UMKC IRB #
Consent Form Template Instructions
This template has been developed to assist investigators with developing an informed
consent document that contains all of the elements of informed consent required by the
Office of Human Research Protections (OHRP) and additional language required by the
University of Missouri-Kansas City. Download and modify this template to meet the
specific needs of the study.
The required sections appear in an order intended to promote research subject
comprehension. Sections may be re-ordered as appropriate. Instructions, guidance and
suggested language are highlighted, bolded, italicized and within brackets ([example]) and
must be replaced or deleted before submitting the newly created consent form.
Text:
In order for a subject to provide informed consent, the research subject must fully
understand the study. Information must be conveyed in a readable manner to enhance
understanding. Language used in a consent form must be understandable to the subject.
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Text should be written in a common, easily readable font (Times New Roman,
Arial, Helvetica) in at least 12-point. Be consistent. Font and case may be changed
to accommodate persons with sight limitations if necessary.
It should be written to target a sixth grade reading level (see instructions below).
Use short sentences, non-technical terms and lay language. If a technical/ scientific
term is required, define it the first time you use it.
Avoid excessive use of acronyms and spell out any necessary ones the first time
they are used.
Do not use qualifying phrases such as “you understand that”.
Avoid language which may appear to waive any rights to which the research subject
is entitled, such as:
o I waive any possibility of compensation for injuries that I may receive as a
result of participation in this research.
o By agreeing to this use, you should understand that you will give up all
claims to personal benefit from commercial or other use of these substances.
o I voluntarily and freely donate any and all blood, urine, and tissue samples
to the U.S. Government and hereby relinquish all right, title, and interest to
said items.
If persons are involved who are unable to give informed consent, provide signature
lines for a legally authorized individual to give consent on the subject’s behalf.
Provide translated versions for non-English speaking people. Translations must be
back translated to ensure accuracy and should be done by a certified translator or
someone with proof of cultural competency education.
Use initial lines for optional portions of the study (e.g., asking permission to store
tape recordings for future research).
If there is more than one consent form for the study, be sure to label each page of
each consent form accordingly (e.g. parent consent form or child assent form).
Consent Form [modify with specifics: parent, control, child assent, etc.]
Page 1 of 8
Version Date: 5/22/2012
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Wording Issues o Use the second person, not first person.
o Do not use the word “invite” (for example, “You are invited to participate
in a research study.”) Instead, use, “You are being asked to take part in a
research study because (insert condition here).”
o Use the words subject and experimental as required in the consent form;
studies have shown that the volunteer is less likely to understand that the
project involves research when words such as patient and participant are
used.
o Always refer to the investigator as researcher.
o Do not use “treatment” or “therapy” to describe an investigational
procedure. For an investigational procedure, use “study procedure” or
“research procedure.”
o When describing randomization for 2 groups use, “like the flip of a coin;”
for more than 2 groups, use "like drawing numbers from a hat."
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Check spelling and grammar before submitting the final version to the IRB.
The reading level should display once the spelling and grammar check are
complete. To turn on this option in Microsoft Word:
o Word 2010 - File >> Options >> Proofing >> Select Check grammar
with spelling (Under When correcting spelling and grammar in Word)
>> Select Show readability statistics.
o Word 2007 - Microsoft Office Button
>> Word Options >> Proofing
>> Select Check grammar with spelling >> Select Show readability
statistics check box (Under When correcting grammar in Word).
o Word 2003 - Tools menu >> Options >> Spelling & Grammar tab >>
Select Check grammar with spelling check box >> Select Show
readability statistics check box >> click OK.
Delete all instructions, guidance and the above instruction pages before saving and
submitting the new consent form.
Consent Form [modify with specifics: parent, control, child assent, etc.]
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Version Date: 5/22/2012
UMKC IRB #
Consent for Participation in a Research Study
[Insert Study Title]
[Insert names and degrees of Principal Investigators and Co-Investigators.]
Request to Participate [Required]
You are being asked to take part in a research study. This study is being conducted at [insert
study location].
The researcher in charge of this study is [insert name of Principal Investigator(s)]. While
the study will be run by [him/her/them], other qualified persons who work with
[him/her/them] may act for [him/her/them]. [If applicable, insert statement listing study
Sponsor]
The study team is asking you to take part in this research study because you have [insert
condition/disease/inclusion criteria here]. Research studies only include people who
choose to take part. This document is called a consent form. Please read this consent
form carefully and take your time making your decision. The researcher or study staff
will go over this consent form with you. Ask him/her to explain anything that you do not
understand. Think about it and talk it over with your family and friends before you
decide if you want to take part in this research study. This consent form explains what to
expect: the risks, discomforts, and benefits, if any, if you consent to be in the study.
Background [Required]
[Provide a brief background that explains the condition, type of subjects and/or
primary interventions to be used in the study. Justify why the subject is appropriate for
recruitment. Merely saying that the possible subject is being asked to participate
because he or she meets the requirements for participation is not enough. You should
state what the requirements are to clearly illustrate why he/she, and not somebody else,
is being asked to participate.]
You will be one of about [# of subjects] subjects in the study at [site location]. [If
applicable, add: About [# of subjects] subjects total will take part across all the places
working on this study.]
Purpose [Required]
[Include a simple explanation of the research question and purpose of the study in
language that is not technical and doesn’t use jargon or acronyms, unless they are
defined. In addition to stating the purpose of the study, the researcher should provide
the rationale for performing the study (e.g. results of previous studies, etc.) If the study
includes deception, or the withholding of information, this section should be written so
that the least possible withholding of information occurs.]
Consent Form [modify with specifics: parent, control, child assent, etc.]
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Procedures [Required; may be split into separate categories]
[Describe what will happen to the subject if they decide to participate, detail in a stepby-step manner the activities subjects will be asked to engage in, how long they will
take, where the research will take place, and how often they will be asked to perform
the research tasks.]
[List all study visits separately, in chronological order and note what procedures are to
be expected. Make sure there is a distinct section that describes all the possible subject
groups and study interventions. Tell the subjects how they will be assigned to an
intervention group. If it is “random” assignment it can be described as being by chance,
like flipping a coin, or like pulling numbers from a hat, depending on the number of
groups. The subject needs to know the ratio (or odds) of possible intervention
assignments: “You have a 1 in 2 chance of receiving” or “The odds that you will be in
group A or group B are 1:1”.
Tell the subject how long they will be involved in the study, how many study visits there
are, where the visits take place, and how long they last. The subject needs to know what
will happen to them at each study visit. All study procedures need to be described, but do
not include procedures and treatments that are routine care or established practice and
not part of the study. Be sure to clarify which procedures are experimental. All
procedures should be described in the simplest wording possible. If terminology is used
a description should be included. Bullet points, charts or tables are encouraged to
increase readability of complicated procedures.
Example:
Visit 1/Week 1/Final Visit
 Neuropsychological Assessment: Pen and paper tasks will be completed
 In-depth interview of current functioning
Follow-up
 Follow-up phone call
If audio- or videotaping will be used, the subject must be informed of taping and, if
optional, given the choice to agree to the recording using a checkbox, initials space or
signature line. Subjects must be informed of whether they can opt out of the recording
and still participate in the study. If taping is required, this must be clearly stated. Explain
who will have access to these tapes, whether the information will be identifiable, how
long the tapes will be maintained and, when the time comes, when and how they will be
destroyed.]
If you agree to take part in this study, you will be involved in this study for [insert length
of time (hours, days, week(s), month(s), or year(s))]. [If applicable, include whether
you intend to collect follow-up information and how long this will be done. For
example, until six months after last study visit, for the rest of your life, etc.]
Consent Form [modify with specifics: parent, control, child assent, etc.]
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When you are done taking part in this study, you will [or will not] still have access to
[the study treatment/intervention].
[Include that participation is voluntary, that subjects may refuse to participate in
certain activities or answer certain questions. Describe any specific procedures for
withdrawing from the study.]
Risks and Inconveniences [Required]
[It is extremely unlikely that there are absolutely no risks associated with a study. Tell
subjects about any risks or discomforts that might occur including psychological,
emotional, physical, social, economic harm, risk of criminal or civil liability, damage to
financial standing, employability, or reputation, loss of privacy or breach of
confidentiality, etc. For example, subjects can be told “You may feel uncomfortable
talking about…” Include risks involved with all study related procedures. If there are
no known risks - say so. If there are possible unforeseen risks – say so. Be sure to
include any measures being taken or procedures in place to minimize the risks to
subjects.]
[If applicable, include: This research is considered to be minimal risk. That means
that the risks of taking part in this research study are not expected to be more than the
risks in your daily life. There are no other known risks to you if you choose to take
part in this study.]
Benefits [Required]
[List any benefits to research subjects or others that may be expected from the
research. Be sure to distinguish between a likely direct benefit (e.g., from therapeutic
or intervention research) and a possible indirect benefit (e.g., talking about/reflecting
on an experience may lead to a better understanding of oneself). Usually there is only a
possibility of benefit or no benefit (state accordingly). Benefits may apply directly to the
participant or indirectly to society. Compensation, financial incentives, learning about
how experiments are conducted, receiving a gift, or earning extra credit for being a
research subject are NOT benefits and should NOT be listed here.]
[Include all of the following that are applicable: It is possible that your [disorder/health
condition] may improve with study treatment.
There are no benefits to you for taking part in this study.
Other people may benefit in the future from the information about
[condition/treatment/therapy/research topic] that comes from this study.]
Fees and Expenses [Required]
Consent Form [modify with specifics: parent, control, child assent, etc.]
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[Describe in detail any monetary costs to the participant, if there are any. If there are
none, please state that.]
Compensation [Required]
[If research participants are to be compensated for participation or reimbursed for
expenses, specify the amount, type of payment, schedule of payment, and conditions for
payment. If class points, extra credit, a gift or some other token are to be received by
subjects include that information here. If compensation is pro-rated when a
participant withdraws prior to completing the study, explain how it is pro-rated. If
subjects will not receive any compensation, state that there is no payment for taking
part in the study.]
Alternatives to Study Participation [Required]
[Disclose appropriate alternative procedures or courses of treatment. Describe how the
subject’s condition or situation would be treated if the study were not a consideration.
What would the subject receive as standard of care, for example, what are the nonexperimental treatments? If there are no alternatives then state “The alternative is not
to take part in the study.” If subjects are students being offered extra credit as
compensation for participating, describe any alternative ways that students who choose
not to participate may obtain the extra credit.]
Confidentiality [Required]
While we will do our best to keep the information you share with us confidential, it
cannot be absolutely guaranteed. Individuals from the University of Missouri-Kansas
City Institutional Review Board (a committee that reviews and approves research
studies), Research Protections Program, and Federal regulatory agencies may look at
records related to this study to make sure we are doing proper, safe research and
protecting human subjects. The results of this research may be published or presented to
others. You will not be named in any reports of the results.
[Describe how subjects’ privacy and confidentiality will be protected. Explain how the
information will be stored, who will have access, and when it will be destroyed. If
subjects’ direct quotes, visual, or audio images will be used in publications or
presentations, obtain separate consent for those uses. If the data will be saved for
future research, explain the research and data use planned and obtain separate,
additional consent for that use using an initial or signature line. Indicate whether or
not the study data collected before a subject leaves will be kept and used if the subject
withdraws from the study. When applicable, explain any foreseeable circumstances
under which the researcher will be required to give information about the research
participant to a third party, such as mandatory reporting of child abuse. If you are
applying for a Certificate of Confidentiality (CoC) from the NIH or other agency, the
CoC language required by the certificate issuer should go in this section.]
Consent Form [modify with specifics: parent, control, child assent, etc.]
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In Case of Injury [Required, if more than minimal risk]
[For studies involving more than minimal risk, indicate whether treatment for
research-related injury will be available, what kinds of treatment, how it can be
accessed, and who will be responsible for covering the costs of that treatment. If there
is sponsor-specific injury language, include it here.]
The University of Missouri-Kansas City appreciates people who help it gain knowledge
by being in research studies. It is not the University’s policy to pay for or provide
medical treatment for persons who are in studies. If you think you have been harmed
because you were in this study, please call the researcher, [Dr. Name] at [provide phone
number].
[If applicable, a contact number should be provided where a research subject will be able
to reach someone knowledgeable about the study 24 hours a day, 7 days a week. For
example, the number might be to have the researcher paged through the hospital
operator or having the specialty doctor on call paged. If you wish to provide your beeper
number or home telephone number you may, although this is not required.
If this is applicable, include: If there is an emergency, where you feel that you need to
contact the researcher immediately, instead of waiting until regular office hours, you
should call [provide name and phone number of 24 hour/7 day per week contact].]
Contacts for Questions about the Study [Required]
You should contact the Office of UMKC’s Institutional Review Board at 816-235-5927 if
you have any questions, concerns or complaints about your rights as a research subject.
You may call the researcher [Name] at [provide phone number] if you have any
questions about this study. You may also call [him/her] if any problems come up.
Voluntary Participation [Required]
Taking part in this research study is voluntary. If you choose to be in the study, you are
free to stop participating at any time and for any reason. If you choose not to be in the study
or decide to stop participating, your decision will not affect any care or benefits you are
entitled to. The researchers, doctors or sponsors may stop the study or take you out of the
study at any time if they decide that it is in your best interest to do so. They may do this
for medical or administrative reasons or if you no longer meet the study criteria. You will
be told of any important findings developed during the course of this research.
You have read this Consent Form or it has been read to you. You have been told why this
research is being done and what will happen if you take part in the study, including the
risks and benefits. You have had the chance to ask questions, and you may ask questions
at any time in the future by calling [Dr. Name] at [provide phone number]. By signing this
consent form, you volunteer and consent to take part in this research study. Study staff will
give you a copy of this consent form.
Consent Form [modify with specifics: parent, control, child assent, etc.]
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Version Date: 5/22/2012
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Signature (Volunteer Subject)
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Date
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Printed Name (Volunteer Subject)
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Signature (Authorized Consenting Party)
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Date
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Printed Name (Authorized Consenting Party)
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Relationship of Authorized Consenting
Party to Subject
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Signature of Person Obtaining Consent
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Date
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Printed Name of Person Obtaining Consent
Consent Form [modify with specifics: parent, control, child assent, etc.]
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