INFORMED CONSENT FOR PARTICIPATION IN RESEARCH ACTIVITIES

Document Sample
INFORMED CONSENT FOR PARTICIPATION IN RESEARCH ACTIVITIES Powered By Docstoc
					University of Connecticut Health Center IRB# 06-162-1
                                                            Alcohol challenge ICF FORM A - Screening


          INFORMED CONSENT FOR PARTICIPATION IN RESEARCH ACTIVITIES
                THE UNIVERSITY OF CONNECTICUT HEALTH CENTER

Principal Investigator: Jonathan Covault, M.D., Ph.D.
Co-Investigators: Amira Pierucci-Lagha, Ph.D.; Albert Arias, M.D.; Henry Kranzler, M.D.; Cheryl
Oncken, M.D., Carolyn Drazinic, M.D., Ph.D.
Project Title: Subjective and Physiological Responses to Alcohol in Healthy Social Drinkers:
Moderating effect of variation in GABRA2
Expected Duration of Participation: 13 weeks

Name of Research Participant: ___________________________________________

      You are being asked to participate in a research study, which will involve consuming alcohol
beverages, answering questionnaires, and performing cognitive and physiological tests. The major
purpose of this study is to understand the role of a gene, called “GABRA2”, and its relation to the acute
effects of alcohol. It is important to identify specific genes for different types of responses to alcohol.
This information may help us to understand why some individuals are more likely to develop alcohol
dependence, or receive some form of protection against alcohol dependence. You are invited to
participate in this study because you are a healthy volunteer and you have reported safely drinking
alcohol beverages similar to the amounts that you will be asked to drink in this study.

Duration of Study:
        The remainder of this study requires a total of three visits. The visits will be conducted at the
University of Connecticut Health Center (UCHC). We are looking to enroll a total of 200 volunteers,
with a goal of 60 volunteers to complete this study. Participation is voluntary, and it is important that
you read this consent form carefully and discuss any questions that you may have with the researcher,
before you decide to participate.

Study Procedures:
        Screening Visit: This visit will take approximately two hours. You will be asked to undergo a
series of interviews about your mental health, drinking habits and family history of alcoholism and you
will be asked to complete several questionnaires. A nurse will ask you about your medical history.
Four tablespoons of blood will be drawn for clinical lab tests and for DNA testing. The purpose of
collecting this DNA sample is to identify genetic variations that influence human behaviors, including
alcohol use.
        You will also be asked to provide a urine sample for routine analysis and screening for illicit
drugs. If you are a woman of reproductive age, your blood will be tested to be sure that you are not
pregnant. You will also be asked to provide a urine sample for pregnancy testing before the start of
each lab session. You will undergo a brief physical examination by a physician or nurse practitioner.
        Based on results of the screening visit you may or may not be invited back to participate in the
alcohol laboratory sessions described below. The decision of whether or not you are invited to
participate in the alcohol lab sessions is based in part on the results of the DNA testing and gender.
Since this study is designed to examine several different versions of candidate genes including
“GABRA2”, we wish to enroll a balanced number of subjects with each version of these genes and
their gender. For example, in order for us to enroll a balanced group of subjects, approximately 50%
of individuals with the most common GABRA2 genotype will be selected at random to participate in

Version Date: 11/9/07                       1 of 5
University of Connecticut Health Center IRB# 06-162-1
                                                            Alcohol challenge ICF FORM A - Screening

the alcohol lab sessions.
Lab Sessions: The remaining three visits (“lab sessions”) will be separated by one month. You will
participate in three identical experimental lab sessions. The lab sessions start at approximately 9:00
A.M. and you will be discharged by 7pm. Prior to beginning the lab session, you will meet with
research staff to go over your drinking history covering the time since your last visit.
         At approximately 11 AM, you will be asked to drink either a high dose of alcohol, a low dose
of alcohol or a placebo-beverage (not containing alcohol) mixed in fruit juice. The amount of alcohol
that will be consumed at each session will depend upon body weight and sex (high dose session:
female 1 drink / 37.5 lbs weight; male 1 drink / 30 lbs weight). For example, a woman who weighs
150 pounds would be asked to drink zero, 2, or 4 standard drinks (i.e., 2-4 large glasses of beer or 2-4
glasses of wine or 2-4 shots of liquor); A man, who weighs 180 pounds, would be asked to drink zero,
3, or 6 standard drinks (i.e., 3-6 large glasses of beer or 3-6 glasses of wine or 3-6 shots of liquor).
Therefore, subjects will be included if they drink socially on a drinking level of 2 or more standard
drinks for women and 3 or more drinks for men. Eight times throughout each lab session, you will be
asked to complete questionnaires that ask about your current feelings, mood, and sensations. Your
breath alcohol level, blood pressure and pulse will be monitored repeatedly throughout the lab session.
At various timepoints during the lab session, you will be asked to stand on a platform to measure your
balance (body sway), and to perform a task that measures working memory and attention. Two light
meals will be served (at approximately 10:00 A.M. and 2:00 P.M.).
         The next two lab sessions will be scheduled a month apart, and you will undergo the same
procedures for each lab session. At no time during the study will you or the research staff know at
which session you received the low dose of alcohol, the high dose of alcohol, or no alcohol (placebo
beverage).
          You will not be released until your breath alcohol level is below 0.020% and you have been
evaluated and confirmed to not be experiencing clinically significant effects of alcohol; this may be
after 7:00pm. If you have any concerns about residual effects of alcohol, you may also wish to arrange
for a friend or family member to take you to and from the University of Connecticut Health Center on
your three alcohol lab visit days. Alternatively, the research staff can call for a taxi to take you home,
the cost of which will be covered by the research study. A research staff member will call you the day
after and ask if you experienced any problems after each lab session.
         The information obtained during the lab sessions will not be available to you as an individual,
but you can learn of the overall results of the study, when available, from Dr. Covault.

Risks:
        The greatest risks in this research are associated with side effects from alcohol. The alcohol
dose that you will be asked to consume is often drunk voluntarily by people. However, adverse effects
such as nausea, vomiting, dizziness and confusion may occur. Adverse effects of alcohol will be
systematically evaluated and recorded. If serious, you will be promptly withdrawn from the study and
given appropriate monitoring until the adverse event resolves. Therefore, a research nurse or a medical
assistant will be present to monitor pulse and blood pressure and to ensure your safety and well being
during the three lab sessions.
        The risks associated with blood collection include: pain, bruising or bleeding at needle site,
dizziness and possibly fainting. The blood will, however, be drawn by experienced staff according to
standard procedures to minimize such risks.




Version Date: 11/9/07                      2 of 5
University of Connecticut Health Center IRB# 06-162-1
                                                              Alcohol challenge ICF FORM A - Screening

What Other Types of Risks Are Involved If I Choose To Participate?
Under some circumstances, it can be a risk for genetic information about you to be known. Variation
in some genes is known to be directly related to risk for certain illnesses. None of the genes we plan to
examine are known to be directly related to risk of illnesses, but might at some point in the future
become known to relate directly to potential for illness. We will not make any of our results available
to you, nor will we add them to your medical record. We hope that this will prevent any genetic
information about you from becoming known to anyone other than the scientists working on this study.
While we cannot foresee situations where we would be forced to reveal potentially sensitive genetic
information about you, or where people who should not have this information could obtain it, it is
possible that presently unforeseen situations may arise where this could happen. (If you want to know
your risk for known genetic illness, we can refer you to a genetic counselor.)

Confidentiality:
        Research records and DNA samples will be treated as confidential. Every effort will be made
to protect the confidentiality of the information we gather from you, but we cannot guarantee 100%
confidentiality. The following procedures will be used to protect the confidentiality of your data. The
study staff (principal investigator, research coordinator, co-investigators, etc.) will keep all study
records (including any codes to your data) under double lock and key in a secure location. Only a code
number will identify your research records, and that number will not be based on any information that
could identify you. While the study is open, the master list linking names and DNA to code numbers
will be kept in a separate locked and secure location until the de-identification of samples begins. All
electronic files (e.g., database, spreadsheet, etc.) containing identifiable patient information will be
password protected. Any computer hosting such files will also have password protection to prevent
access by un-authorized users. Upon completion of subject enrollment and primary outcomes analysis,
all samples and datasets will be de-identified to further protect against breach of confidentiality. If the
investigators present the results of the study at a scientific meeting or publish the results in a scientific
magazine or book, the investigators will not identify you in any way.

     Please see form labeled “ AUTHORIZATION TO USE AND DISCLOSE PROTECTED
HEALTH INFORMATION FOR RESEARCH PURPOSES" for more information.

What is the purpose of collecting the DNA samples?
        Part of the saliva/blood sample from your initial visits will be used to prepare DNA to enable
us to examine the relationship between your genotype (your unique DNA makeup) and your response
to alcohol. We believe that people have different biochemical and behavioral responses to alcohol in
part due to differences in natural genetic variation among individuals. We will examine a number of
genes thought to be involved in the effect of alcohol.
        In addition, we plan to test other genetic markers to identify genes that influence other
behaviors and characteristics that we will ask you about (like smoking or other drug use), or are being
measured as part of this research. We may also use your DNA to measure variation in genetic markers
that enable us to more accurately compare results between subjects with various ethnic backgrounds.
None of the genetic information that we obtain will be disclosed to you.
        The information obtained from your DNA will also be treated as confidential information,
using the same protective measures as mentioned above. Information concerning your genetic makeup
will not be made available to you. However, you will be able to obtain the results of the studies in
which your DNA is used by making a written request to Dr. Covault.


Version Date: 11/9/07                        3 of 5
University of Connecticut Health Center IRB# 06-162-1
                                                            Alcohol challenge ICF FORM A - Screening

        The identification of genes that influence how people respond to alcohol could lead to new
treatments, or new means of prevention, for alcohol use disorders. If you choose to participate in this
study, any samples taken from you become the property of the University of Connecticut Health
Center as more fully explained below.

How will the blood samples and DNA be stored?
Once your DNA sample is collected it will become the property of the UConn Health Center. It will
be stored in the laboratory of Dr. Jonathan Covault. During the study the sample will be stored under a
code that only the PI can link to your name. Upon completion of the study the key linking the sample
and study records ID to you will be destroyed, at that point there will be no way to link the sample
back to you. The de-identified DNA sample will then be kept in storage until fully utilized. These de-
identified samples together with other de-identified observations collected in this study will be used to
conduct the genetic analyses described above and may be shared with other researchers and used in
other projects.

What happens to the DNA if I withdraw from the study?
        If you choose to withdraw from the study after your DNA samples have been obtained, we will
destroy all records in our research files connecting your identity with your sample(s). This way the
samples could only be studied anonymously from this point forward. The samples will become the de-
identified property of UCHC.

 Benefits:
        You will get a free medical evaluation, including standard laboratory tests. There is no other
direct benefit, to you as a participant in this study. The possible benefit to society that would result
from an improved understanding of the biological basis for alcohol effects and alcoholism is an
important potential benefit of this study.
        You will not directly benefit from the genetic testing. Potential societal benefits may include a
greater understanding of the genetic basis of alcohol effects and on the risk of alcohol or drug
dependence or related conditions.

Payment:
         You will be paid $25 for attending this screening visit. You will receive $75 for completion of
the first laboratory session, $100 for completion of the second laboratory session, and $125 for
completion of the third laboratory session. If you choose not to complete the study, you will receive a
lesser amount depending upon the extent of your participation. You will receive $325 for completing
this screening visit and all three laboratory sessions. Further, during each session you will also receive
an incentive worth approximately $10-15, which will be paid in the form of vouchers, for goods only.

Costs to Subjects:
       There will be no cost to you or to your insurance for any of the procedures involved in this
research.

Other Information:
         You are free to not participate in this study. If you choose to participate, you are free to
withdraw from this study at any time. If you choose not to participate or to withdraw from the study,
your decision will not adversely affect your present or future relationship with this hospital or the
doctors here. Also there will be no penalty or loss of benefits to which you are otherwise entitled.

Version Date: 11/9/07                      4 of 5
University of Connecticut Health Center IRB# 06-162-1
                                                          Alcohol challenge ICF FORM A - Screening

Rights as a Research Subject:
       Questions regarding your rights as a research subject can be addressed to a representative of the
UCHC Institutional Review Board (IRB) at 860-679-1019. You are free to ask the investigators, Dr.
Covault (860-679-7560) or Dr. Henry Kranzler (860-679-4151), or any other research staff about
anything you don't understand and you should consider this research and the consent form carefully
before you agree to participate. You may take as much time as necessary to think it over.

         The University of Connecticut Health Center (UCHC) does not provide insurance
coverage to compensate subjects if injured during this research. However, compensation may
still be available by filing a claim against the State of Connecticut. For a description of this
process, contact a representative of the UCHC Institutional Review Board (IRB) at 860-679-1019
or 860-679-8729. The UCHC does not offer free care. However, treatment for a research related
injury may be obtained at UCHC for the usual fee.
         If you need additional information, you may contact the IRB at 860-679-1019, where
someone can review the matter with you, identify the resources that may be available, and
provide you with further information as to how to proceed.

CONSENT TO PARTICIPATE IN THIS STUDY:
By signing this form you acknowledge that you have read, or have had read to you, this informed
consent document, have talked with research personnel about this study and been given the opportunity
to ask questions and have them satisfactorily answered, and voluntarily consent to participate in this
project as described in this form.
___________             _____________________________         _______________________________
Date                    Signature of Study Subject            Printed Name of Subject

By signing this form, the individual obtaining consent is confirming that the above information has
been explained to the subject and that a copy of the signed document will be provided to the subject.

___________             _____________________________         _______________________________
Date                    Signature of Investigator/            Printed Name of Investigator/
                        or Person Obtaining Consent           or Person Obtaining Consent




Version Date: 11/9/07                     5 of 5