SAMPLE - INDIVIDUAL CONSENT (age 18+)
ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY
MONTEFIORE MEDICAL CENTER
JACOBI MEDICAL CENTER
NORTH CENTRAL BRONX HOSPITAL
Individual Information and Consent Form
You are being asked to join this research study.
The title of the study is: (TYPE IN COMPLETE TITLE OF PROTOCOL)
The study is being done under the supervision of:
P
RINCIPAL
I NVESTIGATOR :
O
FFICIAL
A
DDRESS
:
T ELEPHONE
IRB P
N O .:
ROTOCOL
N
O
.:
DO I HAVE TO TAKE PART IN THIS RESEARCH STUDY? o Your participation is voluntary. This means that you decide whether or not you want to join the study after speaking with the research study doctor, or other member of the research team. o If you decide to take part you will be asked to sign this consent form. Your signature means that you agree to be a subject in this research. o After reading this form and having a discussion about what it says, you should ask all the questions you want to ask. You should take as much time as you need to make a decision. o If you do not understand some of the terms used in this form, ask the person who is discussing the study with you to give any additional information that may make this easier to understand. o You do not have to consent to participate in the study immediately, or ever. Take time to decide whether or not you wish to join. You may take home a copy of this consent form to think about it or discuss the information with family or friends before you decide. o If you decide not to participate the care providers at Montefiore Medical Center will give you all of the standard medical care that is appropriate for you. o You will be given a copy of this form whether or not you agree to participate in this study.
Do not sign the form unless you have had all your questions answered and understand exactly what is involved. o If you decide to take part you are still free to withdraw at any time without giving a reason.
This will not affect your care and you will continue to be treated at this hospital. o If you decide to withdraw after receiving the study drug, you should talk with the research study doctor to see how best to complete the withdrawal process.
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o The form discusses:
WHAT THE RESEARCHERS WILL LEARN FROM THE RESEARCH?
WHAT WILL HAPPEN TO YOU DURING THE RESEARCH?
WHAT RISKS AND/OR DISCOMFORTS YOU MIGHT EXPECT/EXPERIENCE AS A
RESEARCH SUBJECT?
IF YOU CAN EXPECT ANY BENEFITS, AND ARE THERE ANY ALTERNATIVES TO
THIS RESEARCH FOR YOUR CONDITION?
STUDY SPECIFICS

This is a clinical study of a new drug called _____________ (include the generic name of the drug once) for the study of __________.

Clinical studies help to get more information about whether or not a new drug will work better than the medicines that are currently available. The study will also help to see if the new drug is safe.

The new medicine is investigational. This means that it is an experimental drug not approved by the U.S. Food and Drug Administration (FDA) for use in the United States.
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?
You will be one of approximately (how many) people who will be participating in this study.
The study will be conducted at approximately (how many) locations outside of Montefiore
Medical Center/Albert Einstein College of Medicine/North Bronx Health Network.
WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?
If you agree to take part in this study you will have tests and examinations to be sure that you qualify for the study.
-Give a general description of the procedures; number of blood draws, amount of blood; radiological procedures, etc. If blood will be taken, specify how many times, the volume in tsp. or tbs. indicating the cc’s in ( ), CT scans, x-rays, etc. All tests or procedures performed under the protocol must be included even if the test/procedure is for clinical care. However, you must distinguish between the procedures that are being done for research purposes only and those that would be done for standard clinical care.
-Explain what procedures are experimental and what is standard clinical care.
-Explain randomization;

Sometime because we do not know which way of treating patients is best, we need to make comparisons. Some people will be put into different groups to see how they differ.

The groups are chosen by a computer that has no information about the people. The groups are chosen by chance (like a flip of a coin).
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
Some people will get the study drug and some will get placebo. A placebo is not real medicine. It is something that looks like the real thing.

People in each group then have different treatment and these are compared. There is a one in
___ chance that you may be given placebo.

This is a double blind study which means that neither you nor the research study doctor will know which treatment you are receiving during the study. However, if the research study doctor needs to find out in the case of an emergency, the research study doctor can do so.
- State “If you are a woman capable of becoming pregnant, you will have a pregnancy test before starting the study.”
- A radiologist will review the MRI performed as a part of this study. This reading is only to detect unexpected abnormalities that might pose a significant health risk to you. The results of this reading will only be available to the research team. Results will not be released to anyone, including your physician, without your written permission. You will only be informed of the results of the MRI interpretation if a significant abnormality is detected. In such a case, [insert
PI’s name here] will inform you and may suggest that you seek follow up medical consultation with a doctor of your choosing. Neither Einstein nor this study will pay for any such medical consultation. However, we can, at your request, make the MRI and report available to your doctor.
- A sample of the protocol template can also be appended.
- You will be in the study for at least ___ but possibly as long as ____.
- You will be expected to return to the clinic for _____ .
- If the study is still continuing at the end of ____, you will be asked to return ___ until the official end of the study.
WILL THIS STUDY INVOLVE GENETIC RESEARCH and/or TESTING?
Genetic means having to do with information that is passed on in families from parents to their children through genes.
CONSENT REQUIREMENTS for Genetic Testing :
PURPOSE (Why are we doing this research) a. A simple explanation of the general description of each specific disease or condition tested for. b. A statement that tests conducted under this research study may reveal genetic information.
GENETIC COUNSELING INFORMATION:
You may wish to obtain professional genetic counseling before signing the informed consent. A genetic counselor is a person qualified to provide information about what the results of this type of test may mean to you and your family. You or your insurance company will be responsible for the cost of these services.
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If the test is positive, it means that there is a ____% chance you might have ….. you may wish to talk with your doctor, go for another blood test or speak to a genetic counselor.
PROCEDURES (How will the test be done?)
We will obtain ___ tea/tablespoons of blood from your arm by a needle stick when you come to
……. This will only be done one time.
ADDITIONAL TESTS ON YOUR SAMPLE
No other tests other than those explained under this study will be done on your sample. The sample will be destroyed at the end of the research study. Alternatively, include the CCI/IRB
Future Use consent language.
Since the tests are being done in a research lab, the results cannot be disclosed to you. However, at your request we can advise your doctor about follow-up testing in an approved lab. No formal counseling will be provided under the research study. If you request it, you will be referred to a genetic counselor. Your or your insurance carrier will be responsible for the genetic counselor's fee.
OR
Since the tests are being done in a research lab, the results cannot be disclosed to you. No formal counseling will be provided under the research study. If you request it, you will be referred to a genetic counselor. You or your insurance carrier will be responsible for the genetic counselor's fee.
Genetic tests may reveal other information unrelated to the study. For example, in cases where parents and children are both tested, the test may disclose the possibility that the father is not the biological parent. Although these types of information will not be disclosed, the participant must be informed about the potential findings.
TESTING FOR HIV
An HIV test will be performed in connection with this research. You must sign a separate consent form for HIV testing and you will be counseled before and after the test is performed.
If as a result of participation in this study you are INITIALLY diagnosed with HIV, the results must be reported to the Commissioner of Health for contact tracing purposes.
If you have tested positive for HIV, you will be asked to sign the New York State form for
“Release of Confidential HIV Related Information.”
HIV-related information may be shared with other members of the research team, besides the
Principal Investigator, as well as others involved in the research .
WHAT ELSE DO I HAVE TO DO?

You must tell the research study doctor about any past and present diseases or allergies you are aware of and about all medications you are taking including “over-the-counter” remedies and nutritional supplements or herbs.

You must take your study drug as instructed, returning any unused study drug (including any empty bottles), at every visit.
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
If you do not feel well at any time, call your doctor or the research study doctor immediately.

Drugs may cause a reaction that, if not treated promptly, could be life-threatening. It is important that you report all symptoms, reactions and other complaints to the research study doctor.

If you think you have become pregnant, contact your research study doctor immediately.

If any other doctor recommends that you take any medicine, please inform him/her that you are taking part in a research study. You should give the other doctor the research study doctor’s name and phone number.

You may carry out all your normal daily activities.
WILL THIS STUDY INVOLVE AUDIO AND/OR VIDEO TAPING?
WHAT ARE THE MAIN POSSIBLE SIDE EFFECTS, DISCOMFORTS, RISKS OR
INCONVENIENCES I CAN EXPECT FROM BEING IN THIS RESEARCH STUDY?
-Give a statement of “here is a list of the known risks associated with this drug/device/research.”
-
Use bulleted formats or tabular columns. Listing most serious → less serious in sections identified as “M
OST C OMMON
”, “C
OMMON
”, and “R
ARE
”.
MOST COMMON (>50%),
COMMON (10 – 50%), RARE (<10%)
Visit http://www.aecom.yu.edu/home/cci/forms/icd_sample_risk.pdf to view a sample of this section.
-Include risk that the drug/device may not work.
-Include risk of no improvement in all arms of the study.
-Include the risks to a fetus or nursing infant. The language below is recommended.
-Include a statement for unforeseen risks such as, “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
1.
Information about known or suspected teratogenic, mutagenic, or other toxic effects on the fetus of the drug being studied.
2.
Whether the effects, when known or suspected, are based on animal studies only, or on studies conducted on humans.
3.
The extent of prior experience with the drug in humans and/or animals
4.
Information about the provision of, or referral for, counseling for contraception to prevent the likelihood of pregnancy during the study, and the length of time that a man should avoid fathering children;
5. If pregnancy occurs in the course of the study, women may be required to end their participation, obtain a referral for counseling by an appropriate health professional. If any studies have shown potential toxic effects on sperm, include appropriate language.

Do not become pregnant or father a baby while on this study, or for _____.

The drug(s) used in this study may cause damage to the fetus.
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
You must use an effective form (or 2 forms) of birth control throughout the course of this study that includes no sexual activity.

A member of the study staff will counsel you on methods of birth control and the importance of preventing pregnancy while you are in this study.

If you do become pregnant, you are to inform your research study doctor immediately, and you will be removed from the study and be referred for care for your pregnancy.

You should not breast feed your baby while on this study because the study drug i appears in the breast milk and could be a risk to the nursing infant.
RISKS FROM RADIATION EXPOSURE OR RADIOISOTOPES
NOTE: Guidance language appears in italics
Use the following table to calculate the total effective dose for the duration of the study. Only include procedures that are above standard clinical care in the calculation.
[UPDATED RADIATION TABLE TO BE INSERTED HERE]
For all levels of exposure:
This research study involves exposure to radiation above that which you will receive during standard clinical care.
(1) To be used when the radiation is up to 10 mSv above 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 is minimal.
(2) To be used when the radiation dose is between 10 and 50 mSv above 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 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)
(3) To be used when the radiation dose is over 50 mSv above 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 is ____ times the natural environmental radiation that you receive every year.
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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?

You will not benefit from being in this research study. However the information learned from this study may, in the future, benefit other people with the same medical condition.
OR

There is almost no chance that you will benefit from being in this research study. However the information learned from this study may, in the future, benefit other people with the same medical condition.
OR

There is little chance you will benefit from being in this research study. However the information learned from this study may, in the future, benefit other people with the same medical condition.
OR

There may or may not be direct medical benefit to you from being in this research study.

Possible benefits are ____.

In addition, the information learned from this study may, in the future, benefit other people with the same medical condition.
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. Your other choices include: [List all alternatives here.]

There are no established treatments for people with your disease.

You may choose not to participate in this study.

You may choose hospice, palliative and/or comfort care.
WILL I BE PAID FOR BEING IN THE STUDY?
Please go to http://www.aecom.yu.edu/home/CCI/advertisement_and_reimbursement.htm
for the payment policy. If the study involves audio and/or videotaping, this section should mention whether subjects will be compensated for allowing themselves to be taped.
WHO MAY SEE MY RECORDS?

The research records will be kept private and your name will not be used in any written or verbal reports.
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
Your research records and medical records may be inspected by members of the research team, designated employees of Montefiore Medical Center, the company conducting the study and supplying the drug, and other institutions that participate in this study.

Support for this research project is provided by:

As this research involves a drug or device, the U.S. Food and Drug Administration (FDA), the agency for regulating the drugs, may inspect your research records and medical records.

The research study doctor and research staff will review your medical records and will keep the information private.

All laboratory specimens, reports, and other records will be identified only by a number known only to the research study doctor. The research records will be kept in a secured manner and computer records will be password protected.

The research records will be kept in a secured manner and computer records will be password protected in the Albert Einstein College of Medicine Clinical Research Center
(CRC).

The Clinical Research Center staff, as well as the research personnel authorized by the research study doctor will have access to these records.

The people who reviewed this research study as members of the Institutional Review Board of The Albert Einstein College of Medicine may also review your research and medical records.

The Office for Human Research Protections (OHRP) may also review your research study records.

All of these groups have been requested to keep your name private.
CERTIFICATE OF CONFIDENTIALITY
WILL THERE BE ANY COSTS TO ME?

Taking part in this study may lead to added costs to you or your insurance company. There may be extra costs that may or may not be covered.

The experimental drug will be free for all study participants. If, however, the experimental drug becomes approved by the U.S. Food and Drug Administration while you are in the study, there is a possibility that you or your insurance company would be asked to pay for the medicine.
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.

No monetary compensation will be offered.

You are not waiving any of your legal rights by signing this informed consent document.

In addition, the sponsor will provide reimbursement for the reasonable costs of medical treatment.
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If you are injured 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.

No monetary compensation will be offered.

You are not waiving any of your legal rights by signing this informed consent document.

If additional treatment is required as a result of a physical injury related to the research, necessary medical treatment will be provided to you and billed to your insurance company or to you as part of your medical expenses.
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.

No monetary compensation will be offered .

You are not waiving any of your legal rights by signing this informed consent document
Immediately report any discomforts, problems or injuries you experience during the course of your participation in the study to.
WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY?
Research Study Doctor’s Name:
Office Address:
Office Phone:

If any questions arise related to this research project, or you believe you have any injury related to this study, you can call the research study doctor above.

You may also call at.

If you have questions regarding your rights as a research subject, you may also call the
Administrator of The Albert Einstein College of Medicine Institutional Review Board at
(718) 430-2253 718-798-0406 Monday through Friday between 9 AM and 5 PM.
WILL ANY OF THE SAMPLES (BLOOD, TISSUE, DNA) TAKEN FROM ME BE USED
FOR FUTURE RESEARCH STUDIES?
Delete the section that does NOT apply to your research.
APPENDIX ‘B’
NOTE: This template is required when obtaining specimens for future research that will be identified (linked back to the original donor).
See Appendix ‘C’ if the specimens will be deidentified.
APPENDIX ‘C’
NOTE: This template is required when obtaining specimens for future research that will be de-identified (not linked back to the original donor).
When uncertain, use the Appendix ‘B’ template.
USE OF IDENTIFIED SPECIMENS FOR
FUTURE RESEARCH:
As of 4/20/11
USE OF DE-IDENTIFIED SPECIMENS
FOR FUTURE RESEARCH:
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In addition to the research you are consenting to In addition to the research you are consenting to under this research study, Dr.
________________ or other researchers at this 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. 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
Information about you may be shared with other know your name or protected health researchers who will keep the information confidential. However, it is possible that information. 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
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 be more than 50 years. also be submitted to a tissue/cell/DNA bank.
The specimens may be kept for a long time and may be more than 50 years. You have the right to withdraw consent to use the tissue for future
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 use at any time by contacting the supervisor of the study named on the first page of the consent. Unused specimens will be destroyed. will not receive any money that may result from any such commercial tests or treatments.
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
Your specimens may be used for future research, even though the purpose of the future research is not known at this time.
___ I consent to have my specimens used for future research studies.
PARTICIPANT:
PLEASE INDICATE YOUR CHOICE BY
INITIALING ONE (1) OF THE
FOLLOWING OPTIONS
___ I consent to have my specimens used for future research studies only for the study of
_____________________________________.
___ I consent to have my specimens used for future research studies.
___ I do NOT consent to have my specimens used for future research studies. (The specimens will be destroyed at the end of the study.)
___ 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
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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 OR MY FAMILY’S HEALTH.
Your wish does not constitute a guarantee that you will be contacted.
CAN I STOP BEING IN THIS RESEARCH STUDY BEFORE THE STUDY IS
FINISHED?
Sometimes the company sponsoring the research or the research study doctor may stop your part in the study for the following reasons:

You fail to follow instructions given to you by the research study doctor.

New information about important medical risks and benefits becomes available.

Other (make sure subjects know it is not their choice).
WHAT IF NEW INFORMATION BECOMES AVAILABLE?

If the research study doctor obtains new information that might lead you to change your mind about continuing in this study, the research study doctor will tell you about it.

If you decide to withdraw, the research study doctor and your personal doctor will make arrangements for your care to continue.
WHAT ARE MY RIGHTS IF I TAKE PART IN THIS RESEARCH STUDY?

Your participation in this study is voluntary.

You do not waive any of your legal rights by participating in this research study.

Your treatment by doctors and staff at the institution(s) involved in this study, now and in the future, will not be affected in any way if you refuse to participate or if you enter the study and withdraw later.
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MAY I STOP THE STUDY AT ANY TIME?

Your participation in this study is voluntary and you may withdraw from the study at any time without giving a reason.

If you decide to withdraw after receiving the study drug, you should talk with the research study doctor to see how best to complete the withdrawal process.

If you agree to participate and withdraw at a later time, some of your information may have already been entered into the study and that will not be removed.

Your treatment by doctors and staff at the institution(s) involved in this study, now and in the future, will not be affected in any way if you agree to participate and withdraw later.

Your decision not to be in this research study will not result in any loss of benefits to which you are otherwise entitled.
Informed Consent Signature Page
The following is a list of items that have been discussed with you 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.

What the study is about.

What I must do when I am in the study.
 The possible risks and benefits to me.

Who to contact if I have questions or if there is a research related injury.

About any costs and payments.

I can discontinue participating in the study at any time without penalty.

Other options.

My name will not appear on interview or other data collection forms.

All written and published information will be reported as group data with no reference to individual study names.

If there is a schedule explaining how the study medicines are to be taken, I will be given the time schedule.

I have been given the name of the research study doctor and others to contact.

I have the right to ask any questions.
I have read the information above and it has been discussed with me. I agree to take part in this research study.
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Printed Name of Participant
Printed Name of Guardian or
Family Member (when applicable)
Signature of Participant Date Time
Printed Name of Person Conducting the Informed Consent Process
Signature of Guardian or
Family Member (when applicable)
Signature of Person
Conducting the Informed
Consent Process
Date
Date
Time
Time
Appendix A
Research Protocol Schema
In this section include the type of event that will occur (i.e. blood draw, X-Ray, CT, etc) and on which days the subject can expect for that event to occur.
Event Dates
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