B.6 LOI3-MHLTH-09 Consent Form

Attach. 6 Consent Form
Parental Mental Health

UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH
CONSENT TO PARTICIPATE IN A RESEARCH PROJECT
Title: A methodological study to assess mental disorders for National Children’s Study birth parents
Principal Investigator:Thomas McLaughlin, Sc.D.
Sponsor:
The National Children’s Study (NCS) is a partnership between institutions in your community and four federal
agencies: 1) The Eunice Kennedy Shriver National Institute of Child Health and Human Development; 2) the
National Institute of Environmental Health Sciences; 3) the U.S. Environmental Protection Agency; and, 4) the
Centers for Disease Control and Prevention.
The National Children’s Study Worcester County is composed of a team of community members, health
professionals, and other individuals trained to carry out the national study in your area. The local partners
include: National Children’s Study Worcester County

Research Subject’s Name:

Date:

Invitation to Take Part and Introduction
You are invited to volunteer for a research study. You are asked to take part because you are 18 or
older and are a pregnant woman or have just delivered a baby in the past four weeks or you are the
male partner (“father”) of a pregnant woman. A total of 1,200 pregnant women and their male partners
will participate in the study in Worcester Co.
Purpose of Research
The purpose of this research study is to test a parental mental health telephone questionnaire called the
Parental Mental Health (PMH) Screen. The goal is to see if the PMH screen can accurately detect
mental disorders (e.g. depression, anxiety) if they are present through asking a series of questions. If
the PMH screen is found to be accurate, it will be used by the National Children’s Study (NCS) as part
of its questionnaire packet.
The National Children’s Study is a long-term study that will follow children from birth through the age
of 21. It seeks to understand the link between children’s physical and emotional health, their
development, and their environment in which they are raised. Approximately 20% of the adult U.S.
population has a diagnosable mental disorder during a given year and that rate has steadily increased
over the past several decades. Women are more likely than men to have depression or anxiety.
Pregnant women are at an increased risk for these disorders. Untreated mental disorders in parents are
risk factors for children’s mental disorders. A screening instrument for mental disorders can identify
women who may be at risk for a mental disorder. If a pregnant woman is found to be at risk for a
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Parental Mental Health

disorder, they can be referred for treatment.
It is hoped that the PMH Screen is able to accurately identify pregnant women who may have a mental
disorder by being administered over the telephone.
Your Rights
It is important for you to know that:
Your participation is entirely voluntary.
You may decide not to take part or decide to quit the study at any time, without any changes in
the quality of the health care you receive.
You will be told about any new information or changes in the study that might affect your
willingness to participate.

PROCEDURES
There are two parts to this study:
1. The Parental Mental Health Screen
a. All pregnant women and men who agree to participate in this study will provide a
phone number to the research assistant and they will schedule a time for a telephone
call.
b. At the agreed upon time, the research assistant will call the pregnant woman or man.
The research assistant will ask the individual a series of questions from the PMH
Screen. This call will last approximately 10 minutes.
2. The Composite International Diagnostic interview (CIDI)
a. Half of the men and half of the women in the study will be randomly chosen to
participate in a second phone call. This means that you will have a 50-50 chance of
being chosen for this second phone call (like choosing heads/tails and then flipping a
coin). This time questions from a mental health screening instrument called the
Composite International Diagnostic interview will be asked. This phone call will last
approximately 30 minutes.
Your participation in the research will last up to one month.
CONFLICT OF INTEREST DISCLOSURE
None
RISKS
This study involves no more than minimal risk. The only discomfort associated with this study is
discomfort one may feel when asked about emotional, behavioral, or substance use difficulties.
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There is a risk of loss of confidentiality because some study personnel will have access to your name
and telephone number, although many efforts will be made to maintain your confidentiality.
If you tell us, or we observe, that a child, a handicapped person, or an elderly person is being abused or
neglected, or that you intend to do harm to yourself or another person, then we are required by law to
report this to the proper authorities. Such a report might result in an investigation which could cause
you significant emotional discomfort.
UNKNOWN RISKS
There may be risks to participating in this study that we don't know about now. You will be informed
of any changes in the way the study will be done and any additional identified risks to which you may
be exposed.
PREGNANCY
During the course of the research study, you will not be asked to make any changes to your prenatal
care or daily health routine.
BENEFITS
There is no direct benefit to you from being in this study. However, your participation may help others
with this condition in the future as a result of knowledge gained from the research.
REASONS YOU MIGHT BE WITHDRAWN FROM THE STUDY WITHOUT YOUR
CONSENT
You may be taken out of the research study if:
1. The investigator decides that continuing in the study would be harmful to you.
2. The study is canceled by National Children’s Study or the University of Massachusetts
Medical School Institutional Review Board.
ALTERNATIVES
The only alternative to participating in this study is not to participate.
COSTS
There will be no additional cost to you from being in this research study.
COMPENSATION
Compensation for Participation
You will receive a monetary token of appreciation of $25 for completing the (first) 10 minute telephone
survey for this research, once the study data are collected. If you are also randomly chosen to
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Parental Mental Health

participate in the (second) 30-minute telephone interview, you will receive an additional $25 monetary
token of appreciation for completing the second interview.
Reimbursement
You will not be reimbursed for any out of pocket expenses such as parking or transportation fees.

CONFIDENTIALITY
Your privacy is important to us. Your research records will be secure to the extent permitted by law,
and will be disclosed only with your permission or as required by U.S. or state law. In research
records, you will be identified by a code number. Research information that directly identifies you
(including your name, address, phone number, hospital medical record number or social security
number) may be viewed by people that have an identified role in oversight of this study and they may
inspect your medical and research records. This includes the study sponsor (the National Children’s
Study), their partners or contractors, as well as US Food and Drug Administration (FDA), the UMass
Institutional Review Board and UMass representatives. All of these individuals are required to keep all
information confidential.
YOUR PARTICIPATION IN THIS PROJECT IS ENTIRELY VOLUNTARY. YOU MAY
WITHDRAW FROM THE STUDY AT ANY TIME.
THE QUALITY OF CARE YOU RECEIVE AT THIS HOSPITAL WILL NOT BE AFFECTED
IN ANY WAY IF YOU DECIDE NOT TO PARTICIPATE OR IF YOU WITHDRAW FROM
THE STUDY.

RESEARCH INJURY COMPENSATION
If you are injured or have any harmful effects as a direct result of your being in this research, treatment
will be made available to you at UMass Memorial Medical Center (UMMMC). You will not have to
pay any charges resulting from the harmful effect or injury of any procedure that would not have
otherwise been done as part of your regular care.
The NCS Worcester County site does not routinely provide any other form of compensation for injury.
It is important that you report any suspected study-related injury to the research team listed at the top
of this form immediately.
QUESTIONS
Before you sign this consent form, please feel free to ask any questions you may have about the study
or about your rights as a research subject. If other questions occur to you later, or if you have concerns
or complaints, or think the research has hurt you, you may contact Dr. Thomas McLaughlin at 508856-3132, the Principal Investigator. You may take as much time as needed to think this over. If at
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Parental Mental Health

any time during or after the study, you would like to discuss the study or your research rights with
someone who is not associated with the research study, you may contact the Administrative
Coordinator for the Committee for the Protection of Human Subjects in Research at UMMS. The
telephone number is (508) 856-4261.

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HSC Docket # H-14126
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Approved UMass Medical School IRB Do not sign this form after this date: 3/20/2014

Attach. 6 Consent Form
Parental Mental Health

CONSENT TO PARTICIPATE IN THE RESEARCH PROJECT
Title: A methodological study to assess mental disorders for National Children’s Study birth parents
Principal Investigator: Thomas McLaughlin, Sc.D.

Subject’s Name:
I understand the purpose and procedures of this research project and the predictable discomfort, risks,
and benefits that might result. I have been told that unforeseen events may occur. I have had an
opportunity to discuss the risks and benefits of this research with the investigator and all of my
questions have been answered. I agree to participate as a volunteer in this research project. I
understand that I may end my participation at any time. I have been given a copy of this consent form.
Date:
Subject’s signature

STATEMENT OF PERSON OBTAINING CONSENT
I, the undersigned, have fully explained the details of this clinical study as described in the consent
form to the subject named above.
Date:
Signature of person obtaining consent

Page 6 of 6

HSC Docket # H-14126
Version 5/16/2013

Approved UMass Medical School IRB Do not sign this form after this date: 3/20/2014