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- INSTRUCTIONAL TEXT APPEARS IN RED AND MUST BE REMOVED PRIOR TO
SUBMISSION TO THE IRB.
- RED TEXT IN PARENTHESES SHOULD BE REPLACED WITH INFORMATION
FROM YOUR STUDY.
SAINT JOSEPH MERCY HEALTH SYSTEM
ANN ARBOR, MICHIGAN
PARTICIPANT CONSENT FOR RESEARCH
Title of Study
(Full title as listed on the IRB application)
Study Number: (this will be assigned by IRB office)
National Clinical Trial Number: (if applicable, consent will not be issued until this number is
provided)
Sponsor: (Name, City, State)
Principal Investigator: (Principal Investigator's name and credentials)
Introduction
You have been asked to participate in a human research study. Before you make a decision to
volunteer, or not to volunteer, we want you to know as much as possible about the study. Please
read this consent document carefully and talk to your doctor if you have any questions about the
study. You may also want to talk about it with your family, friends or other doctors.
These are the general principles that apply to all human research done at Saint Joseph Mercy
Health System:
1. Taking part in the study is entirely up to you. This means that you do not have to
participate if you don’t want to.
2. If you agree to participate in the study, and then change your mind, you can stop being
in the study. There is no penalty for this. You will not lose any benefits you would
have had if you didn’t participate in the study.
3. You may or may not get better as a result of taking part in this study. However, we
may learn more about your disease or condition as a result of your participation, and
this may help others in the future.
4. Participating in a research study is not the same as getting regular medical care. The
purpose of regular medical care is to improve your health. The purpose of a research
study is to gather information. Participating in this study does not replace your regular
medical care. You can still see your personal doctor at any time.
This study is sponsored by (name of sponsor).
Approximately (number) participants will
participate in this study (if applicable: at several centers throughout the United States, including
SJMHS IRB Consent and HIPPA Template
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Saint Joseph Mercy Health System, Ann Arbor). The principal investigator (the person who is
conducting the study; also known as the study doctor) (and researcher’s organization or business,
if applicable) is (or, if applicable: is not) receiving money from the sponsor because of your
participation in this study.
Has this study been reviewed by the hospital's IRB?
Yes. The study has been reviewed by the Institutional Review Board (IRB) at Saint Joseph Mercy
Health System which operates independently of the sponsor and study doctor (principal
investigator). The members of the IRB are physicians, other health care professionals and
community members. They volunteer their time and expertise in reviewing all research studies to
protect the rights and welfare of the people who volunteer to participate in human subjects
research performed at Saint Joseph Mercy Health System. The review of the research does not
mean that the study is without risks.
Why was I asked to be in this study?
You were asked to be in the study because you have (describe disease or condition).
What is the purpose of the study?
(Describe the purpose of the research in non-technical layman’s terms)
What do I have to do in the study?
(For randomized, non-blinded studies:)
If you decide to participate, you will be placed into one of (number) different treatment groups.
The decision about which group you will be in will be based on chance, like flipping a coin. The
process of placing you into the treatment groups is called “randomization” and is generally done
by computer.
(For randomized, double-blind studies:)
If you decide to participate, you will be placed into one of (number) different treatment groups.
The decision about which group you will be in will be based on chance, like flipping a coin. The
process of placing you into the treatment groups is called “randomization” and is generally done
by computer. You will not know which treatment you are receiving, and neither will your study
doctor. However, this information is available in case of emergency.
If you decide to participate, you will (describe treatment program or intervention).
You are encouraged to use a table for complex studies, if this aids in explaining the study.
Your response to treatment will be closely watched.
(Describe all of the following: a) tests, examinations, procedures, interviews and/or
questionnaires which will be performed, b) testing intervals, and c) approximate time that will be
needed to complete tests, questionnaires, diaries and other activities).
How long will I be in the study?
We expect that you will be in the study for (enter number of days, weeks, months or years). You
will continue to be treated in the study unless you develop serious side effects, the treatment is not
helping you or the sponsor stops the study. Your study doctor may also want to take you off the
SJMHS IRB Consent and HIPPA Template
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study if there is a risk to your health. If treatment is stopped before the study is over, your study
doctor will discuss other options with you.
What are the risks and discomforts?
The study (drug(s)/treatment(s)/procedure(s)/devices(s)) you are being asked to take may have
some or all of the risks and discomforts listed below:
(Describe all of the risks and possible side effects of drugs/treatments/procedures in layman
terms. List the risks in a bulleted manner and categorize the risks of drugs and biologicals into
these headings: Common and Non-serious, Common and Serious, Less Common and Nonserious, Less Common but Serious, Rare and Non-serious, Rare but Serious. NOTE: all of the
risks must be listed here and should match or correspond those listed in the application and
protocol.)
In addition, there is always the risk of very bad effects that are rare or previously unknown.
Rarely, complications of the (drug(s)/treatment(s)/procedure(s)/device(s)) may result in death.
(The following paragraph should only be included if appropriate:)
Because the medications used in this study may affect an unborn baby, you should seriously
evaluate any decision to proceed with participating in this study. It is strongly recommended that
you inquire about counseling and obtain more information about preventing pregnancy prior to
participating in this study. You should also discuss with your study doctor any precautions you
are currently taking. Some pregnancy precautions may not be effective for this study treatment.
You should not breastfeed a baby, become pregnant or father a baby while participating in this
study. You cannot take part in this study if you are pregnant or breastfeeding, All women of
childbearing potential who agree to take part in this study must have a pregnancy test done
before they can participate. If you are sexually active, it is important that you do not
become pregnant. If you are a male, you should not father a child. You must agree to take
appropriate precautions to avoid becoming pregnant while on this study, or fathering a
child. The pregnancy precautions defined by the study sponsor is meant to be used along with
any protections women use to prevent the spread of diseases transmitted by sex. If you do become
pregnant or father a child while on this study, you must inform the study doctor immediately.
Once you are no longer receiving study treatment, it is recommended that you discuss with your
study doctor when it might be safe to become pregnant or father a child.
(The paragraph below must be included for all studies:)
Although this information is not intended to alarm you, we want you to be aware of the risks of
the treatment(s). Any risk that you do not fully understand should be further discussed with the
principal investigator (study doctor). His (Her) name and phone number is at the end of this form.
You will be monitored closely to determine if any side effects occur. You should also tell your
doctor of any new or unusual symptoms.
What are the benefits of participating in the study?
We don’t know if the treatment(s) proposed in this investigation will help you. Possible benefits
are (describe possible benefits). Information from this study may also help other peoples in the
future, even if it does not help you.
SJMHS IRB Consent and HIPPA Template
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What other treatments are available if I don’t want to be in the study?
Other ways of treating your disease or condition include (describe alternative drugs, treatments,
therapies, procedures.) Your doctor can provide detailed information about your disease
(condition) and the benefits of the various alternatives available.
What are my rights and responsibilities?
If you choose to participate in this study, you may withdraw later on by calling the principal
investigator. You will be informed of any new developments that may affect your willingness to
continue participating in this study. If new information is provided to you after you have joined
the study, we may ask you to sign a new consent that includes this new information.
If you need to see any doctor other than your own doctor, you should inform him/her that you are
enrolled in a research study.
Will I be reimbursed for my time and/or travel?
You will be paid (amount) for each completed visit (test, procedure, questionnaire) during the
study, for a total of (amount) if you complete all visits [tests, procedures, questionnaires.) (State
when the actual payments will be made, such as after each visit or at the completion of the study
activities).
Or
You will not be reimbursed or paid for the visit (test, procedure, questionnaire) during the study.
For studies involving a drug, device or procedure which may become commercially available
during or after the study:
The (drug(s)/device(s)/procedure(s)/treatment(s)), (name(s) of drug(s)/device(s)/procedure(s)
/treatment(s)), will be provided to you free of charge as long as it is (they are) experimental.
Once the (drug(s)/device(s)/procedure(s)/treatment(s)) is (are) approved, either you or your
insurance company may be responsible for payment for it (them).
Sample Collected for Future Genetic Testing
Remove if this is N/A: For studies involving the use of sample for future genetic testing
(Explain the nature and purpose of genetic testing in this study using layman’s terminology, and
include the following language. All of this may be provided in a separate Genetics Consent
document if desired):
A new Federal law, called the Genetic Information Nondiscrimination Act (GINA),
generally makes it illegal for health insurance companies, group health plans, and most
employers to discriminate against you based on your genetic information. This law
generally will protect you in the following ways:

Health insurance companies and group health plans may not request your
genetic information that we get from this research.
 Health insurance companies and group health plans may not use your
genetic information when making decisions regarding your eligibility or
premiums.
SJMHS IRB Consent and HIPPA Template
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
Employers with 15 or more employees may not use your genetic
information that we get from this research when making a decision to hire,
promote, or fire you or when setting the terms of your employment.
All health insurance companies and group health plans must follow this law by May 21, 2010. All
employers with 15 or more employees must follow this law as of November 21, 2009. Be aware
that this new Federal law does not protect you against genetic discrimination by companies that
sell life insurance, disability insurance, or long-term care insurance.
Financial Conflict of Interest
(For significant financial conflict of interest [see definition], use this paragraph:) The principal
investigator(s) of this research study (and, if applicable: [his/her/their] associates and office
business, [name of business]) declare(s) that [he/she/they has/have] a significant financial
investment
in
(name
of
sponsor),
who
makes
the
experimental
(drug(s)/device(s)/procedure(s)/treatment(s)) used in this study. As a result, (he/she/they) may
personally
profit
from
your
participation
in
this
study.
If
the
(drug(s)/device(s)/procedure(s)/treatment(s)) is (are) marketed commercially for profit, you are
not automatically entitled to a share of any profits. Please ask the principal investigator(s) to
explain this in greater detail if you have any concerns.
(Where there is no significant financial conflict of interest [see definition], use this paragraph:)
The principal investigator(s) of this research study (and, if applicable: [his/her/their] associates
and office business, [name of business]) declare(s) that [he does/she does/they do] not have a
significant financial investment in (name of sponsor), who makes the experimental
(drug(s)/device(s)/procedure(s)/treatment(s))
used
in
this
study.
If
the
(drug(s)/device(s)/procedure(s)/treatment(s)) is (are) marketed commercially for profit, you are
not automatically entitled to a share of any profits.
Who will see my records and how will they be kept confidential?
A record of your progress in the study will be kept in a confidential file at Saint Joseph Mercy
Health System (or, if applicable: name of business entity). Only those people who work on the
study will see any research records that could identify you. Those people may copy all or part of
your records related to this research. The hospital takes its responsibility to protect your health
information from unnecessary disclosure very seriously. You will be asked to sign a separate
Authorization that describes how the primary investigator will collect and use your Protected
Health Information, and who will see it. All of the information collected will be combined with
data collected from other participants for a final review. Your name or any other identification
will not be used in any published reports or presentations to the public.
In addition, as part of routine monitoring of research, members and staff of the Saint Joseph
Mercy Health System Institutional Review Board (IRB), the Food and Drug Administration
(FDA) (if applicable), or other government agencies may review your records. A representative
of the IRB may contact you about your experience with this study.
What happens if I get sick or injured as a result of this research?
SJMHS IRB Consent and HIPPA Template
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(Required for research involving more than minimal risk; For studies involving no more than
minimal risk this may be removed if not applicable.)
As explained above, there is a possibility of side effects that may occur as a result of your
participation in this study. If you get complications or injuries related to the research, the hospital
and researcher will offer treatment to you. Please contact your doctor for essential medical
treatment if you believe you have a research-related injury as a result of this study. If you need
medical attention by any doctor other than your doctor you must inform her/him that you are
enrolled in a research study. You will be treated for any injuries but the cost of treatment will not
be paid for by the sponsor, Saint Joseph Mercy Health System [if applicable: or (name of business
entity)], the principal investigator or anyone else. The hospital and doctor(s) providing medical
care will charge you or the insurance company responsible for your healthcare costs. In the case
of injury resulting from this study, you do not lose any of your legal rights to seek payment by
signing this form.
What are my financial responsibilities?
It is possible that your health insurance company will not pay for the
(drug(s)/treatment(s)/procedure(s)/device(s)) that is (are) used in this study. In that case, you or
the study sponsor will be responsible for the cost. Please ask your doctor for further information.
If I take part in this study, can I also participate in other studies?
Participating in more than one research study at the same time, or even at different times, may
increase the risks to you. It may also affect the results of the studies. You should not take part in
more than one study without getting the permission of the investigators involved in each study.
Talk to your study doctors if you have any questions about this.
If I don’t want to be in the study any more, what should I do?
You are free to leave the study at any time. If you do, there will be no penalty and you will not
lose any benefits that you would have had if you didn’t participate in the study. Before leaving the
study, you may be asked to see the study doctor for one final visit. If you decide to leave the study
early, please notify the principal investigator or study coordinator listed at the end of this form.
Could I be taken out of the study even if I want to continue to participate?
Yes. There are several reasons why you could be taken out of the study. Some examples are:
 The investigator believes that it would not be good for your health to continue in the study
 Your condition changes and you need treatment that is not allowed while you are in the
study
 You have serious side effects from the study that threaten your life
 Study Instructions are not followed or appointments are not kept
 The study is suspended or cancelled for any reason
 Add additional reasons as applicable, i.e. pregnancy
There is no promise from the investigator or the sponsor of any future treatment; your doctor will
discuss other treatment options with you.
SJMHS IRB Consent and HIPPA Template
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What should I do in case of emergency?
If you think you are having a medical emergency, go to the nearest hospital emergency room. Ask
the emergency physician to call the principal investigator or the study coordinator for this study,
at the phone numbers listed below.
Who can I contact for more information about this study?
The names and contact information for the principal investigator (and the study coordinator) are
listed below. You may contact them if you want to:
 Ask more questions
 Obtain more information about the study
 Report a side effect, complication or injury
 Discuss any concerns about the study you may have
 Stop participating in the study before it is finished
Principal Investigator: (add info here)
Mailing Address:
Telephone:
Study Coordinator: (either add info or delete this & the reference to the study coordinator
above)
Mailing Address:
Telephone:
Where can I go for more information?
(Only required for studies that fall under FDA regulations and are required to have clinical trials
#; otherwise remove:) As required by federal law, a description of this clinical trial is available on
the Internet at: http://www.ClinicalTrials.gov. This Web site will not include information that can
identify you. At most, this Web site will include a summary of the results of this clinical trial to
date. You can search this Web site at any time.
Who else can I contact if I have any concerns about the study?
If you have any questions about your rights as a research participant, or have general questions
about what it means to be in a research study or if you sustain any research complications or
injuries, please contact the Saint Joseph Mercy Health System Research Compliance Office at
(734) 712-5470 and ask to speak with the Director of Research Compliance.
========================================
I understand that by consenting to participate in this study, I am responsible for following
instructions and informing study personnel of any side effects, injuries or complications. I will
also express any concerns I may have about continuing to participate in this study. I understand
that I will be informed about any new information regarding the study that might affect my
willingness to continue participation.
SJMHS IRB Consent and HIPPA Template
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I have had an opportunity to ask questions about the study and was given enough time to
consider my participation. I have talked to as many people as I need to help me make my
decision. I understand that my participation is voluntary. I have received a copy of this form
and willingly agree to participate in this research study.
_________________________________________
________________________
Participant’s Signature
Printed Name
(or Legally Authorized Representative’s Signature)
Signature of Person Providing Information
________________________
Printed Name
SJMHS IRB Consent and HIPPA Template
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Date
__________
Date
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REMOVE ALL OF THE TEXT BETWEEN HERE AND THE START OF HIPAA IF IT
DOES NOT APPLY TO YOUR STUDY
(This section is required for studies that have OPTIONAL research studies that are being done
with people who are taking part in the main study. Do not include optional information in the
main body of the consent form. Please use as stand-alone or append here at end of main
consent before HIPAA Authorization.
[Insert information about companion studies here. Provide yes/no options at each decision point.
The following studies are included as examples therefore are written with italicized font. Any text
provided for participants should use the same non-italicized font as used for the rest of the
informed consent document.])
[Example: Quality of Life study (OPTIONAL)]
Please note: This section of the informed consent form is about additional research studies
that are being done with people who are taking part in the main study. You may take part in
these additional studies if you want to. You can still be a part of the main study even if you say
'no' to taking part in any of these additional studies.
You can say "yes" or "no" to each of the following studies. Please mark your choice as indicated.
Quality of Life Study (Optional)
We want to know your view of how your life has been affected by cancer and its treatment. This
“Quality of life” study looks at how you are feeling physically and emotionally during your
cancer treatment. It also looks at how you are able to carry out your day-to-day activities.
This information will help doctors better understand how participants feel during treatments and
what effects the medicines are having. In the future, this information may help patients and
doctors as they decide which medicines to use to treat cancer.
You will be asked to complete 3 questionnaires: one on your first visit, one 6 months later, and
the last one 12 months after your first visit. It takes about 15 minutes to fill out each
questionnaire.
If any questions make you feel uncomfortable, you may skip those questions and not give an answer.
If you decide to take part in this study, the only thing you will be asked to do is fill out the three
questionnaires. You may change your mind about completing the questionnaires at any time.
Just like in the main study, we will do our best to make sure that your personal information will be kept
private.
Please circle your answer.
SJMHS IRB Consent and HIPPA Template
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I choose to take part in the Quality of Life Study. I agree to fill out the three Quality of Life
Questionnaires.
YES
NO
[Example: Use of Tissue for Research (OPTIONAL)]
Please note: This section of the informed consent form is about additional research studies
that are being done with people who are taking part in the main study. You may take part in
these additional studies if you want to. You can still be a part of the main study even if you say
'no' to taking part in any of these additional studies.
You can say "yes" or "no" to each of the following studies. Please mark your choice as indicated.
Consent Form for Use of Tissue for Research (Optional)
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About Using Tissue for Research
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We would like to keep some of the tissue that is left over for future research. If you agree, this
tissue will be kept and may be used in research to learn more about cancer and other diseases.
Please read the information sheet called "How is Tissue Used for Research" to learn more about
tissue research.
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Things to Think About
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The choice to let us keep the left over tissue for future research is up to you. No matter what you
decide to do, it will not affect your care.
Your tissue may be helpful for research whether you do or do not have cancer. The research that
may be done with your tissue is not designed specifically to help you. It might help people who
have cancer and other diseases in the future.
Reports about research done with your tissue will not be given to you or your doctor. These
reports will not be put in your health record. The research will not have an effect on your care.
If you decide now that your tissue can be kept for research, you can change your mind at any
time. Just contact us and let us know that you do not want us to use your tissue. Then any tissue
that remains will no longer be used for research.
In the future, people who do research may need to know more about your health. While the
(sponsor, investigator and/or, study team) may give them reports about your health, it will not
give them your name, address, phone number, or any other information that will let the
researchers know who you are.
SJMHS IRB Consent and HIPPA Template
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Sometimes tissue is used for genetic research (about diseases that are passed on in families).
Even if your tissue is used for this kind of research, the results will not be put in your health
records.
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Benefits
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The benefits of research using tissue include learning more about what causes cancer and other
diseases, how to prevent them, and how to treat them.
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Risks
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The greatest risk to you is the release of information from your health records. We will do our best
to make sure that your personal information will be kept private. The chance that this information
will be given to someone else is very small.
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Making Your Choice
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Please read each sentence below and think about your choice. After reading each sentence, circle
"Yes" or "No". If you have any questions, please talk to your doctor or nurse, or call our
institutional review board.
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1. My tissue may be kept for use in research to learn about, prevent, or treat cancer.
Your tissue will be used only for research and will not be sold. The research done with your tissue
may help to develop new products in the future.
No matter what you decide to do, it will not affect your care.
Yes
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439
Pt. Initials ___ Date ______
2. My tissue may be kept for use in research to learn about, prevent or treat other health
problems (for example: diabetes, Alzheimer's disease, or heart disease).
Yes
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No
No
Pt. Initials ___ Date ______
3. Someone may contact me in the future to ask me to take part in more research.
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Yes
No
Pt. Initials ___ Date ______
SJMHS IRB Consent and HIPPA Template
Revised 01/02/07, 01/28/08, 05/24/10, 10/18/12, 11/13/12, 08/05/14, 01/09/15, 10/21/15
Page 11 of 13
PATIENT AUTHORIZATION FOR USE AND DISCLOSURE OF PROTECTED
HEALTH INFORMATION FOR RESEARCH PURPOSES
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Participant Name:
Last Name, First Name, Middle Initial
(Please print)
I AUTHORIZE THE USE AND DISCLOSURE OF MY HEALTH INFORMATION (Defined
Below):
FROM:
TO: _______________________________________
Name of hospital or health care system or provider
Provide Additional Names as Necessary
Name of researcher or research group
Provide Additional Names as Necessary
My doctor(s) who care for me during this research, including my
primary care doctor and other doctors who may take care of me
during my participation.
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Address
Address
________________________________________
Phone/Fax Number
________________________________________
Phone/Fax Number
RESEARCH STUDY FOR THIS USE AND DISCLOSURE:
Title of Study:
Name of Principal Investigator:
Affiliation of Investigator:
IRB Protocol ID #:
Name of IRB:
The purpose of the use and disclosure is to conduct the research described above. The information that
may be used or disclosed includes: Any and all health care records such as: laboratory, pathology and/or
radiology results; scans; x-rays, and Protected Health Information (PHI) previously collected for
research purposes.
Your protected health information will be used in the following ways: To conduct the research and to
ensure that the research meets legal, institutional or accreditation requirements.
Your authorization to use and disclose the above information has no expiration date.
SJMHS IRB Consent and HIPPA Template
Revised 01/02/07, 01/28/08, 05/24/10, 10/18/12, 11/13/12, 08/05/14, 01/09/15, 10/21/15
Page 12 of 13
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You understand that your access to your study health record (or specify some portion of the record,
delete this note if not being used) will be temporarily suspended until the completion of the research
study and will be reinstated at the end of the study.
You do not have to sign this authorization. If you decide not to sign the authorization it will not effect
your treatment or eligibility for health benefits. However, if you do not sign this authorization you may
not participate in the study. You may withdraw your authorization at any time by notifying the principal
investigator in writing, but the withdrawal will not affect any information already disclosed. However,
you understand that your revocation of this Authorization may result in the termination of the researchrelated treatment being provided to you.
When you sign this authorization, your health information may be re-disclosed by the researcher if
permitted or required by applicable federal or state law.
_____________________________________________________________ ___________
Signature of Research Participant or Personal Representative
Date
__________________________________________________________________________
Name of Personal Representative and description of Authority to act on behalf of the participant
PROVIDE COPY TO PARTICIPANT
SJMHS IRB Consent and HIPPA Template
Revised 01/02/07, 01/28/08, 05/24/10, 10/18/12, 11/13/12, 08/05/14, 01/09/15, 10/21/15
Page 13 of 13