Adolescent Online Research Consent by ksy58133

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									                                                                     Institutional Review Board
Guidelines for the Research Consent Form                              205 W. Touhy, Suite 203
                                                                    Park Ridge, IL 60068-4202
                                                                        Voice: 847.384.3534
Rev. 12/15/05                                                             Fax: 847.384.3537
                                                               E-Mail: IRBMail@AdvocateHealth.com

  NOTE:          While the IRB does not need to approve a protocol‟s PHI Authorization, a copy must
                 be on file with the IRB.

                 The authorization should be treated as a SEPARATE FORM requiring patient
                 signature rather than integrated into the consent document.

                 An Advocate approved template is available from the IRB or on Advocate Online.

  The informed consent document reinforces the discussion between the Investigator, or designated
  staff as listed in the protocol submission to the IRB, and the potential research participant. Informed
  consent demonstrates the principle of respect for persons as set forth in the Belmont Report. The
  FDA and DHHS require documentation of informed consent. The Advocate Health Care
  Institutional Review Board‟s (AHCIRB) standard format requires inclusion of all the headings listed
  below. A blank form with headers only follows the Guidelines, Sample form and Checklist. Note
  that it is likely appropriate for you to reword some parts of the actual consent form. A survey
  research project or a prospective, non-therapeutic data collection effort will require very different
  risks, benefits, alternative therapies, etc. sections than will a Phase II chemotherapy trial. In some
  cases such as surveys, a simple statement atop the first page of the questionnaire may suffice.
  Additional information and samples are available on request.

  Prepare the consent form in the second person (you) and in lay language. The signature page and
  the subject‟s Bill of Rights (see below) are in the first person (I). If medical terminology is used, a
  short description should follow in parentheses, eg, intravenous (into a vein); ECG (heart tracings).

  Generally if you are doing „cut & paste‟ from a sponsor‟s protocol sample consent, start with our
  template and paste into it rather than vice versa. This should help ensure no missing sections and
  should make obvious shortcomings in the sponsor version (eg. total omission of a Costs section as
  many sponsors feel that drug and patient visit expenses are covered in the contract so the researcher
  understands them and therefore, the topic does not need to be referenced in the consent – wrong!).

  Forward a copy of the consent document in Word format as an e-mail attachment (along with any
  ads, announcements, recruiting brochures, etc.) to IRBMail@advocatehealth.com. In the e-mail
  clearly indicate the principal investigator and the title of the study.

  Reminder: All patient materials (ads, brochures, explanatory pamphlets, web sites, etc.) are to be
  included as part of the paper AND the electronic submission. All materials are to be IRB stamped
  as approved before they are used.

  General Format
  Use Times New Roman (preferred), Arial or Tahoma typeface with a font size of 12..
Leave 2 spaces after the period ending a sentence.

Use bulleted text whenever possible to enumerate lists rather than sentence structured text.

All margins should be .9 inches and the footer should be .5 inches. If a local practice‟s name and/or
address is to appear in a banner at the top, it should be placed first, before any text.

Do not use Advocate Health Care letterhead or its logo but you may use a local practice name (eg,
XYZ Headache Clinic with a phone number and address).

Header and footer fonts should be size 10. The footer will always have AHCIRB Protocol # on the
left hand edge and a “Page x of y” in the center or at the right margin. The IRB staff enters the last
IRB consent approval date when the final version is printed. Individual sites may have their own
preferences for other header/footer information (eg, patient initials, sponsor amendment numbers,
sponsor consent versions, etc).

Major section headers should be left justified (not centered or underlined) capitalized and bolded,
(eg, PROCEDURES). Do not use custom style sheets for headers or subsections. The entire
document should be in a single Word style – usually either Normal or Body Text. Do not use
Header Style, TOC Style, Footer Style, etc. and other Word features as these are very time
consuming to maintain consistently when changes are required that alter spacing and pagination in
the materials.

Underlines, italics and bolded materials in the body of the document should be used sparingly. Use
single line spacing throughout and insert an extra carriage return when white space is needed (eg.
between signature lines).

It is generally easier to put columnar formatted text into a table than to use multiple different tab
settings throughout a document. The tables gridlines can be switched off to leave a consistently
formatted, plain text appearance.

If the patient office visit or procedure/testing schedule is long or complex, it is a good idea to
provide a calendar in a tabular format. Such a calendar could also be used to indicate sponsor
covered costs vs. costs for which the patient/insurer are responsible.

In general, do NOT use statements such as “You should understand...” or, “You understand that...”.
You cannot assert what a subject does or does not understand. Use phrasing such as “You should
read this document carefully and ask any questions necessary to help you reach a decision.”

Consent forms that differ significantly from these guidelines consume an unreasonable amount of
staff editing time and slow the IRB approval process for all users. Non-conforming consent
documents will be returned and IRB approval will be withheld until an appropriate form is
submitted.




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Heading and Title

Begin with:
    CONSENT TO PARTICIPATE IN A RESEARCH STUDY as a document heading
    the title of the research study set off with TITLE: as the line header
    the PRINCIPAL INVESTIGATOR: as a line header; per NIH, there may be only a single
       PI
    optionally, list the CO-INVESTIGATOR(S)
    if there is a SPONSOR:, set it in the same style as the title and investigator information. A
       sponsor is the originator of the protocol or provides financial support for the project – if any
       entity beyond the local investigators, the AHCIRB or appropriate governmental entities (eg,
       the FDA, OHRP, etc.) have access to the data or results, they are a sponsor

Optional – STATEMENT OF RESEARCH PRINCIPLES or BACKGROUND, as some sites
prefer, summarizes in general terms the purpose of a consent form, the nature of clinical trials, etc.

Prior to the Purpose, if the consent may be read by a parent and/or a child, insert the following after
Sponsor and before the main text begins.

         Note: If you are the parent or legal guardian of a child who may take part in this study,
                  permission from you and the assent (agreement) if your child is capable, may be
                  required. When the words “you” or “your” appear in this consent form, they refer to
                  the patient whether that is yourself or your child.
-------------------

PURPOSE OR INTRODUCTION

Include:
          a statement that the study involves research
          an explanation of research purpose(s); ideally, a statement beginning with, “You are
               being invited to participate because….”
          the total number of subjects expected to participate
          the expected length of participation
          a statement of AHCIRB approval and continued oversight according to Federal law –
               use the exact language provided below

This study has been reviewed, approved and will be monitored according to Federal law by the
Institutional Review Board of Advocate Health Care, 205 W. Touhy Ave., Park Ridge, IL 60068-
4202.

PROCEDURES

Include:
     step-by-step description of all study procedures, tests, office visits, expectations



                                                                                                         3
     description of possible differential group assignments, if relevant; if randomization is to be
      employed, define the likelihood of assignment to any given treatment and explain „random‟
      as, for example, „like the flip of a coin.‟
    identification of procedures, drug(s) or devices that are experimental
   Note: Identify if an approved drug or device is being used in an as yet unapproved indication.

   If there is a brand name drug employed in the study, the first reference to it, not counting the
   title, in the description should employ the brand name and indicate the generic name in
   parentheses. All future references should be to the generic name. The intent is to avoid having
   the consent form appear to advocate a specific company‟s formulation. If the sponsor is
   supplying a specific brand name drug free of charge, the brand name can be used again in the
   Costs section explaining this to the subject.

Hints:
    If blood will be drawn, identify the amount in common terms, eg, 5cc (approximately
       1 teaspoon).
    Include special directions, such as when study medication is to be taken.
    Include the expected duration of required tests, visits, follow up contacts and/or
       questionnaires.
    Include the amount, method and schedule of payments if the participant is to receive
       reimbursement or payment for participation.
    Describe if applicable the schedule for pro rated reimbursement in case of withdrawal or
       early termination.
    If a graphic is to be used, a table with gridlines omitted may help your formatting; an
       example follows under Risks.

RISKS
    The consent must disclose the potential risks to the subject. The primary risk will often be
     the danger that the subject‟s confidentiality will be breached (if the sample has a linked
     identifier) due to ongoing reference to the sample. The sample may also be subject to legal
     process for uses such as DNA identifications of paternity. Furthermore, subsequent research
     (such as DNA studies) may reveal hidden conditions that the subject may or may not wish to
     know about.
    Describe reasonably foreseeable risks and discomforts in lay terms.

Hints:
    If the research includes standard of care drugs, device use or procedures, the risks associated
       with the use of these procedures must be included.
    Risks are not only physical – psychological risks and the potential loss of confidentiality
       should also be considered.
    If there is a placebo group, identify any risks to a participant if he/she is taken off currently
       prescribed medications.
    Disclose risks to the unborn fetus/embryo or other unforeseen risks.
    If there are reproductive risks for females or a fetus, include the relevance to males (eg.
       „unknown possibility of sperm damage – therefore males should also avoid fathering a child
       while participating in this study.‟

                                                                                                       4
   Explicitly comment if reproductive cautions should extend beyond the immediate end of the
    patient‟s participation in the trial.
   Present in a tabular format similar to that shown on the following page risks and side effects
    associated with individual procedures or medications to be employed in the research. Alter
    column headings to suit the available data and to clearly delineate the likelihood and
    seriousness of the risk. Keep language accessible to subjects by using an eighth grade
    reading level.




                                                                                                 5
   Example of using a table for a graphic display.

                                                           Randomize
                                                                           Erythropoietin
                                                                            (Medication)
                                            Anemia
                     Peg-IFN/RBV
 Untreated           (Medication                                             Reduce the
Individuals              for                                               ribavirin dose
                    hepatitis C)
                                                                                G-CSF
                                          Low white                         (medication)
                                            blood
                                         cell count                          Reduce the
                                                                             interferon
                                                                                dose


   Sample risk outline tables are shown below and on the following page.



            Key for Tables of Chemotherapy Medicines and Their Side Effects

                                                  Approximate Chance of Occurrence
                                                           per 100 cases
                                               Common       Occasional          Rare
Commonly Observed Timing of
                                               21 – 100           5 - 20        1-4
        Occurrences
Immediate Within 1-2 days
Prompt     Within 2-3 weeks (prior to
           next course
Delayed    Any time later during
           therapy
Late       Any time after completion
           of therapy


Many of the cooperative cancer groups have adopted the schema above.




                                                                                          6
        Alternative Sample Descriptions - Possible Side Effects and Risks of the Procedures and Drugs to be Used in this Research

                                             Minor Side                      More serious,                   Serious or possibly
Drug or Procedure Name 1                      Effects                         temporary                          long- term


            Common
   Happens to 21 – 100 patients
        Out of every 100

          Occasional
    Happens to 5 – 20 patients
        Out of every 100

              Rare
  Happens to less than 5 patients
       Out of every 100



                                     Rapidly Developing       Rapidly Developing          Longer term              Longer Term
Drug or Procedure Name 2                   Minor               Possibly Serious             Minor                 Possibly Serious

            Common
   Happens to 21 – 100 patients
        Out of every 100

          Occasional
    Happens to 5 – 20 patients
        Out of every 100

              Rare
  Happens to less than 5 patients
       Out of every 100
BENEFITS

         The first sentence should explicitly assert that no direct benefit can be guaranteed by participation
         in the study. Describe any potential benefits to the participant or others.
Hints:
            If there is no anticipated benefit to the individual, this should be stated.
            Give no guarantees or assurances.
            Reduced cost access to drugs or therapies are NOT to be treated as a Benefit nor referenced in
                  this section.

ALTERNATIVE THERAPY

            Disclose alternative treatments and procedures, if any, that are available to the participant. If
             the participant could receive the identical care without data collection, this should be stated.
            If the project requires only data collection along with standard care, state something like, “This
             is a non-therapeutic study which will involve collecting data {surveys, etc}. Your care will not
             be altered by participating in this study.”

COSTS

            Cost responsibilities should be clearly stated. If participation will result in additional costs to
             the participant, the costs and amount(s) are to be identified.

            Expenses covered by a sponsor, or drugs/procedures/check-ups etc. that will be provided at no
             cost, should be identified.
                 Example: “Research related costs, such as office visits, study related tests, and study
                 medication will be provided at no cost to you. These costs will be covered by the study
                 sponsor.”

            If there is partial coverage of costs, costs that are the participant‟s responsibility should be
             described:
         Example: “The study drug will be provided at no charge. You and/or your insurance company are
         responsible for all other costs related to your medical care.”

         Example: “Drug {or procedure} XYZ will be provided {performed at no cost to you} by the study
         sponsor. You and/or your insurance carrier will be responsible for the charges related to its
         administration; the {OTHER DRUGS USED IN THIS STUDY} will also be your/your insurer‟s
         responsibility.”

         Example: “You will also be charged for any associated professional fees, laboratory, radiology, or
         hospital charges connected with receiving the treatments involved in this research study. These
         costs may or may not be covered by your carrier. Similar costs might also be incurred if you were
         to have chemotherapy treatment not related to this research study. Medication may be prescribed
         to control side effects that could result in added costs to your care. You should verify with your
         insurance carrier what costs will or will not be covered by your insurance."

            If participant is responsible for all costs, this should be clearly stated.
       Example: “You and/or your insurance company are responsible for all costs related to your care in
       this research study. The cost of the experimental device is expected to be $800.”

CONFIDENTIALITY

          The researcher is to disclose the efforts that will be made to protect the privacy and
           confidentiality of subject identity and records in relation to the tissue sample(s), and is to state
           to whom access to this information will be granted (including access required by law or legal
           process.)
          Describe the extent to which confidentiality or records identifying the subject as a research
           participant will be maintained.
          This confidentiality statement is not a substitute for obtaining an explicit HIPAA authorization
           from the patient. It is advisable to maintain the HIPAA statement as a separate document
           which can be signed by a potential participant before they are given the consent form. An
           Advocate statement that requires minimal customization (title, PI name, etc.) is available or
           individual sponsors may supply their own. The IRB does not need to approve a HIPAA form
           but a copy must be on file for all protocols.

RESEARCH RELATED INJURY

          For research involving more than minimal risk, the appropriate compensation statement must
           be included. This statement informs the participant about medical treatment in the event of a
           research-related injury.
          A statement must be included that none of the subject‟s legal rights have been waived by
           signing the informed consent document.
          Neither Advocate nor the local site assume any liability.

“In the event of a research-related injury, compensation is not available from Advocate Health Care nor
from XYZ Headache Clinic for injury or any associated costs. You do not waive any of your legal rights
by signing this form.”

QUESTIONS

          Include names and telephone numbers of contact persons for:
               1. Questions regarding the research or in the event of a research-related injury (the
                  principal investigator.
               2. Questions regarding research subjects‟ rights (the Chairman of the Institutional Review
                  Board – 847.384.3534).

VOLUNTARY PARTICIPATION/WITHDRAWAL

       Include:
        a statement that participation is voluntary and that non-participation will not affect medical
           care in any way
        a statement that participant may withdraw at any time without penalty or prejudice
        the procedures, if any, for safe withdrawal
AHCIRB #xxxx                                                                                Page 10 of 29
App‟d: yyyy
          a statement that the participant will be informed of any significant new findings that may affect
           participation
          outline the circumstances under which the subject may be withdrawn by the investigator
          note if the trial may be discontinued early by a sponsor or the investigator
          an outline of what will be requested of the subjects if they are terminated from the trial; will
           medical follow-up or phone contacts/visits be recommended?

RESEARCHER CONFLICT OF INTEREST DISCLOSURE STATEMENT
(include or modify as appropriate, based on the disclosure form submitted as part of the protocol)

Sample paragraphs – combine and/or modify as appropriate:

      “The (sponsor/manufacturer) (will give/has given) the doctor(s) and/or study [staff money or other
       benefits] [which? Explain if benefits] for [personal or professional] use.”

      “None of the doctors asking you to participate in this research study have received or will receive
       money or other benefits for personal use from the study (sponsor/drug device manufacturer).
       However, the (sponsor/manufacturer) will give money or other benefits [which? Explain if benefits]
       to a [choose appropriate] research foundation, educational program, or other organization with which
       the doctor(s) or study staff is associated.”

      “Money or equipment will be given to a [choose or specify] research fund, foundation, educational
       program,                                                                                       or
       other organization with which the doctor(s) or study staff are associated.”

      “None of the doctors asking you to participate in this research study have received or will receive
       money or other benefits for personal use from the study (sponsor/drug device manufacturer).
       However, the (sponsor/manufacturer) will give money or other benefits [which? Explain if benefits]
       to a [choose appropriate] research foundation, educational program, or other organization with which
       the doctor(s) or study staff is associated.”

      “The doctors or study staff requesting your participation in this research will receive cash payments
       or other benefits based on the number of subjects who participate.”

      “The doctor(s) and/or study staff asking you to participate in this research study have personal,
       financial, or professional interests in the (device/drug/procedure/sponsoring company/manufacturer)
       involved in the study.”

      “None of the doctors, study staff, programs, or affiliated institutions involved with this research will
       receive money or benefits of any type from the (study sponsor/drug:device manufacturer).”

If the opening statement asserts that investigators will receive any benefit at all, then the paragraph should
end with:
        You may ask any questions necessary to assure yourself that these interests have not overly
        influenced the doctors‟ request for you to take part in this study. The decision whether to enroll in
        the study is yours alone. To assist with your decision, you may also want to consult with your
AHCIRB #xxxx                                                                                Page 11 of 29
App‟d: yyyy
        personal physician or a physician not affiliated with this study. You should have all the information
        you need to be comfortable with your decision.

RESEARCH SUBJECT’S BILL OF RIGHTS
     (include with modification only to number 8 as appropriate to include sponsor(s) if needed, using
     either the Parent/Minor or the patient as sole participant version)

CONSENT AND/OR ASSENT STATEMENT(S)                       (with signature spaces on a single page)

           Include a statement of the subject‟s acknowledgment of explanation of the study procedures,
            risks, discomforts, and the opportunity to have asked questions. A statement must be made
            that the participant will receive copy of signed consent form.

Participant Signature and Date

Hint:
           If participant is a minor, a separate assent form is required.

Investigator’s Statement

           Include the AHCIRB standard certification that the Investigator or appropriate designee has
            explained the study to the participant.

Research Representative Signature and Date

           Provide a space for a Representative, as designated in the protocol, to print name and title
            beneath signature.

Witness Signature and Date

           Not required by regulation but recommended - provide a space for Witness to print name
            beneath signature. For no-therapeutic or very low risk studies, you should probably omit the
            witness entry.




AHCIRB #xxxx                                                                                Page 12 of 29
App‟d: yyyy
Guidelines for Research Involving Tissue Banking – if relevant, frequently optional in a study

Research involving the collection and storage of tissue samples for potential use in future studies involves
a number of potential issues of concern for subjects. These must be addressed in the consent form. These
include: risks of breaches of confidentiality, the disclosure or failure to disclose subsequently identified
conditions to subjects and/or their families, and the possibility of commercial exploitation of the tissue
bank samples.

In order to obtain informed consent for this type of research, the consent form should include information
within the following guidelines:

Procedure
The procedure section of the consent form should provide answers to the following
questions (as they may apply):

       1.      Who operates the tissue repository?

       2.      What is the name and contact information for the IRB that supervises the operations of the
               tissue repository? (OHRP recommends that repositories be supervised by IRBs reviewing
               both the initial research under which the samples were acquired as well as subsequent
               research using the tissue)?

       3.      Are samples maintained anonymously or with linked identifiers?

       4.      Are subsequent research uses subject to review by the subject?

       5.      What happens if the subject wishes to withdraw his/her samples?

       6.      Will the subject be informed if subsequent research reveals a hidden or previously
               undetected condition?

       7.      Will the repository be operated for profit?


Elaboration of the issues to be addressed when requesting samples for tissue/specimen repository (bank):


General Concerns:
      Is it necessary to agree to the specimen retention in order to be in the trial? You should clearly
      differentiate specimens that are collected for central laboratory testing to ensure patient safety
      during the trial or used as an outcome marker in the current trial. These uses are properly part of
      the current trial and do not require extra signatures. Tissue that will be used in future research
      efforts are to be addressed in response to the questions below.

       A statement should be included concerning possible financial benefit derived in the future from
       unspecified research (usually states that such is possible but there are no plans to share
       with patients).
AHCIRB #xxxx                                                                              Page 13 of 29
App‟d: yyyy
       Is there a controlling IRB in charge of the repository?

       Is the tissue to be employed only for studies relating to the patient‟s current condition – that which
       makes him/her a suitable subject in the current trial?

Primary Issue: Is the sample(s) ID linked to the patient?

       If No - - simply state for what purposes the sample will be employed and then permit
               Yes/No with patient signature

       If Yes - can data/ results get back to the patient‟s MD or medical record? What confidentiality
                safeguards are there in place?

               - is the research limited to the condition(s) evaluated in the current trial?

               - will there be any genetic testing done?

               - will the sample(s) be sold/shared in any way?

               - will patient be contacted in the future to approve specific uses?

               - can the specimen be withdrawn and if so, how? Provide contact information?

Consents for Tissue/Specimen Use

          Each use of the subject‟s tissue sample should be identified with a separate consent statement.
           At a minimum, the consent form should include a series of bulleted check-offs (in an
           “agree/disagree” format) authorizing:
            the use of tissue in current research
            use of the tissue in other related or unrelated research (though it is preferred that subjects
               be presented the option of being contacted for consent prior to tissue use for subsequent
               research)
            If notice of subsequently discovered conditions is to be offered, a decision as to whether or
               not that information is to be revealed to the subject (and/or the subject‟s family)

All signatures should be at the end of the consent form along with the signature indicating overall consent
to participate. Do not place check boxes and initial/signature lines in the body of the text. Subjects
cannot agree to tissue harvest, etc. without having first signed on to the trial itself.




AHCIRB #xxxx                                                                                   Page 14 of 29
App‟d: yyyy
                 SAMPLE – mandatory text, when the content is applicable, is highlighted

                      CONSENT TO PARTICIPATE IN A RESEARCH STUDY

TITLE:                 A Randomized, Double-Blind Study to Compare the Efficacy and Safety of an
                       Investigational Drug, A Placebo and a Currently Marketed Drug

PRINCIPAL INVESTIGATOR:                John Doe, MD

SPONSOR:               XXX Pharmaceuticals, Inc.


PURPOSE OF THE STUDY
You are being invited to participate in this research study because you have been diagnosed with XXXX.
The purpose of this study is to evaluate the safety and efficacy of__________________________(the
investigational drug XZY) as compared to the current medication in the treatment of
(disease name).

Approximately 600 patients who have_____________________ (specify condition) will be enrolled in this
study nationally with 10 – 15 expected to be enrolled from this institution. Your participation is expected to
last for approximately eighteen months.

This study has been reviewed, approved, and will be monitored according to Federal law by the Institutional
Review Board of Advocate Health Care, 205 W. Touhy Ave., Park Ridge, IL 60068-4202.

PROCEDURES
Before starting this study, you will be evaluated by your physician to make sure you qualify for this study.
This evaluation will include the taking of a medical history and a review of your hospital records. You will
also have blood and urine tests. The blood tests will require that about three teaspoons of blood be taken
from you.

If it is decided that you are eligible to participate in this study, you will be randomly assigned (that is,
assigned by chance, like the flip of a coin) to one of three groups. Neither your physician nor you will know
to which group you have been assigned. However, this information will be available in the event of an
emergency.

You will take the study medication twice a day with a meal. You will return to the clinic after 1, 2, 3, 4, 6,
and 12 weeks, and then once every three months thereafter for the rest the study. At each visit, you will
undergo a check-up, blood tests (which will require about three teaspoons of blood be drawn each time), and
a urine analysis. At each visit, you will receive more study medication.

There may be times when you might be asked to return for additional blood tests or other diagnostic tests
(such as x-rays). In addition, you will keep a daily journal about your health. You will be mailed a
questionnaire every six weeks with questions about how you are doing, which you will be asked to complete
and return.

AHCIRB #xxxx                                                                                Page 15 of 29
App‟d: yyyy
During the course of the study, your medication may be changed, interrupted or discontinued. Your study
physician will tell you if there are any changes in your therapy or visit schedules.

RISKS
All drugs have the potential to cause some side effects or other reactions. However, all reasonable
precautions will be taken to reduce these risks during the study. The most common adverse effects reported
with _________________(name of drug) include: stomach upset, nausea, diarrhea, stomach and intestinal
bleeding, and ulceration. Other less common side effects include: headache and/or body ache, ringing in the
ears, vertigo (dizziness), and hives.

Potential side effects reported include bleeding from tissues and organs (which, in rare circumstances, could
be fatal). Other infrequent side effects include: hair loss, skin rash, skin inflammation, fever, nausea,
diarrhea, stomach cramping, liver problems including jaundice, allergic reactions such as skin rash, shortness
of breath and (rarely) death.

The risks associated with blood drawing may include: bleeding, bruising, and discomfort or infection at the
site of the needle stick.

** Note: Describe any risks which may occur if taken off current medications by assignment to a placebo
group.

** If appropriate: Describe any unforeseeable risks and any known risks to an unborn fetus/embryo. State
whether the participant must agree to practice birth control during the course of the study and notify the
investigator if she becomes pregnant.

BENEFITS
No direct benefits can be guaranteed by your participation in this research study. However, you may benefit
by having the symptoms of your disease reduced. Information gained from this study may help other people
in the future.

ALTERNATIVE THERAPY
The alternative to participating in this study is to receive ________________(X, Y, Z) and receive the
standard care for my condition. Your doctor should discuss these alternatives with you.

COSTS
Research related costs, such as office visits, blood and urine tests, and study medication will be provided at
no cost to you. The study sponsor will cover these costs.

**Note: If some costs are the participant’s responsibility, a statement should be included identifying such
costs as the participant’s and/or his/her insurance carrier's responsibility.

Expenses for your ongoing health care remain your/your insurance carrier‟s responsibility.

COMPENSATION
There is no compensation for participating in this study. Parking expenses for which you have receipts will
be reimbursed.

AHCIRB #xxxx                                                                                 Page 16 of 29
App‟d: yyyy
CONFIDENTIALITY                 (some sponsors may add phrasing related to foreign agencies)
Your identity in this study will be kept confidential. Results of this study may be published, or presented at
scientific meetings, but your identity will not be disclosed. Your name or any material identifying you as a
participant will not be released without written permission except on the occasion that such release is
required by law. You agree that your medical records related to this study may be inspected by the Food and
Drug Administration (FDA) or other appropriate governmental oversight agencies as required by law and/or
authorized representatives of XXX Pharmaceuticals, Inc., and representatives of the Advocate Health Care
Institutional Review Board (IRB).

RESEARCH RELATED INJURY
If you are injured as a direct result of taking part in this study, emergency medical treatment will be made
available.

** If clinical drug trial or device and sponsor company will pay for research related injury costs,
    medical treatment will be made available at no cost to the participant. These costs will be covered by
   the sponsor.

In the event of a research-related injury, compensation is not available from Advocate Health Care for injury
or any associated costs. You do not waive any of your legal rights by signing this form.

Further information can be obtained from _____________________(name of doctor and phone number),
who is prepared to advise you about medical treatment in case you believe you have been injured as a result
of this study.

In the event that you experience a research related injury, or if you have questions about the study, you may
contact: ___________________________(name of principal investigator, designated members of study
staff, and phone number[s]) at any time.

For information on your rights as a study subject, you may contact the Chairman of the Institutional Review
Board of Advocate Health Care at 847.384.3534.

VOLUNTARY PARTICIPATION/WITHDRAWAL
You are under no obligation to participate in this study. If you choose not to participate in this study, your
medical care will not be affected in any way.

You are free to withdraw from this study at any time by notifying ________________(name of principal
investigator). Your withdrawal will not affect your current or future medical care in any way. Your
physician may also withdraw you from this study at any time if he/she feels it is in your best interest. If you
are withdrawn from the study, or if you withdraw voluntarily, you may be asked to cooperate by having
whatever laboratory tests and/or examinations your doctor thinks are necessary.

You will be informed of any significant new developments that may arise or if any new information becomes
available during the course of this study that may influence your continued participation.

RESEARCHER CONFLICT OF INTEREST DISCLOSURE STATEMENT
The device manufacturer will give the doctors money for personal use. You may ask any questions necessary
to assure yourself that these interests have not overly influenced the doctors‟ request for you to take part in
AHCIRB #xxxx                                                                                  Page 17 of 29
App‟d: yyyy
this study. The decision whether to enroll in the study is yours alone. To assist with your decision, you may
also want to consult with your personal physician or a physician not affiliated with this study. You should
have all the information you need to be comfortable with your decision.




AHCIRB #xxxx                                                                               Page 18 of 29
App‟d: yyyy
                         RESEARCH SUBJECT’S BILL OF RIGHTS

The rights explained below are the rights of every person who is asked to be in a research study. As
a research participant I have the right:

1. to have the purpose of the study clearly explained; to learn what the study is attempting to find out;

2. to be told what choices for care I have and how they may differ from participating in the research
   study;

3. to be told what will happen to me and whether any of the procedures, drugs or devices used in the
   study will be different from the routine care I could expect;

4. to be told about any risks, side effects or discomforts that may occur that are due to my research
   participation and how these may differ from routine care;

5. to be told whether I can expect any personal benefit from participating in the research study and the
   likelihood of such a benefit;

6. to ask any questions I have before consenting to participate and throughout my time in the study;

7. to know what medical treatments are available to me and how they will be paid for, if any
   complications arise due to my participation in this study;

8. to have all records bearing any information that could identify me held in confidence by the
   researcher(s) and revealed as is required by law, only for review by appropriate governmental
   oversight authorities such as the Federal Food and Drug Administration. Authorized representatives
   of the Advocate Health Care Institutional Review Board and the study sponsor, XXX Pharmaceuticals,
   Inc., will have access to the research records for review and evaluation purposes and will hold my
   information confidential;

9. to be kept informed of any new medical or technical developments that may affect my condition or my
   willingness to participate in the research;

10. to refuse to participate or to withdraw from the study at any time without affecting my
    regular medical care;

11. to receive a copy of the complete consent form;

12. to be free of pressure while considering whether I wish to agree to be in this study.




AHCIRB #xxxx                                                                                Page 19 of 29
App‟d: yyyy
                                                CONSENT

By signing this form, I acknowledge that this study has been explained to me, including the procedures, and
potential risks and discomforts. I have read this consent form in its entirety and have spoken to the
investigator or his/her representative and have had all questions answered to my satisfaction. I will receive a
completed signed copy of this document. My signature indicates my agreement to voluntarily participate in
this study.



Signature of Patient                                          Date
(Legal Representative, when appropriate)


_______________________________________
Printed Name of Patient/Legal Representative

   If Signed by Legal Representative, describe the relationship to Patient:

       Patient‟s Name: _______________________________________

       Relationship of Signatory: _________________________________________________

       _______________________________________________________________________

Research Representative’s Statement
I have explained this research study to the subject and have answered any questions he/she had.



Signature of Research Representative                          Date

_________________________________________                     AHCIRB #xxxx
Printed Name and Title of Research Representative             Protocol Number

Witness Statement
I acknowledge that I witnessed the Research Representative named above discuss participation in this
research study with the subject, that the subject had opportunity to ask questions about the research, and the
subject agreed to participate in the research and signed to consent to that effect.



Witness Signature                                             Date

_______________________________________
Witness Name (Please print)
                            ASSENT OF CHILD/ADOLESCENT
AHCIRB #xxxx                                                                                Page 20 of 29
App‟d: yyyy
My parent(s) have signed this form giving permission for me to be in a research project. My doctors have
talked to me about what it will mean for me to be a research subject. My being in this research project
may help my doctors, and all doctors who take care of children with sicknesses like mine, to learn about
these sicknesses and how to treat them. My doctors will answer any questions I have about being in this
research project. I do not have to be in this research project in order for my doctors to treat my sickness.
I can ask to talk with my doctors if I want to stop being a part of this research at any time in the future.

By signing this form, I am saying that I want to be in this research project.


Signature of Child                                            Date


Printed Name of Child

Research Representative’s Statement
I have explained this research study to the subject and have answered any questions he/she had.


Signature of Research Representative                          Date


__________________________________________                    AHCIRB #xxxx
Printed Name & Title of Research Representative               Protocol Number

Witness Statement
I acknowledge that I witnessed the Research Representative named above discuss participation in this
research study with the subject, that the subject had the opportunity to ask questions about the research, and
the subject agreed to participate in the research and signed to consent to that effect.


Signature of Witness                                          Date

_______________________________________
Printed Name of Witness

By initialing in the following places, the parent/guardian and physician indicate their opinion that the child
cannot give consent/assent because he/she is:

____Too young at age ____              Initials Parent/Guardian _____      Initials Physician _____

____Too ill. Explanation below         Initials Parent/Guardian _____      Initials Physician _____

______________________________________________________________________


AHCIRB #xxxx                                                                               Page 21 of 29
App‟d: yyyy
                                    CONSENT FORM CHECKLIST

1.    Is the form written:
              a.     in the Second Person (“You”)?
              b.     clearly and in "lay" language?

2.    Are the Basic Elements of Informed Consent included?
      a.     Title of research study
      b.     Statement that the study involves research
      c.     Explanation of research purpose(s), including total number of subjects and number
             expected to be recruited locally
      d.     Description of research procedures
      e.     Expected duration of subjects' participation
      f.     Description of procedures, and identification of procedures that are experimental
      g.     Description of any reasonably foreseeable risks or discomforts
      h.     Description of benefits to the subject and to others
      i.     A disclosure of alternative procedures or treatments, if any, that might be available to the
             subject
      j.     Statement describing the extent, if any, to which confidentiality of records identifying the
             subject will be maintained with specific reference to the sponsor, if any
      k.     For research involving more than minimal risk, the appropriate compensation statement
      l.     Names and numbers of contact persons for questions regarding the research, a research
             related injury, and rights as a research subject
      m.     A statement that participation is voluntary and refusal to participate, or withdrawal from
             study will involve no penalty or loss of benefits
      n.     A researcher Conflict of Interest disclosure statement as appropriate
      o.     A verbatim copy of the Research Subject’s Bill of Rights with sponsor name added if
             needed

3.    Are cost responsibilities clearly stated, and, if the research study will result in additional costs, are
      these costs identified?

4.    Is the form free of any language that suggests the subject is made to waive any legal rights?

5.    If the study involves an investigative drug or device, or, if approved drugs or devices are used in
      an unapproved manner, are they identified as experimental?

6.    If subjects are to be reimbursed, is the amount and method of payment and the schedule of
      payments clearly stated? This statement should be in the Procedures section of the consent
      document.

7.    If the study includes children who may be able to participate in the decision, is there a
      statement of assent from the child and consent from the parents or guardian(s)?

8.    If blood is to be drawn, is the amount to be drawn, (e.g., tsp, tbsp), the number of times blood will
      be drawn, and the time intervals between draws stated, as well as the potential hazards of the
      procedure clearly explained?
AHCIRB #xxxx                                                                                Page 22 of 29
App‟d: yyyy
9.     Is AHCIRB specific language included and format followed?

Note: While the IRB does not need to approve a protocol‟s PHI Authorization, a copy must be on file
      with the IRB.

      Attach the “Authorization to Access Private Health Information” form or the “Request to Waive
      Authorization” application. These are the documentation / request necessary to be compliant with
      the Federal HIPAA regulations in effect as of 04/14/03.

      It is strongly recommended that the authorization be treated as a SEPARATE FORM requiring
      patient signature rather than integrated into the consent document.

      An Advocate approved template is available from the IRB office or on Advocate Online.

10.    E-mail the consent form and all other patient materials (ads, pamphlets, etc.) to
       IRBMail@AdvocateHealth.com           and reference the investigator‟s name and study title in
       the e-mail.




AHCIRB #xxxx                                                                             Page 23 of 29
App‟d: yyyy
                                           Template copy follows:



                      CONSENT TO PARTICIPATE IN A RESEARCH STUDY

TITLE:

PRINCIPAL INVESTIGATOR:

SUB-INVESTIGATORS:

SPONSOR:

INTRODUCTION or BACKGROUND{optional}
Sample….edit as appropriate
This consent form may contain words that you do not understand. Please ask the study doctor or the study
staff to explain any words or information that you do not clearly understand. This is a clinical trial (a type of
research study). Clinical trials include only patients who choose to take part. Before agreeing to participate
in this research study, it is important that you read and understand the following explanation of the proposed
procedures. This statement describes the purpose, procedures, benefits, risks, discomforts, and precautions
of the study. It also describes the alternative procedures that are available to you and your right to withdraw
from the study at any time. No guarantees or assurances can be made as to the results of the study.

This research involves the use of an investigational drug. An investigational drug is one that has not been
approved by the United States Food and Drug Administration (FDA).

Sample 2….edit as appropriate
Please read this consent form carefully before deciding whether you want your baby to participate in this
research study. Feel free to ask as many questions as you'd like before making your decision.

It is important that you carefully read the following explanation. It describes the purpose, procedures,
benefits, risks, and discomforts of the study and the precautions that will be taken. It also describes the
alternatives available and your right to withdraw your baby from the study at any time. You should
recognize that no guarantee or assurance can be made as to the results of the study. You should also be
assured that if your baby does not participate in this study, the neonatal intensive care unit (NICU)
medical and nursing staff will continue to treat your baby as they normally would.

PURPOSE OF THE STUDY
See samples above

This study has been reviewed, approved and will be monitored according to Federal law by the Institutional
Review Board of Advocate Health Care, 205 W. Touhy Ave., Park Ridge, IL 60068-4202.




AHCIRB #xxxx                                                                                  Page 24 of 29
App‟d: yyyy
PROCEDURES

See sample above


RISKS

See sample above


BENEFITS

See sample above

ALTERNATIVE THERAPY

See sample above

COSTS

See sample above

COMPENSATION

See sample above

CONFIDENTIALITY

See sample above


RESEARCH RELATED INJURY

See sample above

In the event of a research-related injury, compensation is not available from Advocate Health Care (nor from
Advocate ...some local site.....) for injury or any associated costs. You do not waive any of your legal rights
by signing this form.

QUESTIONS

See sample above

For information on your rights as a study subject, you may contact the Chairman of the Institutional Review
Board of Advocate Health Care at 847.384.3534.


AHCIRB #xxxx                                                                                Page 25 of 29
App‟d: yyyy
VOLUNTARY PARTICIPATION/WITHDRAWAL

See sample above

RESEARCHER CONFLICT OF INTEREST DISCLOSURE STATEMENT

See samples above




AHCIRB #xxxx                                           Page 26 of 29
App‟d: yyyy
                           RESEARCH SUBJECT’S BILL OF RIGHTS

The rights explained below are the rights of every person who is asked to be in a research study. As
a research participant I have the right:

1. to have the purpose of the study clearly explained; to learn what the study is attempting to find out;

2. to be told what choices for care I have and how they may differ from participating in the research
   study;

3. to be told what will happen to me and whether any of the procedures, drugs or devices used in the
   study will be different from the routine care I could expect;

4. to be told about any risks, side effects or discomforts that may occur that are due to my research
   participation and how these may differ from routine care;

5. to be told whether I can expect any personal benefit from participating in the research study and the
   likelihood of such a benefit;

6. to ask any questions I have before consenting to participate and throughout my time in the study;

7. to know what medical treatments are available to me and how they will be paid for, if any
   complications arise due to my participation in this study;

8. to have all records bearing any information that could identify me held in confidence by the
   researcher(s) and revealed only if necessary for review by appropriate governmental oversight
   authorities such as the Federal Food and Drug Administration, authorized representatives of the
   Advocate Health Care Institutional Review Board, and/or authorized representatives of the study
   sponsor, if any;

9. to be kept informed of any new medical or technical developments that may affect my condition or my
   willingness to participate in the research;

10. to refuse to participate or to withdraw from the study at any time without affecting my
    regular medical care;

11. to receive a copy of the complete consent form;

12. to be free of pressure while considering whether I wish to agree to be in this study.




AHCIRB #xxxx                                                                                Page 27 of 29
App‟d: yyyy
                                                CONSENT

By signing this form, I acknowledge that this study has been explained to me, including the procedures, and
potential risks and discomforts. I have read this consent form in its entirety and have spoken to the
investigator or his/her representative and have had all questions answered to my satisfaction. I will receive a
completed signed copy of this document. My signature indicates my agreement to voluntarily participate in
this study.



Signature of Patient                                          Date
(Legal Representative, when appropriate)


_______________________________________
Printed Name of Patient/Legal Representative

   If Signed by Legal Representative, describe the relationship to Patient:

       Patient‟s Name: _______________________________________

       Relationship of Signatory: _________________________________________________

       _______________________________________________________________________

Research Representative’s Statement
I have explained this research study to the subject and have answered any questions he/she had.



Signature of Research Representative                          Date

_________________________________________                     AHCIRB #xxxx
Printed Name and Title of Research Representative             Protocol Number

Witness Statement
I acknowledge that I witnessed the Research Representative named above discuss participation in this
research study with the subject, that the subject had opportunity to ask questions about the research, and the
subject agreed to participate in the research and signed to consent to that effect.



Witness Signature                                             Date

_______________________________________
Witness Name (Please print)

AHCIRB #xxxx                                                                                Page 28 of 29
App‟d: yyyy
                                  ASSENT OF CHILD/ADOLESCENT

My parent(s) have signed this form giving permission for me to be in a research project. My doctors have
talked to me about what it will mean for me to be a research subject. My being in this research project
may help my doctors, and all doctors who take care of children with sicknesses like mine, to learn about
these sicknesses and how to treat them. My doctors will answer any questions I have about being in this
research project. I do not have to be in this research project in order for my doctors to treat my sickness. I
can ask to talk with my doctors if I want to stop being a part of this research at any time in the future.

By signing this form, I am saying that I want to be in this research project.


Signature of Child                                            Date


Printed Name of Child

Research Representative’s Statement
I have explained this research study to the subject and have answered any questions he/she had.


Signature of Research Representative                          Date

_______________________________________                       AHCIRB #xxxx
Printed Name and Title of Research Representative             Protocol Number

Witness Statement
I acknowledge that I witnessed the Research Representative named above discuss participation in this
research study with the subject, that the subject had opportunity to ask questions about the research, and the
subject agreed to participate in the research and signed to consent to that effect.


Signature of Witness                                          Date

_______________________________________
Printed Name of Witness

By initialing in the following places, the parent/guardian and physician indicate their opinion that the child
cannot give consent/assent because he/she is:

____Too young at age ____              Initials Parent/Guardian _____      Initials Physician _____

____Too ill. Explanation below         Initials Parent/Guardian _____      Initials Physician _____

_____________________________________________________________________________________


AHCIRB #xxxx                                                                               Page 29 of 29
App‟d: yyyy

								
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