Procedure Consent Forms by sdr61652


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									                          Eastern University Institutional Review Board

                                     CONSENT FORMS

1. Do I need to get consent? Can I get a waiver from the consent requirements?

If you are using archived data, consent may not be necessary or even possible. Some data do not
meet the definition of “archived data”, but researchers may still seeks a waiver of consent
requirements. Only studies with a restricted set of conditions may use this option, and each
waiver request is separately reviewed and considered by EUIRB.

2. What if I want to give my subjects anonymity?

You should not use a written consent form. Instead you can use a consent script (e.g., phone
surveys) or a cover letter (e.g., mail surveys). These documents do the same basic job as a
written consent form does informing subjects about the study and their rights. The only
difference is that subjects do not sign their name.

3. Do I need to get consent if my project is exempt?

The requirement for some form of consent applies to ALL research, although most exempt
projects (particularly mail or phone surveys) can use a consent script or cover letter (for implied

4. What if I audio or video tape my subjects?

You will need to get a written consent. The consent procedure needs to specify WHEN the tapes
will be destroyed, WHERE they will be stored, and WHO will have access to the tapes. Use a
version of the WRITTEN CONSENT FORM.

5. What if I want to intentionally identify individuals in my research report (s) (i.e., quote
   individuals who you interviewed and gave their identities)?

Then you will be required to get their written consent.

6. What if my project is BIOMEDICAL in nature?

Use the sample for written consent forms and the BIOMEDICAL CONSENT FORM

7. What are the special consent considerations for children?

If a child is between the ages of 7 and 18, then you should seek consent both written parental and
child assent. The assent form language should be at about the same grade level as the child. If the
child is between the ages of 3 and 7, then you should use a VERBAL ASSENT, which is a

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                          Eastern University Institutional Review Board

consent script with language appropriate for the child’s age. A child younger than age 3 is
considered incapable of participating in the consent process. At all age levels, the final power of
consent is usually left to the parents or guardians.

8. Are there laws that affect the consent process?

In the course of your research, if you become aware that any specific individual is in imminent
danger of harming himself or others (i.e., due to acute depression) or is currently suffering
mental or physical abuse, or abusing another individual, you are required by Washington state
law to inform the appropriate authorities. If there is a reasonable chance that you may discover
such information about your subjects, you must tell them of this requirement when you ask for
their consent, because the law requires you to break confidentiality in these circumstances.
Contact IRB for more information on this topic, including specific language to be used.


The following samples are provided to help you compose your own consent procedure. Decide
which form of consent you will need, and then use the appropriate sample to make your own.
Place the specific information for your project in the appropriate places, as indicated. Once you
have written your own version, read it to make sure all the necessary information is there, that
there are no mistakes, spelling or grammatical errors, and that it is not ambiguous or otherwise
confusing. Below is the Bill of Rights that reflects the philosophy of informed consent and may
be included in your consent form.

                               SUBJECTS’S BILL OF RIGHTS

The rights below are the rights of every person who is asked to be in a study. In participating as a
human subject I have the following rights:

     1. To be told what the study is trying to find out;
     2. To be told what will happen to me and whether any of the procedures, drugs or devices
        are different from what would be used in standard practice;
     3. To be told about the frequent and/or important risks, side effects or discomforts of the
        things that will happen to me for research purpose;
     4. To be told if I can expect any benefit form participating, and, if so, what the benefits
        might be;
     5. To be told of the other choices I have and how they may be better or worse than being in
        the study;
     6. To be allowed to ask any questions concerning the study both before agreeing to be
        involved and during the course of the study;
     7. To be told what sort medical treatment is available if any complications arise;

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                         Eastern University Institutional Review Board

   8. To refuse to participate or to change my mind about participation after the study is started
       (This decision will not affect my right to receive the care I would receive if I were no in
       the study.);
   9. To receive a copy of the signed and dated consent form; and
   10. To be free of pressure when considering whether I wish to agree to be in the study.

                                 SAMPLE COVER LETTER

       Identify who is doing the study. Define the purpose of the study (see example).
       You are being asked to take part in the fifth periodic community-wide survey sponsored
          by the _________ Police Department. Your participation is very important to the
          department’s future plans for service. This series of surveys was designed by the
          ____________ P.D. as another step in its commitment to Community Oriented
          Policing. This commitment reflects three goals:

      First, to give our clients – taxpayers – an opportunity to identify problems in their own
       neighborhoods as well as citywide problems that might involve police services.

      Second, to suggest how much information citizens have about various services police

      Third, this survey will provide a yardstick against which to measure new programs and
       enhanced services that result form the information gained here.

   This is a request for completely voluntary participation, and your responses will remain
   totally anonymous – neither your name not any other identifying information will be asked or
   recorded. This survey is being conducted for _________ P.D. by ______. Your participation
   in this survey should take about ___ minutes. This study has been reviewed and approved by
   the Eastern University Institutional Review Board. If you have questions or concerns
   regarding this study you may contact the Chairperson of Institutional Review Board (IRB):
   Institutional Review Board
   Mailbox 859, McInnis,
   1300 Eagle Rd., Eastern University, St. Davids, PA 19087

                          SAMPLE VERBAL CONSENT SCRIPT

        Hello, my name is ____, and I am a graduate student with the Eastern University
Department of ____. I am collecting data for my research project on (brief description of the
project), and I’d like to ask you for your help by answering a few questions for me regarding
(describe topic of questions). Your participation in this survey should take about ___ minutes.
        These data will be strictly confidential and I will not record your name. Also, your
participation is completely voluntary. You are free to not answer any questions you may find
objectionable, and may withdraw from the study at any time without penalty, just by letting me

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                           Eastern University Institutional Review Board

know you would not like to continue any further. This research has been reviewed and approved
by the Eastern University office of the Institutional Review Board. If you have any questions or
concerns about this research project, you can contact the Chairperson of IRB at
       Are there any questions about my study that I can answer for you at this time? (answer
questions). Would you like to participate in my study?

                            SAMPLE WRITTEN CONSENT FORM

        Identify who is doing the study. Define the purpose of the study. The information in this
consent form is provided so that you can decide whether you wish to participate in this study. It
is important that you understand that your participation is completely voluntary. This means that
even if you agree to participate you are free to withdraw form the experiment at anytime, to
decline to participate in any portion of the study, without penalty.
        Define what the subjects will be asked to do. In addition, you will be videotaped while
you ______, so that we can observe you as you do the task. These videotapes will be viewed
only by project personnel, who will transcribe them, and then the tapes will be places in a locked
file cabinet in my office until the following date: _____, when they will be destroyed. During
this period only ___________ will have access to these tapes.
        This experiment poses no known risks to your health and your name will not be
associated with the findings. Your participation will take approximately ____ minutes. You will
receive $____ at the end of the session for your participation in this research project. Also, upon
completion of your participation in this study you will be provided with a brief explanation of the
question this study addresses. If you have any questions not addressed by this consent form,
please do not hesitate to ask. You will receive a copy of this form, which you should keep for
your records.

Thank you for your time.

Researcher’s Signature
(researcher’s name, office and phone number)

                                   CONSENT STATEMENT:

I have read the above comments and agree to participate in this experiment. I give my permission
to be videotaped, under the terms outlined above. I understand that if I have any questions or
concerns regarding this project I can contact the investigator at the above location or the Eastern
University Institutional Review Board at

________________________                     ____________
(participant’s signature)                    (date)

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                            Eastern University Institutional Review Board


Determine if the consent form is going to be written using first person (I) or second person (you).
The language should avoid technical medical terminology; use uncomplicated and
understandable words. If technical terms must be used, clearly explain in simple language. (e.g.,
Placebo is an inactive medication or “sugar pill” or a placebo contains no medication). Consider
attaching a glossary of terms. The name of the investigator and telephone number should appear
in the consent form.

                            BIOMEDICAL CONSENT FORM CHECKLIST

                          ___ Title of study
                          ___ Investigator name, title and phone number
                          ___ Investigator affiliation

                                 HEADINGS FOR CONSENT FORM

Introduction                     Reimbursement/Compensation for Illness/Injury During Study
__ Description of the study                  __ Name/phone number of treating doctor
__ Role of participant                       __ Where will treatment be given
                                             __ Other forms of compensation, if any

Purpose                                        Confidentiality
__What is being studied                        __Indicate records are confidential
__Why it is being studied                      __ Safeguards used if data published
__ Purpose of research                         __ Who will have access to records
__ Indicate experimental/research

Procedures                                 Patient Rights
__ List of all procedures                  __Name/phone number of investigator
__ Intervals of procedures                 __ Listing of EU IRB (215) 769-3114
__ Length of time participant in study
__What will be given or received and how administered
__ Length of hospital stay, if required
__ Prior experience with drug or device

Risks                                       Voluntary Participation/ Withdrawal
__ Describe all risks in detail           __ Statement regarding voluntary participation
__ Describe all possible side effects     __ Statement regarding withdrawal by participant
   during study
   (in consent form or as attachment)       __Statement regarding withdrawal of participant by
       (in consent form or as attachment)

Benefits to Participant                        Legal Rights/Patient Consent

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                        Eastern University Institutional Review Board

__ Describe in detail                      __ Statement regarding legal rights
__ State if none                           __All questions answered
                                           __ Emergency phone number
Alternative Treatment/Procedures           __ Copy of consent form given to participant
__ Describe in detail                      __ Signature and date line for participant (or
                                           __ Signature and date line for investigator
Exclusions for Nonparticipation            __ Signature and date line for witness
__ Describe in detail
Participant Costs/Payment                  __ Written in first person/second person
__ Payment to be received by participant   __ Technical medical terminology explained
__ Costs to participant, if any
__Insurance coverage, if any

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