Download The University of Mississippi Medical Center

The University of Mississippi Medical Center
Institutional Review Board
2500 North State Street
Jackson, Mississippi 39216-4505
Telephone 601 984-2815 / Facsimile 601 984-2961
http://irb.umc.edu
Consent Form Instructions and Template
Instructions

The consent form is only one part of the ongoing dialogue between
researchers and participants. It is important to remember that obtaining the
consent of each participant is a process that lasts throughout the study.

The consent process and recruitment should be described in the protocol in
specific detail.

The consent form should be written at an eighth grade level and give the
participant a clear understanding of the experience they can expect to have if
they agree to participate. The form should be as easy as possible to read
and understand. Grammar, sentence structure, spelling, and the format of
the document combine with the content to accomplish this goal. Avoid
complex or lengthy sentences, medical, scientific, and/or technical terms, and
dense paragraphs. Use “bullets” or simple tables to explain topics or
regimens clearly. Drawings or pictures might be necessary to help explain
complex procedures or interventions.

The information in the consent document should be limited to the study
question.

Avoid describing study visits, treatments, and procedures in lengthy narrative
form. If the visits, treatments, and procedures are lengthy or complex,
consider using a separate page that can be attached to the consent
document, similar to the lay version of the schedule of events from the
sponsor’s protocol, to describe the study visits, procedures, and treatments in
detail for the participant. The body of the consent document should
summarize the study visits, procedures, or treatments in a simple, concise
format, using headers and bullets where possible.

To help avoid unnecessary delay, please proof read the document before
submitting it to the IRB for review.

For ease of reading, the consent document should be a single sided
document, printed with a minimum of 1 inch margins, (leaving a 1.5 x 1.5 inch
space in the lower right corner of each page for the IRB approval stamp),
using the same font type and size (13 or larger) throughout, double space
between the paragraphs, and bold or underline the section headers.
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
Suggested wording is contained in the consent template. The document
should be written in the second person, using the present or future tense. Do
not begin sentences with “You understand that”, “It has been explained to you
that”, or similar assumptive phrases. To avoid confusion, use “study doctor”
throughout the document, instead of “doctor” and “participant” instead of
“patient” or “subject”.

For studies with optional tissue or specimen banking, this information should
not be included in the main consent document but added as an addendum,
with a full signature block.

For studies enrolling minors between the ages of 9 and 17:
1) an age appropriate Child Assent Form to document obtaining the assent of
the minor participant, or document the reason(s) assent was not obtained
and 2) a parental permission document (similar in format to a consent
document).
Minimal risk studies
One type of assent document may be used for all minor participants (9
through 17 years of age), however, it must be written in language that will be
easily understood by the youngest participants.
Greater than minimal risk studies
Two different types of assent documents are recommended, based upon the
age of participants.
 For minors 9 through 13 years of age, a child assent document. The
document should be written on a 2nd- 3rd grade level, be age appropriate
and contain at a minimum the following elements in simplified language:
o Study purpose
o Procedures
o Common risks
o Expected benefit(s)
o Statement that participation is voluntary
 For minors 14 through 17 years of age, an adolescent assent
document. The document should be written at most on an eighth grade
level. The document can follow the same format as the parental
permission document described above, but the term ‘you’ should be used
throughout the document.

Please review all language in the consent document to ensure that the correct
information specific to your project is relayed to potential participants.

A copy of the signed consent form must be filed in your study file and in the
participant’s medical record, and a copy must be given to the participant.
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
Each page of the consent document must be numbered and contain a header
or footer with the study title and the name and title (Principal Investigator) of
the Principal Investigator, version date, and, for studies with multiple consent
documents, a short description of the document.

HIPAA: The Health Insurance Portability and Accountability Act requires all
consent documents to contain the following information:
Description of health information to be gathered;
Who may use or disclose the information;
Who may receive the information;
Description of the purpose of the use or disclosure;
Expiration date of authorization (for example, end of study);
Statement of right to revoke authorization;
Statement of right to refuse to sign authorization;
Statement regarding re-disclosure;
Individual’s dated signature
Suggested language is included in the consent template.

Any change to the consent document must be submitted to the IRB for review
and approval before the new document may be used.

The IRB office staff will pre-review any consent document upon request.
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CONSENT TO PARTICIPATE IN RESEARCH
The University of Mississippi Medical Center
Study Title:
Principal Investigator:
_____________________________________________________
Introduction
You are being invited to be in this experimental research study because. . .
explain the specific reason(s) in lay language. Please ask us about
anything in this document or that we tell you that you do not understand.
Note: If the study includes minors only, use “Your child” in place of “You” in the
parental permission document.
Purpose
We are doing this study to learn about . . . explain in lay language the
basic purpose(s) of the study.
Procedures
If you agree to participate in this study…..
Briefly explain in lay language the tasks, procedures, therapies, tests, etc.
involved in this study. When applicable, clearly describe:
 whether the drugs or devices are being used in ways that are not FDA
approved;
 the use of placebo;
 whether all participants will receive the same therapy;

the process of randomization, “by chance, like the flip of a coin”, if there
are two study groups, or “like pulling numbers out of a hat”, if there are
more than two study groups;
 if blood will be drawn, state the amount in teaspoons or tablespoons;
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 what will occur at each study visit;
 identify any procedures, therapies, and/or tests that are considered
experimental, and include a list of the tests/procedures being done for
research purposes only. For example, “If you enroll in this study the
following additional tests or procedures will be performed:”;
 the expected duration of study participation.
Use tables and/or charts to simplify this section. If there are multiple
study groups, explain this by listing the groups as follows:
You will be assigned by chance, like the flip of a coin (when there are
more than two study groups insert, “by chance, like pulling numbers out
of a hat” instead), to one of the following groups:
Group A – receives xxx
Group B – receives xxx
Neither you nor your study doctor will know ahead of time what group
you will be in.
Risks
Identify all reasonably foreseeable side effects, risks, discomforts, or
complications that could occur.
For drug studies involving a multi-drug regimen, list the problems
associated with the entire regimen, or, if that is not possible, list separate
information for each individual medication. Whenever possible, risks
should be grouped (either bulleted or in a chart) and identified by severity,
likelihood and duration. For example, “common but not serious”, “unlikely
but serious”, “occasionally” or “rare”, and “temporary” or “permanent” may
be used. Avoid using specific numbers to describe a risk, e.g., “one
person experienced”, which would necessitate a revision to the consent
document each time an adverse event is reported or experienced.
Whenever possible, using a table to summarize risk information should
make the document easier to read and understand.
If genetic research is involved, please identify the risks of genetic research
and also include the following information:
A federal law called the Genetic Information Nondiscrimination Act (GINA)
makes is illegal for health insurance companies, group health plans and
most employers to discriminate against you based on your genetic
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information. GINA does not protect you against genetic discrimination by
companies that sell life insurance, disability insurance, or long-term care
insurance. GINA also does not protect you against discrimination based on
an already-diagnosed genetic condition or disease.
Be sure to include the risks of being in a placebo or observation group. If
participants will be taken off medication they are currently receiving, either
during a washout phase or because they will receive a different
medication, you must include these risks, along with information describing
how they will be monitored.
Note: When the study involves therapy or procedures that would be
recommended if the medical care were delivered outside the setting of a
research protocol, it is appropriate to explain that the risks associated with
such therapy will not be avoided by choosing not to participate in the study.
Sample wording for the final paragraph in the Risks section:
We do not know how your body might respond to the (medications or
procedures) used in this study. We will discuss the risks identified above
with you and the chances that they will happen. There may be risks that
we do not know about at this time. Unknown problems, ranging from a
mild inconvenience to some severe enough to result in death (indicate
highest severity level if death is not applicable), may occur. If you
experience any problems you should report them immediately to the study
doctor, (PI name, telephone number, and after-hours contact information).
Pregnancy (only include this information as appropriate to the study)
The risks of name of drug to an unborn child are unknown. You may not
be pregnant, trying to become pregnant or breastfeeding a baby while
taking part in this research study. Pregnancy tests (identify if blood or
urine) will be done on all women of child bearing potential before beginning
the study and every …xxx… (Who will be responsible for the costs of the
pregnancy test(s), study sponsor or participant, should be included in the
Costs section.)
All women of child bearing potential must use an acceptable method of
birth control, such as (identify the acceptable methods) while being treated
on this study (if necessary to continue after treatment ends add, and for
___ after treatment ends)..
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(If appropriate to the study) Men should avoid fathering a child while
participating in the study, and for (identify the appropriate time period) after
participating.
Benefits
Choose one of the following as the first sentence, whichever is applicable
to your specific study:
 You will not receive a direct benefit from being in this research study.
 You may or may not receive a direct benefit from being in this research
study. (Describe the benefit participants can reasonably expect to
receive from the research. Free medical care or study drug are not
considered benefits of participating in the study.)
Second sentence:
We hope to learn information that may help others in the future.
Alternatives
Explain alternatives in lay language. For treatment studies, identify and
explain the alternative procedures or courses of treatment reasonably
available to the participant.
Explain whether the research therapy or treatment can be obtained off
study:
 You do not have to be in this experimental study to receive the
study treatment/drug/therapy.
 The study treatment/drug/therapy is experimental. This means
that you can only receive it by enrolling in this study.
Costs
Clearly explain the costs that the participant will be responsible for, versus
the charges that will be paid for by the sponsor, and include any additional
costs the participant may incur because of study participation or that may
result from participation in the study. Use suggested wording as
appropriate:
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There will (or will not) be additional costs to you if you participate in this
study.
The (study medication) will be supplied by (sponsor name) at no cost to
you. Any tests, examinations, or other procedures that are done solely for
research purposes, including (identify the tests, examinations and
procedures) as previously described will be paid for by the sponsor of this
study (sponsor name). Insurance companies and other third party payers
will not be billed for research procedures.
(If medical care will be provided as part of the study)The rest of the
medical care that you will receive in this study is considered standard care
for your situation and would be recommended whether or not you
participate in this study. These costs will be billed to you or your insurance
carrier.
Research-related injury
In the case of injury or illness resulting from your participation in this study,
medical treatment is available to you at the University of Mississippi
Medical Center. You will be charged the usual and customary charges for
any such treatment you receive.
(if the study has a sponsor the second paragraph should describe the
sponsor’s policy) The sponsor of this research is XYZ Company. If you
develop an illness or an injury happens because you are in this research
study, the XYZ Company will …enter the appropriate information regarding
the level of liability the sponsor will assume in case of research related
injury or illness.
Do not include exculpatory language or statements, for example, “No other
compensation will be provided[ ]”, or “The sponsor will not pay for anything
else.”
Compensation
You will not be paid for participating in this study.
Or
You will receive . . . (describe the compensation, for example “$10.00 for
each study visit you complete.” Compensation may not be conditioned
upon completion of the study.)
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Voluntary Participation
Your participation is voluntary. If you decide not to participate in this study
you will not suffer a penalty or loss of benefits to which you are otherwise
entitled.
Withdrawal
You may choose to stop your participation in this study at any time. (If
withdrawal could affect medical treatment describe how/the consequences
of a participant’s decision to withdraw, and include a statement asking the
participant to please talk to the study doctor about this decision to ensure
his/her safe withdrawal from the study.) If you decide to withdraw the
information already collected about you may still be used in this study but
additional information will not be collected. Your decision to stop your
participation will have no effect on the quality of medical care you receive
at the University of Mississippi Medical Center (or academic standing, if
appropriate).
Include information about the possibility of termination from the study by
the investigator without regard to the participant’s consent, and the
anticipated circumstances that might cause this to occur.
New Information (only include this section if appropriate to the study)
You will be told of any information we learn during your participation in this
study that may affect your willingness to participate.
Confidentiality
Every effort will be made to keep the information we learn about you
private. Study personnel, the study sponsor (if applicable), the Food and
Drug Administration (FDA), the Office for Human Research Protections
(OHRP) and the University of Mississippi Medical Center’s Institutional
Review Board (IRB) and Office of Integrity and Compliance, and (if
applicable also include:) Grants and Contracts may review the study
records. Study data may be submitted to regulatory agencies in other
countries but you will not be identified. If study results are published your
name will not be used.
If applicable, add the following sentence:
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A copy of this informed consent document will be filed in your medical
record because the experimental research you are agreeing to participate
in involves your care, diagnosis, or treatment.
For interventional studies that will provide data relating to new treatments
or new ways of using known treatments (whether drugs, devices or
behavioral interventions) the following statement is required verbatim:
A description of this clinical trial will be available on
http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will
not include information that can identify you. At most, the Web site will
include a summary of the results. You can search this Web site at any
time.
Protected Health Information
Protected health information is any personal health information through
which you can be identified. (If protected health information will not be
collected in the study the rest of the paragraph should read: Your name
and signature will be on this document but we will not collect any other
identifiable health information for this study.) (If protected health
information will be collected for the study the rest of the paragraph should
be:) The information collected in this study includes: (describe here,
specifically identifying the identifiers and a description of the personal
health information that will be collected). By signing this consent
document, you authorize Dr. ____ and his or her study staff to collect this
information and use your records as necessary for this study. Dr. ____ (if
applicable: and the sponsor, ________,) will use your information to
_____________.
The information collected for this study will be kept (indefinitely or until the
study is complete or insert an expiration date or describe an event upon
which the authorization will expire) and may be combined with information
collected through other research studies or used in other studies but no
information will identify you. (If applicable include the following sentence.)
While this study is ongoing you may not have access to the research
information, but you may request it after the research is completed.
Your medical information and records, once disclosed, may be redisclosed and may no longer be protected by the Privacy Standards of the
Health Insurance Portability and Accountability Act (HIPAA), which is a
federal regulation designed to protect medical information, including
medical information and records created through research.
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You have the right to cancel this authorization at any time by providing Dr.
________ with a written request to cancel the authorization. If you cancel
this authorization medical information and records about you that were
created before the authorization was cancelled will still be used and
disclosed as needed to preserve the integrity of the study.
This authorization has no expiration date (not applicable to all). If you do
not sign this consent document, you will not be allowed to participate in
this study.
Number of Participants
We expect (## of) participants to enroll in this study here and (##)
nationwide.
Questions
If you have questions about this study or need to report any problems, side
effects, or injuries, please call _______ at ________. After hours and on
weekends please call _______.
You may discuss your rights as a research participant with the Chairman of
the University of Mississippi Medical Center’s Institutional Review Board,
2500 North State Street, Jackson, Mississippi 39216; telephone, 601 9842815; facsimile, 601 984-2961. The Institutional Review Board is a group
of people not involved with this study who have reviewed the study to
protect your rights.
You will be given a copy of this consent document (to take home and
review or for your records or if you agree to participate in this study or after
it has been signed, whichever is appropriate).
Statement of Participation
(PLEASE NOTE: The Principal investigator is responsible for ensuring all
participants enrolling in the study have given legally effective informed
consent and/or assent.)
(For treatment studies)
I have been told about this study, including the experimental treatment I
may receive, and the possible risks and benefits. I agree to participate in
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this study, to follow instructions, and to report any side effects to my study
doctor. My participation is voluntary and I may withdraw at any time
without any penalty or loss of benefits to which I am entitled, including
medical care at the University of Mississippi Medical Center.
(For non-treatment studies)
I have been told about this study and the possible risks and benefits. My
participation is voluntary and I may withdraw at any time without any
penalty or loss of benefits to which I am entitled, including medical care at
the University of Mississippi Medical Center.
By signing this form I am not giving up any legal rights (I or my child,
whichever is applicable) may have.
________________________________
Participant’s Printed Name
(Additional signature lines, described in Option 1 and 2 below, should be
inserted here – before the line for the name of the person obtaining
consent)
__________________________________________
Printed Name of Person Obtaining Consent
__________________________________________
Signature of Person Obtaining Consent
________________________________
Date
I acknowledge that the participant identified above has been entered into this
study, with properly obtained informed consent.
________________________________
Signature of Principal Investigator
________________________________
Date*
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*Absent extenuating circumstances, the investigator’s signature should be
obtained within 72 hours of the participant’s signature.
OPTIONAL SIGNATURE BLOCKS – choose at least one
OPTION I – if the study includes adult (18 years of age or older) participants
only:
________________________________
Participant’s Signature
____________________________
Date
OPTION 2 – if the study may include minors or decisionally impaired
participants include the signature lines below
______________________________________________________________
Printed Name of Parent or Legally Authorized Representative and relationship to
participant
______________________________________________
Signature of Parent or Legally Authorized Representative
___________________________________
Date
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