Quorum IRB Consent Excerpts
<<Instructions for Quorum staff: ensure the following two injury statements appear in USF
consent forms in addition to the sponsor’s statement.>>
Sponsor Payment for Research Related Injuries
The Sponsor will pay for reasonable and necessary medical treatment for illness or injury
resulting from the test article or its administration when it is given according to the study plan.
University of South Florida Payment for Research Related Injuries and Self-Insurance
Program
If you believe you have been harmed because of something that is done during the study, you
should immediately call the study doctor at the phone number listed on page 1 of this form. The
University of South Florida has no plans to pay for the cost of any care or treatment that might
be necessary because you get hurt or sick while taking part in this study. The cost of such care
or treatment will be billed at the usual rate. Be aware that your health care payer might not
cover the costs of study-related injuries or illnesses. In addition, the University of South Florida
has no plans to pay for any wages you may lose if harmed by this study.
The University of South Florida is considered a state agency and therefore cannot usually be
sued. However, if it can be shown that the researcher, or other USF employee, is negligent in
doing his or her job in a way that harms you during the study, you may be able to sue. The
money that you might recover from the State of Florida is limited in amount.
You can also call the USF Self Insurance Programs (SIP) at 1-813-974-8008 and ask them to
look into what happened, if you think:
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You were harmed because you took part in this study.
Someone from the study did something wrong that caused you to be harmed, or did not
do something they should have done.
By signing this form, you do not give up any of your legal rights.
<<Instructions for Quorum staff: Delete any HIPAA authorization and/or privacy and
confidentiality section in the model consent form and insert the following USF-specific language.
If the model form included the ClinicalTrials.gov statement in the HIPAA or confidentiality
section, make sure to retain that in the USF form.>>
Authorization to Use and Disclose Protected Health Information
Who will see your health information?
In this research study, we (the study doctor and study staff) use and share your health
information to the extent authorized (permitted) by you. We know that this information is private.
The federal privacy regulations of the Health Insurance Portability & Accountability Act (HIPAA)
protect your identifiable health information. If you authorize us to use your information we will
protect it as required by the law.
[If the research is being conducted in conjunction with another facility, add the following
paragraph.]
Research at [insert facility name] is conducted jointly with the University of South Florida (USF).
By signing this form, you are permitting [insert facility name] and the University of South Florida
to use personal health information collected about you for research purposes. You are also
allowing [insert facility name] to share your personal health information with individuals or
organizations other than USF and [facility name] who are also involved in the research and
listed below.
[If the research is being done solely at USF, add the following paragraph.]
This research is conducted at the University of South Florida (USF). By signing this form, you
are permitting USF to use personal health information collected about you for research
purposes within the USF health care system. You are also allowing USF to share your personal
health information with individuals or organizations other than USF who are also involved in the
research and listed below.
Who will disclose (share), receive, and/or use your information?
To conduct this research, USF and the people and organizations listed below may use or share
your information. They may only use and share your information:
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With the people and organizations on this list;
With you or your personal representative; and
As allowed by law.
In addition to the people and organizations listed below in the Privacy and Confidentiality
section of this document, the following groups of people may also be able to see information
about you and may use the information to conduct the research:
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The medical staff that takes care of you (including the study doctor and study staff and
your regular doctor) and those who are part of this research study;
Each research site for this study. This includes the research and medical staff at each
site and USF;
Any laboratories, pharmacies, or other individuals and organizations that use your health
information as part of the approved plan for this study;
Any designated peer review committees;
Any Data Safety Monitoring Boards or others who monitor the data and safety of the
study;
Additionally, there may be other people and/or organizations who may be given access
to your personal health information. This includes [List any other persons, classes of
persons, and/or organizations. Do not list persons or entities who are likely to change
over the course of the study, instead list them by title or category only. If not applicable,
please delete this item.]
Who else can use and share this information?
Anyone listed above may use consultants in this research and for the purpose of this study, may
share your information with them. If you have questions about who they are, you should ask the
study team. Individuals who receive your health information for this research study may not be
required by the HIPAA Privacy Rule to protect it and may share your information with others
without your permission. They can only do so if permitted by the laws governing them. For
example, the study sponsor may share your information with others. If the sponsor or others
share your information, your information may no longer be protected under the HIPAA Privacy
Rule.
How will my information be used?
By signing this form, you are giving your permission to use and/or share your health information
as described in this document for any and all study/research related purposes. Your
authorization to use your health information will not expire unless you revoke (cancel) it in
writing.
As part of this research, USF may collect, use, and share the following information:
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Your whole research record. This record may include any information about you that the
study doctor needs to do the study including information about study visits, tests, and
procedures described in this form and other identifying information about you, such as
your name, address, phone number, or social security number.
All of your past, current or future medical and other health records held by USF, other
health care providers or any other site affiliated with this study. This includes, but is not
limited to, HIV/AIDs, mental health, substance abuse, and/or genetic information.
[List any other needed information not included above. The descriptions should have
enough detail that you (or any organization that must disclose information pursuant to
this authorization) can understand what information may be used or disclosed.]
You can list any particular information that you do not want us to use or share in the space
below. If you choose not allow certain information to be used and shared that is necessary to
conduct the study, you will not be able to participate in the study. If you list nothing here, we
can use and share all of the information listed above for this research but for nothing else.
For the Research Participant (you) to complete:
I am asking USF and the researchers not to include, use, or share the following health
information in this research (if blank, then no information will be excluded):
Your Rights:
You can refuse to sign this form. If you do not sign this form you will not be able to take part in
this research study and therefore not be able to receive the research related interventions.
However, your health care outside of this study and benefits will not change.
How Do I Withdraw Permission to Use My Information?
You can revoke this form at any time by sending a letter clearly stating that you wish to withdraw
your authorization to the use of your health information in the research. If you revoke your
permission:
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You will no longer be a participant in this research study;
We will stop collecting new information about you;
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We will use the information collected prior to the revocation of your authorization.
This information may already have been used or shared with others, or we may
need it to complete and protect the validity of the research; and
Staff may need to follow-up with you if there is a medical reason to do so.
To revoke this form, please write to:
Principal Investigator [DO NOT insert a name here, merely the title]
For IRB Study Number [Insert IRB Study #]
[Insert complete mailing address]
While we are conducting the research study, we cannot let you see or copy the research
information we have about you. After the research is completed, you have a right to see the
information about you, as allowed by USF policies.
You will receive a signed copy of this form.
Privacy and Confidentiality
We will keep your study records private and confidential. Certain people may need to see your
study records. By law, anyone who looks at your records must keep them completely
confidential. The only people who will be allowed to see these records are:
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The research team, including the Principal Investigator, study coordinator, and all other
research staff.
Certain government and university people who need to know more about the study. For
example, individuals who provide oversight on this study may need to look at your
records. This is done to make sure that we are doing the study in the right way. They
also need to make sure that we are protecting your rights and your safety.
Any agency of the federal, state, or local government that regulates this research. This
includes the Food and Drug Administration (FDA), Florida Department of Health, and the
Department of Health and Human Services (DHHS) and the Office for Human Research
Protection (OHRP). This may also include agencies in other countries.
The USF Institutional Review Board (IRB) and its related staff who have oversight
responsibilities for this study, staff in the USF Office of Research and Innovation, USF
Division of Research Integrity and Compliance, and other USF offices who oversee this
research.
The sponsor(s) of this study and any contract research organization working with the
sponsor(s). These people will use your records to review the study, <<and>> to check
the safety and results of the study <<if applicable (if study drug or device is not yet
approved for any indication): and to seek government <<approval, clearance>> of
<<name of investigational study drug, vaccine, device, product>>.
Quorum Review (a group of people who review research studies to protect the rights and
welfare of research participants).
We may publish what we learn from this study. If we do, we will not include your name. We will
not publish anything that would let people know who you are.