NOTE: Text that appears in BLUE is "help text" and will NOT be included in the printed ICD!

Remove the institutions that are not applicable.
ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY
MONTEFIORE MEDICAL CENTER
JACOBI MEDICAL CENTER
NORTH CENTRAL BRONX HOSPITAL

Use this consent form for 13-17 year-olds.

GENERAL CONSENT GUIDELINES: 
Use conversational language, not technical terminology, whenever possible. If technical terms are unavoidable, explain them at the point at which they are used. Try to simplify the language as much as possible. 
WHO CAN CONSENT: 
The individual subject of the test or, if that individual lacks the capacity to consent, the signature of the person authorized to consent for such individual must sign. An authorized person is a legal guardian.
Information and Parental Permission/Young Adult Assent Form 

You are being asked to join this research study. 
[Type in complete title of protocol] The title of the study is:   

The study is being done under the supervision of: [Complete the information below]

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

DO I HAVE TO TAKE PART IN THIS RESEARCH STUDY?

• Your participation is voluntary.  This means that you decide whether or not you want to join the study after speaking with the researcher, or other member of the research team.
• 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.
• 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. 
• 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. 
• 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. 
• If you decide not to participate the care providers at this facility will give you all of the standard care that is appropriate for you. 
• 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.  
• 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 facility.

STUDY SPECIFICS [Delete what is not applicable to your research]

WHY HAVE I BEEN ASKED TO TAKE PART IN THIS RESEARCH STUDY? [It should be clear to the subject that because they have the condition or disease being studied this is the reason why they are being asked to participate or they are being asked to participate as a healthy volunteer.]

• [Delete if screening is not applicable.]If you agree to take part in this study you will have tests and examinations to be sure that you qualify for the study.  

WHY IS THIS RESEARCH STUDY BEING DONE? [Explain in simple bulleted sentences what the study team seeks to learn from the study.  A detailed explanation of the purpose of the study should be described in this section. If this study involves GENETIC RESEARCH, explain in simple terms why the genetic research is being conducted.]

WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY? [This section should include, in short bulleted statements, what the subject should expect to occur during participation.  Include the number of visits, frequency of visits and duration of each study visit.  MODIFY/REPLACE sample language as appropriate.]

• You will be required to come to see the researcher once a month over the next six months.  Each visit will last approximately 30 minutes to an hour.
• The skin of the forearm is carefully cleansed with alcohol. A needle is then inserted into the vein and of blood will be drawn. This will be only done one time.
• [Required for studies involving the MRRC. DELETE for all other studies.]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 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.

WILL THIS STUDY INVOLVE GENETIC RESEARCH and/or TESTING?[If genetic testing is done, this must be stated up front in the consent. If Genetic testing will NOT be performed under this study, DELETE this heading and all related genetic research paragraphs.
NY State Law definition of Genetic Test "Any laboratory test of human DNA, chromosomes, genes, or gene products to diagnose the presence of a genetic variation linked to a predisposition to a genetic disease or disability in the individual or individual's offspring; such term shall also include DNA profile analysis. ‘Genetic test’ shall not be deemed to include any test of blood or other medically prescribed test in routine use that has been or may be hereafter found to be associated with a genetic variation, unless conducted purposely to identify such genetic variation. (The CCI/IRB also includes any measurement of certain metabolites associated with heritable diseases as a genetic test.)
"Genetic Predisposition shall mean the presence of a variation in the composition of the genes of an individual or an individual’s family member which is scientifically or medically identifiable and which is determined to be associated with an increased statistical risk of being expressed as either a physical or mental disease or disability in the individual or having offspring with a genetically influenced disease, but which has not resulted in any symptoms of such disease or disorder."]

• Genetic means having to do with information that is passed on in families from parents to offspring through genes.
• PURPOSE:[INCLUDE: A simple explanation of the general description of each specific disease or condition tested for.]____. 
• Tests conducted under this research study may reveal genetic information. 
• [REQUIRED: A statement that the participant may wish to obtain professional genetic counseling prior to signing the informed consent.]GENETIC COUNSELING INFORMATION: You may wish to obtain professional genetic counseling prior to 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.
• [The level of certainty that a positive test result for that disease or condition serves as a predictor of such disease. If no level of certainty has been established, this subparagraph may be deleted.]If the test is positive, it means that there is a [Enter chance]____% chance you might have [Condition]____________ you may wish to talk with your doctor, go for another blood test or speak to a genetic counselor.
• PROCEDURES: [Provide detailed information specific to your study.]We will obtain _____ teaspoons/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: [Alternatively, include the CCI/IRB Future Use consent language.]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.
• [Include whether or not participants will be informed of the results of genetic tests, and if so, whether and how counseling will be performed.]Since the significance of these tests are not known for you, we will not disclose the results of the genetic testing, unless you request it. No formal counseling will be provided under the research study. If you request, you will be referred to a genetic counselor. You or your insurance carrier will be responsible for the genetic counselor’s fee. -OR- You will be told the results of the genetic tests and formal counseling will be provided under the research study at no cost to you.
• 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[If this study does not involve HIV, DELETE this heading and all HIV related paragraphs. Studies which involve HIV testing must include language which specifically address testing.
If an HIV test will be performed as part of this research, this language must be included. In addition include the specifics of who will provide counseling and where it will be done.]

• 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.
• [Include this text ONLY when participants may INITIALLY be diagnosed with HIV resulting from required tests performed under the protocol.]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.
• [DELETE the following text if you are NOT recruiting subjects from a known HIV population, OR if this study involves an HIV population, but there are no outside collaborating institutions or sponsors. ]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.

WILL THIS STUDY INVOLVE AUDIO AND/OR VIDEO TAPING? [Delete this section if not applicable to your research.  This section should include:
-What will be recorded (i.e. will the subject's face/name be identifiable; will family members, or others, be identifiable, etc).
- Include the setting of the recording.
- How the recordings will be used (i.e. only for tabulation of finite criteria by the research team; for possible use as a teaching tool to graduate or other students who are not members of the research staff).
- A clear statement as to when the recordings will be destroyed.
- Whether subjects will be compensated.
- How the recordings will be secured and kept confidential.]

WHAT ARE THE POSSIBLE SIDE EFFECTS, DISCOMFORTS, RISKS OR INCONVENIENCES I CAN EXPECT FROM BEING IN THIS RESEARCH STUDY? [The purpose of this section is to give the subject information about what can be expected as side effects or adverse outcomes as a result of participation AND APPLIES ONLY TO RESEARCH TESTS/PROCEDURES.   This section can include risks of insurability, risks if information should improperly be shared and not just medical risks. Use language that the subject can understand and simplify the terms.]

Here is a list of the known risks associated with this research: [MODIFY as appropriate:]

• Rarely, the vein in which the needle has been inserted may become sore and red.
• In addition, a temporary, harmless “black and blue” may develop.
• Very rarely, fainting may occur.

[DELETE this section if not applicable. NOTE: All studies that will produce data with the potential to affect subject insurability are required to include the appropriate language.]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?  [An explanation of the potential benefits from the research is to be described in this paragraph.  Do not overstate the potential benefits of the research. Information about benefits must reflect the reality of the study. The term “benefit” is used in the research context to refer to something of positive value related to health or welfare.  Often the potential benefits accrue to society, and there are no benefits to individual study subjects.  When there is no direct benefit to research subjects, but a benefit to the advancement of scientific knowledge, this must be stated up front, at the beginning of the section. USE BULLETED STATEMENTS. The distinction between “benefits to you” and “benefits to others” must be clear.

NOTE:  Reimbursement for expenses and/or remuneration for participation is NOT to be included here, but rather should appear under the “WILL I BE PAID FOR BEING IN THE STUDY” section (below).]

• [Sample benefit language.  MODIFY as required for your 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 may or may not be direct medical benefit to you from being in this research study. 
  • Possible benefits are[State the specific condition, e.g., may have less pain, etc.] ____. 
  • 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? [This section should include the alternatives such as standard care and other experimental studies that may be available that the subject may be eligible for. Another alternative is not to participate.

Include ALL alternative therapies that are clinically available e.g. approved treatment vs. investigational, or no treatment. Use a bulleted format.]

• You may choose not to participate in this study.

WILL I BE PAID FOR BEING IN THE STUDY?  [DELETE this heading if not applicable.  If subjects are to be paid for their time and inconvenience for participating in the study or reimbursed for costs (e.g. parking, transportation, child care), include a bulleted summary breaking out the payment schedule.  If the study involves audio and/or videotaping, this section should mention whether subjects will be compensated for allowing themselves to be taped.
Please go to http://www.aecom.yu.edu/home/CCI/advertisement_and_reimbursement.htm for the payment policy]

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. 
• Your research records [If medical records will not be accessed, DELETE the words: “and medical records”.]and medical records may be inspected by members of the research team, the sponsor(s), and other institutions that participate in this study.  These are:[Include all applicable sponsors, agencies and participating institutions only if they will have access to the research records or medical records.]  
• [DELETE this sentence if there is no support for this study.]Support for this study is provided by:[Include all agencies providing funding, supplies, or equipment.] 
• [DELETE this sentence if patients’ medical records will NOT be accessed.]The researcher and research staff will review your medical records and will keep the information private.
• [Sample language for securing record confidentiality.  MODIFY as required for your study.]The research records will be kept in a secured manner and computer records will be password protected.
• [For GCRC Studies only.]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). 
• [For GCRC Studies only.]The Clinical Research Center staff, as well as the research personnel authorized by the researcher will have access to these records. 
• [If one of the listed institutions is not involved in the research (i.e. site, personnel, etc.) delete reference to that institution.]The people who reviewed this research study as members of the Albert Einstein College of Medicine Committee on Clinical Investigations (CCI) and the Montefiore Medical Center Institutional Review Board (IRB) may also review your research and medical records.
• The Office of Human Research Protections (OHRP) may also review your research study records.
• All of these groups have been requested to keep your name private.

WILL THERE BE ANY COSTS TO ME? [Any costs that will be incurred by the subjects must be disclosed in this section. If there will be no costs to subjects, that may be stated OR this section may be deleted from the document.]

• 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.
• There will be no costs to you for participating in this study. 

WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY? 

Researcher’s Name: 
[Enter office address, including street number and name, city and zip-code here.]Office Address: 
[Enter phone number, including area code, of PI here. (Use a number that has frequent monitoring to ensure that messages will be returned in a timely manner.)]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 researcher above.
• You may also call [Enter the name and title (MD, PhD, etc.) of another member of the research team who is familiar with the study, who is easily accessible to subjects and who can answer questions.  This person should be included under Key Personnel in the Research Application.]__________ at [Enter the person’s phone number here.  The phone line must provide prompt and easy access to Key Personnel other than the Principal Investigator. ]____________.
• If you have questions regarding your rights as a research subject, you may also call the Manager of The Albert Einstein College of Medicine Committee on Clinical Investigations at (718) 430-2253, 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.]

CAN I BE ASKED TO STOP PARTICIPATING IN THIS STUDY BEFORE THE STUDY IS FINISHED? [If there are any specific conditions or circumstances under which a subject will be terminated from a study, those conditions or circumstances must be stated in this section in simple bulleted sentences. Other examples may be: inclusion in other trials, restrictions from taking certain drugs, etc.  DELETE heading if not applicable.]

Yes, you can be asked to stop if:

• [Specify criteria for subject being removed from study.]You fail to follow instructions given to you by the researcher.

MAY I STOP THE STUDY AT ANY TIME? [This paragraph is required for all research protocols.]

• Your participation in this study is voluntary and you may withdraw from the study at any time without giving a reason.
• 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.

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.

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.

• 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.
• Any costs and payments.
• I can discontinue participating in the study at any time without penalty.
• Other choices.
• All written and published information will be reported as group data with no reference to my name.
• I have been given the name of the researcher and others to contact. 
• I have the right to ask any questions.