*NOTE: Italicized statements are examples of MUSC/VA standard wording.
These statements should be printed in regular type on the actual consent
form.*\
If the study involves using different consent forms for different
populations, identify the population group as the subtitle of the study.

A.  **PURPOSE AND BACKGROUND:\
    **\
    Describe purpose. Studies of drugs/devices or comparison of
    procedures should include a statement that the purpose of the study
    includes an evaluation of the safety and effectiveness of the
    article or procedure.\
    \
    *You are being asked to volunteer for a research study. This
    research is sponsored by* \.... (name study sponsor or if there is
    no outside sponsor state the Ralph H. Johnson VA Medical Center).
    *The purpose of this study is to \.... You are being asked to
    participate in this study because you are \[have\] . . . . The
    investigator in charge of this study is \...* (name the principal
    investigator). *This study is being done at \....* (give number of
    sites) *and will involve approximately \.... volunteers.*

B.  **PROCEDURES:\
    **\
    Outline in chronological order the procedures to be followed. Give
    sufficient detail for the subject to understand the full extent of
    his/her participation. If the study protocol involves routine
    medical care as well as investigative procedures, explicitly state
    what will be done as routine care, and what part of the procedures
    will be carried out for the sole purpose of the research. Identify
    all drugs, devices, and procedures, which are experimental. This
    also includes all drugs or devices, which have FDA approved
    indications but are being used in this investigation for
    non-approved indications. If applicable, describe randomization
    procedures, double-blinds, use of placebos, etc.). State specific
    reasons for subject withdrawal from the study as outlined in
    protocol.\
    \
    *If you agree to be in this study, the following will happen:*

    1.  *You will have a physical examination, your medical chart will
        be reviewed, and blood and urine will be collected for
        laboratory tests. Approximately ... teaspoons (or other commonly
        understood units such as tablespoons or cups) of blood will be
        drawn for these tests. (If the physical examination and test
        results show that you are eligible for study treatment, you will
        be randomly assigned to one of two groups. This means that you
        have a 50/50 chance (like flipping a coin) of being in either
        group. Neither the researchers nor you will make the choice of
        which group to which you are assigned. The two groups are Group
        A (Drug XXX) and Group B (placebo, an inactive substance).*

    2.  *Group A will receive XXX, the investigational drug, in tablet
        form, ... times a week for ...weeks for a total of ... weeks.
        Group B will receive placebo, also in tablet form, according to
        the same schedule.*

    3.  *A x-ray of your lungs will be done once at the beginning of the
        study, and again at the end of the study, in order to check ....
        Each x-ray procedure will take about ... hour(s).*

    4.  *Once every two weeks, you will have a Magnetic Resonance
        Imaging (MRI) exam. For the MRI exam, you will lie down on a
        narrow bed which will then be placed in a tunnel that is 6 feet
        by 22 inches wide and open at each end. You will lie there
        quietly for about one hour, during which time you will hear a
        loud noise. You may feel warm during this procedure.*

    5.  *Once a week, a blood sample will be drawn from a vein in your
        arm. Each sample will be approximately ... teaspoons; a total of
        about ... tablespoons will be drawn for the whole study.*

    6.  *The researchers will check your medical records to gather
        information about ....*

    7.  *You may be withdrawn from the study without your consent if the
        researchers believe it is in your best interest of if you fail
        to follow study procedures.* (State specific reasons why
        subjects may be withdrawn from the study **as outlined in the
        protocol**.)

C.  **DURATION:**\
    *Participation in the study will take about . . .visits over a
    period of \...days/weeks/months.\
    *

D.  **RISKS/DISCOMFORTS:**\
    *Give details of all risks and or discomforts. List risks in order
    of severity, frequency, and possible sequelae.*

    1.  Drug XXX: If you are in the group that receives Drug XXX, the
        following side effects are possible: ....... These side effects
        are serious but have occurred in less than ... of previous human
        studies of XXX using comparable doses. If ... occurs, it will be
        treated by ...., (and you will be taken off the study). Other
        side effects, which are less severe but may occur more
        frequently are ....

    2.  Randomization: You will be assigned to a treatment program by
        chance. The treatment you receive may prove to be less effective
        or to have more side effects than the other study treatment(s)
        or other available treatments.

    3.  Placebo: If you are in the group that receives placebo, your
        condition will go without active treatment for ... weeks.

    4.  Radiation: The amount of radiation, you will be exposed to is
        relatively small. Such doses of radiation may be potentially
        harmful, but the risks are so small that they are difficult to
        measure. If you have already had many x-rays, you should discuss
        this with the researchers before agreeing to be in the study.
        -OR- As a result of participating in the study, you will receive
        a significant amount of radiation. The amount is similar to that
        received in many standard x-ray procedures, but is far more than
        you would receive from natural daily exposure or in the normal
        course of treatment, and carries at least a theoretical risk. If
        you are especially concerned with radiation exposure, you should
        discuss this with the researchers.

    5.  MRI: Because the MRI machine acts like a large magnet, it could
        move iron-containing objects in the MRI room during your
        examination, which could in the process possibly harm you.
        Precautions have been taken to prevent such an event from
        happening; loose metal objects, like pocket knifes or key
        chains, are not allowed in the MRI room. If you have a piece of
        metal in your body, such as a fragment in your eye, aneurysm
        clips, ear implants, spinal nerve stimulators, or a pacemaker,
        you will not be allowed into the MRI room and cannot have a
        MRI.\
        \
        \
        Having a MRI may mean some added discomfort to you. In
        particular, you may be bothered by feelings of claustrophobia
        and by the loud banging noise during the study. Temporary
        hearing loss has been reported from the loud noise. This is why
        you will be asked to wear earplugs. At times during the test,
        you may be asked not to swallow for a while, which can be
        uncomfortable.

    6.  Venipuncture: The risks of drawing blood include temporary
        discomfort from the needle stick and bruising, fainting could
        occur.

    7.  Unknown Risks: The experimental treatments may have unknown side
        effects. The researchers will let you know if they learn
        anything that might make you change your mind about
        participating in the study.

E.  **BENEFITS:**\
    \
    Outline the direct benefit to the subject, if none, say so.\
    \
    (If subject is randomized) The potential benefit to you is that the
    treatment you receive may prove to be more effective than the other
    study treatment or than other available treatments, although this
    cannot be guaranteed.\
    \
    If you are in the group that receives Drug XXX and it proves to
    treat your condition with fewer side effects than the current
    standard therapy, you may benefit from participating in the study;
    however, this cannot be guaranteed.\
    \
    OR:\
    \
    There will be no direct benefit to you from participating in this
    study. However, it is hoped that the information gained from the
    study will help in the treatment of future patients with conditions
    like yours/will help the researcher learn more about ....

F.  **COSTS:**\
    \
    Any charges to subjects for investigational drugs or devices must be
    authorized by the Food and Drug Administration.

> *You will not be required to pay for medical care or services received
> as a participant in a VA research project except as follows: Some
> veterans are required to pay co-payments for medical care and services
> provided by VA. These co-payment requirements will continue to apply
> to medical care and services provided by VA that are not part of this
> study.*

G.  **COMPENSATION:**\
    \
    Include amount and specific payment schedule. State how subjects
    will be paid (cash at each visit; check by mail, etc.) Payment
    should accrue as the study progresses and should not be contingent
    upon the subject completing the study. If participants are not to be
    compensated, then state so.\
    \
    You will not be paid for participating in this study.\
    \
    Or:\
    \
    In return for your time, effort and travel expenses, you will be
    paid \$... for participation in this study. If you do not complete
    the study, you will receive ... for each week of participation.

H.  **ALTERNATIVES:**\
    \
    Describe all appropriate alternative procedures or courses, if any,
    of treatment that might be advantageous to the subject. To enable a
    rational choice to participate in the research study, subjects
    should be aware of the full range of options available to them. The
    person obtaining the subject=s consent should be able to discuss
    available alternatives include side effects of these alternatives
    and answer questions that the subject may raise about them.\
    \
    *If you choose not to participate in this study, you could receive
    other treatments for your condition. The standard therapy for your
    condition is ...\
    *\
    **Include any of the following additional elements of consent as
    applicable. Continue to use outline form (I, J, K, etc.)**\
    \
    \_\_\_ **New Information**: *If there are significant new findings
    during the course of the study, you will be notified.*\
    \
    \_\_\_ **Release of Medical Records to Any One Other Than the
    Investigators:** *You will be asked to sign a separate release for
    the release of your medical records. (Required if medical records
    other than research related medical records are to be used.)*\
    \
    \_\_\_ **Student Paragraph:** *Your participation or discontinuance
    will not constitute an element of your academic performance nor will
    it be a part of your academic record at this Institution.*\
    \
    \_\_\_ **Employee Participation**: *Your participation or
    discontinuance will not constitute an element of your job
    performance or evaluation nor will it be a part of your personnel
    record at this Institution.*\
    \
    \_\_\_ **Confidentiality Certificate:** *(If a DHHS Confidentiality
    Certificate has been obtained, include the following paragraph.)*\
    \
    *A Certificate of Confidentiality has been obtained from the Federal
    Government for this study to help insure your privacy. This
    certificate means that researchers cannot be forced to tell people
    who are not connected with the study, including courts, about your
    participation, without your written consent. If we see something
    that would immediately endanger you, your child, or others, we may
    discuss it with you, if possible, or seek help.*\
    \
    \_\_\_ **Sponsor Commitment:** Sponsoring companies often request
    that their own wording be used for treatment and compensation for
    study related injuries. Sponsors may include a description of what
    the sponsor will cover in this section only. The wording of MUSC\"s
    standard statement was formulated with the advice of legal counsel
    with the intent of adhering to the requirements of Federal and State
    regulations and cannot be changed.

**IF STUDY IS NOT FDA REGULATED INCLUDE THE SECTION BELOW:**

**CONSENT**

Results of this research will be used for the purposes described in this
study. This information may be published, but you will not be
identified. Information that is obtained concerning this research that
can be identified with you will remain confidential to the extent
possible within State and Federal law. The investigators associated with
this study, the sponsor, and the MUSC Institutional Review Board for
Human Research will have access to identifying information. All records
in South Carolina are subject to subpoena by a court of law.

The VA will provide necessary medical treatment to a research subject
injured by participation in a research project. This requirement does
not apply to treatment for injuries that result from non-compliance by a
research subject with study procedures. If you sustain an injury as a
direct result of your study participation, medical care will be provided
by this VA Medical Center. Financial compensation is not available for
such things a lost wages, disability or discomfort due to an injury*.*

Your participation in this study is voluntary. You may refuse to take
part in or stop taking part in this study at any time. You should call
the investigator in charge of this study if you decide to do this. Your
decision not to take part in the study will not affect your current or
future medical care or any benefits to which you are entitled.

The investigators and/or the sponsor may stop your participation in this
study at any time if they decide it is in your best interest. They may
also do this if you do not follow the investigator's instructions.

**Volunteers Statement**

I have been given a chance to ask questions about this research study.
These questions have been answered to my satisfaction. If I have any
more questions about my participation in this study or study related
injury, or if I have comments, concerns or complaints, I may contact:
insert PI's name and phone number here. I may contact the VA Medical
Center's Medical Director (843.789.7200) concerning medical treatment.

If I have questions, comments, concerns or wish to voice a complaint, I
may contact the VA Research Compliance Officer at (843.789.6708).

If I have any questions about my rights as a research subject in this
study I may contact the Medical University of SC Institutional Review
Board for Human Research at (843.792.4148).

I agree to participate in this study. I have been given a copy of this
form for my own records.

If you wish to participate, you should sign below.

  ----------------------------------------------------- ------ ------------------------------------------------------------------------------------ --------
  *[                                                           [                                                                    ]{.underline}   
          ]{.underline}*                                                                                                                            

  Signature of Person Obtaining Consent                 Date   Signature of Participant                                                             Date

                                                                                                                                                    

                                                               [                                             ]{.underline}                          

                                                               Signature of Witness**\***                                                           Date
  ----------------------------------------------------- ------ ------------------------------------------------------------------------------------ --------

**Note: If the IRB has approved the use of surrogate consent (LAR, legal
guardian, etc), please add "Signature of Legal Guardian" to the lower
left signature block.**

**\*The role of the witness is to witness the subject signing the form.
If the subject or subject's legally acceptable representative is unable
to read, an impartial witness (one not affiliated with the research
team) should be present during the entire informed consent discussion.**

**IF STUDY IS FDA REGULATED INCLUDE THE SECTION BELOW:**

**CONSENT**

Results of this research will be used for the purposes described in this
study. This information may be published, but you will not be
identified. Information that is obtained concerning this research that
can be identified with you will remain confidential to the extent
possible within State and Federal law. The sponsor and the Food and Drug
Administration (FDA) will receive copies of the research records. The
investigators associated with this study, employees of the sponsor, the
FDA, and the MUSC Institutional Review Board for Human Research will
have access to identifying information. All records in South Carolina
are subject to subpoena by a court of law.

The VA will provide necessary medical treatment to a research subject
injured by participation in a research project. This requirement does
not apply to treatment for injuries that result from non-compliance by a
research subject with study procedures. If you sustain an injury as a
direct result of your study participation, medical care will be provided
by this VA Medical Center. Financial compensation is not available for
such things a lost wages, disability or discomfort due to an injury.

Your participation in this study is voluntary. You may refuse to take
part in or stop taking part in this study at any time. You should call
the investigator in charge of this study if you decide to do this. Your
decision not to take part in the study will not affect your current or
future medical care or any benefits to which you are entitled.

The investigators and/or the sponsor may stop your participation in this
study at any time if they decide it is in your best interest. They may
also do this if you do not follow the investigator's instructions.

**Volunteers Statement**

I have been given a chance to ask questions about this research study.
These questions have been answered to my satisfaction. If I have any
more questions about my participation in this study or study related
injury, or if I have comments, concerns or complaints I may contact
insert PI's name and phone number here. I may contact the VA Medical
Center's Medical Director (843.789.7200) concerning medical treatment.

If I have questions, comments, concerns or wish to voice a complaint, I
may contact the VA Research Compliance Officer at (843.789.6708).\
\
If I have any questions about my rights as a research subject in this
study I may contact the Medical University of SC Institutional Review
Board for Human Research at (843.792.4148).\
\
I agree to participate in this study. I have been given a copy of this
form for my own records.\
\
If you wish to participate, you should sign below.

  ----------------------------------------------------------------------------------------------- ------ ------------------------------------------------------------------------------------ -------
  *[                                                                             ]{.underline}*          [                                                                    ]{.underline}   

  Signature of Person Obtaining Consent                                                           Date   Signature of Participant                                                             Date

                                                                                                                                                                                              

                                                                                                         [                                                                    ]{.underline}   

                                                                                                         Signature of Witness**\***                                                           Date
  ----------------------------------------------------------------------------------------------- ------ ------------------------------------------------------------------------------------ -------

**\*The role of the witness is to witness the subject signing the form.
If the subject or subject's legally acceptable representative is unable
to read, an impartial witness (one not affiliated with the research
team) should be present during the entire informed consent discussion.**

**Note: If the IRB has approved the use of surrogate consent (LAR, legal
guardian, etc), please add "Signature of Legal Guardian" to the lower
left signature block.**

**(Revised 10/10/2008)**