SBE ICF/Research Authorization Consent Form Template 04-2015
Leave 5 blank lines in the header to allow room for IRB approval stamp
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
Subject Informed Consent Document and Research Authorization
TITLE OF RESEARCH STUDY
Instructions are in Red Ink (remove before submitting)
NOTE: Use the Instruction Sheet for each section as it contains required language that may
not be located within this template. Delete this notation when completing the consent.
Sponsor assigned number:
Grant assigned number:
Industry Contracts number:
Sponsor(s) name & address:
Investigator(s) name & address:
Site(s) where study is to be conducted:
Phone number for subjects to call for questions:
Introduction and Background Information
You are invited to participate in a research study. The study is being conducted by (principal
investigator/faculty member and degree) and (name and degree/role, e.g., student,
community agency). The study is sponsored by (list if the study is sponsored by an outside
source) and the University of Louisville, Department of (give department name). The study will
take place at (name of sites where study will be conducted). Approximately (give local
number) subjects will be invited to participate.
Purpose
The purpose of this study is to (include a brief description of the scientific purpose of the
study. This description should be in lay terms, written so subjects reading at the Middle
School level could understand the terms.
Procedures
In this study, you will be asked to (List the name and purpose of any questionnaires, surveys
or other instruments the subject will be asked to complete. Include information in this
paragraph about how long it should take the subject to complete the questionnaires or
other procedures. Include total study length and session length. Include a statement that
the subject may decline to answer any questions that may make them uncomfortable.
Include how long their participation in the study will last.)
Potential Risks
There are risks associated with (study procedure). Those risk(s) is/are (Describe any risk(s)
that may occur in the study. Possible risks to subjects you may address are: physical,
psychological, social, economic, and/or legal risks if they are a part of the research). There
may be unforeseen risks. If there are no foreseeable risks, say “There are no foreseeable risks
other than possible discomfort in answering personal questions.” There may also be unforseen
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SBE ICF/Research Authorization Consent Form Template 04-2015
Leave 5 blank lines in the header to allow room for IRB approval stamp
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
risks. If there are no foreseeable risks at all say "There are no foreseeable risks, although there
may be unforeseen risks".
Benefits
The possible benefits of this study include (list any possible benefits for the subject or for
humankind). The information collected may not benefit you directly. The information learned in
this study may be helpful to others.
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 by Visa gift card (If another method of payment must be used it must be approved
by the Controller’s Office (852-6273)for your time, inconvenience, or expenses while you are in this
study. (If subjects will be compensated, state how much. Explain how payments to study subjects
are 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 and/or the
sponsor (select the appropriate one or both if both will pay)] may collect your name, address, social
security number, 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 $600 or more in one year by the
University. This will not include payments you may receive as reimbursement, for example mileage
reimbursement. 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. You can still be in the study even if
you don’t want to be paid.
Instruction: Do not state that subjects will be paid for their participation. If there is no
compensation, leave this section out.
Study Related Physical Injury (not required for minimal risk research)
If you are injured by being in this study treatment is available. The sponsor, the study site, or the
investigator 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 study you
should find out whether your insurance will cover an injury in this kind of study. You should talk to
the investigator or staff about this. 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 study related injury, please call the investigator.
(If your study is greater than minimal risk, is sponsored, and could entail physical risk that
might cause economic loss to the participant, please contact the Human Subjects
Protection Program Office for assistance in wording the Study Related Physical Injury
paragraph.)
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SBE ICF/Research Authorization Consent Form Template 04-2015
Leave 5 blank lines in the header to allow room for IRB approval stamp
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.
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. (If “will not” is chosen, delete the following sentence) 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.
In our research, the research team 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 use or share your health information
from the following sites:
Affiliated Sites:
*List any applicable affiliated sites – See choices listed in the instructions Appendix I.
Unaffiliated Sites:
*List any applicable unaffiliated sites – See choices listed in the instructions Appendix I.
University of Louisville Research Foundation (ULRF) Clinical Sites:
*List any applicable ULRF clinical sites – See choices listed in the instructions Appendix I.
Faculty Practice Group Sites:
*List any applicable Faculty Practice Group sites – See choices listed in the instructions Appendix
I.
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SBE ICF/Research Authorization Consent Form Template 04-2015
Leave 5 blank lines in the header to allow room for IRB approval stamp
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
Protected health information (PHI) that will be used or shared for research
*List any applicable choices as listed at the end of the instructions in Appendix II. Include any
other options applicable for your study.
Revocation of Research Authorization
You may cancel the permission you have given 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 will be requested to complete a written “Revocation of Research
Authorization” form located at the end of this document. You may also obtain a copy from your
study doctor, designated personnel or from the Human Subjects Protections Program Office
website (http://louisville.edu/research/humansubjects/links-to-forms).
Confidentiality
Total privacy cannot be guaranteed. Your privacy will be protected 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.
Your information may be shared with the following:
The sponsor and companies hired by the sponsor to oversee the study (include only if study is
sponsored)
 The University of Louisville Institutional Review Board, Human Subjects Protection Program
Office, and Privacy Office (include Privacy Office only if HIPAA involved), and others
involved in research administration at the University
 The local research team.
 People who are responsible for research and HIPAA oversight at the institutions where the
study is conducted (include only if study conducted in a covered entity)
 Government agencies, such as: (List all that apply)
 Office for Human Research Protections (OHRP),
 Office of Civil Rights (specify if HIPAA is required), and
 Other (please specify)
OR: Your identity as a subject in this study and the information you provide may be released and
published (only to be used if the subject agrees that the information may be made public).
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SBE ICF/Research Authorization Consent Form Template 04-2015
Leave 5 blank lines in the header to allow room for IRB approval stamp
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
Conflict of Interest (Please remove if not applicable)
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 in it.
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.
Security
Your information will be kept private by
Describe what methods will be used to ensure that the data collected is secured (e.g.,
locked in a file cabinet, kept in a secured area, or kept in a password protected computer).
Voluntary Participation
Taking part in this study is voluntary. You may choose not to take part at all. If you decide to be in
this study you may stop taking part at any time. If you decide not to be in this study or if you stop
taking part at any time, you will not lose any benefits for which you may qualify.
You will be told about any changes that may affect your decision to continue in the study. (if
appropriate)
Contact Persons, Research Subject’s Rights, Questions, Concerns, and Complaints
If you have any concerns or complaints about the study or the study staff, you have three options.
You may contact the principal investigator at xxxxxxxxxx.
If you have any questions about your rights as a study subject, questions, concerns or
complaints, you may call the Human Subjects Protection Program Office (HSPPO) (502)
852-5188. You may discuss any questions about your rights as a subject, in secret, with a
member of the Institutional Review Board (IRB) or the HSPPO staff. The IRB is an
independent committee composed of members of the University community, staff of the
institutions, as well as lay members of the community not connected with these institutions.
The IRB has reviewed this study. (Do not state approved. This section is mandatory for
all studies.)
If you want to speak to a person outside the University, you may call 1-877-852-1167. You
will be given the chance to talk about any questions, concerns or complaints in secret. This
is a 24 hour hot line answered by people who do not work at the University of Louisville.
__________
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SBE ICF/Research Authorization Consent Form Template 04-2015
Leave 5 blank lines in the header to allow room for IRB approval stamp
TITLE OF RESEARCH STUDY This needs to be on the top of the second through last page of the consent.
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.
______________________________________
__________________________________________
Subject Name (Please Print)
Signature of Subject
___________________________________________
Printed Name of Legal Representative (if applicable)
______________________________________________
Signature of Legal Representative
Date Signed
Date Signed
___________________________________________
Relationship of Legal Representative to Subject
_________________________________________
Printed Name of Person Explaining Consent Form
___________________________________________
Printed Name of Investigator
______________________________________________
Signature of Person Explaining
Date Signed
Consent Form (if other than the Investigator)
______________________________________________
Signature of Investigator
Date Signed
______________________________________________________________________________________________
List of Investigators:
Phone Numbers:
(If, due to formatting, any of the signatures are bumped to the last page with no text of the consent,
the HSC advises investigators to use the HEADER function and include a study title header on all
pages. That allows anyone reviewing or auditing the file to be clear that the signature page actually
goes with the consent. Please remove this note from the consent form before saving your consent
document.)
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SBE ICF/Research Authorization Consent Form Template 04-2015
Leave 5 blank lines in the header to allow room for IRB approval stamp
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
Do not sign this letter unless you are withdrawing from this research. You will be
sent confirmation that this notice was received.
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 me and 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.
____________________
Printed Name and Signature of Subject
___
_____
________
Date Signed
____________________
___
_____
Signature of Subject’s Legal Representative (if subject is unable to sign)
Date Signed
___________________
Printed Name of Subject’s Legal Representative
_____
________
Birthdate of Subject
___
_____
________
Subject’s Phone Number
Optional:
I am ending my participation in this study because:
___________________
___
_____
__
___________________
_____
________
___
________
_________________________________________________
Relationship of Legal Representative to Subject
____________________
Subject’s Address
___
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