Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy
Phase: NA
Conditions: Fistula, Abdominal Injury, Negative Pressure Wound Therapy
Sponsor: Andrew Bernard

Document Coversheet
Study Title: Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific 
Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure 
Wound Therapy 
Institution/Site: 
University of Kentucky 
Document (Approval/Update) Date:
1/22/2021 
NCT Number:
NCT04978090
IRB Number
46641
Coversheet created:
8/23/2023

 
Combined Consent and Authorization to Participate in a Research Study  
KEY INFORMATION FOR: Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific 
Enteroatmospheric Fistula Isolation and Management Device  
Independent of Negative Pressure Wound Therapy.  
We are inviting you to take part in a clinical research study to test the benefits and safety of a customized  
device to manage enteroatmospheric fistulas in the setting of open abdomen, without negative pressure wound 
therapy involvement. 
WHAT IS THE PURPOSE, PROCEDURES, AND DURATION OF THE STUDY? 
An enteroatmospheric fistula (EAF) occurs when an abnormal connection develops from your intestine and 
creates a track from the inside of your intestine through to the outside of your abdomen 
. 
as complications from open abdomen (OA) surgery, and they can complicate your wound 
management process. 
(drainage) onto the surrounding wound, causing 
damage and infection. If an EAF develops, the number one priority 
drainage from the rest of the wound. Researchers want to find out if a new investigational device can help people 
 This device would be designed specifically for you using 3D printing technology, and would act as a 
shunt, diverting fistula drainage away from your open abdomen wound. Researchers believe the use of this 
device will streamline the wound care process and improve your overall well-being. The purpose of this study is to 
determine if this device can be used as an effective enteroatmospheric fistula management strategy. The 
research procedures will be conducted at the University of Kentucky Hospital, with the potential for continuation 
upon discharge. If you decide to be in this study and the research team confirms you are able, you will be enrolled 
in the study for up to one year, or until your EAF is closed, whichever occurs first.  
WHAT ARE THE REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
The study device may help take care of your EAF and wound bed, and improve your overall quality of life as 
compared to other treatment options. It is designed to decrease the work and time required to change your wound 
dressings, and to allow you to more easily get up and move around. Information from this study will be used to 
improve device design and help other patients with enteroatmospheric fistulas in the future. There is no cost to 
you to participate in this study. All study materials and procedures will be provided free of charge.  
WHAT ARE THE REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
The investigational device is designed to fit securely over your fistula. However, there is a chance that it could slip 
or move, which might cause leakage and require readjustment. The placement of the device might cause irritation 
or discomfort. There are other adverse events associated with simply having an EAF that are not related to the 
use this device.  
DO YOU HAVE TO TAKE PART IN THE STUDY? 
You do not have to be in this study to get help for your EAF. If you choose not to participate in this study, you will 
receive the method of treatment determined by your doctor to be best for your situation. This may include 
negative pressure wound therapy, aquarium dressings, suction units, or various other techniques. Your EAF will 
most likely eventually require surgery to fix it, regardless of the wound care option used. This study device would 
only be used to help manage your EAF during the wound care phase.  
 
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS, OR CONCERNS? 
The person in charge of this study is Andrew Bernard, MD, of the University of Kentucky, Department  
of Surgery. If you have questions, suggestions, or concerns regarding this study, or if you want to withdraw  
from the study, you may contact him at 859-323-
-330-
1488. 
If you have any questions about your rights as a volunteer in this research, contact the staff in the Office of 
Research Integrity at the University of Kentucky between the business hours of 8am and 5pm EST, Mon-Fri at 
859-257-9428 or toll free at 1-866-400-9428. We will give you a signed copy of this consent form to take with you. 
Continue to the Detailed Consent 

 
 
Combined Consent and Authorization to Participate in a Research Study  
 
 
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula 
Isolation and Management Device Independent of Negative Pressure Wound Therapy. 
 
Protocol Number: 46641 
 
Principal Investigator: Andrew Bernard, MD 
 
 
WHY ARE YOU BEING INVITED TO TAKE PART IN THIS RESEARCH? 
You are being invited to take part in a research study about enteroatmospheric fistulas (EAF) and 
wound care. You are being invited to take part in this research study because you have an abdominal 
wall defect which is open to air. An enteroatmospheric fistula (EAF) occurs when an abnormal 
connection develops from your intestine and creates a track from the inside of your intestine through to 
 
 
If you volunteer to take part in this study, you will be one of about 5 people to do so at the University of 
Kentucky.  
 
Legally Authorized Representative 
When reading this consent 
study rather than a legally authorized representative (LAR) who might sign this form on behalf of the 
person in this study. 
 
(a person designated under applicable law or by a judicial or other body to consent to healthcare 
treatment on behalf of the subject when the subject is unable such as a guardian or next of kin).  In 
evaluating the following information, you understand that you should attempt to decide what 
______________________ would do if he/she were able to choose whether or not to be in the study. 
You may also choose whether the patient should participate or not based on what you think is in the 
It is up to you to decide if you want the patient to take part in this study.  If you 
would like the patient to join, you must sign the pages at the end of this form to show that you agree 
 
 
WHO IS DOING THE STUDY? 
The person in charge of this study is Andrew Bernard, MD (Principal Investigator, PI) of University of 
Kentucky, Department of Surgery.  There may be other people on the research team assisting at 
different times during the study.  
 
WHAT IS THE PURPOSE OF THIS STUDY? 
You have been diagnosed with an enteroatmospheric fistula in the setting of open abdomen. An 
enteroatmospheric fistula (EAF) is an abnormal connection between the inside of your intestine and the 
outside world. You have fluids leaking out of your intestine. It is a serious complication, usually from 
open abdominal surgery. An EAF makes managing your open abdomen challenging. Intestinal contents 
can leak through an EAF into the surrounding wound causing irritation, infection, and/or delayed 
healing.  
 

 
Researchers want to find out if a custom fit investigational device can help people with 
Researchers want to do this by using patient-matched devices to isolate the fistula and observing the 
subsequent wound care process. This device is not yet approved by the Food and Drug Administration 
(FDA) for commercial use, but is being studied under an Abbreviated Investigational Device Exemption 
(IDE) protocol allowed by the FDA and monitored by the University of Kentucky.   
 
If you decide to participate in this study, researchers will use 3D printing technology to design a device 
specific to your fistula and your wound. The device will be used in combination with regular wound 
dressings and an ostomy appliance for the duration of your hospital stay. Dressing changes will occur 
when required, as normal, by your healthcare team. Your wound care will not involve any form of 
negative pressure wound therapy or suction therapy. If your fistula or wound changes shape, 
researchers will design a new device for you.  
 
HOW DOES THIS DEVICE WORK? 
Your intestine is full of waste products, digestive enzymes, and acidic secretions. If those contents leak 
out of your fistula, they can damage your wound, cause infection, and delay healing. Leakage also 
causes dressings to fail, requiring more frequent dressing changes. This device is designed to 
effectively carry those intestinal contents from your fistula into an ostomy bag, in hopes of protecting 
the surrounding wound and reducing the number of required dressing changes. 
 
Open abdomen wounds are often managed with a vacuum dressing. This dressing involves a vacuum 
device that is hooked up to dressings in a wound, and 
the wound together, theoretically 
speeding up healing. However, vacuum dressings that you are connected to the vacuum unit and that 
you use special dressing supplies, which are expensive and can be difficult to properly place. 
Researchers believe tha
a vacuum dressing may often be 
outweighed by its disadvantages.  
 
The device being studied may make care of the EAF more simple. The main goal in caring for an EAF 
is to allow the drainage from the intestine to get out of the wound and into a bag or collection device. 
The device being studied is perhaps simpler and therefore, less cumbersome for patients. Because it 
does not involve elaborate instruments and because it is easy to apply and clean, patients may find this 
device achieves the goals of wound care (getting drainage from the intestine out of the wound and 
coverage of the wound) much more simple than either the vacuum dressing or plastic sheeting over the 
wound. The study device uses standard wound care dressings that are available at any pharmacy. The 
method of holding the device onto the wound is a simple abdominal binder, which can be washed in the 
washing machine as needed. The collection of drainage from the intestine requires only a standard 
stoma appliance bag, which can be purchased through a pharmacy or medical supply store. The device 
requires no suction, which may permit patients to leave the hospital. 
 
ARE THERE REASONS WHY YOU SHOULD NOT TAKE PART IN THIS STUDY? 
You should not participate in this study if you are younger than 18 years old.  
 
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?  
The research procedures will be conducted at the University of Kentucky Hospital. If you decide to be in 
this study and the study team confirms you are able to take part, you will be in the study for the duration 
of your hospital stay. Your involvement in the study will have no effect in determining your length of stay 
in the hospital.  
 
While in the hospital, your EAF and open wound will be closely monitored by your healthcare team to 
make sure you are safe. This is also where you will have the procedures described in this consent form 
performed.  
 

 
In case you are discharged home, the study team and your doctor will work with you to determine your 
treatment course of action. If you wish to continue using the study device, the study team will evaluate if 
you can manage its use on your own. If it is determined possible to continue the study at home, the 
study team will work with home health to make sure the device is properly placed. The study team will 
also check in with you weekly to monitor your health and the wound management process. The study 
team will provide you with instruction for cleaning your device. 
 
Whether you are in the hospital or at home, your device will be exchanged every four weeks regardless 
of condition, to ensure structural integrity. 
 
WHAT WILL YOU BE ASKED TO DO? 
While you are in the study, you must: 
 
Follow the instructions you are given.  
 
Tell the study doctor or study staff about any changes in your health or the way you feel.  
 
Tell the study doctor or study staff if you want to stop being in the study at any time. 
  
Study Timeline: 
different amounts of time, depending on their specific 
fistula and how their wound is healing. Your doctor will determine the length of your hospital stay. Your 
participation in this study will have no effect on how long you stay in the hospital. If you decide to 
participate in this study, the study device will be used in your wound care for the remaining duration of 
your stay.  
 
If you are discharged home, it is likely that you will have home health nurses visit you to help take care 
of your wound. If this happens, the home health service may provide the additional supplies needed for 
dressing changes, aside from the study device, but the home health nurse will not be involved in 
applying the device. This will be your responsibility.  
 
Data will be collected daily by research personnel or participating healthcare staff while you are in the 
hospital. You will also periodically be evaluated by research personnel for study purposes. If you 
remain on the study following your discharge, you will be monitored (weekly) by research staff until your 
fistula resolves or until the study ends. This may include phone calls with research staff and if able, you 
may be asked to send photos of your wound to the study team for visualization. You will come back to 
 
 
If you decide later to leave this study, we will not use this information to locate you. 
 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? 
The study device is designed to be comfortable and secure. However, there is a chance it may slip or 
dislodge. You will be closely monitored by your healthcare team and study personnel in case this 
happens. The device is also designed to effectively shunt fistula contents away from your wound, but 
there is no guarantee it will do this perfectly. Every fistula management technique allows some degree 
of leakage that requires re-dressing of the wound. Fistula leakage can cause irritation, itchiness, skin 
damage or infection. Again, you will be closely monitored so that if this happens, we can promptly 
change the dressings.  
 
This device requires the use of an abdominal binder, which is a strap that loops around your body, to 
hold the device in place. The abdominal binder may cause skin irritation or discomfort if too tight.  
If the study device or the abdominal binder is positioned too tight against your skin for too long, it may 
cause pressure ulceration. Care will be taken to check for ulceration at each dressing change. If you 
feel like there is too much pressure in a specific spot, tell your healthcare team or study staff.  
 

 
The study device is made out of medical grade silicone. There is a very small chance that you might be 
allergic to silicone. You will be asked about allergies before participating in the study, and you will be 
 silicone.  
 
Some things that can happen during an allergic reaction are: 
 
a rash 
 
having a hard time breathing 
 
wheezing 
 
a sudden drop in blood pressure (making you feel dizzy or lightheaded) 
 
swelling around the mouth, throat, or eyes 
 
a fast pulse 
 
sweating 
 
The medical staff will assist you immediately if any of these or other side effects occur during your 
hospital stay. If it is determined that they were caused by the study device, you will be switched to a 
different wound management plan. If any of these effects happen when you are discharged home, you 
should get medical help immediately.  
 
It is possible that other side effects may occur that are not listed here. If you feel like any of these or 
other side effects are happening, contact your doctor or study staff. 
  
During the course of this study new information concerning risks and advantages of the clinical study or 
procedures may become known.  If this happens, your study doctor will tell you. If you change your 
mind about being in this study because of this new information, tell your study doctor who will discuss 
this with you in detail and will provide you with the necessary assistance appropriate to your situation.  
The study doctor will also tell you if new management strategies become available for your wound.   
 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
The study device may help manage your EAF. Researchers believe that use of the device will result in 
fewer required dressing changes, faster dressing changes, and easier wound management. The device 
may help prevent infection or other complication by protecting your wound from EAF leakage. The 
study device may improve your quality of life by helping you be more mobile, or it may help in allowing 
you to manage your own wound care at home. Information from this study might help researchers to 
develop better EAF management therapies in the future.  
 
DO YOU HAVE TO TAKE PART IN THE STUDY? 
If you decide to take part in the study, it should be because you really want to.  You will not lose any 
benefits or rights you would normally have if you choose not to volunteer.  You can stop at any time 
during the study and still keep the benefits and rights you had before volunteering.   If you decide not to 
take part in this study, your decision will have no effect on the quality of medical care you receive. 
 
 
You do not have to be in this study to get help for your EAF.  There is no fixed, standardized wound 
management plan for patients with EAF in OA. If you choose not to be in this study, your doctor will 
work with you to determine the best management plan for you. The most popular method of managing 
EAF is a vacuum dressing. The advantage to this system, if it seals well, is convenience and infrequent 
changes of the dressing/system. However, achieving a seal is difficult in some wounds and in some 
patients. In wounds that will not tolerate a vacuum dressing many patients are treated with a wound 
care system that involves sheets of plastic over the wound connected to suction. This wound care 
system requires continuous suction, and therefore continuous hospitalization. Both the vacuum 
dressing and the system involving plastic sheeting can require frequent dressing changes, which some 

 
patients find unpleasant and inconvenient. 
to resolve the fistula.  
   
WHAT WILL IT COST YOU TO PARTICIPATE? 
You and/or your insurance company, Medicare or Medicaid will be responsible for the costs of all care 
and treatment you receive during this study that you would normally receive for your condition. These 
are costs that are considered medically reasonable and necessary and will be part of the care you 
receive if you do not take part in this study.  
 
Participation in the study will not cost you or your insurance company anything extra. The device and 
any research visits will be provided free of charge. 
 
WHO WILL SEE THE INFORMATION THAT YOU GIVE? 
We will make every effort to keep confidential all research records that identify you to the extent 
allowed by law. 
 
Your information will be combined with information from other people taking part in the study. When we 
write about the study to share it with other researchers, we will write about the combined information we 
have gathered. You will not be personally identified in these written materials. We may publish the 
results of this study; however, we will keep your name and other identifying information private.  
We will make every effort to prevent anyone who is not on the research team from knowing that you 
gave us information, or what that information is. You should know, however, that there are some 
circumstances in which we may have to show your information to other people.  For example, the law 
may require us to show your information to a court or to tell authorities if you report information about a 
child or adult being abused or if you pose a danger to yourself or someone else.  
 
Officials of the Food and Drug Administration, the University of Kentucky, and the U.S. Government 
may look at or copy pertinent portions of records that identify you. 
 
CAN YOUR TAKING PART IN THE STUDY END EARLY? 
If you decide to take part in the study, you still have the right to decide at any time that you no longer 
want to continue. You will not be treated differently if you decide to stop taking part in the study. If you 
choose to withdraw from the study early, the data collected until that point will remain in the study 
database and may not be removed.  If you stop being in the study early, the study doctor or study staff 
may ask you some questions about being in the study.   
 
The individuals conducting the study may need to withdraw you from the study. This may occur if you 
are not able to follow the directions they give you, if you are unable to effectively use the device the 
way it was intended to be used, or if the study staff find that your being in the study causes more risk 
than benefit to you. Subjects who withdraw or are withdrawn will no longer receive this study device 
and it is not currently available commercially. 
 
ARE YOU PARTICIPATING OR CAN YOU PARTICIPATE IN ANOTHER RESEARCH STUDY AT 
THE SAME TIME AS PARTICIPATING IN THIS ONE? 
It is important to let the investigator/your doctor know if you are in another research study.  You should 
also discuss with the investigator before you agree to participate in another research study while you 
are enrolled in this study. 
 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
In the event of a medical emergency, dial 911 immediately.  If you require emergency care, be sure to 
tell the emergency care provider about your participation in this study.  Contact the study doctor as 
soon as possible.         
 

 
If you believe you are hurt or if you get sick because of something that is due to the study, you should 
call Andrew Bernard, M.D. at 859-323-6346 immediately. You may also call the research team pager, 
859-330-1488. Andrew Bernard, M.D. and the study team will determine what type of treatment, if any, 
is best for you at that time. 
 
It is important for you to understand that the University of Kentucky does not have funds set aside to 
pay for the cost of any care or treatment that might be necessary because you get hurt or sick while 
taking part in this study. Also, the University of Kentucky will not pay for any wages you may lose if you 
are harmed while participating in this study.   
 
The medical costs related to your care and treatment because of research related harm may be paid by 
your insurer if you are insured by a health insurance company (you should ask your insurer if you have 
pay under these circumstances), or may be paid 
by Medicare or Medicaid if you are covered by Medicare or Medicaid (If you have any questions 
regarding Medicare/Medicaid coverage you should contact Medicare by calling 1-800-Medicare 
(1-800-633-4227) or Medicaid 1-800-635-2570.). 
 
A co-payment/deductible may be needed by your insurer or Medicare/Medicaid (even if your insurer  
or Medicare/Medicaid has agreed to pay the costs). The amount of this co-payment/deductible  
may be costly. 
 
You do not give up your legal rights by signing this form. 
 
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? 
This study does not offer any additional rewards for participation. 
 
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS, CONCERNS, OR COMPLAINTS? 
Before you decide whether to accept this invitation to take part in the study, please ask any questions 
that might come to mind now.  Later, if you have questions, suggestions, concerns, or complaints about 
the study, you can contact the investigator, Andrew Bernard, M.D. at 859-323-6346.  If you have any 
questions about your rights as a volunteer in this research, contact the staff in the Office of Research 
Integrity at the University of Kentucky between the business hours of 8am and 5pm EST, Mon-Fri at 
859-257-9428 or toll free at 1-866-400-9428. We will give you a signed copy of this consent form to 
take with you. 
 
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR 
DECISION TO PARTICIPATE? 
If the researcher learns of new information in regards to this study, and it might change your willingness 
to stay in this study, the information will be provided to you.  You may be asked to sign a new informed 
consent form if the information is provided to you after you have joined the study.  
 
WHAT ELSE DO YOU NEED TO KNOW? 
There is a possibility that the data collected from you may be shared with other investigators in the 
future.  If that is the case, the data will not contain information that can identify you unless you give your 
consent/authorization or the University of Kentucky Institutional Review Board (IRB) approves the 
research.  The IRB is a committee that reviews ethical issues, according to federal, state and local 
regulations on research with human subjects, to make sure the study complies with these before 
approval of a research study is issued. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. 
Law. This website will not include information that can identify you.  At most, the website will include a 
summary of the results.  You can search this website at any time.  
 

 
WILL YOUR INFORMATION BE USED FOR FUTURE RESEARCH?
All identifiable information (e.g., your name, medical record number, or date of birth) will be removed 
from the information or samples collected in this study. After we remove all identifiers, the information 
or samples may be used for future research or shared with other researchers without your additional 
informed consent.  
 
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH INFORMATION  
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to 
protect your health information.  The following sections of the form describe how researchers may use 
your health information for the purposes related to this research study.   
 
Your health information that may be accessed, used and/or released includes: 
 
Demographic (personal information) and geographic information including some or all of  
the following:  name, gender, ethnic origin, address, including street, zip codes or equivalent 
geocodes, relatives' name or address, telephone, medical record number and  
study numbers, email address 
 
Dates including birth date, hospital/clinic admission or discharge dates, dates of  
medical events 
 
Health and medical history 
 
Medication history and ongoing medication use 
 
Social history 
 
Surgical details 
 
Health status 
 
Results of physical exams pertaining to this study 
 
Results of imaging studies pertaining to this study 
 
Results of other diagnostic exams pertaining to this study 
 
Photographs of EAF and/or wound 
  
The Researchers may use and share your health information with: 
 
 
 
Law enforcement agencies when required by law 
 
University of Kentucky representatives 
 
University of Kentucky Medical Center 
 
University of Kentucky Center for Clinical and Translational Science 
 
U.S. Food and Drug Administration (FDA) 
 
University of Kentucky Hospital Investigational Drug Service (IDS) 
 
Other regulatory agencies in the U.S. and other countries 
 
The researchers agree to only share your health information with the people listed in this document.   
 
Should your health information be released to anyone that is not regulated by the privacy law, your 
health information may be shared with others without your permission; however, the use of your health 
information would still be regulated by applicable federal and state laws.   
 
You will not be allowed to participate in the research study if you do not sign this form.   If you decide 
not to sign the form, it will not affect your: 
 
 
Current or future healthcare at the University of Kentucky 
 
Current or future payments to the University of Kentucky   
 
Ability to enroll in any health plans (if applicable) 

 
 
Eligibility for benefits (if applicable) 
After signing the form, you can change your mind and NOT let the researcher(s) release or use 
your health information (revoke the Authorization). If you revoke the authorization: 
 
 
You will send a written letter to: Andrew Bernard, M.D., 800 Rose St., Office C224,  
Lexington, KY, 40536 to inform him of your decision. 
 
Researchers may use and release your health information already collected for this  
research study. 
 
Your protected health information may still be used and released should you have a bad 
reaction (adverse event). 
 
You may not be allowed to participate in the study. 
 
The use and sharing of your information has no time limit.  
 
If you have not already received a copy of the Privacy Notice, you may request one.  If you have 
any questions about your pri
Privacy Officer between the business hours of 8am and 5pm EST, Mon-Fri at: (859) 323-1184. 
 
You are the subject or are authorized to act on behalf of the subject.  You have read this 
information, and you will receive a copy of this form after it is signed. 
 
_________________________________                          ________________________ 
Signature of research subject (if applicable)  
 
Date 
  
 
 
 
 
 
_________________________________ 
 
 
__________________________ 
Printed name of research subject (if applicable) 
 
 
  
 
research subject 
 
*(If, applicable) 
elationship to subject and include a description  
 
 
_________________________________                  
_________________________           
Name of [authorized] person  
 
    
 
Date 
obtaining informed consent 
  
_________________________________ 
Signature of Principal Investigator  
or Sub/Co-Investigator 
 
CONSENT OF THE PATIENT TO CONTINUE TO BE IN THE STUDY 
Your legal representative gave his/her consent for you to be in this research study. This is because you 
were not able to make your own decision due to your illness. Your condition has now improved. You 
are being asked to decide whether to continue to be in this study. Your decision is voluntary. This 
means your decision is up to you. 
You have read the information in this form and someone has explained to you what study  
procedures will be continuing. Your questions have been answered to your satisfaction. You believe 
you understand all of the information about this study. You have decided to continue taking part  
in this study. 
 

 
_________________________________   
________________________
Signature of research subject  
 
 
 
Date 
 
_________________________________ 
 
 
 
Printed name of research subject  
 
 
_________________________________                  
_________________________           
Name of [authorized] person  
 
    
 
Date 
obtaining informed consent 
  
 
_________________________________ 
Signature of Principal Investigator  
or Sub/Co-Investigator