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

The consent form heading should reference the names of only those institutions that are participating in the protocol. DELETE the institutions that are NOT involved in the research.
BENJAMIN N. CARDOZO SCHOOL OF LAW
AZRIELI GRADUATE SCHOOL OF JEWISH EDUCATION AND ADMINISTRATION
BERNARD REVEL GRADUATE SCHOOL OF JEWISH STUDIES
FERKAUF GRADUATE SCHOOL OF PSYCHOLOGY
STERN COLLEGE FOR WOMEN
YESHIVA COLLEGE
SY SYMS SCHOOL OF BUSINESS
WURZWEILER SCHOOL OF SOCIAL WORK

DELETE "OF YESHIVA UNIVERISTY" if NOT a Yeshiva school.
OF YESHIVA UNIVERSITY

Use this consent form for Adults (18+)

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.
Individual Information and Consent 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 (Researcher Conducting the Study): 
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. ]

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.]

• 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.

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 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.]

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. 

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.