ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY
MONTEFIORE MEDICAL CENTER
JACOBI MEDICAL CENTER
NORTH CENTRAL BRONX HOSPITAL

 


Information and Parental Permission/Young Adult Assent Form  

You are being asked to join this research study. 
The title of the study is:   

The study is being done under the supervision of:

Principal Investigator (Researcher Study Doctor): 
Office Address: 
Telephone #: 
Protocol #: 

DO I HAVE TO TAKE PART IN THIS RESEARCH STUDY?

STUDY SPECIFICS

WHY HAVE I BEEN ASKED TO TAKE PART IN THIS RESEARCH STUDY?

WHY IS THIS RESEARCH STUDY BEING DONE?

HOW MANY PEOPLE WILL TAKE PART IN THE RESEARCH STUDY?

WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?

WILL THIS STUDY INVOLVE GENETIC RESEARCH and/or TESTING?

TESTING FOR HIV

WHAT ELSE DO I HAVE TO DO?

WILL THIS STUDY INVOLVE AUDIO AND/OR VIDEO TAPING?

WHAT ARE THE POSSIBLE SIDE EFFECTS, DISCOMFORTS, RISKS OR INCONVENIENCES I CAN EXPECT FROM BEING IN THIS RESEARCH STUDY?

Here is a list of the known risks associated with this drug/device/research:

MOST COMMON:

COMMON:

RARE:

In addition to the risks listed above, there is always the possibility that you will have a reaction that is currently not known and not expected.

PREGNANCY AND IMPREGNATION DURING THIS STUDY

RISKS FROM RADIATION EXPOSURE OR RADIOISOTOPES

 

This research study involves exposure to radiation above that which you will receive during standard clinical care.

The research study involves radiation from (name all additional procedures to be done for research purposes). The amount of radiation from these procedures is _____ mSv above standard clinical care. This can be compared to the natural environmental radiation that you receive every year, which in the New York City area is about 3 mSv. The risks to your health from the radiation dose you will receive from these additional procedures are minimal.

The research study involves radiation from (name all additional procedures to be done for research purposes). The amount of radiation from these procedures is _____ mSv above standard clinical care.  This is ____ times the natural environmental radiation that you receive every year. Exposure to this level of radiation will moderately increase your risk of developing cancer some time in the future.  (or will moderately increase your future health risks)

The research study involves radiation from (name all additional procedures to be done for research purposes). The amount of radiation from these procedures is _____ mSv above standard clinical care.  This is ____ times the natural environmental radiation that you receive every year. Exposure to this level of radiation will significantly increase your risk of developing cancer some time in the future. 

WILL THE RESULTS OF THIS STUDY OR ANY OF THE PROCEDURES AFFECT MY INSURABILITY?

Some tests reveal information that may affect a person’s insurability. The tests done under this study may reveal _______, which may affect your ability to get or keep medical, health or life insurance.

ARE THERE LIKELY TO BE ANY BENEFITS TO TAKING PART IN THIS RESEARCH STUDY? 

WHAT OTHER CHOICES DO I HAVE IF I DO NOT TAKE PART IN THIS RESEARCH STUDY?

Before agreeing to join the study and before signing this consent form your personal doctor should have discussed with you what, and if, standard treatments are available and/or other research protocols.

WILL I BE PAID FOR BEING IN THE STUDY? 

WHO MAY SEE MY RECORDS?

CERTIFICATE OF CONFIDENTIALITY

WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS RESEARCH STUDY?

If you are injured as a result of this research, only immediate, essential, short-term medical treatment, as determined by the participating hospital or sponsoring company, will be available for the injury without charge to you personally.

If there is a physical injury as a result of this research, only immediate, essential, short-term medical treatment as determined by the participating hospital, will be available for the injury without charge to you personally.

If you are injured as a result of this research, only immediate, essential, short term medical treatment, as determined by the participating hospital or sponsoring company will be available for the injury without charge to you personally.

Immediately report any discomforts, problems or injuries you experience during the course of your participation in the study to ______________.

WILL THERE BE ANY COSTS TO ME?

WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY? 

Researcher’s Name: 
Office Address: 
Office Phone: 

WILL ANY OF THE SAMPLES (BLOOD, TISSUE, DNA) TAKEN FROM ME BE USED FOR FUTURE RESEARCH STUDIES?

 

USE OF IDENTIFIED SPECIMENS FOR FUTURE RESEARCH:

In addition to the research you are consenting to under this research study, Dr. ________________ or other researchers at this or other institutions may wish to study the samples in future research, including genetic analysis. These samples, taken from your body, would be able to be linked back to you. Information about you may be shared with other researchers who will keep the information confidential. However, it is possible that information about you may become known to people other than the researchers.

At this time, the researcher does not know what the future studies will be. Your specimens may also be submitted to a tissue/cell/DNA bank. The specimens may be kept for a long time and may exceed 50 years. You have the right to withdraw consent to use of the tissue for future use at any time by contacting the supervisor of the study named on the first page of the consent or Einstein IRB Administrative office at 718-430-2253. Unused specimens will be destroyed.

In some research using human blood or tissue, the specimens and their parts may enable researchers to develop medical tests or treatments that have commercial value. You will not receive any money that may result from any such commercial tests or treatments.

Your specimens may be used for future research, even though the purpose of the future research is not known at this time.

PARTICIPANT:
PLEASE INDICATE YOUR CHOICE BY INITIALING ONE (1) OF THE FOLLOWING OPTIONS

___ I consent to have my specimens used for future research studies.

___ I consent to have my specimens used for future research studies only for the study of _____________________________________.

___ I do NOT consent to have my specimens used for future research studies. The specimens will be destroyed at the end of the study.

PARTICIPANT:
FOR FUTURE CONTACT, PLEASE INITIAL YOUR CHOICES BELOW

I consent to be contacted in the future to learn about:

_____ New research protocols that I may wish to join.

_____ General information about research findings.

_____ Information about the test on my sample that may benefit me or my family members in relation to choices regarding preventive or clinical care.

_____ I DO NOT AGREE TO BE CONTACTED IN THE FUTURE, EVEN IF THE RESULTS MAY BE IMPORTANT TO MY HEALTH OR MY FAMILY'S HEALTH.

Your wish does not constitute a guarantee that you will be contacted.

 

USE OF DE-IDENTIFIED SPECIMENS FOR FUTURE RESEARCH:

In addition to the research you are consenting to under this research study, Dr. ________________ or other researchers at this or other institutions may wish to study the samples in future research, including genetic analysis. These samples, taken from your body, would NOT be linked back to you. No one will know your name or protected health information.

At this time, the researcher does not know what the future studies will be. Your specimens may also be submitted to a tissue/cell/DNA bank. The specimens may be kept for a long time and may exceed 50 years.

In some research using human blood or tissue, the specimens and their parts may enable researchers to develop medical tests or treatments that have commercial value. You will not receive any money that may result from any such commercial tests or treatments.

Your specimens may be used for future research, even though the purpose of the future research is not known at this time.

PARTICIPANT:
PLEASE INDICATE YOUR CHOICE BY INITIALING ONE (1) OF THE FOLLOWING OPTIONS

___ I consent to have my specimens used for future research studies.

___ I consent to have my specimens used for future research studies only for the study of _____________________________________.

___ I do NOT consent to have my specimens used for future research studies. (The specimens will be destroyed at the end of the study.)

CAN I BE ASKED TO STOP PARTICIPATING IN THIS STUDY BEFORE THE STUDY IS FINISHED?

Sometimes the company sponsoring the research may stop the study for the following reasons:

WHAT IF NEW INFORMATION BECOMES AVAILABLE?

MAY I STOP THE STUDY AT ANY TIME?

WHAT ARE MY RIGHTS IF I TAKE PART IN THIS RESEARCH STUDY?

Informed Consent Signature Page

The following is a list of items we discussed about this research study.  If you have any questions about any of these items, please ask the person who is discussing the study with you for more information before agreeing to participate.

 

Printed Name of Participant   Signature of Participant   Date
 
Name of Person Conducting the Informed Consent Process   Signature of Person Conducting the Informed Consent Process   Date

PARENTAL PERMISSION:
I voluntarily give permission for my child to participate in the research protocol. 
Printed Name of Parent or Guardian   Signature of Parent or Guardian   Date