SBE ICF template
v. 03Jan2014
Subject Informed Consent Document
TITLE OF RESEARCH STUDY
Investigator(s) name & address (identify WSU Department):
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). 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,
testing experiments or other studies the subject will be asked to complete. Include
information in this paragraph about how long it should take the subject to complete the
questionnaires, tasks or other procedures. Include total study length, number of sessions
and session length. If there are surveys or questionnaires, include a statement that the
subject may decline to answer any questions that may make them uncomfortable.)
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). If there
are no foreseeable risks, say “There are no foreseeable risks.” or “There are no foreseeable
risks other than possible discomfort in answering personal questions.” (as appropriate)
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. If there are no benefits to the subject, state There are no
benefits to you for participating in this study. The information learned in this study may be helpful
to others.
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SBE ICF template
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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 the statement below
applies, remove sentence above.)
You will be paid (or receive) (state the form or method of payment; $ in cash, given a $ gift
card, extra credits, 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.)
Study Related Injury (not required for minimal risk research)
(If your study is greater than minimal risk and could entail risk that might cause economic
or social loss or other harm to the participant, please contact the IRB Office for assistance
in wording the Study Related Injury paragraph.)
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.
Your information may be shared with the following:
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The sponsor and companies hired by the sponsor to oversee the study (include only
if study is sponsored)
The Wright State IRB and Office of Research and Sponsored Programs
People who are responsible for research and HIPAA oversight at the institutions
where the study is conducted (include only if study is conducted in a covered
entity)
Government agencies, such as: (List all that apply)
Office for Human Research Protections (OHRP),
Office of Civil Rights (if PHI is being collected), and
Other (please specify)
Security
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).
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Conflict of Interest (if study is externally sponsored)
This study may involve a conflict of interest because the institution and/or the investigator will be
compensated for your participation in it. Please ask the investigator how the institution and/or
investigator will benefit by your participation in the study.
*Significant Financial Interests (external interests) must be disclosed to the Office of
Research and Sponsored Programs. If it is determined that a Financial Conflict of Interest
exists, additional restrictions and appropriate consent wording will be required. This
applies to all investigators and key personnel.
HIPAA Research Authorization (use this only if you are collecting PHI/are obtaining
identifiable information that can be found in a medical record)
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides federal
safeguards for protected health information (PHI).
Examples of PHI are your name,
address, and birth date. PHI may also include your medical history, results of health exams
and lab tests, drugs taken and results of this study. Your PHI cannot 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.
Site(s) where health information about you will be used or shared for this research:
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 ask for your health
information from the following: (list)
Revocation of Research Authorization to Use Protected Health Information
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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:
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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.
You may cancel your permission by writing to the investigator at the address on page one.
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)
Research Subject’s Rights, Questions, Concerns, and Complaints
You may contact the principal investigator at ____________. (For student PIs, do not include
home phone number here - provide email address instead. Also include contact info for
Faculty advisor.)
If you have any questions about your rights as a study subject, questions, concerns or complaints,
you may call the Wright State IRB Office (937) 775-4462. You may discuss any questions about
your rights as a subject with a member of the IRB or 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 paper tells you what will happen during the study if you choose to take part. Your signature
means that this study has been discussed with you, that your questions have been answered, and
that you will take part in the study. This informed consent document is not a contract. You are not
giving up any legal rights by signing this informed consent document. You will be given a signed
copy of this consent to keep for your records.
______________________________________________
Signature of Subject/Legal Representative
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__________________
Date Signed
SBE ICF template
v. 03Jan2014
_______________________________________________
Signature of Person Obtaining Consent
(if other than the Investigator)
_________________________________________________
Signature of Investigator
________________
Date Signed
_____________
Date Signed
__________________________ __________________________________ ______________
Printed Subject Name
Signature of Subject
Date
Signed
_______________________________
________________________ _____________
Legally Authorized Representative (Please Print) Signature of LAR
Date
(include only if applicable)
___________________________________________
Relationship of Legally Authorized Representative to Subject (include only if applicable)
___________________________________________
Signature of Person Obtaining Consent
(if other than the Investigator)
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_____________________
Date Signed