Medical ICF
v. 03Jan2014
INFORMED CONSENT AND RESEARCH AUTHORIZATION
TITLE OF RESEARCH STUDY
Investigator(s) name, Degree, University Department, & address:
Sponsor(s) name and address: (if externally funded)
Site(s) where study is to be conducted:
Phone number for subjects to call for questions:
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 you have been diagnosed with ____. The study is being conducted under the direction
of _____ (list degree), Principal Investigator. About ____ local subjects will be invited to take part in
this research. The total number of subjects across all sites will be ____ (omit if study is not being
conducted at multiple sites).
Purpose
The purpose of this study is (describe in lay language)
Procedures
Your participation in this study will last for _____. If you consent to participate, you will have the
following procedures while you are in this study. (describe in lay language)
Potential Risks
The following table details the known risks related to this research and how often they may occur.
(Delete those N/A. List the most serious risks in the category first.)
Very Common
Greater than 10%
Common
Between 1% and
10%
(%)
(%)
Uncommon But
Serious
Between 0.1% and
1%
(%)
Rare But
Serious
Between 0.01%
and 0.1%
(%)
Very Rare But
Serious
Less than
0.01%
(%)
There may also be other procedures required as part of the study. The risks associated with these
procedures are: (describe in lay language)
Other possible risks to you may include (psychological, social, economic or legal, as appropriate)
Studies in animals have shown (include only if little or no human data is available)
In addition, you may suffer harms that we have not seen before.
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Possible Pregnancy Risks (as applicable)
You should discuss pregnancy risks with the investigator before signing this consent form. Women
who are pregnant or breast feeding may not participate in this research study. If you are pregnant or
become pregnant, your unborn child may suffer harms that we have not seen before. If you (or your
partner) become pregnant while in this study, the sponsor may ask to follow the outcome of the
pregnancy. If you agree to allow investigator 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.
If you are a man taking part in the study and your partner becomes pregnant, the investigator 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 above.
Before starting this research study, females able to have children will have a pregnancy test. Talk to
the investigator about the best method of birth control to use while you are in this study. It is
important that you call the investigator at _____ right away if you become pregnant or father a child
during the course of this study. If you or your partner becomes pregnant, a decision may have to be
made whether or not to end the pregnancy.
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, the investigator will discuss the possible risks to your unborn child and your options should you
become pregnant while in this study.)
Research Involving Genetic Information (include only if genetic testing is involved)
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
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The possible benefits of this study include (If there are none, state: “You may not benefit by
participating in this study. The information collected may not benefit you directly; however,
the information may be helpful to others.”)
Alternatives
Instead of taking part in this study, you could choose to (List alternative procedures or courses of
treatment, if any, which might be advantageous to the subject. If these treatments are
available without participating in the study, state that the treatment is available without being
a part of the study. Also state that the subject may choose to receive standard of care
treatment or comfort care treatment, and not participate in this study.)
Research Related Injury (if there is no risk of injury for participants, this section does not need
to be included)
If industry sponsored: (verify with individual who negotiated the study contract)
If you are injured by being in this research study, the investigator will arrange for you to get medical
treatment. The sponsor will pay for any reasonable medical costs related to the treatment of your
injury. 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 the investigator at (provide PI’s name and 24 hour phone number here).
If grant sponsored or unfunded:
If you are injured by being in this research study, the investigator will arrange for you to get medical
treatment. Neither Wright State University, the study site, nor the investigator has 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 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 research related injury,
please call the investigator at (provide PI’s name and 24 hour phone number here).
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 (state the amount and form/method of payment: cash, gift card, other) for your
time, inconvenience, or expenses while you are in this study. (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.)
Costs (verify language with individual who negotiated the study budget)
“There may/will (choose one or the other) be additional costs to you for participating in this research
study over the usual costs of your routine care outside of this research study. You will not be billed
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for the following office visits, tests, medications, and procedures that are done for this research study:
(list all not billed). The charges for these items will be paid for by the Sponsor. However, you or
your insurance company will be billed for all other office visits, tests, medications and procedures
related to this research study.
Additionally, you or your insurance company will be billed for all office visits, tests, medications and
procedures that are part of your routine medical care outside of this research study. You will be
responsible for paying your co-pay that is associated with any office visit, test, medication or
procedure. Some insurance companies will not pay for medical bills for people who participate in a
research study. It is your responsibility to find out what costs, if any, your insurance company will
cover before taking part in the study. If you need help finding out what your insurance company will
cover, please ask the investigator or staff for assistance. If your insurance company does not pay for
your bills associated with this study, you will be responsible for paying them.”
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.
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
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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:



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.
Information Available on ClinicalTrials.gov (if applicable)
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S.
Law. This website will not include information that can identify you. At most, the website will include a
summary of the results. You can search this website at any time.
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 (Omit any that do not apply):








The sponsor (name the sponsor and CRO if applicable) and others hired by the sponsor to
oversee the research, such as Data Safety Monitoring Board(s) related to the study
The Wright State IRB and Office of Research and Sponsored Programs
The local research team
Researchers at other sites participating in the study (if applicable)
People responsible for billing, sending and receiving payments related to your participation in
the study
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)
o Office for Human Research Protections (OHRP),
o Food and Drug Administration,
o Office of Civil Rights (if PHI is being collected), and
o Other (please specify)
Others (please specify)
Data 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 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.
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
The investigator, the IRB or the study sponsor has the right to stop this study at any point. The
investigator may take you out of this study with or without your permission. Reasons why this may
occur include: (describe)
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)
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 the investigator know if you are in another research study.
Research Subject’s Rights, Questions, Concerns, and Complaints
If you have any questions, concerns, or complaints about the research study you may contact the
principal investigator at ____________. You may also contact ____________ (if applicable)
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”.)
Acknowledgment and Signatures
This form 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
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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
____________________________ ___________________________________ ______________
Printed Subject Name
Signature of Subject
Date Signed
_______________________________________ ________________________ _____________
Legally Authorized Representative (Please Print) Signature of LAR
Date Signed
(include only if applicable)
___________________________________________
Relationship of Legally Authorized Representative to Subject (include only if applicable)
___________________________________________
Signature of Person Obtaining Consent
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_____________________
Date Signed