Home Visitor Consent Form

OMB CONTROL NUMBER: 0704-XXXX
OMB EXPIRATION DATE: XX/XX/XXXX
CONSENT FOR RESEARCH
The Pennsylvania State University
Title of Project: Navy New Parent Support Program Evaluation
Principal Investigator: Dr. Ryan P. Chesnut
Address: 402 Marion Place, University Park, PA 16802
Telephone Number: (814) 865-9637
Subject’s Printed Name: _____________________________
We are asking you to be in a research study. This form gives you information about the research.
Whether or not you take part is up to you. You can choose not to take part. You can agree to take part
and later change your mind. Your decision will not be held against you and there will be no penalty or
loss of benefits to which you are entitled.
Please ask questions about anything that is unclear to you and take your time to make your choice.
1. Why is this research study being done?
This research is being done to improve Navy NPSP home visitation programming effectiveness and
to ensure that Navy families can rely on high quality home visitation programs for new parents.
Approximately 20 home visitors will take part in this research study across 6 CONUS installations.
2. What will happen in this research study?
Whether or not you agree to participate in the evaluation, you will provide NPSP home visits and
programming as determined by leadership at your installation. Home visits will involve using the Take
Root Home Visitation curriculum or services as usual depending upon your installation.
Following the training you receive, you will provide information regarding your impression of
evidence-based programs.
Following each visit with a family, you will provide information on what content was covered in the
visit via a short checklist.
At baseline (Time 1), 3-4 months after baseline (Time 2), and 6-7 months after baseline (Time 3), you
will complete measures on family outcomes. You will also do this when a client completes NPSP
services or the study ends, whichever occurs first for the client.
Following the completion of the research, one home visitor from each installation will provide
information on program penetration and reach.
3. What are the risks and possible discomforts from being in this research study?
The likelihood and severity of harm or discomfort anticipated in this research is not greater than those
ordinarily encountered in daily life or during performance of routine psychological examinations. Some
of the questions may make you feel uncomfortable about your responses and/or question your own
attitudes/behaviors. You may decline answering questions and/or withdraw from participation without
penalty.
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There is a risk of loss of confidentiality if your information or your identity is obtained by someone other
than the investigators, but precautions will be taken to prevent this from happening. The confidentiality
of your electronic data created by you or by the researchers will be maintained as required by applicable
law and to the degree permitted by the technology used. Absolute confidentiality cannot be guaranteed.
4. What are the possible benefits from being in this research study?
4a. What are the possible benefits to you?
There is no guarantee that you will benefit from this research. The possible benefits you may
experience from this research study include learning new information and skills that may help you
better serve your clients.
4b. What are the possible benefits to others?
The results of this research may guide future decisions about how the Navy delivers NPSP home
visits. Thus, your participation may help to ensure future NPSP home visitors deliver and future
NPSP families receive high quality home visitation programs for new parents.
5. What other options are available instead of being in this research study?
You may decide not to participate in this research study. There is no penalty for not participating, and
your decision to participate, or not participate, in the evaluation will not influence the services you
provide your clients.
6. How long will you take part in this research study?
If you agree to take part, it will take you about 12 months to complete this research study. You will
be asked to do the following:
• Provide feedback on evidence-based programming after your training session (<5 minutes)
• Complete measures on family outcomes at Time 1 (<80 minutes), Time 2 (<20 minutes),
Time 3 (<80 minutes), and NPSP service or study completion (<80 minutes).
• Report on delivery fidelity after each visit (<2 minutes).
7. How will your privacy and confidentiality be protected if you decide to take part in this research
study?
7a. What happens to the information collected for the research?
Efforts will be made to limit the use and sharing of your personal research information to people who
have a need to review this information. Reasonable efforts will be made to keep the personal
information in your research record private. However, absolute confidentiality cannot be
guaranteed.
•

A list that matches your email address with your ID number will be kept in a password protected file
located in a password protected folder on a secure server requiring two-factor authentication

•

Your research records will be labeled with your ID number and will be kept in a safe area in a
password protected data file in a password protected folder on a secure server requiring two-factor
authentication.

•

Your responses will be linked to the responses provided by your client through the unique
combination of your ID number and the client’s ID number. At no point will any identifiable
information be associated with the collected data.

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In the event of any publication or presentation resulting from the research, no personally
identifiable information will be shared.
We will do our best to keep your participation in this research study confidential to the extent
permitted by law. However, it is possible that other people may find out about your participation in this
research study. For example, the following people/groups may check and copy records about this
research.
• The Office for Human Research Protections in the U. S. Department of Health and Human
Services.
• The research study sponsor, the National Institute of Food and Agriculture.
• The Institutional Review Board (a committee that reviews and approves research studies) and
Penn State’s Human Research Protection Program.
7b. What will happen to my research information and/or samples after the study is completed?
Your information or samples that are collected as part of this research will not be used or
distributed for future research studies, even if all of your identifiers are removed.
8. What are the costs of taking part in this research study?
There are no costs associated with participating in this research study.
9. Will you be paid or receive credit to take part in this research study?
You will not receive any payment or compensation for being in this research study.
10. Who is paying for this research study?
The institution and investigators are receiving a grant from the National Institute of Food and
Agriculture to support this research.
11. What are your rights if you take part in this research study?
Taking part in this research study is voluntary.
§ You do not have to be in this research.
§ If you choose to be in this research, you have the right to stop at any time.
§ If you decide not to be in this research or if you decide to stop at a later date, there will be no
penalty or loss of benefits to which you are entitled.
12. If you have questions or concerns about this research study, whom should you call?
Please call the head of the research study (principal investigator), Ryan P. Chesnut at 814-865-9637 if
you:
§ Have questions, complaints or concerns about the research, including questions about
compensation.
§ Believe you may have been harmed by being in the research study.
You may also contact the Human Research Protection Program at (814) 865-1775, [email protected] if
you:
§ Have questions regarding your rights as a person in a research study.
§ Have concerns, complaints, or general questions about the research.
§ You may also call this number if you cannot reach the research team or wish to offer input or
to talk to someone else about any concerns related to the research.

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You may visit the Human Research Protection Program website at
https://www.research.psu.edu/irb/participants for:
§ Information about your rights when you are in a research study;
§ Information about the Institutional Review Board (IRB), a group of people who review the
research to protect your rights; and
§ Links to the federal regulations and information about the protection of people who are in
research studies. If you do not have access to the internet, copies of these federal regulations
are available by calling the HRPP at (814) 865-1775.
INFORMED CONSENT TO TAKE PART IN RESEARCH
Signature of Person Obtaining Informed Consent
Your signature below means that you have explained the research to the subject or subject
representative, provided the subject or subject representative an opportunity to discuss and consider
whether or not to participate in the research, and have answered any questions the subject or subject
representative has about the research.
______________________________
_________
________________
Signature of person who explained this research Date
Printed Name
(Only approved investigators for this research may explain the research and obtain informed consent.)
Signature of Person Giving Informed Consent
Before making the decision about being in this research you should have:
• Discussed this research study with an investigator,
• Read the information in this form, and
• Had the opportunity to ask any questions you may have.
Your signature below means that you have received this information, have asked the questions you currently
have about the research and those questions have been answered. You will receive a copy of the signed and
dated form to keep for future reference.
Signature of Subject
By signing this consent form, you indicate that you voluntarily choose to be in this research and agree to
allow your information to be used and shared as described above.
___________________________
Signature of Subject

__________
Date

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________________
Printed Name