For ORI Use Only:
Combined Consent and Authorization to Participate in a Research Study
TITLE OF STUDY
WHY ARE YOU BEING INVITED TO TAKE PART IN THIS RESEARCH?
You are being invited to take part in a research study about ________________________ (insert general
description of study). You are being invited to take part in this research study because _____________
(If there is a condition or circumstance that makes the person eligible for the study, specify this information. This
statement may not be applicable for some social science studies). If you volunteer to take part in this study, you
will be one of about _______ people to do so. If applicable, you may add "...one of about _____ people to do so
nationally, and one of ______ at the University of Kentucky".
WHO IS DOING THE STUDY?
The person in charge of this study is _________________ (Principal Investigator, PI) of University of Kentucky,
Department of ________________(list department). If the PI is a student they should disclose this fact, and, add
the following sentence: He/She is being guided in this research by _______________ (Advisor). There may be
other people on the research team assisting at different times during the study.
WHAT IS THE PURPOSE OF THIS STUDY?
Describe, in lay terms, the purpose of the study.
By doing this study, we hope to learn _________________.
If this study falls within the jurisdiction of the Food and Drug Administration use the following sentence:
The purpose of this research is to gather information on how safe and effective ____________(state name of
drug, device, etc.) is. The results of this study will be shared with the company providing financial support for the
study, the Food and Drug Administration and other federal agencies, if required. (Note, if this is a Phase I study,
delete the words “and effective” in the first sentence.)
ARE THERE REASONS WHY YOU SHOULD NOT TAKE PART IN THIS STUDY?
State in basic lay language reasons a subject could be excluded from volunteering, such as being a smoker,
being under 18 years of age, being pregnant, etc.). Include only those events/conditions which would not be predetermined by a review of records or by the decision of an attending physician. Include those events/conditions
of which the potential subject would ordinarily be aware.
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?
The research procedures will be conducted at ________________ (state the general facility such as UK Medical
Center, Sanders Brown Center on Aging, etc.). You will need to come to _______________ (state the site where
the research will be conducted, including the room if possible) XXX times during the study. Each of those visits
will take about XXX (state in minutes or hours). The total amount of time you will be asked to volunteer for this
study is XXX over the next XXXX (state in days, months or years).
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WHAT WILL YOU BE ASKED TO DO?
Tell the subject what to expect. Give a time-line description of the procedures that will be performed, the drugs or
devices that will be administered, all hospitalizations and all outpatient visits. Describe all procedures in lay
language, using simple terms and short sentences.
Answer the following questions for the subject: What procedures are experimental? What is being performed as
part of the research? For patient based studies, differentiate procedures being conducted for research versus
those for standard of care. Any procedures that are experimental must be clearly identified. For example, if the
study will include investigational drugs (drugs that have not been approved by the Food and Drug Administration),
this must be explained in simple language.
Prepare a time-line chart or schema to accompany descriptions of procedures and tests for studies that require
more than 1 or 2 steps/visits.
Provide a lay description of the randomization procedures, if applicable, and describe the chances of being
assigned to any one group. Define randomization in simple language such as “by chance.”
Add information regarding pregnancy testing for women of childbearing potential, if required and actions that may
be taken if the participant (or a participant‘s partner) becomes pregnant such as reporting outcomes to sponsor
etc. Indicate the frequency of pregnancy testing. Birth control measures required for the study should be
described here. Provide a telephone number where the Principal Investigator may be reached if the subject
becomes pregnant. (For additional guidance regarding pregnancy, see item #6 and #7 in the instructions for
proposed informed consent document.)
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?

If there are risks to participation, describe them for each investigational procedure, drug, device or
biological.

Group the risks into those that are expected, ranking them as rare, occasional, or often and describe
them as such. List all reasonably expected side effects in lay terms.

List all side effects in lay terms, no matter how rare, that are life altering or potentially life altering. For
example: visual loss, allergic reaction, paralysis.

Explain the ramifications of some risks. For example: what will happen to the subject if liver enzyme tests
indicate an abnormality.

Add a statement that the particular treatment or procedure may involve risks to the embryo or fetus which
are currently unforeseeable if the participant is or becomes pregnant.

Studies that present real and potential risks of fetal or reproductive harm should have a description of this
risk. If the risk of fetal harm is not known, indicate so. (For additional guidance regarding risk in
pregnancy, see item #6 in the instructions for proposed informed consent document.)

If venipuncture is being performed as part of the research, include each of the following as a potential risk
of that procedure: soreness, bruising, pain, infection, possible fainting, bleeding.
The IRB suggests that, in some cases, the volunteer may more easily understand the risks of therapy/procedures
in the study if the information is presented in table form. This may help the volunteer understand not only what
risks are associated with participating in the study but how likely it is that those risks may occur. An example of
such a table follows:
Possible
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How serious is it?
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Risk/Side Effect
Headaches
Rash
occurred?
It may occur just after
drug administration
It occasionally occurs
Liver damage
It is extremely
uncommon
Skin discoloration
It is uncommon
Usually of short
duration
It usually involves the
face and arms and may
cause scratching
Very serious
It will not impact your
overall health
Yes
It will go away with treatment
The damage is permanent
and can affect the rest of
your health
No
The risk section must also contain the following statement (the first sentence may not be applicable for social
science studies): There is always a chance that any medical treatment can harm you, and the investigational
treatment in this study is no different. In addition to the risks listed above, you may experience a previously
unknown risk or side effect.
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY?
There is no guarantee that you will get any benefit from taking part in this study. However, some people have
experienced __________________(insert potential benefit) when ________________________(qualify when
potential benefit experienced). Your willingness to take part, however, may, in the future, help doctors better
understand and/or treat others who have your condition.
OR
You will not get any personal benefit from taking part in this study.
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any
benefits or rights you would normally have if you choose not to volunteer. You can stop at any time during the
study and still keep the benefits and rights you had before volunteering. (Add the following, if applicable: If you
decide not to take part in this study, your decision will have no effect on the quality of medical care you receive.)
Add the following for student volunteers: As a student, if you decide not to take part in this study, your choice will
have no effect on your academic status or grade in the class.)
IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES?
If you do not want to take part in the study, there are other choices such as ____________________(If this is a
medical treatment study: describe what would occur should the person choose not to participate, i.e., standard of
care. Also, describe any other treatments that might be available. If this is a social/behavioral study, describe
whether or not there are any procedures the subject could participate in to receive the same level of benefit).
OR
If you do not want to be in the study, there are no other choices except not to take part in the study.
WHAT WILL IT COST YOU TO PARTICIPATE?
You and/or your insurance company, Medicare or Medicaid will be responsible for the costs of all care and
treatment you receive during this study that you would normally receive for your condition. These are costs that
are considered medically reasonable and necessary and will be part of the care you receive if you do not take part
in this study.
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The University of Kentucky may not be allowed to bill your insurance company, Medicare or Medicaid for the
medical procedures done strictly for research. Subjects should be informed of any additional costs that may result
from participation in the research. Add study specific language here by selecting appropriate options e.g:
Therefore, these costs:
will be your responsibility; or
will be paid by the sponsor (insert sponsors name here); or
the sponsor (insert sponsors name here) has agreed to pay $XXX of those costs ; or
may be paid by your insurer if you are insured by a health insurance company (you should ask your insurer if you
have any questions regarding your insurer’s willingness to pay these costs); or
may be paid by Medicare or Medicaid if you are covered by Medicare, or Medicaid, ( if you have any questions
regarding Medicare/Medicaid coverage you should contact Medicare by calling 1-800-Medicare (1-800-633-4227)
or Medicaid at 1-800-635-2570.
A co-payment/deductible from you may be required by your insurer or Medicare/Medicaid even if your insurer or
Medicare/Medicaid has agreed to pay the costs. The amount of this co-payment/deductible may be substantial.
WHO WILL SEE THE INFORMATION THAT YOU GIVE?
If data are going to be collected and/or stored electronically, please refer to the guidance document:
Confidentiality and Data Security for Electronic Data for appropriate procedures. The document can be found in
the online IRB Survival Handbook under the topic “Privacy and Confidentiality”:
http://www.research.uky.edu/ori/IRB-Survival-Handbook.html#Privacy.
(IF THE STUDY IS ANONYMOUS): (There can be absolutely no link to identifiers anywhere, including any code
lists)
This study is anonymous. That means that no one, not even members of the research team, will know that the
information you give came from you.
(IF THE STUDY IS NOT ANONYMOUS):
We will make every effort to keep confidential all research records that identify you to the extent allowed by law.
Your information will be combined with information from other people taking part in the study. When we write
about the study to share it with other researchers, we will write about the combined information we have gathered.
You will not be personally identified in these written materials. We may publish the results of this study; however,
we will keep your name and other identifying information private. If you are collecting social security numbers,
inform subjects of this fact. Tell subjects whether they can withhold their social security number and still
participate.
We will make every effort to prevent anyone who is not on the research team from knowing that you gave us
information, or what that information is. (Insert description of procedure(s) used for protecting confidentiality of
data including paper records, computer records, jump drives and portable storage devices)
You should know, however, that there are some circumstances in which we may have to show your information to
other people (Insert circumstances in which subject’s data could be shown or reported to others). For example,
the law may require us to show your information to a court or to tell authorities if you report information about a
child being abused or if you pose a danger to yourself or someone else. (If you have questions about what
constitutes a reportable disease and/or condition in the state of Kentucky, see ORI’s summary sheet: “Reporting
Requirements for Diseases and Conditions in Kentucky”).
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Officials of the Food and Drug Administration (if applicable), the National Institutes of Health (if applicable), the
National Cancer Institute (if applicable), Department of Defense (if applicable), the University of Kentucky, and
________________ (indicate the sponsor’s name and/or the contract research organization or any group that
may have access to information) may look at or copy pertinent portions of records that identify you.
Add the following information if commercial survey companies are used for your research:
“Please be aware, while we make every effort to safeguard your data once received from the online survey/data
gathering company, given the nature of online surveys, as with anything involving the Internet, we can never
guarantee the confidentiality of the data while still on the survey/data gathering company’s servers, or while en
route to either them or us. It is also possible the raw data collected for research purposes may be used for
marketing or reporting purposes by the survey/data gathering company after the research is concluded,
depending on the company’s Terms of Service and Privacy policies.”
Add the following information if REDCap is being used as a survey instrument for your research:
“Please be aware, while we make every effort to safeguard your data once received on our servers via REDCap,
given the nature of online surveys, as with anything involving the Internet, we can never guarantee the
confidentiality of the data while still en route to us.”
CAN YOUR TAKING PART IN THE STUDY END EARLY?
If you decide to take part in the study you still have the right to decide at any time that you no longer want to
continue. You will not be treated differently if you decide to stop taking part in the study.
Include the following information if this is an FDA clinical investigation:
“If you choose to withdraw from the study early, the data collected until that point will remain in the study database
and may not be removed.
The individuals conducting the study may need to withdraw you from the study (Include the following information if
applicable: …….and the study intervention, medication and/or device will no longer be provided by the
investigator and may not be accessible commercially). This may occur if you are not able to follow the directions
they give you, if they find that your being in the study is more risk than benefit to you, or if the agency funding the
study decides to stop the study early for a variety of scientific reasons.
Information should be added here to describe any adverse effects on the subjects’ health or welfare, or follow-up
that may be requested if they decide to withdraw from the study. For example: Certain drugs may harm you if you
stop taking them suddenly. To make sure this doesn’t happen, the doctor may ask you to gradually reduce the
amount of medication (number of tablets, capsules or injections you are taking, if you want to stop taking part in
the study.”
ARE YOU PARTICIPATING OR CAN YOU PARTICIPATE IN ANOTHER RESEARCH STUDY AT THE SAME
TIME AS PARTICIPATING IN THIS ONE?
Include the following information if participating in other studies could put your subject at risk:
You may/may not (please indicate choice) take part in this study if you are currently involved in another research
study. It is important to let the investigator/your doctor know if you are in another research study. You should
also discuss with the investigator before you agree to participate in another research study while you are enrolled
in this study.
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY?
If you believe you are hurt or if you get sick because of something that is due to the study, you should call
_____________ (PI’s or medical supervisor’s name) at _____________ immediately. [For greater than minimal
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risk research add information for one (or a combination) of the following as a contact for subjects to use in case
of illness or injury during his/her participation in the study:
1. a dedicated pager number;
2. a dedicated cell phone number;
3. other reliable 24-hour contact option at your discretion, and/or
4. as deemed necessary, in addition to one or more of the above, referral to 911 for an emergency.]
__________________ (PI’s or medical supervisor’s name) will determine what type of treatment, if any, that is
best for you at that time.
It is important for you to understand that the University of Kentucky does not have funds set aside 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.
Also, the University of Kentucky will not pay for any wages you may lose if you are harmed by this study.
The medical costs related to your care and treatment because of research related harm (add study specific
language by selecting appropriate options… e.g.,
will be your responsibility; or
will be paid by the sponsor (only option if industry sponsor and industry trial ) (insert the sponsor’s name here) for
medical expenses incurred by treating injuries that directly result from participating in the study, with some
exceptions. The exceptions are instances such as your failure to follow the sponsor’s directions or the
investigator’s failure to follow the sponsor’s directions; or
may be paid by your insurer if you are insured by a health insurance company (you should ask your insurer if you
have any questions regarding your insurer’s willingness to pay under these circumstances); or
may be paid by Medicare or Medicaid if you are covered by Medicare, or Medicaid (if you have any questions
regarding Medicare/Medicaid coverage you should contact Medicare by calling 1-800-Medicare (1-800-633-4227)
or Medicaid 1-800-635-2570.
A co-payment/deductible from you may be required by your insurer or Medicare/Medicaid even if your insurer or
Medicare/Medicaid has agreed to pay the costs). The amount of this co-payment/deductible may be substantial.
You do not give up your legal rights by signing this form.
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY?
You will receive ________ for taking part in this study. (If this is a monetary reward/payment, explain how this will
be pro-rated should the subject choose to withdraw early. If this is not a cash payment then the IRB strongly
suggests that the reward be given to the subject regardless of completion of the study. This information should be
explained here.) (If applicable, provide the following statement: “ if you earn $600 or above by participating in
research, it is potentially reportable for tax purposes”.
OR
You will not receive any rewards or payment for taking part in the study.
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS, CONCERNS, OR COMPLAINTS?
Before you decide whether to accept this invitation to take part in the study, please ask any questions that might
come to mind now. Later, if you have questions, suggestions, concerns, or complaints about the study, you can
contact the investigator, ______________________ at ___________. If you have any questions about your
rights as a volunteer in this research, contact the staff in the Office of Research Integrity at the University of
Kentucky between the business hours of 8am and 5pm EST, Mon-Fri at 859-257-9428 or toll free at 1-866-4009428. We will give you a signed copy of this consent form to take with you.
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WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR DECISION
TO PARTICIPATE?
If the researcher learns of new information in regards to this study, and it might change your willingness to stay in
this study, the information will be provided to you. You may be asked to sign a new informed consent form if the
information is provided to you after you have joined the study.
POTENTIAL FUTURE USE (delete sections that are not applicable)
Contacting Research Subjects for Future Studies
(If you are planning to contact these research subjects in the future regarding their potential participation in
additional research studies, their permission to do so is recommended. Please add the following check box to
make sure that current research subjects are willing to be contacted by the principal investigator or research staff
regarding future studies. Please note that if you are planning on creating a subject pool, a separate IRB
application should be submitted.)
Do you give your permission to be contacted in the future by ___________(insert investigator or staff) regarding
your willingness to participate in future research studies about how to prevent, detect, or treat __________(insert
name of disease)?
Yes
No
_________Initials
Banking biologic material (tissues/specimens) for future use
(If protocol involves banking biologic material for future use; optional banking sub-studies; genetic testing; or
establishing a research repository, consult the ORI guidance document below and revise the consent form
accordingly.
“Issues to be Addressed and Sample Consent Language for Tissue/Specimen Repositories or Individual
Studies Banking Material for Future Use” [PDF]
The document includes issues to address relative to purpose, procedures, secondary and future use, risks,
benefits, confidentiality, payment, cost, commercialization, significant new findings, alternatives, optional banking
sub-studies, and other elements of informed consent. The document also contains reference to the Genetic
Information Nondiscrimination Act (GINA) for inclusion in studies involving genetic testing; reference to largescale data sharing such as the National Institutes of Health (NIH) Genome-Wide Association Studies (GWAS);
and a HIPAA Authorization tailored to specimen banking.
Because there is extensive variation in the design and operation of research repositories, a “one size fits all”
template is not feasible. A sample repository template is available on the IRB Survival Handbook webpage (see
Informed Consent/Assent - Templates). Customize the final consent form to fit the unique characteristics the
repository.
WHAT ELSE DO YOU NEED TO KNOW?
There is a possibility that the data/tissue/specimens/blood collected from you may be shared with other
investigators in the future. If that is the case the data/tissue/specimen/blood will not contain information that can
identify you unless you give your consent/authorization or the UK Institutional Review Board (IRB) approves the
research. The IRB is a committee that reviews ethical issues, according to federal, state and local regulations on
research with human subjects, to make sure the study complies with these before approval of a research study is
issued.
Disclose what institution(s) (such as NIH, NCI, etc.) or companies are involved in the study through funding,
cooperative research, or by providing study drugs or equipment. An example of such a statement would be as
follows:
_______________________ (name of institution/company) is providing financial support and/or material for this
study.
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Applicable FDA regulated drug (including biological products) and device clinical trials must include in the
informed consent form the following statement regarding clinical trial information being entered into a national
clinical trial registry data bank: “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.”
Note, if the IRB determines that disclosure of financial interest is necessary to protect the subjects’ rights and
welfare, you may be asked to include a statement which informs subjects of the investigator’s financial interests in
the study (i.e., the source of funding and funding arrangements for the conduct and review of the research, or
information about a financial arrangement of the investigator and how it is being managed).
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH INFORMATION
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to protect your
health information. The following sections of the form describe how researchers may use your health information.
Your health information that may be accessed, used and/or released includes:

(List all of the protected health information to be collected for this protocol/study such as
demographic information, results of physical exams, blood tests, X-rays, and other diagnostic and
medical procedures as well as medical history. Also include Medicare Health Insurance Claim
Numbers (HICN), Social Security Numbers (SSN) and Employer Identification Numbers (EIN) if
regulated by Medicare reporting provisions)
The Researchers may use and share your health information with:
(Note: The information listed in this section should include all the agencies/researchers included in the consent
form; however, the authorization may require additional information or more specific information than the consent
form.)












The University of Kentucky’s Institutional Review Board/Office of Research Integrity.
Law enforcement agencies when required by law.
University of Kentucky representatives.
(UK Hospital if applicable. You must include this item if you are providing financial compensation for
study participation or obtaining lab results from UKMC.)
(If your research fall under the purview of a government agency (i.e., FDA, NIH, etc) list them in this
section of the authorization form.)
(Investigational Drug Service (IDS) if investigational drugs are dispensed through IDS.)
(Center for Clinical and Translational Science (CCTS) if CCTS staff are involved in the study.)
(National Cancer Institute (NCI) for cancer related studies only)
(List any collaborators, outside laboratories, etc.)
(If applicable – list the sponsor’s name and its agent(s) or government agency funding your research.)
(List any other groups with whom the information may be shared.)
(If applicable - statement that primary physician will be contacted if researcher in the course of the
project learns of a medical condition that needs immediate attention.)
The researchers agree to only share your health information with the people listed in this document.
Should your health information be released to anyone that is not regulated by the privacy law, your health
information may be shared with others without your permission; however, the use of your health information would
still be regulated by applicable federal and state laws.

Name, Address, Dates Directly Related to an Individual, Telephone/Fax Number, E-mail/Internet Protocol or Web URL Address, Social
Security Number, Medical Record or Health Plan Number, Account Number, Certificate of License Number, Photographic Images, Vehicle
Identifiers, Device Identifiers, Biometric Identifiers, Any Other Unique Code
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You may not be allowed to participate in the research study if you do not sign this form. If you decide not to sign
the form, it will not affect your:




Current or future healthcare at the University of Kentucky
Current or future payments to the University of Kentucky
Ability to enroll in any health plans (if applicable)
Eligibility for benefits (if applicable)
After signing the form, you can change your mind and NOT let the researcher(s) collect or release your
health information (revoke the Authorization). If you revoke the authorization:



You will send a written letter to: (name and contact information) to inform (him/her) of your decision.
Researchers may use and release your health information already collected for this research study.
Your protected health information may still be used and released should you have a bad reaction
(adverse event).
[Optional item: You understand that you will not be allowed to review the information collected for this research
study until after the study is completed. When the study is over, you will have the right to access the information.]
The use and sharing of your information has no time limit.
If you have not already received a copy of the Privacy Notice, you may request one. If you have any
questions about your privacy rights, you should contact the University of Kentucky’s Privacy Officer
between the business hours of 8am and 5pm EST, Mon-Fri at: (859) 323-1184.
You are the subject or are authorized to act on behalf of the subject. You have read this information, and
you will receive a copy of this form after it is signed.
(When developing the consent/authorization form, please format to ensure the signature lines fall on a page
containing text.)
_________________________________
Signature of research subject (if applicable:)
or *research subject’s legal representative
____________________________
Date
_________________________________
Printed name of research subject (if applicable:)
or *research subject’s legal representative
__________________________
Representative’s relationship to
research subject
*(If, applicable) Please explain Representative’s relationship to subject and include a description of
Representative’s authority to act on behalf of subject:
_____________________________________________________________________________
_____________________________________________________________________________
________________________________________________________________
Name of [authorized] person obtaining informed consent/HIPAA authorization
_________
Date
_________________________________________
Signature of Principal Investigator or Sub/Co-Investigator
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