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					                                                      INFORMED CONSENT DOCUMENT # A
                                                        INCLUDES HIPAA AUTHORIZATION
                                                     St. Christopher’s Hospital for Children
                      DREXEL UNIVERSITY COLLEGE OF MEDICINE
                         INSTITUTIONAL REVIEW BOARD (IRB)

                          INFORMED CONSENT
          GUIDELINES FOR PREPARING A RESEARCH CONSENT FORM
                        AND CONSENTING PROCESS
         FOR CLINICAL RESEARCH REQUIRING HIPAA AUTHORIZATION

NOTE ABOUT HIPAA
   If you are using any medical information that pertains to a research subject, you need to
     obtain authorization from the subject to access their Protected Health Information (PHI).
     This is commonly referred to as the HIPAA Authorization and is included in this consent
     form template.
   If you do not require any information that would identify a research subject (e.g.
     identifiers), but you only want to access the PHI, you must obtain Waiver of
     Authorization. Then you DO NOT use this consent form.
   These forms can be found at www.research.drexel.edu under “medical” IRB information.

CONSENT PROCEDURES AND CONSENT FORMS
Informed consent is one of the primary ethical requirements underneath research with human
subjects. It reflects the basic principle of respect for persons. Informed consent assures that
prospective human subjects will understand the nature of the research and can knowledgeably
and voluntarily decide whether or not to participate. This assurance protects all parties, whose
autonomy is respected, and the investigator, who otherwise faces legal hazards.

The "proxy consent" of someone other than the subject is not the same as the subject's own
consent. An acceptable substitute, when a subject is unable to give informed consent, is
primarily governed by the State law where the consent was signed or study is being conducted.
(See policy of consenting subjects who have diminished capacity to consent).

Subjects who are unable to give their own consent, the State law may require consent from a
legally authorized representative or a previously designated individual who can give healthcare
proxy or by a family member, when the investigator clearly justifies that the procedure or
treatment provides significant healthcare benefit to the subject.

RESEARCH CONDUCTED AT ANOTHER INSTITUTION
If research will be conducted at another institution and is approved by that institution's IRB, then
the consent form from that institution must be used, as the research conducted at that institution
is strictly under the jurisdiction of that institution’s IRB. The “In Case of Injury Paragraph”
must state that “Drexel University or Drexel University College of Medicine” (use whichever is
applicable), will not be responsible for costs related to the injury.
When research is conducted at another institution, Drexel University/Drexel University College
of Medicine may sign a reliance/authorization agreement with the other institution. A reliance
agreement is a formal, written document that provides a mechanism for an institution engaged in
research to delegate IRB review to an independent IRB or an IRB of another institution. This
agreement facilitated by Office of Regulatory Research Compliance (ORRC) may cover single
studies, categories of studies, or all human subjects research under an organization’s Federalwide
Assurance (FWA). Please contact ORRC for additional information on securing reliance on
another institution. Other institutions may also rely on Drexel University/Drexel University
College of Medicine when research is conducted in our institution. Reliance may also be used
when a participating research entity does not have its own IRB.

Please make sure to observe the guidelines below and present the consent form document in the
format that has been suggested to facilitate proper review of your research project. Use of other
formats, such as formats provided by third party sponsors cause confusion in the language and
may unnecessarily create delays in receiving approval.

GUIDELINES
In general, these guidelines are put together to assist you in developing a consent form that meets
the following criteria:
      Full disclosure of the nature of the research including risks and benefits
      Clear and understandable language from the view point of the study subject
      Inclusion of salient points required by the Institution’s policy and regulatory agencies
      Standard format to provide a logical flow of concepts
      Assent form (See Assent Form Template).

USE THE SECOND PERSON PERSPECTIVE
Use the second person singular throughout the form with the EXCEPTION of the final paragraph
that should be in the first person perspective. It should be written as if the investigator were
speaking directly to the subject. Avoid language that appears to be speaking for the subject.
This should assist prospective research subjects to better judge whether or not they fully accept
the statements contained in the consent form.

USE EVERYDAY NON-TECHNICAL LANGUAGE
Use layperson’s language, avoiding words and terms that are not in common everyday use or not
readily understandable to a person in junior high school. There is a website available that lists
the technical and medical terms. The address of this website is:
http://allserv.rug.ac.be/~rvdstich/eugloss/EN/lijsta.html
There are software programs such as Word and Word Perfect available to judge reading level.
Some useful hints are to avoid multi-syllabic (>2 syllables) words and to explain unavoidable
technical language in lay terms.
TAKE THE PARTICIPANT'S PERSPECTIVE
As you draft your consent form, try to take the perspective of the subject in your planned
protocol. This should assist you in the description of time and effort burdens, and in the
development of all other aspects of the consent form.

THE CONSENT FORM SHOULD TRACK YOUR PROTOCOL IN ALL IMPORTANT
RESPECTS
Make sure that your consent form matches the research protocol on which it is based. For
example: if procedures are described in the protocol, the consent form should track the
description of those procedures (although not necessarily word- for word); any risks mentioned
in the consent form should have been addressed in your protocol.

AVOID UNDUE EMPHASIS OF THE BENEFITS/RISKS OF PARTICIPATING IN THE
STUDY
Generally, your discussion of the research should be conservative in tone in order to avoid undue
expectations by the subject. Avoid understating risks or overstating benefits.

UNDERLINE THE EXPERIMENTAL PART OF THE PROTOCOL
See consent form template.

RESEARCH INVOLVING CHILDREN OR MINORS
In the case of children or minors, the IRB is required to determine that adequate provisions are
made for soliciting the assent of children in addition to the permission of parents/guardians.
Judgment must be made as to whether the children are capable of providing assent. In
determining capability for assent, age, maturity and psychological state should be taken into
account. An assent document should be written using simple language so a child can generally
understand what he/she can expect by being in the study. (See Assent Form Template)
Permission form for parent/guardian is also required.

PERSON AUTHORIZED TO OBTAIN CONSENT
Informed consent can only be obtained from one of the individuals listed under the final
paragraph on the consent form. The Principal Investigator (PI) is responsible for ensuring that
individuals listed are qualified to obtain consent.

FORMAT
Subject's/patient's initials must be on the top of each page.
Pages must be numbered (i.e., 1 of 3, 2 of 3, 3 of 3 etc…).
Leave 1.5 inches space in the bottom of each page for the IRB approval stamp.
Consent signature page should be kept on the same page.

CONSENT PROCESS - STANDARD OPERATING PROCEDURES
The PI will document all informed consents approved by the IRB in writing and each IRB
approved document will be signed and dated by the investigator, the person obtaining the
consent, and the subject or his/her legally authorized representative (LAR), but not by next of
kin, unless he/she is the LAR.
As applicable, a child becomes an adult at age 18. Therefore, the participant child who turns 18
must be consented as an adult if study extends beyond the child’s 18th year of age with an IRB
approved consent form. For more information on consenting children, see the IRB Guidelines
and the Policy on Substituted (Surrogate) Consent.

PROCEDURES FOR INFORMED CONSENT
A.  The PI will ensure that informed consent is obtained from each subject prior to the
    beginning of a clinical or behavioral research study.
B.  Only IRB approved, stamped consent forms are to be used for consenting subjects.
C.  Each consent form will contain the following:
         1.     Sequentially numbered pages;
         2.     Space for subject’s initials on each page;
         3.     Institution’s Name;
         4.     Name of the Study;
         5.     Investigator's Name;
         6.     Subject's Name;
         7.     Location where study will be done;
         8.     IRB stamp on each page indicating the approval and expiry date;
         9.     A consent sign-off page for subject, IRB authorized individuals to obtain
                consent, investigator's and witness's signature;
         10.    Instruction stamp for the subject not to sign the consent form beyond the
                noted expiry date.
D.  The PI will review the consent form with potential study subjects.
E.  The potential subject will receive a copy of the informed consent to read. The PI will
    review each section and answer all questions.
F.  If the subject wishes to speak with the PI or the Sub-Investigators associated with the trial
    before signing the consent, the subject will be scheduled to meet with the investigator to
    have all questions answered prior to signing the document.
G.  The subject should be encouraged to take a blank consent home to reread or discuss with
    family members or personal physician. In this regard, a copy of the consent should be
    provided.
H.  All informed consents will be signed and dated by the subject or their legal representative
    and the consentor prior to beginning any study-related procedures. A copy of the consent
    form must be provided to the subject or their legal representative.
I.  All informed consents will be signed by and dated by a witness and/or the investigator as
    required by the IRB and the sponsor.
J.  Investigators may pre-screen research subjects as approved by the IRB by personal
    interview, telephone, or chart reviews to determine general eligibility for a study prior to
    the informed consent being signed.
K.  Prior to signing the consent form, the subject will be asked to reply, in his or her own
    words, and without immediate reference to the consent form, to the following questions:
    Do not include these questions on the consent form.
         1.     What is the purpose of this study?
         2.     What will be done?
          3.      What risks and discomforts may occur from participating in this study?
          4.      What benefits may the subject gain from participating in this study?
L.   A subject may participate in a study only if his/her answers demonstrate an informed
     understanding.
M.   If the proposed procedures are complex or hazardous, the IRB may suggest or require
     that subjects be encouraged to discuss them with their own physicians or other respected
     persons before making a decision.
N.   If a protocol involves major risks, the IRB may require that subjects be briefed twice with
     at least two (2) days intervening between briefings. If it is anticipated that the second
     briefing may have to be waived in some circumstances, the PI should include information
     to this effect in the protocol submitted for approval by the IRB.
O.   All research subjects will be asked to initial every page of the informed consent to
     document that all pages were presented to them during the informed consent discussion.
P.   The investigator will maintain an informed consent documentation sheet in the study
     binder indicating the name of the study, the time and date of informed consent signed.
Q.   The investigator will document that a copy of the consent form has been provided to the
     research subject prior to the beginning of the study. This document will become part of
     the subject’s source document.
Consent Version Date                                                        Page 1 of __
                                                                            (Paginate each page)


                     DRAFT TEMPLATE OF INFORMED CONSENT

GENERAL TEMPLATE INSTRUCTIONS:
For your convenience, the below template was developed with the instructions embedded in the
document. Instructions are included throughout this template in red text. Any template language
highlighted in grey indicates template sample language that includes two or more alternative
templates which you must choose based on the characteristics of the study. As you draft the
informed consent for your study, delete the red text and grey highlight from your final draft.

        If you are from St. Christopher’s Hospital for Children, title the consent form as
                          "Drexel University College of Medicine"
"Permission/Consent to Take Part In a Study Conducted at St. Christopher's Hospital for
Children"

                                    Consent to Take Part
                                    In a Research Study
     (Change to “Permission to Take Part” in the case of minors, legal guardians or power of
                                           attorney)

1.     CHILD’S NAME                          _____________________________

       PARENT/GUARDIAN’S NAME _____________________________

2.     TITLE OF RESEARCH                     ____________________________

       Must be identical to sponsor’s protocol or grant application

3.     INVESTIGATOR'S NAME                   ____________________________

4.     RESEARCH ENTITY

       This research study is being done by a member of the Philadelphia Health & Education
       Corporation (doing business as Drexel University College of Medicine) teaching faculty,
       who is based at St. Christopher's Hospital for Children. Note that both Drexel University
       and St. Christopher's Hospital for Children are corporations separate and distinct from
       Philadelphia Health & Education Corporation, which is the entity responsible for this
       research study.

       If a third party is providing funding and/or supply of study drug or device, use one of the
       sentences below.




                                                            Parent/Guardian Initials__________
     [Identify third party] is providing funding for this study.

     Or

     [Identify third party] is providing the supply of study [drug/ device] for this study.

     Or

     [Identify third party] is providing funding and the supply of study [drug/ device] for this
     study.



5.   CONSENTING FOR THE RESEARCH STUDY
     This is a long and an important document. If you sign it, you will be authorizing St.
     Christopher’s Hospital for Children and its researchers to perform research studies on you.
     You should take your time and carefully read it. You can also take a copy of this consent
     form to discuss it with your family member, physician, attorney or anyone else you would
     like before you sign it. Do not sign it unless you are comfortable in participating in this
     study.

     THIS PARAGRAPH IS MANDATORY FOR ALL CONSENT FORMS.

6.   YOUR RIGHT TO PRIVACY AND CONFIDENTIALITY
     Very specific information on your right to privacy and the confidentiality of the use and
     disclosure of your personal health information can be found at the end of this consent
     form. We need your authorization to use and disclose the health information that we may
     collect about you during this research study. To be in this research study you must read
     and sign the authorization at the end of this consent form.

     THIS PARAGRAPH IS MANDATORY FOR ALL CLINICAL TRIALS OR ANY
     OTHER RESEARCH STUDY THAT INVOLVES THE USE OF PHI (PROTECTED
     HEALTH INFORMATION) OF A RESEARCH SUBJECT.

7.   PURPOSE OF RESEARCH
     You are being asked to participate in a research study. The purpose of this study is to
     find out if -------------------

     Remember to use lay language, non-medical and non-technical terms (unless clearly
     explained). Make sure this tracks throughout the consent form. Be sure to avoid any
     implied pressures or coercive statements. If you are a graduate student doing this
     research project as a partial fulfillment to obtain your degree, please make sure to state
     that in this section. If you are someone who has a financial interest in this project, such
     as receiving remuneration as a direct subject in the study, please include your financial
     involvement in this project. Salary or compensation received for the % effort invested



                                                            Parent/Guardian Initials__________
     for the performance of this research project is not considered a conflict and they need not
     be mentioned.]

     Indicate why the subject has been asked to take part. Include the approximate number of
     subjects expected to be enrolled nationally/internationally and at this site.

     It is important for the subject to know why they are in the study (even if only as a
     control) and why their participation may end. Also important is a listing of exclusion
     criteria (why they cannot participate in the study) about which the patient would have
     knowledge. These should be clearly indicated.

     You should also discuss possible prior treatment or medication, which may affect the
     subject’s risks/benefits of taking part in the study. The subjects must know that they may
     choose not to be part of the study or may withdraw when they wish. They should also
     know what conduct or circumstances might end their participation in the study and any
     resulting loss or changes in treatment.

8.   PROCEDURES AND DURATION
     You understand that the following experimental procedures will be performed in this
     study. (Experimental Procedures must be underlined). [OR] You understand that all of
     the following things that will be done to you are experimental procedures that will be
     performed in this study. (Don’t Underline)

     Sample
     The following tests and procedures will be done at some or all of the study visits.
      Physical exam (visits __, __, __ and __)
      Blood and urine sample collection for routine tests (visits __, __, __ and __)
      Pregnancy test for all female subjects (visits __, __, __ and __)
      Electrocardiogram (ECG - tracing of the electrical activity of the heart) (visits __, __,
        __ and __)
      Blood collection for viral load (visits __, __, __ and __)
      etc.

     The procedures listed below are experimental and are only done for the research:
      [name of item, if any] ( e.g. angiogram)
      [More name of items, if any] etc.

     The subject’s participation should be described in detail, underline any experimental
     procedures (unless all are experimental) and include at least the following:
      Types of procedures, the number of each procedure, individual and cumulative
        durations, up to years of treatment, if appropriate; time and effort requirements for the
        subject, in terms of visits, their duration and frequency (a chart of graph may be
        helpful if the treatment protocol is particularly difficult to describe in words only.
        This chart may be an appendix to the consent form).



                                                          Parent/Guardian Initials__________
        Whether hospitalization will be involved, or if an extension of hospitalization will be
         caused by participation in this study.
        What the subject will experience during the study, particularly indicating whether
         more invasive procedures (such as biopsies, endoscopies, intra-arterial placements or
         like) are principally indicated, complemented by research procedures. Indicate
         number of blood draws, the interval between draws, and how much in teaspoon or
         tablespoon and in total.]

9.   RISKS AND DISCOMFORTS/CONSTRAINTS
     For social and behavioral studies, use the below template:
     The following are risks associated with participating in this study: [list all the below types
     of risks]
          Physical risks
          Psychological risks
          Social/economical risks


     For medical/clinical studies, use the below template:
     The most serious possible side effects known of [name of item] are:
      _____
      Allergic reaction to [name of item] is possible. Serious allergic reactions can be life
        threatening.
      Etc.

     The most common side effects known of [name of item] are:
     
     

     Less common side effects known of [name of item] are:
     
     

     Rare side effects known of [name of item] are:
     
     

     Drawing blood from your arm may cause pain, bruising, lightheadedness, and, on rare
     occasions, infection.
     List all potential risks and discomforts and their frequency as well as maximum possible
     severity including death. If you are performing a clinical trial, carefully read the
     investigator’s brochure to determine what some of the expected adverse experiences are
     and include those problems on the consent form since they are expected problems.]




                                                           Parent/Guardian Initials__________
      Refer to your protocol and make sure that the consent form is consistent with the
      protocol.
       Risks should include any risks or radiation, other minor procedures, which may be
          part of the study, side effects or other unknown effects of a drug, particularly if the
          drug is investigational. (If possible, relate such risks to interventions about which the
          risks are more commonly known like x-ray, aspirin, etc).
       Discomforts may include physical or mental discomfort, such as those of
          venipuncture, of answering personal questions, of remaining in the same position for
          a long time, or the like.
       In discussing probability, try not to use odds such as “one in a thousand.” You may
          consider description such as:

            i.   >0.05 Use “frequent”
           ii.   0.05 - 0.01 Use “occasional”
          iii.   0.01 – 0.001 Use “uncommon”
          iv.    <0.001       Use “rare”

          Include risks from washout periods or placebo arms or risks of discontinuing current
           medications.
          Indicate if the subject’s regular activities may be affected by participation in the
           study. For example, if a drug may promote drowsiness, react with alcohol, the
           subject should be advised of those risks. More minor changes of daily routine, such
           as the timing of meals or sleep should also be discussed even if these are only
           inconveniences.
          Include precautions to minimize risks or to protect subjects from adverse events. This
           must be presented in a balanced way.

10.   UNFORESEEN RISKS
      There may be side effects which are unknown at this time. Unexpected reactions,
      hazards, discomforts and inconveniences may affect the quality of life and may include
      life-threatening events or death.

      Your [disease, condition, symptoms] may not get better or may become worse while you are
      in this study.

      If unforeseen risks are seen, they will be reported to the Office of Regulatory Research
      Compliance.

      Only you can take the study drug. It must be kept out of the reach of children and persons
      who may not be able to read or understand the label. << Use if a study drug is taken at
      home>>

      In addition to anticipated/expected risks, certain studies may involve unforeseen
      reactions, hazards, discomforts, and inconveniences affecting the quality of life including
      life threatening events or death associated with the use of drug/device/procedure. A


                                                            Parent/Guardian Initials__________
      statement must be included that "participation in the study may involve unforeseen
      risks." Where possible, list such risks, indicate what will be done to avoid or minimize
      such unforeseen risks. PLEASE INCLUDE THE FOLLOWING STATEMENT. “If
      unforeseen risks are seen, they will be reported to the Office of Regulatory Research
      Compliance.”

11.   PREGNANCY WAIVER SECTION
      Women who are pregnant or nursing a child may not participate in this study. IN such a
      case, you must confirm that, to the best of your knowledge, you are not now pregnant,
      and that you do not intend to become pregnant during the study. We do not know what
      impact this drug will have on your fertility (your ability to conceive a child or impregnate
      a female). We also do not know what effects this drug will have on a pregnancy. You
      must use effective birth control throughout the course of this study and for -------- months
      after that. If female, you must avoid getting pregnant. If you become pregnant while in
      the study, you must tell the study doctor as soon as possible. If male, you should avoid
      impregnating a female. You must use effective birth control throughout the course of this
      study and for [how long] months after that. While you are in this study, if your partner
      becomes pregnant you must tell the study doctor as soon as possible.


             --------------------------------------           -------------------
             Subject’s Signature                           Date

      Include this section only if there are risks known or unknown of physical or genetic
      damage to a fetus or to the genes of the fetus. Wording may be modified to meet more
      stringent requirements of sponsors or if only one gender participates.

      This section may not be necessary for social or behavioral studies in which pregnancy is
      not a concern. It is anticipated that this wording would apply to most Phase III and late
      Phase II studies in which women can be enrolled after baseline animal fertility studies
      have been completed. It may also be applied to earlier studies if appropriate.

12.   BENEFITS
      Your [disease/symptoms/conditions] may get better, there is no guarantee of this. There
      may be no direct benefits to you from participating in this study.

      Indicate possible benefits to the subject, if any, including no benefits or condition may
      worsen by taking part in the study, if appropriate. Generally, you should not include such
      benefits as “the advancement of science” or any remuneration or inducement. Benefits
      should be discussed in conservative terms in order to avoid undue expectations or
      coercion of the subject. If a drug is investigational and a therapeutic benefit is
      experienced, discuss whether treatment may continue after the end of the study, or
      whether a relapse or loss of benefit is possible during or after a subject has been
      withdrawn from the study.




                                                           Parent/Guardian Initials__________
13.   ALTERNATIVE PROCEDURES/TREATMENT
      Describe other procedures or courses of treatment, which are available to the subject in
      place of this one. This should include current therapies as well as the option not to
      participate if there are no alternatives.
                                                OR

      The alternative is not to participate in this study. If you decide not to enter this study,
      there may be other treatments [modify “treatments” if needed] available. These include
      [list of major drugs, therapies]. The study doctor will discuss these with you. You do not
      have to participate in this study to be treated for [disease, condition, symptoms].

                                               OR

      This is not a treatment study. Your alternative is not to participate in this study. (Use
      this language if this is not a treatment study).


14.   REASONS FOR REMOVAL FROM STUDY
      You may be required to stop your participation before the end of the study for any of the
      following reasons:
          a) A change in your child’s medical condition;
          b) Discontinuation of all or part of the study; or
          c) Other reasons, including new information available to the investigator or harmful
              reasons experienced by you or other subjects in this study.
      If you leave the study before the final regularly scheduled visit, the study doctor may ask
      you to make a final visit for some of the end of study procedures.

      Indicate any resulting changes in treatment including necessity of weaning from
      drug/treatment, or other effects that the subject may experience in case of
      removal/withdrawal.

      This section may be deleted if the participation in this study is a onetime event as so
      indicated in the section on procedures and durations. This should also be reinforced with
      subject with the signing of the consent agreement.

15.   VOLUNTARY PARTICIPATION
      Participation in this study is voluntary. You may refuse to be in the study or you may stop
      at any time without the loss of the care benefits to which you are entitled. However, you
      will be expected to follow the instructions provided by the research staff, in order to ensure
      your safety.

      In the event that an individual requires additional treatment in order to withdraw from the
      study (e.g., weaning from a drug), this should be set forth with specificity in this
      paragraph. Include who is responsible for the costs of such treatment/procedures,
      especially if incurred by subject as opposed to sponsor or third party payers.



                                                             Parent/Guardian Initials__________
16.   COMPENSATION FOR PARTICIPATION
      You will be paid $      if you complete all scheduled study visits. If you do not complete
      the study, you will be paid $     for each completed study visit.

      Include any monies a subject will receive and conditions related to payment.

17.   RESPONSIBILITY FOR COST
      If the study is social or behavioral, explain who will bear the responsibility for cost. If
      there is no cost, use the following sentence:
      There is no cost to you for participating in this study.

      If this study is clinical/medical and only involves reviewing subjects’ medical records
      (e.g. observational study), use the following:
      This study will only involve reviewing your medical records. No additional procedures
      or medicine will be given to you. There is no cost to you for participating in this study.
      You or your insurance company will still be billed for tests or procedures that are
      considered “standard of care” and would have been part of your medical treatment even if
      you did not participate in this study. These treatment costs include but are not limited to
      drugs, routine laboratory tests, x-rays, scans, surgeries, routine medical care, and
      physician charges. Your health insurance company may not pay for these “standard of
      care” charges because you are in a research study. If your insurance company does not pay
      for costs associated with this research study that are considered “standard of care” for
      your medical treatment, then you will be billed for these costs. You are responsible for
      paying for any insurance co-pays and any deductibles due under your insurance policy,
      and any charges your insurance company does not pay.


      If this study is clinical/medical and additional procedures and/or medication will be
      administered, use the following:
      You will not be charged for any tests specifically required for this research study, but you
      or your insurance company will still be billed for tests or procedures that are considered
      “standard of care” and would have been part of your medical treatment even if you did
      not participate in this study. These treatment costs include but are not limited to drugs,
      routine laboratory tests, x-rays, scans, surgeries, routine medical care, and physician
      charges. Your health insurance company may not pay for these “standard of care” charges
      because you are in a research study. If your insurance company does not pay for costs
      associated with this research study that are considered “standard of care” for your
      medical treatment, then you will be billed for these costs. You are responsible for paying
      for any insurance co-pays and any deductibles due under your insurance policy, and any
      charges your insurance company does not pay.

      The [study drug or device], [identify the drug(s) and/or devices], will be provided by the
      sponsor. You will not be charged for the study drug or device. [Include this sentence if
      drug or device involved in study.]



                                                             Parent/Guardian Initials__________
      So that you do not have unexpected expenses from being in this study, ask your study
      doctor for a list of the tests or procedures that will be paid by the sponsor of the study.

18.   COMPENSATION FOR RESEARCH RELATED INJURY
           Please read the instructions below to use the appropriate paragraphs for in case of injury.
           If the study is sponsored by industry use paragraph “A” below.
           For all other studies use paragraph “B” below.
           If the study involves non-sensitive questionnaires, you do not require an injury paragraph
            unless recommended by the IRB.
           If the study involves post market surveys, you do not require an injury paragraph.

      A. INDUSTRY-SPONSORED STUDY
      If your child becomes ill or injured during this study, please contact Dr. [name] at telephone no.
      (XXX) XXX-XXXX. If your child requires immediate medical attention, you should go to the
      nearest emergency room or call 9-1-1. It is important that you inform all emergency medical staff
      that your child is participating in this study.

      The medical treatment for your child’s research-related injury will be provided at no cost to you.
      A “research related-injury” means injury caused by any Study [drugs/device] or procedures
      required by the research which your child would not have experienced if your child had not
      participated in the research study. You, or your child’s medical insurance, will be responsible for
      other medical expenses resulting from your child’s medical condition. You will not be paid for
      any other injury- or illness-related costs, such as lost wages. However, you are not waiving any
      legal rights by your child participating in this study. If you or your child has questions, please
      call Dr. [name] at telephone no. (XXX) XXX-XXXX.

      It is important for you to follow the instructions provided by your child’s physician including
      notifying your study physician as soon as you are able of any complication or injuries that you
      experience.

      If you are injured or have an adverse reaction, you should also contact the Office of Regulatory
      Research Compliance at 215-255-7857.


          B. ALL OTHER STUDIES (INTERNAL, GOVERNMENT FUNDED, PRIVATE NOT-
            FOR-PROFIT)
      If your child becomes ill or injured during this study, please contact Dr. [name] at telephone no.
      (XXX) XXX-XXXX. If your child requires immediate medical attention, you should go to the
      nearest emergency room or call 9-1-1. It is important that you inform all emergency medical staff
      that your child is participating in this study.

      If a research-related injury results from your child’s participation in this research study, medical
      treatment will be provided. You, or your child’s medical insurance, will be responsible for the
      medical expenses resulting from your research-related injury. A “research related-injury” means
      injury caused by any study [drugs/device] or procedures required by the research which your
      child would not have experienced if your child had not participated in the research study. In



                                                                  Parent/Guardian Initials__________
      addition, you will not be paid for any other injury- or illness-related costs, such as lost wages.
      However, you or your child are not waiving any legal rights by participating in this study. If you
      or your child has questions, please call Dr. [name] at telephone no. (XXX) XXX-XXXX.

      It is important for you to follow the instructions provided by your child’s physician including
      notifying your study physician as soon as you are able of any complication or injuries that you
      experience.

      If you are injured or have an adverse reaction, you should also contact the Office of Regulatory
      Research Compliance at 215-255-7857.

19.   CONFIDENTIALITY AND PRIVACY
      A.  Individually identifiable health information that will be collected
          The following personal health information about you will be collected and used
          during the research study and may be given out to others:
                  [Modify the following list as needed]
                 Your name, address, telephone number, date of birth;
                 Personal and family medical history;
                 Information from laboratory tests, blood and urine tests, x-rays, physical
                  exams and other tests or procedures described in this consent form.
                 Information learned during telephone calls, surveys, questionnaires and
                  office visits done as part of this research study;
                 Information in medical records located in your doctor’s office or at other
                  medical facilities you may have received treatment.
                 List any additional information that may be obtained from participants that
                  is not covered by the activities and procedures listed in the Consent Form.
                  Examples might include information about financial and social
                  circumstances, or educational level.

      B.      Who will see and use your health information within Drexel University
              College Of Medicine Or Drexel University
              The research study investigator and other authorized individuals involved in the
              research study at St. Christopher’s Hospital for Children will see your health
              information during and may give out your health information during the research
              study. These include the research investigator and the research staff, the
              institutional review board and their staff, legal counsel, research office and
              compliance staff, officers of the organization and other people who need to see
              the information in order to conduct the research study or make sure it is being
              done properly. Such individuals may include employees or agents of Drexel
              University College of Medicine or Drexel University since both provide research
              services to St. Christopher’s Hospital for Children. Your health information may be
              disclosed or transmitted electronically.

      C.      Who else may see and use your health information




                                                               Parent/Guardian Initials__________
     Other persons and organizations outside of St. Christopher’s Hospital for Children
     may see and use your health information during this research study. These
     include:
           Governmental entities that have the right to see or review your health
            information, such as the Office of Human Research Protections and the
            Food and Drug Administration
            [List the following only if applicable]
           Doctors and staff at the hospital where this research study will take place.
           Doctors and staff at other places that are participating in the research
            study.
           The sponsor of this research study and persons that the sponsor may hire
            to work on the research study. The name of the sponsor is
            ________________________.
           A data safety monitoring board.
           The contract research organization that is helping the sponsor manage this
            research study. The name of the organization is __________
            ____________________________.
           The research data management organization that is analyzing data
            collected during this research study. The name of the organization is
            ___________________.
             [Any other outside entity with whom health information will be shared]

     If your health information is given to someone not required by law to keep it
     confidential, then that information may no longer be protected, and may be used
     or given out without your permission.

D.   Why your health information will be used and given out
     Your health information will be used and given out to carry out the research study
     and to evaluate the results of the study. Your health information will also be
     used so the sponsor may receive FDA approval for a new product or drug
     resulting from this research study.
                                           AND/ OR
     Your information may also be used to meet the reporting requirements of
     governmental agencies. [If this is an FDA study, add one or both of the above
     statements, if applicable]

E.   If you do not want to give authorization to use your health information
     You do not have to give your authorization to use or give out your health
     information. However, if you do not give authorization, you cannot participate in
     this research study.

F.   How to cancel your authorization
     At any time you may cancel your authorization to allow your health information
     to be used or given out by sending a written notice to the Office of Regulatory
     Research Compliance, 1601 Cherry Street, 3 Parkway Bldg., Mail Stop 10-444,


                                                  Parent/Guardian Initials__________
     Philadelphia, Pennsylvania, 19102. If you leave this research study, no new
     health information about you will be gathered after you leave. However,
     information gathered before that date may be used or given out if it is needed for
     the research study or any follow-up.

G.   When your authorization ends
     Your authorization to use and give out health information will continue until you
     withdraw or cancel your authorization.
                                              OR
     Your authorization to use and give out your health information will end when the
     research study is finished. [If authorization will terminate at end of study, insert
     following instead]

     After the research study is finished, your health information will be maintained in
     a research database. Drexel University College of Medicine or Drexel
     University (use whichever is appropriate) shall not re-use or re-disclose the
     health information in this database for other purposes unless you give written
     authorization to do so. However, the Drexel University College of Medicine
     Institutional Review Board may permit other researchers to see and use your
     health information under adequate privacy safeguards. [Insert this paragraph if
     research database will be maintained after the study is completed]


H.   Your right to inspect your medical and research records
     You have the right to look at your medical records at any time during this
     research study. However, the investigator does not have to release research
     information to you if it is not part of your medical record.

                                            OR

     You will not be able to look at your research records while you are taking part in
     this research study. Your personal information will be made available in an
     emergency if doctors need this information to treat you. You can have access to
     your medical record and any research study information when the study is over.
     However, the investigator does not have to release research information to you if
     it is not part of your medical record. [Use this paragraph for blinded or other
     studies where access will be denied.]


     NOTE: In some cases, the IRB may require “Confidentiality Certification” from
     the National Institute of Health. The Office of Regulatory Research Compliance
     will provide you guidance to obtain such certification. Certifications are provided
     by the NIH only after IRB has approved your protocol. WIRB will add the
     following to the consent form when proof of the Certificate has been submitted.




                                                   Parent/Guardian Initials__________
         Information about a Certificate of Confidentiality for this research
         _____________ (name of research site and investigator) has received a Certificate
         of Confidentiality from the government which will help protect the privacy of
         research subjects. The certificate protects against the involuntary release of
         information about subjects collected during the course of this research. The
         researchers involved in this study cannot be forced to disclose any information
         collected in this study in any legal proceedings. However, the subject may choose
         to voluntarily disclose the protected information and this certificate do not
         prohibit such voluntary disclosure. Furthermore, the parties listed in the
         Confidentiality/Authorization section of this consent form may review our records
         under limited circumstances and this certificate does not prohibit such disclosure.

I.       Information about Genetic Information Nondiscrimination Act (GINA)
         A new Federal law, called the Genetic Information Nondiscrimination Act
         (GINA), generally makes it illegal for health insurance companies, group health
         plans, and most employers to discriminate against you based on your genetic
         information. This law generally will protect you in the following ways:
        Health insurance companies and group health plans may not request your genetic
         information that we get from this research study.
        Health insurance companies and group health plans may not use your genetic
         information when making decisions regarding your eligibility or premiums.
        Employers with 15 or more employees may not use your genetic information that
         we get from this research study when making a decision to hire, promote, or fire
         you or when setting the terms of your employment.

     However, GINA will not protect you if you already have a genetic disease or disorder
     and does not prohibit discrimination on the basis of an existing genetic disease or
     disorder. In addition, this new Federal law does not protect you against genetic
     discrimination by companies that sell life insurance, disability insurance, or long-term
     care insurance.

     The GINA language section above must be included in your consent form if the
     research proposal involves any genetic evaluation of human tissue samples. If the
     proposal does not involve genetic analysis, this section may be omitted from the
     consent form.

J. WWW. CLINICALTRIALS.GOV
   A description of this clinical trial will be available on http://www.clinicaltrials.gov ,
   as required by U.S. Law. This web site will not include information that can identify
   you. At most, the Web site will include a summary of the results. You can search
   this Web site at any time.

     FDA regulations require that the consent form include disclosure that clinical trial
     information collected as part of the study will be entered into the clinical trials.gov
     databank. Therefore, any study that needs to be registered in clinical trials.gov must


                                                       Parent/Guardian Initials__________
          include the above statement on the consent form. If you are not sure whether your
          consent form requires this disclosure, please contact the Office of Regulatory
          Research Compliance at (215) 255-7857.

20.   NEW INFORMATION
      If new information becomes known that will affect you or might change your decision to be
      in this study, you will be informed by the investigator.


21.   QUESTIONS
      If you have any questions about this study or your participation in this study, or if at any
      time you feel you have experienced a research-related injury or a reaction to the study
      medication, contact:
      Dr._______ at telephone no. (XXX) XXX-XXXX.

      If you have questions about your rights as a research subject, you may contact:

             Drexel University College of Medicine
             Office of Regulatory Research Compliance
             1601 Cherry Street, 3 Parkway Bldg.
             Mail Stop 10-444
             Philadelphia, PA 19102

      WIRB is a group of people who perform independent review of research.

      You may also contact the Office of Regulatory Research Compliance at 215-255-7857.

      Do not sign this consent form unless you have had a chance to ask questions and have
      received satisfactory answers to all of your questions.

      If you agree to participate in this study, you will receive a signed and dated copy of this
      consent form for your records.

ADD NEW SECTION: If your sponsor requests a section outlining inclusions and
exclusion criteria, include ONLY items of which the subject will have reasonable
knowledge.




                                                            Parent/Guardian Initials__________
22.    CONSENT

             I have been informed of the reasons for this study.
             I have had the study explained to me.
             I have had all of my questions answered to my satisfaction.
             I have carefully read this consent form, have initialed each page, and have
              received a signed copy.

I freely consent for my child to participate in this research study.

I authorize the use and disclosure of my child’s personal health information as explained in
this consent form.


_____________________________________________                              _______________
Subject or Legally Authorized Representative                               Date

_____________________________________________                            _______________
Father’s signature                                                       Date
(Signature from the child’s father is required for research involving pregnant women, human
fetus and neonates. For exceptions from obtaining the father’s signature, contact Office of
Regulatory Research Compliance).


CONSENT SIGNATURE:
Standard Signatures

List of Individuals Authorized to Obtain Consent/Permission, as specified on the protocol or by
the IRB.


Name                  Title                 Day Phone #            24 Hr Phone #




ONLY THOSE INDIVIDUALS NAMED HERE MAY CONDUCT THE CONSENT
PROCESS AND SIGN THE CONSENT FORM.




                                                           Parent/Guardian Initials__________

				
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