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
SY SYMS SCHOOL OF BUSINESS
WURZWEILER SCHOOL OF SOCIAL WORK
DELETE "OF YESHIVA UNIVERISTY" if
NOT a Yeshiva school.
OF YESHIVA UNIVERSITY
Use this permission document for behavioral and questionnaire studies along with the Simplified Consent Document for Adults (age 18 or over) who may not be able to understand the individual consent document. The adult with diminished capacity would sign the Simplified Consent, and the family member would sign this permission document. Use of this document requires approval by YU legal counsel.
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.
Third Party Permission and Information Form
Your relative is 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):
DOES MY RELATIVE HAVE TO TAKE PART IN THIS RESEARCH STUDY?
STUDY SPECIFICS [Delete what is not applicable to your research]
WHY HAS MY RELATIVE 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. ]
WHAT WILL HAPPEN IF MY RELATIVE TAKES 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.]
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 MY RELATIVE 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).]
WHAT OTHER CHOICES DOES MY RELATIVE HAVE IF MY RELATIVE DOES 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.]
WILL MY RELATIVE 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, relative 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 RELATIVE'S RECORDS?
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.]
WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY?
[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:
CAN MY RELATIVE 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, your relative can be asked to stop if:
MAY MY RELATIVE STOP THE STUDY AT ANY TIME? [This paragraph is required for all research protocols.]
WHAT ARE MY RELATIVE'S RIGHTS IF MY RELATIVE TAKES PART IN THIS RESEARCH STUDY?
Parental Permission 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|
|Printed Name of Family Member||Signature of Family Member||Date|
|Printed Name of Person Conducting the Informed Consent Process||Signature of Person Conducting the Informed Consent Process||Date|