UNM Consent

The University of New Mexico Health Sciences Center
Consent to Participate in Research
Hepatitis: Treatment and Integrated Prevention (H-TIPS)
03/12/2015
Introduction
You are being asked to participate in a research study that is being done by Kimberly
Page, PhD, who is the Principal Investigator and her partners, from the Department of
Epidemiology. This research is to study how often people become infected with the
hepatitis C virus (HCV), what their risk factors are and if there are any benefits from extra
care.
The purpose of this study is to look at the rate of HCV diagnosis and if that rate is
changed by a management program.
You are being asked to participate in this study because you have a history of injection
drug use. At least 338 people will be enrolled into this study at the University of New
Mexico.
This study is funded by the U.S. Centers for Disease Control (CDC) and Prevention.
This form will explain the research study, and the possible risks and benefits to you. We
encourage you to talk with your family and friends before you decide to participate in
this research study. If you have any questions, please ask one of the study investigators.
What will happen if I decide to participate?
After you have gone through the consent process and signed the consent form, we will
test your blood for HCV and the hepatitis B virus (HBV). You can also be tested for
Human Immunodeficiency Virus (HIV) if you want. Then, we will interview you (using a
questionnaire) to find out more about you, like your background and injection drug use
history. You will need to return to the clinic van in two weeks so that we may provide
you with the results.
We will also use a digital fingerprint technology to identify you for research purposes
only.
HRPO #:
APPROVED:

14-313
04/13/2015

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If your blood test results show that you have been exposed to HCV, the following things
will happen:





You will have a one-on-one education session with a member of the study staff,
that will cover 1) what HCV does to your body, 2) how to reduce the risk of
spreading HCV, 3) things you can do to keep your liver healthy, and 4) the current
treatments available.
You will be referred for standard HCV care
You will have follow up HCV testing

Depending on which region you live in (Northeast or Southwest New Mexico), you may
also be in a treatment management group, which means that you will get payments if
you go to your treatment appointments. This is described below in the payment
section. The study does not pay for your treatment, it only gives you referrals for where
to go for treatment.
If you test negative for HCV exposure, we will give you referrals for prevention services
as well as addiction and behavioral care. You will also have a follow up HCV test every 3
months for one year. At months 3 and 9, if you want, you can have anti-HCV testing and
blood collection for future HCV RNA testing. At months 6 and 12, your visit will include a
survey and blood tests.
All blood samples will be identified with only your participant ID number to keep your
personal information confidential. The participant ID number is a number created by
scanning your fingerprint. This number will be assigned to you and only you so that we
can keep all of your information together without having to identify you. Your
fingerprint will only be used to create this number and will not be used for anything
else. We will not save a copy of your fingerprint. A sample will be stored in a secure lab
facility at the University of New Mexico for five years to do comparison testing if you
become re-infected with HCV while you are part of the study.
How long will I be in this study?
You will be in the study for one year. There will be up to 6 visits with study staff, for up
to a total of 24 hours over the entire year.

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Visit

Procedure
Baseline Interview

1st visit

1

Anti-HCV Test and Blood st
1 visit
Draw for RNA

1.1

HCV RNA Results

1 week after 1st visit

2

3 Month Check In
(Optional Anti-HCV
testing)

3 months after 1st visit

3

6 Month Follow Up Visit
with Interview and HCV
Testing

6 months after 1st visit

4

9 Month Check In
(Optional Anti-HCV
Testing)

9 months after 1st visit

5

12 Month Follow Up Visit
with Interview and HCV
1 year after 1st visit
Testing and Results

What are the risks or side effects of being in this study?
There are risks of stress, emotional distress, inconvenience and possible loss of privacy
and confidentiality associated with participating in a research study.
Being tested for HCV, HIV and HBV may cause anxiety about test results, whether they
are positive or negative.
Risks relating to blood draws include: bruising, discomfort and possible infection.
For more information about risks and side effects, ask the investigator.
What are the benefits to being in this study?
You will be able to know for sure if you have been exposed to HCV if you participate in
this study. You may benefit from HCV risk reduction counseling as well as from referrals
or linkage to medical care. The information you provide may help health professionals
and researchers better understand and prevent HCV infection in young drug users. You
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will also have the chance to learn your HIV and HBV status and receive additional risk
reduction counseling, referrals and linkage to medical care if you are interested.
What other choices do I have if I do not want to be in this study?
You do not have to be in this study. If you choose not to be in this study, we can refer
you to other providers in the area that offer harm reduction services, HIV/HBV/HCV
testing and referrals. You should discuss all available options with your doctor.
How will my information be kept confidential?
We will take measures to protect the security of all your personal information, but we
cannot guarantee confidentiality of all study data.
Information in your study records is used by study staff and, in some cases it will be
shared with the CDC who sponsors the study. The University of New Mexico Health
Sciences Center Human Research Review Committee (HRRC) that oversees human
subject research and the United States Centers for Disease Control and Prevention,
and/or other organizations may be allowed to access your records. There may be times
when we are required by law to share your information. If you get the Twinrix® vaccine
we are required by New Mexico law to enter that information into the New Mexico
Department of Health Immunization Registry, a confidential database. If you test
positive for HIV, HBV or HCV, we are required by law to report this to the Department of
Health. You may be contacted by them. They are required to keep your information
confidential. Your name will not be used in any published reports about this study.
To help us protect your privacy, we have received a Certificate of Confidentiality from
the National Institutes of Health (NIH). With this Certificate, the researchers cannot be
forced to release information that may identify you, even by a court subpoena, in any
federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The
researchers will use the Certificate to resist any demands for information that would
identify you, except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of the
United States Government that is used for auditing or evaluation of federally funded
projects, like this study, or for information that must be released in order to meet the
requirements of the NIH.

HRPO #:
APPROVED:

14-313
04/13/2015

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You should understand that a Certificate of Confidentiality does not prevent you from
voluntarily releasing information about yourself or your involvement in this research. If
any person or agency gets your written consent to receive research information, then
the researchers may not use the Certificate to refuse to give that information. The
researchers will not share any of your answers to the interview or any of your test results
with anyone.
The Certificate of Confidentiality does not prevent the researchers from reporting
without your consent, information that would identify you as a participant in the
research project if you tell us about matters that must be legally reported such as child
and elder abuse, sexual abuse, or wanting to harm yourself or others. We may need to
report this to local law authorities to keep that person safe.
In this study you will be asked about drug use and other possibly illegal activities. Upon
consent, you will be asked to provide contact information so that research staff can
remind you to come back for appointments in case you forget. The researchers and staff
will keep information about you as confidential as possible, but complete confidentiality
cannot be guaranteed. Your blood samples and interview will be labeled with a study ID
code and date of birth only. Your interview will be kept in a locked file and only Dr. Page
and her co-investigators will have access to it. Therefore, no one will be able to connect
blood samples or answers you give in the interview back to you. No information that
might identify you will be used in any reports or publications that may result from this
study.
A copy of this consent form will be kept in your medical record.
HIPAA Authorization for Use and Disclosure of Your Protected Health Information
(HIPAA)
As a part of this study, we will be collecting health information about you. This
information is “protected” because it is identifiable or “linked” to you.
Protected Health Information (PHI)
By signing this consent document, you are allowing the investigators and other
authorized personnel to use your protected health information for the purposes of this
study. This information may include: medical history, previous and/or current
treatments, laboratory tests, general health status and medical record number. By
signing the medical release form, you are authorizing the study staff to contact your
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treatment providers to check your treatment and attendance at appointments. This
information will be used only for study purposes.
Right to Withdraw Your Authorization
Your authorization for the use of your health information for this study shall not expire
unless you cancel this authorization. Your health information will be used as long as it is
needed for this study. However, you may withdraw your authorization at any time if you
notify the research team in writing. Please know that the research team will not have to
destroy or retrieve any of your health information that has already been used before
your withdrawal is received.
Refusal to Sign
If you choose not to sign this consent form and authorization for the use and disclosure
of your PHI, you will not be allowed to take part in the research study.
What are the costs of taking part in this study?
There will be no costs to you as a result of participating in this study.
What will happen if I am injured or become sick because I took part in this study?
If you have an injury or illness that is caused by your participation in this study,
reimbursement for all related costs of care will be sought from your insurer, managed
care plan, or other benefits program. If you do not have insurance, you may be
responsible for these costs. You will also be responsible for any associated co-payments
or deductibles required by your insurance.
It is important for you to tell the investigator immediately if you have been injured or
become sick because of taking part in this study. If you have any questions about these
issues, or believe that you have been treated carelessly in the study, please contact the
Human Research Review Committee (HRRC) at the University of New Mexico Health
Sciences Center, Albuquerque, New Mexico 87131, (505) 272-1129 for more information.
Will I be paid for taking part in this study?
If you test positive for the HCV test, you may receive up to $105 (Region 1 - Northwest
NM) or $35 (Region 2 - Southwest NM) as shown by the table below. If you are in
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Region 1, you will receive a pre-paid debit card at the end of Visit 1 with $25 for the first
visit, and then the rest of the payments will be loaded onto the card after each visit,
once it has been confirmed that you completed each visit. If you are in Region 2, you
will receive payment in cash at the end of Visits 1 and 9.
Visit

Region 1

Region 2

1

HCV Infection education
session

$25

$25

2

Initial Assessment

$5

0

3

Laboratory Visit

$5

0

4

Follow Up Assessment #1 $5

0

If receiving HCV
treatment:
5

HCV Treatment Follow Up
$10
Week 2

0

6

HCV Treatment Follow Up
$10
Week 4

0

7

HCV Treatment Follow Up
$10
Week 8

0

8

HCV Treatment Follow Up
$15
Week 12

0

9

12 Months HCV Results

$10

$10

$105

$35

TOTAL

If you test negative for the HCV test, you may receive up to $60 according to the table
below. You will receive payment in cash in the amount listed below at the end of each
visit.
Visit

Procedure

Amount

Baseline Interview

$10

1

Anti-HCV Test and Blood
$5
Draw for RNA

1.1

HCV RNA Results

$15

2

3 Month Check In

$5

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(Optional Anti-HCV
testing)
3

6 Month Follow Up Visit
with Interview and HCV
Testing

$10

4

9 Month Check In
(Optional Anti-HCV
Testing)

$5

5

12 Month Follow Up Visit
with Interview and HCV
$10
Testing and Results
$60

TOTAL

How will I know if you learn something new that may change my mind about
participating?
You will be informed of any significant new findings that become available during the
course of the study, such as changes in the risks or benefits resulting from participating
in the research or new alternatives to participation that might change your mind about
participating.
Can I stop being in the study once I begin?
Your participation in this study is completely voluntary. You have the right to choose not
to participate or to withdraw your participation from the study at any time during the
study. If you withdraw you are entitled to keep anything that you have received from
the study, including all compensation that you have received. After withdrawing, you
will no long receive any further compensation. The study has the right to keep all data
samples that you have provided while you were a part of the study. Withdrawing from
the study will not affect your future health care or other services that you are entitled to.
Your study doctor may also withdraw you from the study if participating is no longer in
your health's best interest or for noncompliance with study related activities/visits.
Whom can I call with questions or complaints about this study?
If you have any questions, concerns or complaints at any time about the research study,
Kimberly Page, PhD, or her associates will be glad to answer them at (505) 272-2520.
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If you would like to speak with someone other than the research team, you may call the
UNMHSC HRRC at (505) 272-1129.
Whom can I call with questions about my rights as a research participant?
If you have questions regarding your rights as a research participant, you may call the
UNMHSC HRRC at (505) 272-1129. The HRRC is a group of people from UNM and the
community who provide independent oversight of safety and ethical issues related to
research involving human participants. For more information, you may also access the
HRRC website at http://hsc.unm.edu/som/research/hrrc/.

HRPO #:
APPROVED:

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04/13/2015

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CONSENT
You are making a decision whether to participate in this study. Your signature below
indicates that you read the information provided (or the information was read to you).
By signing this consent form, you are not waiving any of your legal rights as a research
participant.
I have had an opportunity to ask questions and all questions have been answered to my
satisfaction. By signing this consent form, I agree to participate in this study. A copy of
this consent form will be provided to you.
____________________________ ____________________________ ___________
Name of Adult Subject (print)

Signature of Adult Subject

Date

INVESTIGATOR SIGNATURE
I have explained the research to the participant and answered all of his/her questions. I
believe that he/she understands the information described in this consent form and
freely consents to participate.
_________________________________________________
Name of Investigator/ Research Team Member (type or print)
_________________________________________________ ___________________
(Signature of Investigator/ Research Team Member)

HRPO #:
APPROVED:

14-313
04/13/2015

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Date

Version:
EXPIRES:

The University of New Mexico Institutional Review Board (HRRC)

03/12/2015
03/02/2016