Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs
Conditions: Epilepsy, Pregnancy
Sponsor: Stanford University

Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs 
(MONEAD) 
 
Informed Consent Form Version 7.2 dated 17NOV2021 
 
 
Principal Investigators: 
 
Kimford J. Meador, M.D. 
Stanford University 
Palo Alto, California 
& 
Page B. Pennell, M.D. 
Harvard Brigham & Women’s Hospital 
Boston, Massachusetts 
 
Data and Statistical Center PI: 
Abigail Matthews, Ph.D. 
The Emmes Corporation 
Rockville, Maryland 
 
 
Supported by: 
 
The National Institute of Neurological 
Disorders and Stroke (NINDS) & Eunice Kennedy Shriver National Institute of Child 
Health and Human Development (NICHD) 
 
Grant #1U01-NS038455 
 
 
 
NCT 01730170 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       1 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
 
 
 
Please check all that are applicable: 
 
 I am an adult participant in this study. 
 
Print your name here:  
 
______________________________________________________ 
 
 
 I am the parent or guardian granting permission for a child in this study (the use of "you" 
refers to "your child" or “your ward.”) 
  
Print child’s name here:  
 
______________________________________________________ 
 
 
FOR QUESTIONS ABOUT THE STUDY, CONTACT:  
Dr. Kimford Meador 
Department of Neurology & Neurological Sciences Stanford Comprehensive Epilepsy Center  
Stanford University School of Medicine 
213 Quarry Road  
Palo Alto, California 94304 
(650) 725-6648 
DESCRIPTION: You are being asked to continue participating in a research study.  This form 
is designed to tell you everything you need to think about before you decide to consent 
(agree) continue in the study or not to be in the study.  It is entirely your choice.  If you 
decide to take part, you can change your mind later on and withdraw from the research study.  
You can skip any questions that you do not wish to answer. 
Our preliminary genetic analyses are providing interesting findings, but we are concerned that 
we will run out of genetic samples before completing all of our future genetic studies. We are 
requesting to collect an additional genetic sample from you and your child.  
Before making your decision: 
• 
Please carefully read this form or have it read to you 
• 
Please ask questions about anything that is not clear 
You can take a copy of this consent form, to keep.  Feel free to take your time thinking about 
whether you would like to participate.  By signing this form you will not give up any legal 
rights. 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       2 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. law.  This Web site will not include information that can identify you.  At most the Web 
site will include a summary of the results.  You may search this Web site at any time. 
STUDY OVERVIEW: Mothers with epilepsy, mothers without epilepsy, and their children are 
being asked to continue in this project.  You are being asked to participate in this project 
because you are currently enrolled or have been enrolled in the MONEAD study. You cannot 
participate in a clinical trial at the same time you participate in this study.   You will be one of 
approximately 451 women and their children to continue in this study in the study at 20 
clinical sites across the United States. 
Yours or your child’s medical care and treatment will not be altered in any way for this study.  
Your participation in this study will not change your treating obstetrician, neurologist, primary 
care physician, or pediatrician.  You will receive no medications or other types of treatment as 
part of this study.  You will be asked to agree to have medical records such as your medical 
history, obstetrical, delivery, and pediatric records released to the study staff. 
 
PROCEDURES: You and your child’s participation will require up to 4 visits and 16 telephone 
contacts depending on how old your child is currently. Occasionally, your interview with a 
research assistant might be audio/videotaped so that we can make sure our research 
assistants are scoring these standard scales the same way each time.  These interviews will be 
labeled with a study number, stored in a locked cabinet and destroyed at the conclusion of the 
study. 
When your child is 15, 18 & 21 months, you will be contacted by the study staff by telephone.  
You will not have to come into the study offices, but completing the telephone interviews are 
just as important to the study.  During these calls, you will be asked if you and your child had 
any health problems and if you are continuing, changing, or starting new medications since 
the last visit. 
When your child is 24 months (2 years) of age (Visit 9), you will be asked if you and your child 
had any health problems.  You will be asked to complete questionnaires on changes in 
employment, your stress levels, and mood, and your child’s development.  You will be asked 
to complete questionnaires about your child’s behavior.  Your child will have a physical and 
neurological exam and have a test of behavior and thinking abilities.  Your child’s handedness 
will be evaluated.  If the assessments show any cause for concern, your child will be referred 
for further testing and follow-up. 
When your child is 27, 30, and 33 months of age you will be contacted by the study staff by 
telephone.  You will not have to come into the study offices, but completing the telephone 
interviews are just as important to the study.  During these calls, you will be asked if you and 
your child had any health problems. 
When your child is 36 months (3 years) of age (Visit 10) you will be asked if you and your 
child had any health problems.  You will be asked to complete questionnaires on your stress 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       3 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
levels and mood, your child’s development.  You will be asked to complete questionnaires 
about your child’s behavior.  Your child will have a physical and neurological exam and have 
tests of behavior and thinking abilities.  Your child will also have testing of memory, logic, and 
motor skills performed.  Your child’s handedness will be evaluated.  The assessments should 
not take more than 2 hours.  If the assessments show any cause for concern, your child will 
be referred for counseling and follow-up. 
When your child is 39, 42, 45, 48, and 51 months of age you will be contacted by the study 
staff by telephone.  You will not have to come into the study offices, but completing the 
telephone interviews are just as important to the study.  During these calls, you will be asked 
if you and your child had any health problems.   
When your child is 54 months (4 ½ years) of age (Visit 11) you will be asked if you and your 
child had any health problems.  You will be asked to complete questionnaires on your stress 
levels and mood, your child’s development.  You will be asked to complete questionnaires 
about your child’s behavior.  Your child will have a physical and neurological exam and have a 
test of creative thinking.  This assessment should not take more than an hour.  
When your child is 57, 60, 63, 66, and 69 months of age you will be contacted by the study 
staff by telephone.  You will not have to come into the study offices, but completing the 
telephone interviews is just as important to the study.  During these calls, you will be asked if 
you and your child had any health problems.   
When your child is 72 months (6 years) of age (Visit 12) you will be asked if you and your 
child had any health problems.  You will be asked to complete questionnaires on your stress 
levels and mood, your child’s development.  You will be asked to complete questionnaires 
about your child’s behavior.  Your child will have a physical and neurological exam and have 
tests of behavior and thinking abilities.  Your child will also have testing of memory, logic, and 
motor skills performed.  Your child’s handedness will be evaluated.  The assessments should 
not take more than 6 hours.  This testing session will include a break for your child and, if 
necessary, can be split over 2 days.  If the assessments show any cause for concern, your 
child will be referred for counseling and follow-up.  
Occasionally, your interview with a research assistant might be audio/videotaped so that we 
can make sure our research assistants are scoring these standard scales the same way each 
time. 
I give consent to be audio/videotaped during this study: 
Please initial: ___Yes ___No 
If you provide permission, your child’s teacher will be asked to participate in the study as well. 
The teacher’s involvement will consist of filling out a questionnaire about your child’s behavior. 
It is important that you report any hospitalizations, illnesses or other health problems you may 
have to the study staff at any time while you are participating in the study.  If you are taking 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       4 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
medications, you may be asked to bring a container of each in so the study staff may obtain 
accurate information about its dose and how often you should take it. 
You have previously provided the project a genetic sample by blood draw, heel stick or 
swabbing.  The goal is to increase the amount of sample we have already collected to ensure 
there is enough for possible future research projects investigating any enzymes or genetic 
susceptibility in the subjects that interact/work with AED metabolism and if those are related 
to any mother or child outcomes. 
You will rub a cotton swab firmly against the inside of your and your child’s cheek to collect 
this sample. Each will use a separate swab. If you are not comfortable doing this yourself, the 
study staff can do the collection for you.  
We plan to perform genetic research using you and your child’s tissue samples that have been 
collected. All living things are made of cells. DNA is the material in cells that makes up your 
genes which contain the instructions telling our bodies how to grow, work, and determine 
physical characteristics such as hair and eye color. Genes are passed from parent to child. As 
we do not yet know which genes fit our current hypotheses about how anti‐epileptic 
medications may impact early development in exposed infants, we will utilize continually 
improving DNA sequencing technologies for our studies. Your genetic information may be 
shared with other investigators in other study groups. The swab samples will be 
stored at the University of Minnesota. The genetic data will be coded to protect 
your identity. 
Check ONE answer below: 
Even if you initially agree to participate, later you can have your sample destroyed if you 
change your mind and decide you do not want to participate by notifying your study doctor in 
writing. 
_____ Yes, I agree to participate and to allow my child to participate in the project’s genetic 
studies.  
_____ Yes, I agree to participate but I do not want my child to participate. 
_____ Yes, I agree to allow my child to participate, but I do not want to participate. 
_____ No, I do not want myself or my child to participate in the genetic sampling in this 
project. 
If you are coming in-person to research visits, you are required to be fully vaccinated—2 
doses (1 for Johnson and Johnson), 2 weeks out and to provide proof of your vaccination 
(e.g., CDC COVID-19 Vaccination Card, e-Health record, etc.) to the researcher prior to 
study participation.  Alternately, you can provide a negative COVID test within 72 hours 
of your visit. 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       5 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
 
RISKS AND BENEFITS: The main risks of participation are fatigue and feelings of unease 
answering questions.  Your child may become restless with the tests and questions.  We will 
make every attempt to schedule and perform the tasks so as to reduce these risks.  You and 
your child may refuse to answer any question that upsets you.  Side effects and problems not 
listed above and not expected at this time may occur.  You will be told of any changes in the 
way the study is done and of any risks to you or your child.  
 
This study is not designed to benefit you directly.  The study results may be used to help 
others in the future. We cannot and do not guarantee or promise that you will receive any 
benefits from this study.  It is possible that the researchers will learn something new during 
the study about the risks of being in it.  If this happens, they will tell you about it.  Then you 
can decide if you want to continue to be in this study or not.  You may be asked to sign a new 
consent form that includes the new information if you decide to stay in the study. 
 
Your decision whether or not to participate in this study will not affect your 
employment/medical care. 
You and/or your child may feel some discomfort when taking the samples.   
Confidentiality: The Data Management Center located at The EMMES Corporation in 
Rockville, Maryland is the company that developed and maintains the electronic database 
where information collected in the study is entered and stored for analysis.  Although no 
information that identifies you is entered into this database, The EMMES Corporation will send 
out representatives to each center in the study to review the information collected and to 
make sure that the data is being collected and entered correctly.  A study number rather than 
your name will be used on study records wherever possible.  Your name and other facts that 
might point to you will not appear when we present this study or publish its results.   
TIME INVOLVEMENT: Your participation, and that of your child, in this experiment will take 
approximately 4 years. 
PAYMENTS: You will be paid for each completed study visit as noted in the following table: 
 
Visit/Telephone Contact 
Stipend 
Visits 8a, 8b, 8c (15, 18, & 21 mo.) 
$15 each  45 
Visit 9 (2 yr.) 
$200 
Visits 9a, 9b, 9c (27, 30, & 33 mo.) 
$15 each  45 
Visit 10 (3 yr.) 
$300 
Visits 10a, 10b, 10c, 10d, 10e (39, 42, 45, 48 & 51 mo.) 
$15 each 
Visit 11 (4 ½ yr.) 
$300 
Visit 11a, 11b, 11c, 11d, 11e (57, 60, 63, 66, & 69 mo.) 
$15 each 
Visit 12 (6 yr.) 
$500 
 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       6 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
If you do not finish the study, you will not be paid for the visits you have not completed.  You 
will receive $1,540 total, if you complete all study visits. 
 
We will also give your child an age appropriate card or toy at their 2, 3, 4 ½ and 6 YO visits. 
 
Periodically you will receive a study related newsletter. 
 
You will receive a stipend of $15 for each sample collected from the you and your child(ren). 
 
Payments may only be made to U.S. citizens, legal resident aliens, and those who have a work 
eligible visa.  You may need to provide your social security number to receive payment. 
  
PARTICIPANT’S RIGHTS: If you have read this form and have decided to participate in this 
project, please understand your participation is voluntary and you have the right to withdraw 
your consent or discontinue participation at any time without penalty or loss of benefits to 
which you are otherwise entitled.  
The results of this research study may be presented at scientific or professional meetings or 
published in scientific journals.  However, your identity will not be disclosed. 
You have the right to refuse to answer particular questions.  
 
 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       7 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
Authorization To Use Your Health Information For 
Research Purposes  
Because information about you and your health is personal and private, it 
generally cannot be used in this research study without your written authorization.  
If you sign this form, it will provide that authorization.  The form is intended to 
inform you about how your health information will be used or disclosed in the 
study.  Your information will only be used in accordance with this authorization 
form and the informed consent form and as required or allowed by law.  Please 
read it carefully before signing it.   
 
What is the purpose of this research study and how will my health 
information be utilized in the study? 
Most Women with epilepsy have normal pregnancies, but appear to be at risk for 
problems during pregnancy (e.g., seizures, change in medications, depression, c-
sections) and adverse outcomes in their children (e.g., thinking or behavioral 
problems).  The purpose of this observational study is to establish the risk and 
determine the factors or contributions to those risks. 
 
If you sign this form, you give us your permission to use your PHI for the conduct 
and oversight of this research study.  Your health information may be used in 
future publications.   
 
Do I have to sign this authorization form? 
You do not have to sign this authorization form.  But if you do not, you will not be 
able to participate in this research study.   
Signing the form is not a condition for receiving any medical care outside the 
study. 
 
If I sign, can I revoke it or withdraw from the research later? 
If you decide to participate, you are free to withdraw your authorization regarding 
the use and disclosure of your health information (and to discontinue any other 
participation in the study) at any time.  After any revocation, your health 
information will no longer be used or disclosed in the study, except to the extent 
that the law allows us to continue using your information (e.g., necessary to 
maintain integrity of research).  If you wish to revoke your authorization for the 
research use or disclosure of your health information in this study, you must write 
to: Dr. Kimford Meador at 213 Quarry Road, Palo Alto CA 94304.  
 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       8 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
What Personal Information Will Be Obtained, Used or Disclosed? 
Your health information related to this study, may be used or disclosed in 
connection with this research study, including, but not limited to,  
your medical and psychiatric history; HIV or VDRL status, demographics such as 
age, educational achievements, employment status and physical factors such as 
height, weight, measurement of the size of your head, and imaging results.  Other 
PHI may include your mental health status, alcohol, drug and tobacco use.  
Information about your child’s delivery, health and development will be used.  You 
and your child’s medical records from your primary care physician, neurologist, 
obstetrician and pediatrician will be used to collect or confirm this information. 
Upon agreement, your voice may be recorded on videotape to  
evaluate the study assessor’s performance submitted to the Psychiatry  
Core. Other PHI to be collected may include outside assessments/diagnoses of 
autism and/or developmental delay, child interventions such as Early Intervention, 
Head Start and Special Education services and information about your mental 
health status. 
 
Who May Use or Disclose the Information? 
The following parties are authorized to use and/or disclose your health information 
in connection with this research study: 
• The Protocol Director Dr. Kimford Meador 
• The Stanford University Administrative Panel on Human Subjects in Medical 
Research and any other unit of Stanford University as necessary 
• Research Staff 
 
Who May Receive or Use the Information? 
The parties listed in the preceding paragraph may disclose your health information 
to the following persons and organizations for their use in connection with this 
research study:  
 
• The Office for Human Research Protections in the U.S. Department of Health 
and Human Services 
• The study’s funding institution, Emory University 
• National Institute of Neurological Disorders and Stroke/Eunice Kennedy 
Shriver National Institute of Child Health and Human Development are the 
Sponsors of this Research.  The Sponsor(s) may use and disclose your PHI 
to make sure the research is done correctly.  They may also use your PHI to 
collect and analyze the results of the research.  The Sponsor may have other 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       9 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
people and groups help conduct, oversee, and analyze the study.  These 
people or groups will use your PHI. 
• The following groups may also use and disclose your PHI.  They will do this 
to make sure the research is done correctly and safely.  The groups are: 
o the Emory University Institutional Review Board 
o the Emory University Office of Research Compliance 
o research monitors and reviewers 
o The EMMES Corporation, the Data & Statistical Center. 
o the Office for Human Subjects Research Protections the FDA, and the 
National Institutes of Health  
o public health agencies  
o University of Arkansas, Psychiatry Core 
 
This research is covered by a Certificate of Confidentiality from the National 
Institutes of Health. The researchers with this Certificate may not disclose or use 
information, documents, or biospecimens that may identify you in any federal, 
state, or local civil, criminal, administrative, legislative, or other action, suit, or 
proceeding, or be used as evidence, for example, if there is a court subpoena, 
unless you have consented for this use. Information, documents, or biospecimens 
protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that 
requires disclosure (such as to report child abuse or communicable diseases but 
not for federal, state, or local civil, criminal, administrative, legislative, or other 
proceedings, see below); if you have consented to the disclosure, including for 
your medical treatment; or if it is used for other scientific research, as allowed by 
federal regulations protecting research subjects. 
 
Your information may be re-disclosed by the recipients described above, if they 
are not required by law to protect the privacy of the information. 
 
When will my authorization expire? 
Your authorization for the use and/or disclosure of your health information will end 
on Janurary 1, 2050 or when the research project ends, whichever is earlier.  
 
Description of Representative's Authority to Act for Subject Will access 
to my medical record be limited during the study? 
To maintain the integrity of this research study, you may not have access to any 
health information developed as part of this study until it is completed.  At that 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       10 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
point, you would have access to such health information if it was used to make a 
medical or billing decision about you (e.g., if included in your official medical 
record).  
 
 
________________________________             
   ______________ 
Signature of Adult Participant                                           Date 
 
 
________________________________             
 
Print Name of Adult Participant                                         
 
 
_______________________________                        ______________ 
Signature of Legally Authorized Representative (LAR)          Date 
(e.g., parent, guardian or conservator) 
 
 
________________________________             
 
Print Name of LAR                                         
 
________________________________________________________ 
LAR’s Authority to Act for Participant 
(e.g., parent, guardian or conservator) 
 
 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       11 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
WITHDRAWAL FROM STUDY 
You have the right to leave a study at any time without penalty.  You may refuse to do any 
procedures you do not feel comfortable with, or answer any questions that you do not wish 
to answer. 
 
The Protocol Director may also withdraw you from the study without your consent for one or 
more of the following reasons:   
o Failure to follow the instructions of the Protocol Director and study staff. 
o The Protocol Director decides that continuing your participation could be 
harmful to you. 
o You were to object to any future changes that may be made in the study 
plan 
o The study is cancelled.  
o Other administrative reasons. 
o Unanticipated circumstances. 
 
You have the right to refuse to allow the investigators to share your sample at any time without 
penalty. If you change your mind, you may be able to withdraw the remaining sample at a later 
time by notifying the MONEAD staff. 
 
CONTACT INFORMATION:  
If you have any questions, concerns or complaints about this research study, its procedures, 
risks and benefits, or alternative courses of treatment, you should ask the Protocol Director, 
Dr. Kimford Meador, at (650) 725-6648.  You should also contact him at any time if you feel 
you have been hurt by being a part of this study.  
Independent Contact: If you are not satisfied with how this study is being conducted, or if you 
have any concerns, complaints, or general questions about the research or your rights as a 
participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone 
independent of the research team at (650) 723-5244 or toll free at 1-866-680-2906.  You can 
also write to the Stanford IRB, Stanford University, 1705 El Camino Real, Palo Alto, CA 94306. 
 
FUTURE PARTICIPATION 
The researchers may want to contact you after your participation in this project ends. They may 
want to get more information or perform more procedures for this project or they may want to ask 
you and/or your child to participate in another project.  You should indicate below whether or not 
you agree to allow the study staff to contact you for these reasons by placing an “X” by the 
appropriate statement.  Your answer will not affect your ability or anyone else’s to participate in 
this study.  If you change your mind at any time, please contact the study staff. 
 
 
_______ I agree to allow the study staff to contact me if they need more information from me 
for this study or if they would like to offer me participation in another project. 
 
_______ I do not want the study staff to contact me after I finish participating in this study. 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       12 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
EXPERIMENTAL SUBJECTS BILL OF RIGHTS: As a research participant you have the 
following rights.  These rights include but are not limited to the participant's right to: 
• 
be informed of the nature and purpose of the experiment;  
• 
be given an explanation of the procedures to be followed in the medical experiment, and 
any drug or device to be utilized;  
• 
be given a description of any attendant discomforts and risks reasonably to be expected;  
• 
be given an explanation of any benefits to the subject reasonably to be expected, if 
applicable;  
• 
be given a disclosure of any appropriate alternatives, drugs or devices that might be 
advantageous to the subject, their relative risks and benefits; 
• 
be informed of the avenues of medical treatment, if any available to the subject after the 
experiment if complications should arise;  
• 
be given an opportunity to ask questions concerning the experiment or the procedures 
involved;  
• 
be instructed that consent to participate in the medical experiment may be withdrawn at 
any time and the subject may discontinue participation without prejudice;  
• 
be given a copy of the signed and dated consent form; and  
• 
be given the opportunity to decide to consent or not to consent to a medical experiment 
without the intervention of any element of force, fraud, deceit, duress, coercion or undue 
influence on the subject's decision. 
The extra copy of this signed and dated consent form is for you to keep. 
 
________________________________  
 
    _____________ 
Signature of Adult Participant  
 
 
 
 
  Date 
 
_____________________________________             
Print Name of Adult Participant                                        
 
 
_____________________________________                ____________         
Signature of Legally Authorized Representative (LAR)  
  Date  
(e.g., parent, guardian or conservator)                                  
 
 
_____________________________________             
Print Name of LAR                                         
 
 
_____________________________________ 
LAR’s Authority to Act for Participant  
 
 
(e.g., parent, guardian or conservator) 

 
 
STANFORD UNIVERSITY   Research Consent Form 
Protocol Director: 
Kimford Meador, MD 
Protocol Title:  Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) V7.2-Mother 
 
 
Form: MONEAD V7.2 dated 17NOV2021                                       13 of 13 
IRB Use Only 
Approval Date:   November 30, 2022 
Expiration Date: November 30, 2023 
 
 
 
_____________________________________                ____________  
(If available) Signature of Other Parent or Guardian               Date       
 
 
_____________________________________             
Print Name of Other Parent or Guardian                                         
 
                       
_____________________________________ 
Authority to Act for Participant  
 
 
 
 
_____________________________________                    ____________       
Signature of Person Obtaining Consent  
               
  Date 
 
 
_____________________________________             
Print Name of Person Obtaining Consent 
 
The following witness line is to be signed only if the consent is provided as a summary form and 
accompanied by a short form foreign language consent. 
 
 
_____________________________________                       ____________ 
Signature of Witness                                                                 Date 
 
 
 
__________________________________              
Print Name of Witness                                         
 
(e.g., staff, translator/interpreter, family member, or other person who speaks both English and the 
participant's language) 
 
• Translated short form must be signed and dated by both the participant (or their LAR) AND the 
witness. 
• The English consent form (referred to as the "Summary Form" in the regulations): 
o Must be signed by the witness AND the Person Obtaining Consent (POC). 
o The non-English speaking participant/LAR does not sign the English consent. 
o The non-English speaking participant/LAR should not sign the HIPAA participant line 
o If the participant or the LAR is non-English speaking, the Person Obtaining Consent (POC) must 
ensure that 1) the LAR's Description of Authority is completed and 2) that any questions or options 
presented by the consent form are documented and initialed by the POC on the Summary Form, per 
the participant's wishes, as they are understood during the consent process.