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 studies that will enroll Children (0-17) and 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 Consent/Parental Permission/Young Adult Assent  

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 Study Doctor): 
Office Address: 
Telephone #: 
Protocol #: 

If you are a parent or legal guardian of a child who may take part in this study, permission from you and the assent (agreement) of your child may be required. When the word “you(r)” / “my” / “me” / “I” appears in this consent form, we mean the participant (you or your child); “we” means the research study doctors and research staff.

DO I HAVE TO TAKE PART IN THIS RESEARCH STUDY?

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.]

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. ]

HOW MANY PEOPLE WILL TAKE PART IN THE RESEARCH STUDY?

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. 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 ( ). For all radiological tests and isotopes, include the approximate total number of tests to be given under the study, e.g. CT Scans, x-rays, MUGA scans, 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.

For complicated drug regimens, you are encouraged to use tables so that participants can easily follow their drug regimen. The table describing the drug regimen should be provided to participants as a separate sheet for reference as a display chart.]

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 Einstein 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."]

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.]

WHAT ELSE DO I HAVE TO DO?

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. (However, risks of all drugs, including those used in this study for standard of care, need to be described.) 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 [delete as appropriate:]drug/device/research:[Use a bulleted format. Listing most serious → less serious in sections identified as “MOST COMMON”, “COMMON”, and “RARE”. MOST COMMON (>50%), COMMON (10 – 50%), RARE (<10%). See pages 3-4 of the sample ICD:  http://www.einstein.yu.edu/uploadedfiles/cci/forms/icd_sample_risk.pdf.  
  Include risk that the drug/device may not work.
-Include risk of no improvement in all arms of the study.]

MOST COMMON:

COMMON:

RARE:

[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[For research protocols enrolling women of reproductive potential, or for men capable of fathering children, the following information must be included in short, bulleted, simple sentences. REMEMBER: The information must be understandable to the layperson and written on an 8th grade level.
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.]

[SAMPLE language for risks to a fetus. MODIFY as appropriate for your study.]

RISKS FROM RADIATION EXPOSURE OR RADIOISOTOPES [Delete this section if not applicable to your research.]

[Include the risks to radiation exposure only for procedures being performed for research purposes. For procedures performed only for clinical care, the risks should not be stated in the consent. However, the tests must be included in the ‘WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?’ paragraph and the total number of tests to be performed for clinical purposes must be stated for the specific test(s).]

[For all levels of exposure:]This research study involves exposure to radiation above that which you will receive during standard clinical care.

Use the Radiation Exposure Form (http://www.einstein.yu.edu/uploadedFiles/CCI/Radiation_Exposure_Form.xls) to calculate the total effective dose for the duration of the study and then choose the appropriate option below to explain how the dosage amount translates to the subject's normal exposure.

(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 are 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. 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?[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.]

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.

ONCOLOGY STUDIES: DO NOT USE ONCOLOGY JARGON. If you are conducting a tumor study be very careful to avoid technical terms such as ‘tumor response’ and ‘intent to treat’. These terms are often misunderstood by lay people. Note that the benefits for phase I studies should not be misleading.

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).]

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 with no experimental drugs/device and other experimental studies that may be available that the subject may be eligible for. An alternative may be a hospice and palliative care paragraph, depending on the type/phase of research. Another alternative is not to participate.

Indicate clearly whether the drugs being studied are available outside the study. Include ALL alternative therapies that are clinically available e.g. approved treatment vs. investigational, or no treatment. Use a bulleted format.]

[When the protocol involves a heterogeneous population with numerous alternatives this language is recommended.]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. [List all alternatives here.]

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.  Payments must be prorated.
Please go to http://www.einstein.yu.edu/home/CCI/page.aspx?id=9732 for the compensation guidelines]

WHO MAY SEE MY RECORDS?

CERTIFICATE OF CONFIDENTIALITY[For protection against compelled disclosure of identifying information about participants of biomedical, behavioral, clinical and other research, go to http://ohrp.osophs.dhhs.gov/humansubjects/guidance/certconpriv.htm. Delete if not applicable.]

WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THIS RESEARCH STUDY? [If the protocol is determined to be "greater than minimal risk," include this heading and one of the three paragraphs below. Be sure to DELETE the other 2 paragraphs.]

[For Montefiore/Einstein Private Industry Sponsored Research Protocols. Changes to this language must be approved by legal counsel.]
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.

[For Montefiore/Einstein and/or JMC/HHC/NYMA Non-Private Industry Sponsored or Investigator- Sponsored Research Protocols (i.e. ECOG, NCI, NIH, and non funded research). Changes to this language require approval by legal counsel.]
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.

[For JMC/HHC/NYMA Private Industry Sponsored Research Protocols. Changes to this language require prior approval by HHC Legal Counsel.]
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 [Insert researcher’s name, time to call and phone number.]______________.

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.  MODIFY sample text as appropriate to your 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: 

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 de-identified.

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 the 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.

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 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? [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. If pregnancy is contra indicated, is must be stated. Other examples may be: inclusion in other trials, non-compliance with drug regimen, restrictions from taking certain drugs, etc. DELETE heading if not applicable.]

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? [This paragraph is required for all research protocols. Include in this section any instruction to subjects as to how they should notify the Investigator of the intent to withdraw.]

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.

The signature section is specially formatted - please do not modify.

Printed Name of Participant   Signature of Participant (Not applicable for participants under age 13)   Date   Time

 

Printed Name of Parent/Guardian (when applicable)   Signature of Parent/Guardian (when applicable)   Date   Time
 
Printed Name of Person Conducting the Informed Consent Process   Signature of Person Conducting the Informed Consent Process   Date   Time