Informed Consent template by gigi12

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									                   Integrated Scientific and Ethical Review Board
                   Saint Vincent Catholic Medical Centers
                   170 W. 12th Street – Staff House
www.svcmc.org      New York, NY 10011
                   IRB Number:

                    INFORMED CONSENT FORM TO PARTICIPATE IN RESEARCH

    Consent version date: update if ICF is revised       Principal Investigator:
    ISERB #
                     INFORMED CONSENT FORM TO PARTICIPATE IN RESEARCH

    [Instruction to PI: For each section, specific guidance is provided in the shaded boxes below the section
    heading. Please delete all the guidance language in the final version of the informed consent document.

    Please delete any parts of the standard consent template that are irrelevant for your specific study.

    The SVCMC Integrated Scientific and Ethical Review Board requires that the informed consent
    document and the HIPAA Authorization be two separate forms.
    Remember the consent is to be written in lay language and should be kept at a 6th-8th grade level. Please
    note that almost 50% of American adults read at or below the 8th grade level. (In Word, Tools, Options,
    Spelling and Grammar, check Show Readability Statistics, click OK, then highlight text to check level and press F7.) Spell out
    all acronyms the first time they are used. If there is more than one consent for the study, please be sure to
    label each page of each consent accordingly, e.g. patient consent, or control consent.

    The terms “subject” and “investigator” must be used throughout the consent in reference to the research
    participant and the principal investigator respectively. The terms “patient” and “doctor” are not
    acceptable in the context of a research protocol.

    If Saint Vincent’s is being compensated for this study, it must be disclosed in the consent.

    All Informed Consent documents must be on SVCMC Stationary.

    TITLE OF RESEARCH STUDY:


    [This is the only section where medical/scientific terminology may be used. The title should conform to the
    title of any grant application/protocol.]

    A. PURPOSE OF THE STUDY:

    [In addition to stating the purpose of the study, the investigator should provide the rationale for performing the
    study (e.g. results of previous studies, etc.). A clear statement indicating the study is voluntary and the subject
    may withdraw at any time must be included in the first paragraph of this section.]

    This Consent Document is approved for use by
    Saint Vincent Catholic Medical Centers Integrated Scientific and Ethical Review Board
    Only the IRB-stamped approved form may be used.

    Informed Consent
    Form Revision Date: December, 2007                                                                           Page 1 of 9
You are being asked to volunteer in a research study. This consent form includes information about this study.
The purpose of this study is         . You are being asked to participate in this study because  . Your
participation in this research is voluntary and you can stop at any time.


B. SUBJECT PARTICIPATION:

We estimate that the following number of subjects will enroll in this study:
At this site:         Total at all sites:

[Estimate the number of subjects that will be enrolled (a) at the SVCMC and affiliate site; and (b) at all sites for
multi-center trials. This number is the number of enrollees needed to obtain a valid result.]

SUBJECT PARTICIPATION:
     Inpatient
     Outpatient
     Other [healthy subjects, etc.] Please specify:

[The IRB expects that research will be available, as appropriate, to all persons regardless of race, gender, age, or
economic circumstances]

Your participation will involve        number of visits, which will take place over       .
 [Indicate the approximate total length of the subject‟s proposed participation by the number of days, months or
years (from screening to final termination).]

Each of these visits will take the following amount of time:
 [Indicate the approximate length of each visit in minutes or hours. (For example, Visits 1, 3 and 5 will each
involve approximately 2 hours; visits 2 and 4 will each involve approximately 30 minutes.)]


C. DESCRIPTION OF THE RESEARCH:


[If the research includes procedures that the subject would undergo in the course of standard diagnostic and/or
therapeutic treatment as well as procedures that would not be performed in the course of standard diagnostic
and/or therapeutic treatment, describe separately the research procedures and standard diagnostic and/or
therapeutic procedures. If hospitalization is involved, the length of days should be stated. If blood will be
drawn, indicate the amount in teaspoons per single specimen and the number of specimens. If urine, CSF, etc.
are to be collected, any stated amounts should be in teaspoons. If tests will be repeated, the schedule should be
described. If a drug is to be given, indicate the dosage, the route of administration, and the duration of
administration. If the study is randomized, double-blind and/or involves a placebo, this must be stated and
explained. Randomization should be explained as “You will be assigned to one of the groups by chance. The
chance of being in each group is ____________” (whatever that chance is, depending on the randomization
scheme). Also explain who will be blinded to whether a participant has been randomized to receive study drug
or a placebo. Explain what substance will be used for the placebo. Define terms such as “placebo” and
“blinded”.] NB: If birth control/contraception is a requirement of the protocol, the description of birth control

This Consent Document is approved for use by
Saint Vincent Catholic Medical Centers Integrated Scientific and Ethical Review Board
Only the IRB-stamped approved form may be used.

Informed Consent
Form Revision Date: December, 2007                                                                   Page 2 of 9
must be preceded with the following language: “The following section(s) related to contraception has not been
proposed nor necessarily advocated by this institution and may express positions, opinions or attitudes which
are not those, or in conformance with those, of this institution or the Roman Catholic Church or the Ethical and
Religious Directives for Catholic Health Care Services, 4th ed., 2001.”

If there are optional studies, describe them briefly here and state “You will be consented to participate in these
studies separately. You may participate in none, any or all of these optional studies.”




D. COSTS/REIMBURSEMENTS:

[If the research involves treatment or procedures that are only for research purposes and not part of standard
care for the treatment of the subject‟s condition, insurers will not pay for the research treatment or procedure. If
the research treatment or procedure is not covered by Medicare, Medicaid, third-party insurers or the research
sponsor, the subject will be responsible for payment. In such cases, state which treatment or procedures are not
likely to be covered by insurers and state the approximate charge for each. If the research treatment or
procedure is covered, the subject should be informed that he/she will be responsible for any applicable co-
payments. (Since the IRB expects that research be accessible to all without regard to the subjects‟ economic
circumstances, Investigators should contact the SVCMC Office of Research and Clinical Trials (212-604-7470)
to discuss the availability of SVCMC resources to support the study.) The ethical principal of justice demands
equitable access to care, particularly for those projects or centers supported by public funds. Additionally,
private sponsors often charitably support access to protocols/drugs/devices under investigation as diagnostic or
therapeutic interventions.]

[Include in this section all of the following that are relevant:

1)     If the drug or device is being provided free of charge but no payment to SVCMC or PI.
"The sponsor, [Sponsor Name], is providing the [drug or device by name] free of charge to participating
research subjects."

2)      For research that includes treatment:
"You will be receiving medical care as a part of this research study. You or your insurance company will [will
not] be charged or held responsible for the costs of that care."

3)      Or where relevant:
"All study-related costs associated with your being in this study will be paid by the sponsor, [Sponsor Name].
You or your insurance company will [will not] be charged or held responsible for the costs of your routine care
(the care you would have received if you were not in this study)."

“If you do not sign this consent form, you will continue to receive care, but not as a part of this study.”

4) "The sponsor of this study,         [Sponsor Name], is paying St. Vincent‟s Catholic Medical Centers to
perform this research."
or

This Consent Document is approved for use by
Saint Vincent Catholic Medical Centers Integrated Scientific and Ethical Review Board
Only the IRB-stamped approved form may be used.

Informed Consent
Form Revision Date: December, 2007                                                                   Page 3 of 9
5) “This study is being sponsored by a grant from the National Institutes of Health. Portions of Dr.               [PI
name]‟s and         [his/her] research team‟s salaries are being paid by this grant.”


E. POTENTIAL RISKS AND DISCOMFORTS:

The following risks or discomforts may be occurring by being in this research study.
[List potential risks or discomforts of each test/procedure (procedures performed as standard care and research-
related tests and procedures. NB: Do not write “there are no risks.” All research has associated risks – even if
there is no intervention, there will be risks associated with breeches of privacy and confidentiality – these must
be clearly described). These include not only physical injury, but also possible psychological, social or
economic harm, discomfort or inconvenience, or breach of confidentiality.
[Include the following if relevant to the specific study: It is possible that the particular treatment or procedure
may involve risks to you (or to the embryo or fetus, if you are or may become pregnant) that are not currently
known or foreseeable. For research involving pregnant women and fetuses, provide data for assessing potential
risks to pregnant women and fetuses, such as “The risk assessment can be based on pre-clinical studies,
including studies in pregnant animals, and clinical studies involving studies on non-pregnant women.”]


F. POTENTIAL BENEFITS:

[Describe direct benefits, if any. In addition, include one or more of the following therapeutic objectives, as
appropriate (e.g., a + c)].
(a)     “This research study includes procedures that may change the treatment you would otherwise receive.
We hope knowledge gained will be of benefit to you.”
(b)      “You may receive no direct benefit from being in this study. However, your taking part may help
patients get better care in the future”
(c)     “This research study is designed to select by chance which treatment you will receive. It is not known if
the treatment you will receive will be of benefit to you. There may be no direct benefit from agreeing to
participate in this study.”

G. ALTERNATIVES TO PARTICIPATING IN THE STUDY

[Describe appropriate alternative procedures/treatments, if any that might be advantageous to the subject. Any
standard treatment that is being withheld must be listed as an alternative. The IRB considers the frequently
used language „discuss alternatives with your doctor‟ inadequate as a discussion of alternatives.
There is always an alternative to participating in a study, such as

(a)      “You are eligible for this study because you have not responded to all standard therapies. One
         alternative is no additional intervention which could result in your disease getting worse.”
        or
(b)      “You do not have to participate in this study to receive ongoing care for your condition”,
        or
(c)      “This is not a study related to diagnosis or treatment of a disease or condition in eligible subjects. You
         are free to choose not to participate in the study.”]


This Consent Document is approved for use by
Saint Vincent Catholic Medical Centers Integrated Scientific and Ethical Review Board
Only the IRB-stamped approved form may be used.

Informed Consent
Form Revision Date: December, 2007                                                                   Page 4 of 9
H. COMPENSATION/TREATMENT IN THE EVENT OF INJURY:

All forms of medical (or mental health) diagnosis and treatment – whether routine or experimental – involve
some risk of injury. In addition, there may be risks associated with this study that we do not know about. In
spite of all precautions, you might develop medical complications from being in this study.

If you sustain any injury during the course of the research or experience any side effect to a study drug or
procedure, please contact the Principal Investigator         at the following telephone number          If such
complications arise, the study investigator will assist you in obtaining appropriate medical treatment but this
study does not provide financial assistance for medical or other injury-related costs. You do not give up any
rights to seek payment for personal injury by signing this form.

Saint Vincent Catholic Medical Centers will provide immediate essential care for any injury resulting from your
participation in this research protocol. However, neither long-term hospital treatment nor financial
compensation will be available from Saint Vincent. You may receive this treatment from any provider.

SVCMC‟s policy requires that the sponsor cover research-related injury. Indicate that information here. Add all
or any part of the following paragraph. If this is a grant funded study or a study funded by St. Vincent‟s and
there is no money available for research-related injury, add the following: “No money will be provided by the
hospital or study investigator‟s practice, or by the organization that provided money for this study to
compensate you for a research-related injury. You or your insurance company will be charged for medical care
and/or hospitalization.”

[Some studies do not relate to medical diagnosis or treatment, such as educational and social science research.
This section should be modified to reflect this, depending on the specific study.

If the Sponsor has agreed in writing to provide compensation for medical or other costs arising from an adverse
event, state here exactly what the Sponsor has agreed to.]


I. VOLUNTARY PARTICIPATION:

You don‟t have to be in this research study. You can agree to be in the study now and change your mind later.
Your decision will not affect your regular care. You doctor‟s attitude toward you will not change and your
decision will not affect the care you receive and will not result in any loss of benefits to which you are entitled.

We may learn new things during the study that you may need to know. We can also learn about things that
might make you want to stop participating in the study. If so, you will be notified about any new information.
You can then decide if you want to continue to be in the study.

J. CONFIDENTIALITY:
[A section on confidentiality must be included in addition to the separate HIPAA Authorization.]


This Consent Document is approved for use by
Saint Vincent Catholic Medical Centers Integrated Scientific and Ethical Review Board
Only the IRB-stamped approved form may be used.

Informed Consent
Form Revision Date: December, 2007                                                                   Page 5 of 9
The only people who will know that you are a research subject are members of the research team and, if
appropriate, your physicians and nurses. No information about you, or provided by you during the research,
will be disclosed to others without your written permission, except:
        - if necessary to protect your rights or welfare (for example, if you are injured and need emergency
          care); or
        - if required by law.

 When the results of the research are published or discussed in conferences, no information will be included that
would reveal your identity. [If applicable:] If photographs, videos, or audio-tape recordings of you will be used
for educational purposes, your identity will be protected or disguised. [Describe the subject's right to
review/edit the tapes, who will have access, and when they will be erased. Describe how personal identities
will be shielded, disguised, etc.]
 [When the research records may be subject to inspection by FDA, a funding agency, or an industrial
sponsor, you must adapt and add:]
Authorized representatives of the Food and Drug Administration (FDA) [or a funding agency, such as the
National Institutes of Health] and the manufacturer of the drug [or device] being tested [insert name of
company] may need to review records of individual subjects. As a result, they may see your name; but they are
bound by rules of confidentiality not to reveal your identity to others.
[Then add information about the following: 1) Give a brief description of how personal information, research
data, and related records will be coded, stored, etc. to prevent access by unauthorized personnel. 2) Explain
how specific consent will be solicited, if any other uses are contemplated. 3) State if and when individually
identifiable data will be destroyed.]


K. CONTACT PERSON(S):

You can ask questions about this study at any time and you are encouraged to do so. If you have questions
about your rights as a research subject, or if you are not satisfied with the manner in which this study is being
conducted and would like to discuss your participation with an institutional representative who is not part of this
study, please contact the Administrator, Integrated Scientific and Ethical Review Board (ISERB), Telephone
Number 212-604-7470.

If you have any questions or sustain any injury during the course of the research, or if you experience any
adverse reaction to a study drug or procedure, please contact the Principal Investigator        at the following
telephone number

[Indicate the correct names and numbers for subject to use.]


L. WITHDRAWAL FROM THE STUDY:

If you decide to take part in the study, you may withdraw from participation at any time without penalty or loss
of benefits to which you would otherwise be entitled. Your participation maybe ended without your consent if
you become ineligible to continue in the study, if you fail to follow the instructions of the study investigator, if
you experience a study-related injury, or for any other reason determined by the principal investigator (or


This Consent Document is approved for use by
Saint Vincent Catholic Medical Centers Integrated Scientific and Ethical Review Board
Only the IRB-stamped approved form may be used.

Informed Consent
Form Revision Date: December, 2007                                                                   Page 6 of 9
sponsor.) When your participation in the study ends, you must agree to go through the termination procedures
the study investigator considers necessary for your safety.

If you do decide to withdraw your consent to participate in the study, you cannot continue to take part in the
study and we ask that you contact Dr.        [PI name] in writing and let       [him/her] know that you are
withdrawing from the study. [His/her] mailing address is [address].
[Be sure to include the PI‟s name and full mailing address.]

The Principal Investigator or another member of the study team will discuss with you any considerations
involved in discontinuing your participation in the study. You will be told how to withdraw from the study and
may be asked to return for a final check-up.
[Include the necessary considerations, such as in some cases, the need to taper off a drug rather than end it
abruptly, and requiring the return of all unused study medications.]

The study investigator may also decide to withdraw you from the study for certain reasons. Some possible
reasons for withdrawing a subject from the study would be worsening health or other conditions that might
make it harmful for you.

[Consider and include, if applicable, the following circumstances for withdrawing a patient from a study:
(a)    you fail to keep appointments, follow directions or take medications as instructed
(b)    staying in the study would be harmful to you
(c)    you need treatment that is not allowed in the study
(d)    the study sponsor ends the study.
(e)    you become pregnant]

[If applicable, include “For withdrawal of samples: If you agree to allow your tissue/blood/cells to be kept for
research, you are free to change your mind at any time. We ask that you contact Dr. [PI name] in writing and
let [him/her] know you are withdrawing your permission for your tissue/blood/cells to be used for research.
[His/her] mailing address is [address]. Any unused tissue/blood/cells will [be destroyed.] OR [have all
identifying information removed that would link the sample to you. The sample may then be used for other
research, but no one will be able to relate those research results to you. "]

AGREEMENT TO PARTICIPATE:

 I have read this consent form
  or
 it was read to me by: ______________________.

Any questions I had were answered by: _____________________.

I  am  am not participating in another research project at this time.
(If yes, you should discuss this with the study investigator.)


I voluntarily agree to participate in this research program at:

     St. Vincent‟s Hospital – Lower Manhattan
This Consent Document is approved for use by
Saint Vincent Catholic Medical Centers Integrated Scientific and Ethical Review Board
Only the IRB-stamped approved form may be used.

Informed Consent
Form Revision Date: December, 2007                                                                 Page 7 of 9
    St. Vincent‟s Hospital – Westchester
    Bishop Mugavero Center for Geriatric Care
    Holy Family Home – Brooklyn
    Monsignor Fitzpatrick Skilled Nursing Pavilion – Queens
    St. Elizabeth Ann‟s Health Care & Rehabilitation Center


I understand that I am entitled to and will be given a copy of this signed Consent/Authorization Form.

WHEN THE SUBJECT IS AN ADULT:

[This section is to be completed if the subject is 18 years of age or older. If the subject is a child, the form
“WHEN THE SUBJECT IS A CHILD” is to be completed and the “Adult” page deleted. If the study involves
both adults and children, both pages are to be included.]




This Consent Document is approved for use by
Saint Vincent Catholic Medical Centers Integrated Scientific and Ethical Review Board
Only the IRB-stamped approved form may be used.

Informed Consent
Form Revision Date: December, 2007                                                                Page 8 of 9
* For subjects who may not be capable of providing informed consent, the signature of a legal representative is
required.

____________________                    _____________________/_____
Print Name of Participant               Signature of Participant Date
or Legal Representative*                       or Legal Representative*


____________________                    _____________________/_____
Print Name of Person                    Signature of Person      Date
Obtaining Consent                              Obtaining Consent


[Use this section only when a witness is required.]

** When the elements of informed consent are presented orally to the subject or representative, a witness to the
oral presentation is required.
____________________               _____________________/_______
Print Name of Witness**            Signature of Witness**          Date




This Consent Document is approved for use by
Saint Vincent Catholic Medical Centers Integrated Scientific and Ethical Review Board
Only the IRB-stamped approved form may be used.

Informed Consent
Form Revision Date: December, 2007                                                                Page 9 of 9

								
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