF_IRB_Tips.pdf).



National Healthy Marriage Resource Center. “Marriage and Relationship Education
Program Development and Management Manual.” August 2013. Chapter 12 of this manual
(“Evaluation”) briefly discusses the need for IRB approval and the role of IRBs in ensuring
research subject protections. (http://www.healthymarriageinfo.org/resourcedetail/index.aspx?rid=4025).



San Diego State University. This website provides a tutorial and case study examples about
maintaining confidentiality of data. The “Handling Information” section of the tutorial
briefly discusses important issues such as proper documentation of the consent process,
secure storage, informed consent, and other precautions that should be taken when
conducting research with human subjects.
(http://ori.hhs.gov/education/products/sdsu/handling.htm).

14

APPENDIX A

EXAMPLE CONSENT FORM

OMB Control No:

0970-0273

Expiration Date: 03/31/2008

BUILDING STRONG FAMILIES STUDY
THE BUILDING STRONG FAMILIES PROGRAM
Building Strong Families helps unmarried couples with a new baby learn how to get along better with
each other and be better parents for their children. Couples will learn about marriage, communication,
trust, affection, dealing with stress, and relating to their baby. They also can get referrals to employment
assistance, health care and mental health services, and other needed services.
WHAT IS THE STUDY ABOUT?
Building Strong Families is part of a national study being conducted by a research team from
Mathematica Policy Research, Inc. based in Princeton, New Jersey. The study is sponsored by the U.S.
Department of Health and Human Services. The study is being done to learn more about which services
help couples build better relationships and healthy marriages.
If you participate in this study, we will ask you some questions about yourself, the baby you are
expecting or have just had, your living arrangements, your employment, how you are feeling about
yourself, and how you are feeling about your relationship with the other parent of your child. Later, the
research team will interview both of you two or three times. The researchers may also ask you for
permission to do some activities with your child to see how your child is growing up. The interviews will
be about how things have gone for you as a couple and as parents. Your answers could help in
providing services in the future to other parents like you, who want to learn more about relationships,
marriage, and being parents.
If you agree to be part of the study, it means you are giving permission for the Building Strong Families
program to share information with the research team about services you received, and for state and local
agencies to release information to the research team about earnings and benefits you might get from
government programs.
The Building Strong Families program will not have room for all couples who might be eligible. If you
want to be in the program and agree to be in the study, a lottery will decide whether you can be in the
program. You can go through this lottery and have a chance to be in the program only if both parents
agree. Whether you are selected or not, you will still be part of the study. If you are not selected for
Building Strong Families, you can still receive other services in your community.
YOUR ANSWERS WILL BE KEPT PRIVATE
Everything you tell the research team will be kept strictly confidential and will not be shared with any
agency. Only the researchers will be able to see information you give them and nothing will ever be said
about you as an individual. Instead, information about you will be combined with information about
everybody else in the study, so the researchers can say things like “30 percent of couples in the program
have two children.”
YOUR PARTICIPATION IS VOLUNTARY
We hope that you will want to be in the Building Strong Families study, but you only have to be in the
study if you want to. However, if you do not want to participate in the study, you and the other parent of
your baby cannot receive Building Strong Families services.

Consent to Participate in Building Strong Families Study
I have read the information on the reverse side.
$

I understand that the Building Strong Families program will not have space for all couples,
and I agree to participate in a lottery to determine whether we can receive services. I
understand that if we cannot receive Building Strong Families services, we can still get
other program services in my community.

$

I agree to complete an information form now, and to participate in later interviews. I
understand that I may be asked some questions about personal things, but I will not have
to answer any questions that make me feel uncomfortable. I understand that later I may be
asked permission for researchers to include my child in the study as well.

$

I give permission for the study team to collect information on Building Strong Families
services I receive. I give permission for state and local agencies to release information to
the study team about earnings and benefits I may receive from government programs

$

I understand that all information will be kept strictly confidential, except as required
by law or I request otherwise in writing. Only the research team will be able to look at the
information I give. The information will be used only for the study. However, I do
understand that if a person on the study team observes child abuse, it must be reported.

$

collect at
I can call
an answer about any questions I may have.

at Mathematica Policy Research, Inc. to get

Name of Participant (Printed)
Signature of Participant

Date

Name of Person Administering this Form (Printed)
Signature of Person Administering this Form

Date

APPENDIX B

NEIRB APPROVAL OF FAMLE CROSS-SITE PROJECT

October 14, 2015
Sarah Avellar, PhD
Mathematica Policy Research
1100 First Street NE #1200
Washington, DC 20002
IRB#: 15-369
Sponsor Protocol Number: HHSP23320095642WC/HHSP23337050T
Study Title: "Fatherhood and Marriage Local Evaluation (FaMLE) and Cross-Site Project"

Notification of Study Approval
This is to inform you that New England Independent Review Board (NEIRB) has approved the above-referenced research

protocol and the participation of the above-referenced investigative site in the research.

Reviewed by: Expedited Review (Thursday Board)

Date(s) of Review: 10/14/2015

Expedited Review Category: (5) Research involving materials (data, documents, records, or specimens) that have been

collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

Action Date (first day of study approval period): 10/14/2015

End Approval Date (last day that the study is approved): 10/13/2016

Waiver of Consent Approval: NEIRB has approved a Waiver of Informed Consent, in accordance with NEIRB’s standard

operating procedures.

Continued approval is conditional upon your compliance with the following requirements:

•
•
•
•

Compliance with all aspects of NEIRB’s Investigator Responsibilities (available at www.neirb.com).
The study cannot continue after the End Approval Date unless re-approved by NEIRB. A Study Continuing Review
Report must be completed and returned to NEIRB prior to the end date of the approval period.
Compliance with all federal, state and local laws pertaining to this research.
Any and all necessary FDA approvals must be received prior to your initiation of the trial.

Please contact NEIRB with any questions about this determination.
Copy:

NEIRB study file

85 Wells Avenue . Suite 107 . Newton, MA 02459

Phone: 617-243-3924 . Fax: 617-969-1310 www.neirb.com

APPENDIX C

PERFORMANCE MEASURE AND DATA COLLECTION LOGISTICS

2015 RFHM Grantees
Performance Measure and Data Collection Logistics
Purpose of this document. This is a guidance document which provides best practice
approaches to logistics around collecting performance measure data. This document is in
development and will be updated. Not every RFHM situation is addressed in this document.
In all situations, we suggest developing a comprehensive plan for your specific
programming context along with your FPS.
General principles:
1. Privacy: client privacy is paramount. Use every effort to protect your clients’ privacy:
a. Identify places in your data collection processes (or your partners’) where privacy
could be compromised. For example: Will clients tell you private information in a
place where they could be overheard? Will you use any paper files, even just
attendance rosters, and is that paper quickly locked safely or destroyed? When
you go onto nFORM, will anyone be able to look over your shoulders?
b. Strategize on ways to eliminate and/or reduce risk.
c. Create a plan for what you will do if client privacy is compromised.
 Please see the Appendix for important approaches to protecting personally
identifiable information (PII).
2. Consistency: data should be collected the same way every time . Think about how
you will do intake, distribute tablets/computers for client surveys, and enter participation
information. Create a process, and then follow it every time.
3. Completeness: every question should be answered. Grantee staff should complete
all data fields in nFORM. Clients can refuse to answer questions or entire surveys, but
they should be encouraged to complete them.
Establishing data collection processes. Consider undertaking these steps:
1. Use your resources (funding, staff) to create a comprehensive data collection
process. Working with your performance measure and/or local evaluation staff, think
about every step of your data collection efforts. Identify ways to ensure the three
principles (privacy, consistency, and complete data collection). Think of complications
that could arise, and identify ways to address them.
2. Write down the plan. That way, others will quickly understand your procedures, and
later you can review your plan and make changes.
3. Test-run the data collection process with staff. Walk through each step of the plan to
fine-tune it.
4. Train all staff on their roles. Grantee staff, even those who won’t use nFORM, should
be trained to understand their roles and expectations for priva cy, consistency, and
completeness. Ask staff to test-run processes, too.
5. Check data collected, and check-in with staff, at least quarterly and more
frequently until your data collection process is running smoothly. Analyze data
frequently to identify whether specific questions or even whole surveys are not being
completed, or are being competed in an odd way. (You may need to use the export

Performance Measure and Data Collection Logistics – page 1

function to check on entrance and exit surveys.) Check-in with staff about how data
collection is going: Have they run into any problems? Do they have any suggestions on
improvements to the processes?
6. Make changes when needed, communicate changes to team, and update written
plan. Continue checking your data and coordinating with staff to make sure changes
are implemented and effective.
Standard Approach
(Applicable in Most RFHM Contexts)
The nFORM User Manual provides detailed procedures for data collection, case management,
and reporting using the nFORM system. Following are additional recommended practices to
incorporate into your grant’s data collection plan:
A. Conducting intake for applicants using nFORM:
1. Add the client to nFORM:
 Take client to quiet area where your discussion will not be overheard.
2. Ask the client for information to complete the Application Form. Type answers directly
into nFORM (avoid writing them down on paper, if possible).
3. Have client complete Applicant Characteristics Survey:
 Set up survey on separate tablet/computer for client use.
 Hand the tablet/computer to client.
 Have client sit in quiet place where the answers won’t be seen by others.
 Offer earbuds/headphones to client so that they can hear the survey questions, if
they wish. Show the client how to adjust the volume on the device. If the client
does not want to listen to the questions, show them how to mute the audio.
 Tell client that if they have questions to let you know; stay visible to the client so
that if they have questions they can ask you.
 When the client is done, ask whether they have clicked “Submit.” Confirm
submission by going into nFORM (on staff computer) and confirming that Status
is “Complete.”
B. Conducting entrance/exit surveys using nFORM:
Conduct the entrance survey at the beginning of the first class, before any instruction occurs
(perhaps right after introductions). Conduct the exit survey at the end of the last class, after all
instruction is finished.
1. Set up surveys ahead of time using a separate tablet/computer for each client.
2. Hand the tablet/computer to each client.
3. Have the client(s) sit in a quiet place where the answers won’t be seen by ot hers.
4. Offer earbuds/headphones to (each) client so that they can hear the survey questions, if
they wish. Show the client how to adjust the volume on the device. If the client does not
want to listen to the questions, show them how to mute the audio .
5. Tell client(s) that if they have questions to let you know; stay visible to the client so that if
they have questions they can ask you.

Performance Measure and Data Collection Logistics – page 2

6. When the client(s) is done, ask whether they have clicked “Submit.” Confirm submission
by going into nFORM (on staff member’s computer) and confirming that Status is
“Complete.”
7. Wait to begin instruction until (all) client(s) have completed the survey.
C. Entering Case Management and Workshop Participation Information in nF ORM:
 Enter this information as soon as possible into nFORM - within an hour if possible, and
no later than 24 hours after session.
 If you have written anything down (e.g. case notes, e.g. attendance log), after entering
into nFORM either shred the paper or keep it in a locked cabinet.
Special Scenarios
School-based programs - conducting intake and entrance surveys. For school-based
programs, it may be possible to ask students to complete the Applicant Characteristics Survey
and the Entrance Survey in one sitting. We suggest using multiple staff members to facilitate
this, depending on the number of students to be surveyed:
 Prior to First Class:
o Enter basic information on all students in nFORM, so that each student has an
nFORM ID.
o Bookmark the survey URL in each tablet/computer (a separate tablet/comput er
for each student) so the survey is ready to launch.
o Generate a passcode for each student, and document the student’s ID and
passcode on an index card or other method.
o Passcodes for each survey are valid for one hour—clients must begin the survey
within one hour of grantee staff generating the student’s passcode. Staff should
plan accordingly based on the number of students who will be taking the survey
and the class setting.
 During First Class:
o Applicant Characteristics Survey:
 When class begins, make brief introductory remarks.
 Hand out the tablets/computers to students. Hand out the index cards to
each student by name with the student’s ID and passcode to each
student. Ask students to insert their earbuds, click on the bookmark to
navigate to the applicant characteristics survey log-in screen, and then
enter the information on the index card.
 Ask students to confirm after log-in that their identity appears correctly. If
there are any mix-ups, it may be necessary to regenerate passcodes.
 Ask students to complete the Applicant Characteristics Survey.
 After logging-in to the survey, a student may be logged out after 30
minutes of inactivity.
 Instruct students that, when they have finished the Applicant
Characteristics Survey, they should click “Submit” and bring the device
back to the instructor.

Performance Measure and Data Collection Logistics – page 3





At the front of the room, with each individual student, take the
tablet/computer, and confirm in nFORM on staff computer that the student
has completed the Applicant Characteristics Survey. (Reassure the
students that you are not checking their responses, just that the previous
survey was submitted, so that they can begin the next part.)
o Entrance Survey
 In nFORM, obtain the student’s passcode for the Entrance Survey
(different from the Applicant Characteristics Survey passcode), and write
it on the index card.
 Hand the tablet/computer back to the student with the index card. Ask
student to return to their desk and insert their earbuds, click on the
bookmark to navigate to the entrance survey log-in screen, and then
enter the information on the index card.

During Last Class:

o Follow the same process described for the Applicant Characteristics Survey, but
instead generate the student’s passcode for the Exit Survey (different from the
Applicant Characteristics and Entrance Survey passcodes).

Programs without internet access. In some places internet is not accessible. There are two
options for administering surveys (the Applicant Characteristics Survey, the Entrance Survey,
and the Exit Survey) without internet access.
 Applicants/clients can complete paper surveys, and grantee staff can enter the
information into nFORM later. If you use this option, you will need to think through how
to help applicants/clients navigate the paper surveys (there are “skip patterns” t hat are
seamless in nFORM but that may be hard to follow on paper.) Also, carefully guard any
paper copies with client information following your organization’s best practices for data
security; for example, secure the copies in locked cabinets and shred them when
specified by your organization or, if applicable, your designated institutional review
board.
● Via a phone conversation, grantee staff can ask the questions of
applicants/clients, and record the information as they go . Grantee staff should take
measures to ensure that the applicant/client is in quiet location where answers cannot be
easily overheard. Also, make plans for how to reconnect if the phone service cuts out.
Programs with differently-abled applicants/clients who cannot respond to a

tablet/computer survey, even with the audio assistance. In this instance, grantee staff can

ask clients the questions, and input the data as the client provides answers.

Programs with clients who cannot speak English or Spanish. There are two related options:

 Grantees should create paper versions of the surveys in other languages. The
grantee should work closely with a professional translation service to ensure that all
translations are accurate and appropriate for the grantee’s population.

Performance Measure and Data Collection Logistics – page 4



As needed, grantee staff can sit with clients and ask the questions from these
translated paper surveys question-by-question. This will allow clients with literacy
issues to complete the surveys.

Two methods of survey administration are not permitted due to security requirements:
● Grantees cannot send the nFORM ID and passcode to clients to complete the
surveys off-site.
● Grantees cannot reproduce the surveys in another system (e.g. surveymonkey) in
order to transfer the questions later.

Performance Measure and Data Collection Logistics – page 5

Appendix: Protecting Personally Identifiable Information (PII)
Over the course of working with clients, you will ask for and have access to confidential
personal information. The confidentiality of this information—called “personally identifiable
information” or “PII” for short—must be preserved. While you are working within nFORM or in
any other capacity, be sure to safeguard applicants’ personally identifiable information (PII). The
nFORM system is being developed as a “FISMA moderate” system: this means that several
security safeguards are built into the system. These safeguards are described in the nFORM
User Manual. However, grantees will need to build additional safeguards into their processes
as described in this appendix.
The Federal Office of Management and Budget (OMB) defines PII as “information which can be
used to distinguish or trace an individual’s identity, such as their name, social security number,
biometric records, etc. alone, or when combined with other persona l or identifying information
which is linked or linkable to a specific individual, such as date and place of birth, mother’s
maiden name, etc.” The most common forms of PII are social security number, name, address,
phone, and date of birth, but PII can also involve other information. You must use your judgment
in deciding whether information you work with is confidential; some information that would not
appear to be PII on its own, may in fact be PII when combined with additional information. For
example, a first name, when combined with a last name and home address or a date of birth,
could be considered PII. If you have any questions about whether information you work with is
considered confidential PII, please contact your program director or FPS.
To safeguard PII and other sensitive information, you should control access to these data.
There are many ways to maintain the confidentiality of personally identifiable information (PII)
and you probably already use some of these methods.
 Discussions, including phone calls, about individuals must remain confidential. When
discussing individuals with other staff or evaluation team members, please do so in a
private room, if possible, or a restricted area out of earshot of unauthorized people.
 Under no circumstances should you email PII to anyone, including other program
staff.
 Keep all project materials such as the letters, printouts, and other documents with PII out
of sight and locked up in appropriate locking storage (such as a file cabinet) when no t in
use.
 Keep all work surfaces and open storage areas (such as bookcases) clear of information
containing PII. Never leave paper documents containing PII and other sensitive
information unattended.
 When displaying screens with PII on your computer monitor, ensure that unauthorized
persons cannot see the information (for example, by looking over your shoulder from a
hallway or through a window). When possible, shut office doors, close window blinds, or
position your computer monitor so that it is not visible to others.
 Activate your screen saver whenever you leave your computer. Usually, this is
accomplished by pressing CTRL+ALT+DELETE, then ENTER. If possible, set your
screen saver to auto-activate after a short time period of inactivity on your computer.

Performance Measure and Data Collection Logistics – page 6

 Do not allow any other person to use your computer accounts, and always keep your
passwords secure. Note that this is intended to prevent unauthorized users from having
access to restricted files by using your account.
 PII should not appear on any unencrypted device including shared network drives or
unencrypted portable media such as CDs, flash/thumb drives, or a laptop.
General guidance on human subjects protections can be found in the 12 -page document found
in the human subjects training we recommended for applicable staff
(http://www.neirb.com/Investigator_Training). Be sure to consult with your governing
organization and, if applicable, your local evaluator, to determine if you need to seek institutional
review board exemption or approval. This process will involve review of your grant’s specific
procedures for protecting client confidentiality.

Performance Measure and Data Collection Logistics – page 7

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