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CONSENT FORM EXAMPLE by Breathe Carolina

VIEWS: 19 PAGES: 12

									 Main Consent Form


                                       <Insert protocol title here>

Principal Investigator:

Co-Investigator:


1.   INTRODUCTION:

     In this consent form, the word “you” means you and/or your child.

     You are being given the opportunity to participate in this research study . Research studies
     include only people who choose to take part. Please read this consent form carefully and
     take your time making your decision. As your study doctor or study staff discusses this
     consent form with you, please ask him/her to explain any words or information that you do
     not clearly understand. We encourage you to talk with your family and friends before you
     decide to take part in this research study. The nature of the study, risks, inconveniences,
     discomforts, and other important information about the study are listed below.

     Please tell the study doctor or study staff if you are taking part in another research study.

     The purpose of this study is to

     Approximately _____ subjects will be participating in this study at approximately _____
     centers , and _____ subjects will be participating locally.

     The study will take place at

     Your participation in this study will last _____

2.   PROCEDURES TO BE FOLLOWED:

      “You will be randomly assigned (like the flip of a coin) to receive like drawing numbers
     from a hat. One is standard treatment and the other is the experimental treatment. It is not
     known whether the experimental treatment is as good as or better than the standard treatment.
     The investigator will not be the person who decides which treatment you receive. You have
     a ___ in ___ chance of receiving the study drug.


<Preparation/Reference Date>                   Page 1 of 12                        Subject Initials _____

                                       Subject or Parent/Legally Authorized Representative Initials _____

                                                 Parent/Legally Authorized Representative Initials _____

                                                        Subject/Legally Authorized Representative _____
 Main Consent Form


   A placebo is an inactive substance given in the same form as the active drug, _____.

   Neither you, the study doctor nor any study personnel will know which treatment you are to
   receive or have received. This is important for the research design so that neither you nor the
   investigators will know about the developing trends in the data. However, in case of an
   emergency, the study doctor can find out which treatment you have received.

   A Phase II Study is the second step of testing a new drug in humans, primarily to obtain
   initial information about the efficacy and safety at the chosen dose.


   Day 1/Visit 1:
       Electrocardiogram (EKG), a tracing of the electrical activity of your heart
       2 tablespoons of blood will be drawn from your arm by needle stick for blood tests

   Day 2/Visit 2:
       Complete a questionnaire
       You will receive the study drug intravenously (into your vein) for 2 hours

3. RISKS ASSOCIATED WITH PARTICIPATION:


   There are no physical risks associated with this study. There is, however, the potential risk
   of loss of confidentiality. Every effort will be made to keep your information confidential;
   however, this cannot be guaranteed. Some of the questions we will ask you as part of this
   study may make you feel uncomfortable. You may refuse to answer any of the questions and
   you may take a break at any time during the study.


   As a result of your participation in this study, you are at risk for the following side effects.
   You should discuss these with the study doctor and your regular health care provider if you
   choose.

       (Study Drug Name) may cause some, all or none of the side effects listed below.

       Very Common (50-100%)
          

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                                   Subject or Parent/Legally Authorized Representative Initials _____

                                              Parent/Legally Authorized Representative Initials _____

                                                    Subject/Legally Authorized Representative _____
 Main Consent Form


           

       Occasional (6-20%)
          
          


   Risks associated with drawing blood from your arm include minimal discomfort and/or
   bruising. Infection, excess bleeding, clotting, lightheadedness and/or fainting are also
   possible, although unlikely.

   There are only minor risks associated with the DEXA test. It may feel uncomfortable, as you
   have to lie on an open table for 12-20 minutes as the DEXA scans your body. The amount of
   radiation to which you will be exposed is 1/20 th of what you would receive from a chest x-ray
   or about the same amount of radiation received during an airline trip from New York to Los
   Angeles.

   You will undergo screening for illicit (street) drug(s). If others find out you have tested
   positive for illegal drugs, it may cause mental stress, unfair treatment from other people,
   problems with getting insurance or finding a job, legal difficulties or other unknown
   problems. It is important to seek medical care if you have a drug abuse problem.
   Information obtained during the course of the study, which in the opinion of the
   investigator(s), suggests that you may be at significant risk of harm to yourself or others may
   be reported to a third party to protect the rights and welfare of those at potential risk.

   The pads placed on your chest for the ECG may cause a mild allergic reaction.

   The potential discomforts associated with fasting are minor and include dizziness, headache,
   stomachache or fainting.

   You will be tested for HIV (AIDS virus) during this study. If test results show that you have
   the virus that causes AIDS, the study staff will tell you the results and refer you to the health
   department to confirm the test results and give you someone to talk to about this disease. We
   will talk with you before and after testing, and your test result will be given to you only in
   person. You should know that the study staff must give your name to the Tennessee
   Department of Health if you test positive because this is the law. If others find out you have
   this virus, it may cause mental stress, unfair treatment from other people, problems getting


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                                   Subject or Parent/Legally Authorized Representative Initials _____

                                             Parent/Legally Authorized Representative Initials _____

                                                    Subject/Legally Authorized Representative _____
 Main Consent Form

   insurance or finding a job, or other unknown problems. It is important to seek medical care
   if you have HIV.

   There are no known major risks with an MRI scan. But it is possible that harmful effects
   could be found in the future. Even though the tunnel is open, it may bother you to be placed
   in a tight space (claustrophobia), and to hear the noise made by the magnet during the scan.
   You will be given earplugs to reduce the noise. You may also feel the table vibrate and/or
   move slightly during the scan. It may be hard to lie on the table during the scan. If you have
   any metal pieces in your body, they could move during the scan and damage nearby tissues
   or organs.

   This blood test may show that one or both of your parents are not related to you (adoption).

   Being a part of this study while pregnant may expose the unborn child to significant risks.
   Therefore, pregnant women will be excluded from the study. If you are a woman and are able
   to become pregnant, you will have a test to make sure that you are not pregnant before you
   receive treatment in this study. If sexually active, you must agree to use appropriate
   contraceptive measures for the duration of the study and for months afterwards. Medically
   acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or
   hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches,
   implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a
   spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B(TM),
   sold for emergency use after unprotected sex, are not acceptable methods for routine use.
   Also, women must not breast feed while in this study.

   Your participation in this research may damage your sperm, which could cause harm to a
   child that you may father while on this study. If you are sexually active, you must agree to
   use a medically acceptable form of birth control in order to be in this study and for months
   afterward. Medically acceptable contraceptives include: (1) surgical sterilization (such as a
   vasectomy), or (2) a condom used with a spermicide. Contraceptive measures such as Plan
   B(TM), sold for emergency use after unprotected sex, are not acceptable methods for routine
   use. You should inform your partner of the potential for harm to an unborn child. She should
   know that if pregnancy occurs, you will need to report it to the study doctor, and she should
   promptly notify her doctor.

   Being a part of this study while pregnant may hurt an unborn child. If you take part in this
   study, you and any person that you have sex with must use birth control such as birth control
   pills, birth control shots, IUD, diaphragm, or condoms while you are in this study. If you


<Preparation/Reference Date>              Page 4 of 12                        Subject Initials _____

                                  Subject or Parent/Legally Authorized Representative Initials _____

                                            Parent/Legally Authorized Representative Initials _____

                                                   Subject/Legally Authorized Representative _____
 Main Consent Form

   become pregnant or father a child while you are in this study, you must tell your doctor at
   once. Also, girls must not breast feed while in this study. If you are a girl and are able to
   become pregnant, you will have a test to make sure that you are not pregnant before you
   receive treatment in this study.
   If you are assigned to the placebo group, the following symptoms of may get worse: .

   Completion of the _________ may make you feel uncomfortable or cause troublesome
   feelings or emotions. You may refuse to answer any of the questions and you may take a
   break at any time during the study.

   A part of this study requires you to have the following procedures performed: (list)
   ________. The amount of radiation you will receive because of this procedure is about the
   same as that normally received for (state number of days) of exposure to the sun and other natural
   sources.

   Having your photograph taken, your voice recorded and being videotaped may make your
   feel uncomfortable. You may take a break during any time of the study. There is also a
   potential risk of loss of confidentiality as someone who views your video and photograph or
   listens to your audio recording might identify you. Every effort will be made to keep your
   information confidential; however, this cannot be guaranteed.

   During the washout period, the following symptoms of ______ may get worse: .


   Any significant new findings developed during the course of this research project, which may
   impact upon the safety and efficacy of the procedure or treatment under study and
   consequently influence your willingness to continue participation, will be provided to you.

4. BENEFITS ASSOCIATED WITH PARTICIPATION:


   Subjects receiving the active (or study) medication may benefit insofar as the size of the
   hemorrhage may be reduced, although this cannot be guaranteed. However, subjects
   receiving placebo will not benefit from the active (or study) medication.



5. ALTERNATIVES TO PARTICIPATION:

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                                   Subject or Parent/Legally Authorized Representative Initials _____

                                             Parent/Legally Authorized Representative Initials _____

                                                    Subject/Legally Authorized Representative _____
 Main Consent Form


   You may receive _____ without participating in this study.
   Treatments, other than those being evaluated in this study are available. These options
   include _________.
   You will not have to undergo _____ if you do not participate in this study.

   You will receive the same treatment for _____ whether or not you participate in the study.

   You will receive the same treatment for _____ whether or not you participate in the study.

   You will not have to undergo _____ if you do not participate in this study.


6. CONFIDENTIALITY:

   All your paper research records will be stored in locked file cabinets and will be accessible
   only to research personnel.

   All you electronic research records will be computer password protected and accessible only
   to research personnel.

   Your _____ sample will be maintained at _____ during the study and will be labeled with a
   code. Your _____ sample will be maintained at _____ during the study and will be labeled
   with your _____ .

   Your research records and your _____ will be transmitted to _____ and will be labeled with
   a code. A master key which links your name with the code on your ______ will be
   maintained at the local investigative site.

   Under federal privacy regulations, you have the right to determine who has access to your
   personal health information (called “protected health information” or PHI). PHI collected in
   this study may include your medical history, the results of physical exams, lab tests, x-ray
   exams, and other diagnostic and treatment procedures, as well as basic demographic
   information. By signing this consent form, you are authorizing the researchers at the
   University of Tennessee to have access to your PHI collected in this study and to receive
   your PHI from your physician facilities where you have received health care. In addition,
   your PHI may be shared with other persons involved in the conduct or oversight of this
   research, including researchers at the Food and Drug Administration (FDA); and your


<Preparation/Reference Date>              Page 6 of 12                        Subject Initials _____

                                  Subject or Parent/Legally Authorized Representative Initials _____

                                             Parent/Legally Authorized Representative Initials _____

                                                   Subject/Legally Authorized Representative _____
 Main Consent Form

   medical insurance carrier. Your PHI may also be shared with , which sponsors and provides
   funds for this research; which has been hired by the sponsor to coordinate the study; and a
   Data and Safety Monitoring Committee ). However, these latter organizations may not have
   the same obligations to protect your PHI. The Institutional Review Board (IRB) at the
   University of Tennessee Health Science Center may review your PHI as part of its
   responsibility to protect the rights and welfare of research subjects. Your PHI will not be
   used or disclosed to any other person or entity, except as required by law, or for authorized
   oversight of this research study by other regulatory agencies, or for other research for which
   the use and disclosure of your PHI has been approved by the IRB. Your PHI will be used
   only for the research purposes described in the Introduction of this consent form. Your PHI
   will be used until the study is completed for as long as the sponsor reports study data to the
   FDA indefinitely.

   You may cancel this authorization in writing at any time by contacting the principal
   investigator listed on the first page of the consent form. If you cancel the authorization,
   continued use of your PHI is permitted if it was obtained before the cancellation and its use is
   necessary in completing the research. However, PHI collected after your cancellation may
   not be used in the study. If you refuse to provide this authorization, you will not be able to
   participate in the research study. If you cancel the authorization, then you will be withdrawn
   from the study. Finally, the federal regulations allow you to obtain access to your PHI
   collected or used in this study. However, in order to complete the research, your access to
   this PHI may be temporarily suspended while the research is in progress. When the study is
   completed, your right of access to this information will be reinstated.

    Information about your participation in this study or the results of procedures performed in
   this study will be placed in your medical record; as such, this information could be made
   available to your employer or insurer.

   You will not be identified in any presentations or publications based on the results of this
   research study.

   To help us further protect your privacy, the investigators have obtained a Confidentiality
   Certificate from the Department of Health and Human Services (DHHS).

   With this certificate, the investigators cannot be forced (for example, by court subpoena) to
   disclose research information that may identify you in any Federal, State, or local civil,
   criminal, administrative, legislative, or other proceedings. Disclosure will be necessary,
   however, upon request of DHHS for audit or program evaluation purposes.


<Preparation/Reference Date>               Page 7 of 12                        Subject Initials _____

                                   Subject or Parent/Legally Authorized Representative Initials _____

                                             Parent/Legally Authorized Representative Initials _____

                                                    Subject/Legally Authorized Representative _____
 Main Consent Form


   You should understand that the Confidentiality Certificate does not prevent you or a member
   of your family from voluntarily releasing information about yourself or your involvement in
   this research. Note however that if an insurer or employer learns about your participation,
   and obtains your consent to receive research information, then the investigator may not use
   the Certificate of Confidentiality to withhold this information. This means that you and your
   family must also actively protect your own privacy.

   Finally, you should understand that the investigator is not prevented from taking steps,
   including disclosure of your research information to authorities, in order to prevent serious
   harm to yourself or others.

7. COMPENSATION AND TREATMENT FOR INJURY:

   You are not waiving any legal rights or releasing the University of Tennessee or its agents
   from liability for negligence. In the event of physical injury resulting from research
   procedures, the University of Tennessee does not have funds budgeted for compensation
   either for lost wages or for medical treatment. Therefore, the University of Tennessee does
   not provide for treatment or reimbursement for such injuries.
   You are not waiving any legal rights or releasing the University of Tennessee, the Regional
   Medical Center at Memphis or the agents of either, from liability for negligence. In the event
   of physical injury resulting from research procedures, neither the University of Tennessee
   nor the Regional Medical Center at Memphis has funds budgeted for compensation either for
   lost wages or for medical treatment. Therefore, neither the University of Tennessee nor the
   Regional Medical Center at Memphis provides for treatment or reimbursement for such
   injuries.
   You are not waiving any legal rights or releasing the University of Tennessee, Le Bonheur
   Children’s Medical Center, or the agents of either, from liability for negligence. In the event
   of physical injury resulting from research procedures, neither the University of Tennessee
   nor Le Bonheur Children’s Medical Center has funds budgeted for compensation either for
   lost wages or for medical treatment. Therefore, neither the University of Tennessee nor Le
   Bonheur Children’s Medical Center provides for treatment or reimbursement for such
   injuries.

   You are not waiving any legal rights or releasing the University of Tennessee, Methodist Le
   Bonheur Healthcare, or the agents of either, from liability for negligence. In the event of
   physical injury resulting from research procedures, neither the University of Tennessee nor
   Methodist Le Bonheur Healthcare has funds budgeted for compensation either for lost wages


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                                  Subject or Parent/Legally Authorized Representative Initials _____

                                             Parent/Legally Authorized Representative Initials _____

                                                   Subject/Legally Authorized Representative _____
 Main Consent Form

   or for medical treatment. Therefore, neither the University of Tennessee nor Methodist Le
   Bonheur Healthcare provides for treatment or reimbursement for such injuries.


   You are not waiving any legal rights or releasing the University of Tennessee, Methodist
   Healthcare-Memphis Hospitals, or the agents of either, from liability for negligence. In the
   event of physical injury resulting from research procedures, neither the University of
   Tennessee nor Methodist Healthcare-Memphis Hospitals has funds budgeted for
   compensation either for lost wages or for medical treatment. Therefore, neither the
   University of Tennessee nor Methodist Healthcare-Memphis Hospitals provides for treatment
   or reimbursement for such injuries.
   You are not waiving any legal rights or releasing the University of Tennessee, UT Medical
   Group, Inc. or the agents of either, from liability for negligence. In the event of physical
   injury resulting from research procedures, neither the University of Tennessee nor UT
   Medical Group, Inc. has funds budgeted for compensation either for lost wages or for
   medical treatment. Therefore, neither the University of Tennessee nor UT Medical Group,
   Inc. provides for treatment or reimbursement for such injuries.

   If you suffer a research related injury, your study doctor will provide acute medical treatment
   and will provide you with a subsequent referral to appropriate health care facilities.

   You and/or your insurance carrier will be billed for the costs associated with the medical
   treatment of a research related injury.



8. QUESTIONS:

   If you have any questions about this research study you may contact __________________
   at ___________ .

   In the event of a research related injury, contact ____________ at ______________
   You may contact Dr. Terrence F. Ackerman, Ph.D., UTHSC IRB Chairman at 901-448-4824
   if you have any questions about your rights as a participant in this study or your rights as a
   research subject.

9. PAYMENT FOR PARTICIPATION:



<Preparation/Reference Date>              Page 9 of 12                        Subject Initials _____

                                  Subject or Parent/Legally Authorized Representative Initials _____

                                            Parent/Legally Authorized Representative Initials _____

                                                   Subject/Legally Authorized Representative _____
 Main Consent Form

   You will receive $ ____ for travel and parking costs. You will receive a lump sum of $____
   for expenses at the completion of this study. You will receive $____ upon the completion of
   each study visit. If you complete all the study visits, you will receive a maximum payment
   of You will receive $ _____ if you finish the whole study. If you do not finish the entire
   study, you will receive $_____ for each study visit that is completed. You will not be paid
   for participation in this research study.


   You will receive a $_____ gift certificate to ______ at the completion of each study visit. If
   you complete all the study visits, you will receive a total of _____ gift certificates worth $
   ______.


10. COSTS OF PARTICIPATION:

   The study medication, _____, will be provided to you free of charge.


   In some cases, insurers may not reimburse claims submitted for medical procedures or
   treatments performed as part of a research study. Therefore, you could incur some additional,
   uninsured expenses as a result of participating in this research study. You may wish to
   consult your insurer regarding the extent of your coverage for procedures and treatments
   performed in the study.

11. PREMATURE TERMINATION:

   Your participation in this research study may be terminated by the investigator (or the
   sponsor) without regard to your consent for the following reasons:
      
      
      

12. VOLUNTARY PARTICIPATION:

   Your participation in this research study is voluntary and your refusal to participate or your
   decision to withdraw will involve no penalty or loss of benefits to which you are otherwise
   entitled.



<Preparation/Reference Date>               Page 10 of 12                       Subject Initials _____

                                   Subject or Parent/Legally Authorized Representative Initials _____

                                             Parent/Legally Authorized Representative Initials _____

                                                    Subject/Legally Authorized Representative _____
 Main Consent Form

   If you decide to stop taking part in this research study, you should tell your study doctor.
   Deciding to not take part in this research study will not change your regular medical care in
   anyway. If you decide to withdraw from the study, the information you have already
   provided will be kept in a confidential manner and the study doctor will discuss further
   treatment options with you. If you decide to withdraw from the study, the information you
   have already provided will be kept in a confidential manner and you will be asked to return
   to the clinic to have all the final clinical evaluations completed and laboratory tests
   performed.

   If you decide to withdraw from this study, you should tell your study doctor and you may ask
   that your identifiable samples be destroyed.

   If you decide to stop being part of the study, you should tell your study doctor. In addition,
   any information that you have already provided will be kept in a confidential manner.

   If you are a student, you understand participating or not participating in this study will in no
   way influence your grade in any course. If you are an employee of the university, you should
   realize that participating or not participating will not affect your employment status.

13. CONFLICT OF INTEREST:


   Please note that receives consulting fees from holds the patent on the product being tested
   owns stock in> the company providing funds for this research, .

   Some subjects want to know if the investigators or other persons involved in conducting the
   research study have a financial interest in the product being tested or the company sponsoring
   the research. You should know that receives consulting fees from holds the patent on the
   product being tested by owns stock in in the company providing funds for this research
   project, .




<Preparation/Reference Date>               Page 11 of 12                       Subject Initials _____

                                   Subject or Parent/Legally Authorized Representative Initials _____

                                             Parent/Legally Authorized Representative Initials _____

                                                    Subject/Legally Authorized Representative _____
14. CONSENT OF SUBJECT:

   You have read or have had read to you a description of the research study as outlined above.
   The investigator or his/her representative has explained the study to you and has answered all
   the questions you have at this time. You knowingly and freely choose to participate in the
   study. A copy of this consent form will be given to you for your records.


   __________________________________________                      ___________       _________
   Signature of Research Subject                                   Date              Time


   _________________________________________
   Printed Name of Research Subject


   __________________________________________                      ___________       __________
   Signature of Person Obtaining Consent                           Date              Time


   __________________________________________
   Printed Name of Person Obtaining Consent


   In my judgment, the subject or the legally authorized representative has voluntarily and
   knowingly given informed consent and possesses the legal capacity to give informed consent
   to participate in this research study.

   __________________________________________                      ___________       _________
   Signature of Investigator                                       Date              Time



   __________________________________________                      ___________       __________
   Signature of Legally Authorized Representative                  Date              Time

   ___________________________________________
   Relationship of Legally Authorized Representative



   ____________________________________________                    ___________       _________
   Assent of Minor (Ages 14-17)                                    Date              Time

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