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For IRB Approval Stamp
SUBJECT INFORMED CONSENT AND RESEARCH AUTHORIZATION DOCUMENT
TITLE OF RESEARCH STUDY
(Delete any of the first four lines that are not applicable. Answer line five if the IRB number
has been assigned. Lines 6-8 must be answered. Delete all instructions in RED shown in
this template.)
Sponsor assigned number:
Industry Contracts number:
Grants number:
Sponsor(s) name & address:
IRB assigned number:
Investigator(s) name & address:
Site(s) where study is to be conducted:
Phone number for subjects to call for questions:
[After reading, remove this information section: Researchers are strongly encouraged to
register any research that appears to meet the Food and Drug Administration Amendments
Act of 2007 (FDAAA) definition of a Clinical Trial at ClinicalTrials.gov or the International
Committee of Medical Journal Editors (ICMJE) definition of a Clinical Trial. If there is any
question at all about whether or not a study should be registered, then it should probably
be registered. ICMJE journals will consider trials only if registration occurred before the
first subject was enrolled (“prospective registration”). The consequence of not registering,
if a journal editor thinks the study should have been registered, is refusal by a journal to
publish the work. See the document ICMJE Guidelines for Clinical Trial Registration for
additional information.]
Introduction and Background Information
You/Your child (referred to as you in the rest of this document) are invited to take part in a
research study because (tell why). The study is being conducted under the direction of (principal
investigator/faculty member-list degree) and (Co-PI). Approximately _______ local subjects will
be invited to participate. Your participation in this study will last for (give time in days, months,
years, or hours).
Purpose
The purpose of this study is to (include a brief description in lay terms of the scientific
purpose of the study. This description should be written so subjects reading at the middle
school level can understand the terms.)
Procedures
Consent version date___________
Page 1 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
(As much as possible, describe in lay terms all study and screening procedures that may be
required. Explain which procedures are standard of care and which are experimental
(research). If the study involves multiple sessions, estimate the amount of time for each
session. State whether hospitalization is required and where the subject will be
hospitalized. If the study involves randomization, state that and explain that this process is
similar to “flipping a coin”. If questionnaires are used (e.g., Quality of Life), state that the
subjects may decline to answer any question that may make them uncomfortable, or, if
applicable, which may render them prosecutable under law.)
(OPTIONAL (remove entire sentence if not using:)
See Appendix _____ (page _____) for the procedures table that gives a timeline of study
visits and when study procedures will be done.
Potential Risks
There are (no-remove unless true) known physical risks linked with ________ (specify study
drug(s), device, or procedure(s)). Studies in animals have shown that _______ (include only if
there is little or no human risk data).
In a tabular form (see table below) list probable and possible physical risks and frequency
of occurrence (by percent of occurrence if known) and use a descriptive term such as Very
Common (Greater than 10%), Common (Greater than 1% but less than 10%), Uncommon
(Greater than 0.1% but less than 1%), Rare (Greater than 0.01% but less than 0.1%). Other
terminology such as Frequent, Rare, Infrequent, Very Rare, etc., may be used but the
terminology should be consistent with terminology used in the study protocol if different
from the current table headings. Describe risks/adverse events in lay terms as much as
possible, e.g. heart attack instead of acute coronary syndrome or ACS. Where known,
show the frequency of occurrence expressed as a percent (%) for each risk/adverse event.
State all medical terminology in lay wording. Remove this instruction.
The following table details the known adverse events related to this research and how often they
may occur. (Use this table format to report known adverse events; Select the header line you
wish to use and delete the other line)
Very Common
Greater than 10%
Common
Greater than 1%
but less than 10%
Very Common
Greater than 50%
Common
Likely
Greater than 25% Greater than 10% but
but less than 50%
less than 25%
(%)
Uncommon
Greater than 0.1%
but less than 1%
(%)
(%)
Consent version date___________
Page 2 of 14
Rare
Greater than
0.01% but less
than 0.1%
Infrequent
Greater than 1%
but less than
10%
(%)
Very Rare
Less than
0.01%
Rare
Less than 1 %
(%)
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
There may also be other procedures required as part of the study. The risks associated with these
procedures are: [list procedures and related risks (e.g., Colonoscopy, described in lay terms)
that are part of this study]. (If additional consents for procedures are required, state that
the subject may need to sign more than one consent.) (If applicable, include risks of blood
draws.)
Other possible risks to you may include: (address: psychological, social, economic, and/or
legal risks if they are a part of the research).
In addition, you may suffer harms that we have not seen before.
(If there are no risks to pregnant females or females of child bearing age, you do not need
to include any of the following statements in the informed consent.)
Possible Pregnancy Risks
(If pregnant or nursing women are excluded from the study, include in the protocol and
consent a statement supporting the rationale for not including pregnant women).
(For studies that involve the use of drugs or procedures with risk(s) to the fetus in females
of child bearing potential, choose the most appropriate of the following statements:
a. There is evidence of potential for birth defects; or
b. Animal studies have shown potential for birth defects and there are no human studies; or
c. There are no known animal or human data on the potential for birth defects.
You should discuss these risks with your doctor before signing this consent form. If you are
pregnant or become pregnant, your unborn child may suffer harms that we have not seen before. If
you become pregnant while in this study, the sponsor may ask to follow the outcome of the
pregnancy. If you agree to allow the study doctor to follow your pregnancy, you will be asked to
read and sign a separate consent form for permission to follow the outcome of your pregnancy for
(specify length of time)[Pregnancy Consent template is available on the HSPPO website - remove].
If you are a man taking part in the study and your partner becomes pregnant, the study doctor may
ask you to ask your partner for permission to follow her pregnancy. If she agrees, she will be
asked to sign a separate consent form mentioned in the previous paragraph.
Before starting this research study, females able to have children will have a pregnancy test. Talk
to your doctor about the best method of birth control to use while you are in this study (tailor
instruction to needs of the study). It is important that you tell (name of person to contact) at
(phone number of person to contact) right away if you become pregnant or father a child during
Consent version date___________
Page 3 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
the course of this study. <Choose one of the following and delete the other> If you or your
partner becomes pregnant, a decision may have to be made whether or not to end the pregnancy.
<OR> We do not know the effects of <study drug name> on an unborn baby. There is a risk that
your unborn baby could be harmed if you become pregnant during your participation in the study.
(If you ask, your study doctor will discuss the possible risks to your unborn child and your options
should you become pregnant while in the study.)
Research involving genetic information (Remove if the research does not involve genetic
testing. If the research involves a separate consent form for genetic testing, include this
paragraph in that consent form and remove from this consent)
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:
1. Health insurance companies and group health plans may not request your genetic
information that we get from this research or use your genetic information when making
decisions regarding your eligibility or premiums.
2. 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.
Employers with 15 or more employees, health insurance companies, and group health plans must
follow this law. This new law does not protect you against genetic discrimination by companies
that sell life insurance, disability insurance, or long-term care insurance.
Benefits
The possible benefits of this study include (list any possible benefits for the subject or for
future patients. Don’t overstate the potential benefits). <or> The information collected may or
may not benefit you directly; however, the information learned in this study may be helpful to
others.
Alternatives
Instead of taking part in this study, you could choose to: [(list alternatives, including choosing
not to participate as that is always an alternative.)(If same treatment is available without
participating in the study state that the treatment is available without being a part of the
study.)]
Research Related Injury
(Choose one of the following options. If industry sponsored, pick the option that best
matches the proposed contract language and remove the other options. You may have to
edit some language in the selected paragraph to make an exact fit to the contract language.
After you select the best paragraph, remove this instruction as well as the remaining
sample paragraphs under Research Related Injury.)
(Sponsor pays for injury)
Consent version date___________
Page 4 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
If you are injured by being in this research study, the study doctor will arrange for you to get
medical treatment. The sponsor will pay for any necessary medical cost related to the treatment of
your injury. (Add sentences if sponsor will pay for research related injury) To pay these
medical expenses, the sponsor will need to know some information about you like your name, date
of birth, and social security number. This is because the sponsor has to check to see if you
receive Medicare and, if you do, report the payment it makes to Medicare. The sponsor will not use
this information for any other purpose. If you are injured, there is no money set aside for lost
wages, discomfort, disability, etc. You do not give up your legal rights by signing this form. If you
think you have a research related injury, please call (name of person to contact) at (phone
number of person to contact).
(Instruction:
a. If limiting treatment sites, the investigator must state specifically where the
treatment will be provided.
b. If the sponsor attaches conditions for paying for the treatment state them, e.g., if
the subject has followed all the instructions of the investigator, or if the investigator
has followed all the procedures in the research study.)
(Sponsor pays what insurance does not pay for injury) [Note: Some affiliated study sites
may not allow the use of this option-check with the Research Office in your study site(s)]
If you are injured by being in this research study, the study doctor will arrange for you to get
medical treatment. Your insurance will be billed for the cost of treatment. The sponsor will pay for
any necessary medical cost related to the treatment of your injury due to your taking part in the
study and not paid by your insurance or any other payer. (Add sentences if sponsor will pay for
research related injury) To pay these medical expenses, the sponsor will need to know some
information about you like your name, date of birth, and social security number. This is because
the sponsor has to check to see if you receive Medicare and, if you do, report the payment it
makes to Medicare. The sponsor will not use this information for any other purpose. If you are
injured, there is no money set aside for lost wages, discomfort, disability, etc. You do not give up
your legal rights by signing this form. If you think you have a research related injury, please call
(name of person to contact) at (phone number of person to contact).
(Instruction:
a. If limiting treatment sites, the investigator must state specifically where the
treatment will be provided.
b. If the sponsor attaches conditions for paying for the treatment state them, e.g., if
the subject has followed all the instructions of the investigator, or if the investigator
has followed all the procedures in the research study, or will pay for whatever your
insurance will not cover.)
(Sponsor does not pay for injury)
If you are injured by being in this research study, the study doctor will arrange for you to get
medical treatment. The sponsor, the study site, or your study doctor has not set aside money to
pay for treatment of any injury. You and your insurance will be billed for the treatment of these
injuries. Before you agree to take part in this research study you should find out whether your
insurance will cover an injury in this kind of research. You should talk to the study doctor or staff
about this. If you are injured, there is no money set aside for lost wages, discomfort, disability, etc.
Consent version date___________
Page 5 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
You do not give up your legal rights by signing this form. If you think you have a research related
injury, please call (name of person to contact) at (phone number of person to contact).
Compensation
You will not be compensated for your time, inconvenience, or expenses while you are in this study.
<OR> (If the sentence above applies, remove the paragraph below. If below applies, remove
sentence above.)
You will be paid (state the form or method of payment; $ in cash, given a $ gift card, other) for
your time, inconvenience, or expenses while you are in this study. (If subjects will be
compensated, state how much. Payments to study subjects must be pro-rated and
distributed equally, if appropriate, or distributed according to time commitment and
potential discomfort for each visit.) (The following sentences must be in the consent if
subjects are paid.) Because you will be paid to be in this study the University of Louisville must
collect your name, address, social security number, ask you to sign a W-9 form, and keep records
of how much you are paid. You may or may not be sent a Form 1099 by the University. This will
only happen if you are paid more than $600 in one year by the University. We are required by the
Internal Revenue Service to collect this information and you may need to report the payment as
income on your taxes.
This information will be protected and kept secure in the same way that we protect your other
private information. If you do not agree to give us this information, we can’t pay you for being in
this study. You can still be in the study even if you don’t want to be paid.
Cost
There will be no additional cost to you for participating. (<or> If there are additional cost, so
state, and give approximate amounts and state who pays.) However, you or your insurance
company will be billed for all office visits and procedures that are part of routine medical care. It is
your responsibility to find out what cost, if any, your insurance company will cover before taking
part in the study.
Instruction: Do not say there will be no additional cost if the sponsor will not pay for
research related injuries or, if insured and the subject is responsible for co-pays or
deductibles.
If you are injured by the research, there may be additional cost for participating in the research.
Otherwise there will be no additional cost to you.
(Choose one of the following options. If industry sponsored, pick the option that best
matches the proposed contract language and remove the other options. You may have to
edit some language in the selected paragraph to make an exact fit to the contract language.
After you select the best paragraph, remove this instruction as well as the remaining
sample paragraphs under Cost.)
If nothing is billed or paid for by the research program
Consent version date___________
Page 6 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
You and/or your insurance company will be billed for all of the cost of treating you in this study.
Examples include doctor’s office visits, blood tests, x-rays, CT scans, and EKGs that would be
done even if you weren’t participating in this study. You will be responsible for paying your co-pay
that is associated with any procedures. None of the charges from the doctor’s office or hospital
during your participation in this study will be paid for by the research program. Some insurance
companies will not pay for treatment cost for people who participate in a research study. You may
call your insurance company to find out what they will and will not pay for before participating in
this research study. If your insurance company does not pay for your bills associated with this
study, you will be responsible for paying them.
If nothing is billed to the program but will be paid upon insurance denial.
You and/or your insurance company will be billed for all of the cost of treating you in this study.
Examples include doctor’s office visits, blood tests, x-rays, CT scans, and EKGs that would be
done even if you weren’t participating in this study. You will be responsible for paying your co-pay
that is associated with any procedures. Some insurance companies will not pay for treatment cost
for people who participate in a research study. You may call your insurance company to find out
what they will and will not pay for before participating in this research study. If your insurance
company does not pay for your bills associated with this study, please bring them to the research
office for payment.
If items are split between payers and the sponsor pays for denied claims.
You and/or your insurance company will be billed for the cost of treating you in this study.
Examples include the doctor’s office visits, blood tests, x-rays, CT scans, and EKGs that would be
done even if you weren’t participating in this study. You will be responsible for paying your co-pay
that is associated with these normal procedures. Some insurance companies will not pay for
treatment cost for people who participate in a research study. You may call your insurance
company to find out what they will and will not pay for before participating in this research study. If
your insurance company does not pay for your bills associated with this study, please bring them
to the research office for payment.
You will not be billed for the tests and procedures that are only done for this research study. The
charges for these items will be paid for by the research program. They include (name the
procedures that are included as a part of the research.)
If items are split between payers and the sponsor does not pay for denied claims.
You and/or your insurance company will be billed for the cost of treating you in this study.
Examples include the doctor’s office visits, blood tests, x-rays, CT scans, and EKGs that would be
done even if you weren’t participating in this study. You will be responsible for paying your co-pay
that is associated with these normal procedures. Some insurance companies will not pay for
treatment cost for people who participate in a research study. You may call your insurance
company to find out what they will and will not pay for before participating in this research study. If
your insurance company does not pay for your bills associated with this study, you will be
responsible for paying them.
You will not be billed for the tests and procedures that are only done for this research study. The
charges for these items will be paid for by the research program. They include (name the
procedures that are included as a part of the research).
Consent version date___________
Page 7 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
HIPAA Research Authorization
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides federal
safeguards for your protected health information (PHI). Examples of PHI are your name, address,
and birth date together with your health information. PHI may also include your medical history,
results of health exams and lab tests, drugs taken and results of this research study. Your PHI
may not be used or shared without your agreement, unless it meets one of the HIPAA exceptions.
(Add the following if there are sub-studies with this protocol. If not, delete the following
three sentences.) This research has an optional sub-study. If you agree to take part in this substudy you may be asked to sign a separate informed consent and "Research Authorization" form.
This allows the use and sharing of your PHI by those listed in the “Research Authorization.”
Site(s) where health information about you will be used or shared for this research:
In our research, we will look at and may share information about you and your health. Federal law
requires that health care providers and researchers protect the privacy and security of health
information that identifies you. We may ask for your health information from the following:
(Select sites where you may obtain PHI. Delete all other sites. Make this table as small as
possible. Remove this instruction.)
Affiliated Sites:
Non-Affiliated Sites
[9]
[]
Louisville Metro Public Health & Wellness
[]
[]
KY Cabinet for Health & Family Services
Seven Counties Services
[]
Other(s):
[]
[]
[]
University of Louisville (Do not remove this
check.)
Jewish Hospital & St. Mary’s Healthcare
Norton Healthcare, Inc., including Kosair
Children’s Hospital
University of Louisville Hospital/J. Graham
Brown Cancer Center
University of Louisville Research Foundation (ULRF) Clinical Sites
[]
[]
[]
[]
[]
[]
Children & Youth Clinic
Dentistry Clinics (Undergraduate DMD;
Graduate, Perio, Endo and Ortho; Oral Surgery
and GPR at ACB; Faculty Practice, Graduate
Pedodontic Clinic)
Family Medicine – (Newburg and Cardinal
Station; also Geriatrics and Sports Medicine at
Cardinal Station)
Kidney Disease Program (Dialysis Unit and UL
Renal Transport Lab)
Neonatal Follow Up Program
University Allergy & Immunology Clinic
[]
[]
UL Pathology Flow Cytometry Lab (BCC)
UL Pathology Special Procedures Lab
[]
UL Molecular Pathology Services
[]
Weisskopf Child Evaluation Center
[]
[]
WINGS Clinic – (ACB)
University Health Services (HSC and Belknap)
Faculty Practice Group Sites
Consent version date___________
Page 8 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
[]
[]
University Anesthesiology Associates, PSC
University Radiological Associates, PSC
[]
[]
[]
University Physicians Associates (UPA)/ UPG –
Radiology, PSC
University Emergency Medicine Associates, PSC
University Family Practice Associates, PSC
University Physicians Associates (UPA), PSC
University Medical Associates, (UMA), PSC
University of Louisville Neurosurgical Faculty
Group, PLLC
University Neurologists, PSC
Associates in Dermatology, PLLC
University GYN/OB Foundation, Inc.
University OB/GYN Associates, PSC
Ophthalmological Services, Inc. – Primary Eye
Clinic
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
Eye Specialists of Louisville, PSC
Kentucky Vision Center, Inc.
Shea, Tillett, Malkani, Caborn , PSC
Orthopedic Trauma Associates, PSC
University Pathologists, PSC
Louisville Pathology Laboratory Associates, Inc.
[]
[]
[]
[]
[]
[]
[]
[]
Bone Marrow Transplant, LLC
Other:
[]
[]
University Pediatric Gastroenterology, PSC
University Pediatrics Foundation, Inc. d/b/a
University Child Health Specialists, Inc. (UCHS)
University Children’s Infectious Disease
Specialists, LLC
University Children’s Sleep Specialists, LLC
University Children’s Kidney Specialists, LLC
University Children’s Sedation Service, LLC
University Pediatric Endocrinology, LLC
University Pediatric Rheumatology of
Kentucky, LLC
Neonatal Associates, PSC
Pediatric & Perinatal Pathology Associates, PSC
Pediatric Cardiology Associates, PSC
Pediatric Hematology/Oncology Specialists, PSC
Pediatric Pulmonary Medicine, PSC
University Psychiatric Foundation, Inc.
University Psychiatric Services, PSC
University Radiotherapy Associates, PSC
University Surgical Associates, PSC
University Pediatric Surgery Associates, PSC
University Cardiothoracic Surgical Associates,
PSC
University Urology, PLLC
Other:
State and federal privacy laws protect your health information. In most cases, health information
that identifies you can be used or shared by the research team only if you give your permission by
signing this form.
If you sign this form your health information will be used and shared to answer the research
questions described above and to make sure that the research was done correctly. The time
period when information can be used or shared ends when all activities related to this study are
completed.
Your access to your health information will/will not (choose will or will not) be limited during this
study. When the study is over, you will have the right to see your health information related to this
research.
You do not have to sign this form. If you do not sign this form you may not participate in the study
and health information that identifies you will not be shared with the research team.
Protected health information (PHI) that will be used or shared for research (Delete all check
offs that do not apply)
Consent version date___________
Page 9 of 14
IRB # :
[]
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
Consultation reports
Diaries and questionnaires
Discharge summaries
Specimens
Healthcare provider orders
[]
[]
[]
[]
[]
[]
[]
[]
[]
[]
Records of your operation(s)
Medical progress notes
Photos, videotapes, or digital or other images
Records about the study device
Records about the study drug and other
drugs you may be taking
Other:
[]
History and physical exams
[]
Laboratory, x-ray, and other tests
(If not looking at any of these below, delete the entire section)
[]
THE INFORMATION WE MAY LOOK AT OR GATHER FOR THIS RESEARCH MAY INCLUDE:
[]
HIV / AIDS status
Hepatitis infection
Sexually transmitted diseases
The diagnosis and treatment of a mental health condition
Other reportable infectious diseases
[]
[]
[]
[]
Revocation of Research Authorization
You may cancel the permission you have given us to use and share your protected health
information at any time. This means you can tell us to stop using and sharing your protected
health information. If you cancel your permission:
•
•
•
We will stop collecting information about you.
You may not withdraw information that we had before you told us to stop.
o We may already have used it or shared it.
o We may need it to complete the research.
Staff may ask your permission to follow-up with you if there is a medical reason to do so.
To cancel your permission, you must complete a written “Revocation of Research Authorization”
form at the end of this document. A revocation form is attached to this form or you may obtain a
copy from your study doctor, designated personnel or from the Human Subjects Protections
Program Office website (http://louisville.edu/research/humansubjects/subject-information).
Confidentiality
Total privacy cannot be guaranteed. We will protect your privacy to the extent permitted by law. If
the results from this study are published, your name will not be made public. Once your information
leaves our institution, we cannot promise that others will keep it private. [Insert the following four
sentences exactly as written if this study is an applicable clinical trial that is published or
required by law to be published on ClinicalTrials.gov. Remove all four sentences if this
study does not meet the definition of an applicable clinical trial-remove this instruction] A
description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S.
Law (remove “as required by U.S. Law” if study is registered because of ICMJE guidelinesdelete this instruction). This Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this Web site at any time.
Consent version date___________
Page 10 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
Your information may be shared with the following:
•
•
•
•
•
•
•
The sponsor and others hired by the sponsor to oversee the research
The University of Louisville Institutional Review Board, Human Subjects Protection Program
Office, Privacy Office and others involved in research administration at the University
People who are responsible for research and HIPAA oversight at the institutions where the
research is conducted
People responsible for billing, sending and receiving payments related to your participation
in the study
Government agencies, such as: (List all that apply)
o Office for Human Research Protections
o Office of Civil Rights
o Food and Drug Administration (include only if study involves a drug or device)
Data Safety Monitoring Board(s) related to the study (include only if study involves a
drug, device, or procedures greater than minimal risk)
Others (please specify)
Security
Your information will be kept private by (describe how the subject information will be protected
from disclosure and physically secured, e.g., locked cabinet, encrypted, password
protected computer or secured server, limited access, locked area, etc.).
Conflict of Interest
This study involves a conflict of interest because (Select one of the following three options.
Delete the remaining options and instructions prior to submission.) (1) the institution, (2) the
investigator or (3) the institution and investigator will be compensated for your participation. If you
want to know, please ask the investigator how (Select one of the following three options. Delete
the remaining options and instructions prior to submission. This selection should agree
with your previous choice.) (1) the institution, (2) the investigator or (3) the institution and
investigator will benefit by your participation in the study.
Voluntary Participation
Taking part in this study is completely voluntary. You may choose not to take part at all. If you
decide not to be in this study, you won’t be penalized or lose any benefits for which you qualify. If
you decide to be in this study, you may change your mind and stop taking part at any time. If you
decide to stop taking part, you won’t be penalized or lose any benefits for which you qualify.
You will be told about any new information learned during the study that could affect your decision
to continue in the study.
Termination
Your study doctor has the right to stop this study at any point. Your study doctor may take you out
of this study with or without your okay. Reasons why this may occur include: (disclose
anticipated circumstances under which the subject’s participation may be terminated by the
investigator without regard to the subject’s consent)
Consent version date___________
Page 11 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
(Include the following language if there are adverse consequences (physical, social,
economic, legal, or psychological) of a participant’s decision to withdraw from the
research-if no adverse consequences, delete the following.)
If you stop taking part in this study, it could harm you. You may be asked to follow these steps for
your own safety: (Describe all procedures for orderly termination of participation.)
Participation in Other Research Studies
You may/may not (choose one or the other) take part in this study if you are currently in another
research study. It is important to let your doctor know if you are in another research study.
Contact Persons
If you have any questions, concerns, or complaints about the research study, please contact
(Name and phone number, including area code, of the researcher. This section is
mandatory for all studies.)
Research Subject’s Rights
If you have any questions about your rights as a research subject, you may call the Human
Subjects Protection Program Office at (502) 852-5188. You may discuss any questions about your
rights as a research subject, in private, with a member of the Institutional Review Board (IRB). You
may also call this number if you have other questions about the research, and you cannot reach
the study doctor, or want to talk to someone else. The IRB is an independent committee made up
of people from the University community, staff of the institutions, as well as people from the
community not connected with these institutions. The IRB has reviewed this research study. (Do
not state approved. This section is mandatory for all studies.)
Concerns and Complaints
If you have concerns or complaints about the research or research staff and you do not wish to
give your name, you may call the toll free number 1-877-852-1167. This is a 24 hour hot line
answered by people who do not work at the University of Louisville. (This section is mandatory
for all studies.)
Acknowledgment and Signatures
This informed consent document is not a contract. This document tells you what will happen
during the study if you choose to take part. Your signature indicates that this study has been
explained to you, that your questions have been answered, and that you agree to take part in the
study. You are not giving up any legal rights to which you are entitled by signing this informed
consent document. You will be given a copy of this consent form to keep for your records. (This
section is mandatory for all studies.)
Do you want your primary care physician notified that you are a subject in this study? ˆYes ˆNo
___________________________________________ ________________________________
Printed Name of
Signature of Subject/Legal Representative
Date Signed
Subject/Legal Representative
Consent version date___________
Page 12 of 14
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
__________________________________________
Relationship of Legal Representative to Subject
___________________________________________ ________________________________
Printed Name of Person
Signature of Person Explaining
Date Signed
Explaining Consent Form
Consent Form (if other than the Investigator)
___________________________________________________________________________
Printed Name of Investigator
Signature of Investigator
Date Signed
(The person who explains the consent must sign this form at the time of consent. If the
investigator is not the person explaining the consent form, then the investigator must sign
the Informed Consent Document within two weeks of the subject or subject’s legal
representative.)
LIST OF INVESTIGATORS
PHONE NUMBERS
(If the research study involves subjects that are children, an “Assent to Participate for
Children” is required.)
Consent version date___________
Page 13 of 14
HSC Approved 1/1/02
IRB # :
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
REVOCATION OF AUTHORIZATION FOR USE AND DISCLOSURE OF YOUR HEALTH INFORMATION FOR
RESEARCH
Return To:
PI Address:
(Add PI Address)
OR
PI Phone:
Institutional Review Board
MedCenter One, Suite 200
501 E. Broadway
Louisville, KY 40202
Title of Study:__________________
__________________
IRB #: ________________
To Whom It May Concern:
I would like to discontinue my participation in the research study noted above. I understand that health information
already collected will continue to be used as discussed in the Authorization I signed when joining the study.
Your options are (choose one):
□
Withdraw from Study & Discontinue Authorization:
Discontinue my authorization for the future use and disclosure of protected health information. In some instances,
the research team may need to use your information even after you discontinue your authorization, for example, to
notify you or government agencies of any health or safety concerns that were identified as part of your study
participation.
□
Withdraw from Study, but Continue Authorization:
Allow the research team to continue collecting information from my personal health information. This would be
done only as needed to support the goals of the study and would not be used for purposes other than those
already described in the research authorization.
Do not sign this letter unless you are withdrawing from this research. I understand that I
will receive confirmation of this notice.
____________________
Signature of Subject
_____
___
________
Date Signed
____________________
___
Signature of Subject Representative (if subject unable to sign)
_____
____________________
Printed Name of Subject OR Subject Representative
_____
________
Date Signed
___
________
Birthdate of Subject
_________________________________________________
Relationship of Legal Representative to Subject
____________________
Address
_____
___
________
Phone Number
Optional:
I am ending my participation in this study because:
___________________
___
_____
______________
___________________
___
_____
______________
Consent version date___________
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