The following template should cover most research situations (involving human participants)
which require some sort of Informed Consent Form (ICF). Please use the template as a guide.
As mentioned in the paragraphs below, not all sections may be required for every research
proposal. Thus, include in your ICF only the sections you need. However, please use the order
of sections as presented in the template.
Suggestions for text are provided in some sections. Again, these are merely suggestions and you
should use language appropriate to your research proposal.
If you have suggestions for improving the template, please send them to the chair of the IRBHP.
NOTE: Those sections indicated with an asterisk (*) are required by federal requlations.
--------------------TEMPLATE--------------------
CONSENT TO PARTICIPATE IN RESEARCH
[Insert title of the study]
{Insert study subtitle if applicable}
If the study involves using different consent forms for different populations, identify the
population group as the subtitle of the study.
[Suggested text to use to introduce the study to potential subjects]:
We invite you to participate in a research study conducted at the [Insert the study site] by
[insert name (s) and affiliations of investigator(s)] Your participation in this study is
voluntary. You should read the information below. Ask questions about anything you do
not understand before deciding whether or not to participate.
*PURPOSE OF THE STUDY
Explain what the study is designed to discover or establish.
*DURATION AND LOCATION
Describe the expected duration of the individual’s participation in the study and the location
of the project (i.e., Integrative Health Science Laboratory, Duncan Gallery of Art, In-home,
etc.).
2
[Suggested text]:
Your participation in this study will last for approximately (insert the estimated
time commitment per participant). This study will be conducted at (name of
facility or facilities if more than one location is involved in the research).
*PROCEDURES
[Suggested text]:
If you volunteer to participate in this study, you will be asked to do the following
things: List exactly what each participant will experience in chronological order.
Guidelines:
Describe the procedures chronologically using lay language, short sentences,
and short paragraphs. The use of table or flow diagrams might help to
organize this section and increase readability. Use the tools provided by your
word processing system to check spelling and grammar. Also, if your system
provides a readability index, check that your form has a readability level at
the 8th or 9th grade level. (The readability level is available with Word as an
option for the Spelling and Grammar check under the Tools heading. The
Flesch-Kincaid Grade Level is the appropriate number to reference.)
2.) In the case of medical experiments, distinguish between experimental and
standard clinical treatment procedures. Include screening evaluations and a
listing of inclusion/exclusion criteria. Define and explain any medical and
scientific terms.
Specify the participant’s assignment to study groups, the number of
participants expected to be enrolled, and the length of time for participation
in each procedure. Also specify the total length of time for participation,
frequency of procedures, location of the procedures to be done, etc.
4.) Specify the number, frequency and duration of visits.
5.) Describe anything participants should bring or wear to the testing sessions.
6.) Specify the requirements of the research subject. Examples are post-treatment
follow-up, dietary cards, questionnaires, etc.
7.) For research involving randomization of participants into different groups,
specify the randomization procedures.
8.) For medical research involving the use of placebos, describe “placebo” in lay
terms
9.) If pregnant women will be excluded, include a statement on pregnancy
prevention.
IRBHP Consent Form Template (Rev. 2/18/2014)
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*POTENTIAL RISKS AND DISCOMFORTS
Guidelines:
Identify each procedure and then describe any reasonably foreseeable risks,
discomforts, and inconveniences. Describe how you will minimize them.
Quantify risks using understandable comparisons if you can.
2.) No study is without some risk. Please do not assume that your study bears no
risk. Consider possibilities of minor discomfort, psychological discomfort
when answering survey or interview questions, inconvenience to participants,
or minor risk of loss of confidentiality or anonymity.
3.) In addition to physiological risks/discomforts, describe any psychological,
social, or legal, risks that might result from participating in the research. If
screening involves drug screening, serologic HIV or hepatitis C testing,
explain the extent to which data will be kept confidential. Address local or
federal reporting requirements, if any. Inform the participants about
availability of follow up or referral for treatment.
4.) If applicable, conclude this section with "there may also be risks and
discomforts which are not yet known".
*ANTICIPATED BENEFITS TO SUBJECTS
Describe the anticipated direct benefits to participants resulting from their participation in the
research. If consent will be obtained from a legal representative of the participant, the direct
benefit to the participant must be elaborated in the consent form.
Guidelines:
1.) If there is no likelihood that participants will benefit directly from their
participation in the research, state as much in clear terms. For example: “You
should not expect your condition to improve as a result of participating in
this research.” Or, “This study is not being done to improve your condition
or health. You have the right to refuse to participate in this study.”
2.) Another option is to state, "You will receive no direct benefit from your
participation in this study, but your participation may help health care
providers better understand …”
3.) Do not include payment for participating in this section. Description of
payment to participants should be described later in the PAYMENT FOR
PARTICIPATION section.
IRBHP Consent Form Template (Rev. 2/18/2014)
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*ALTERNATIVES TO PARTICIPATION
(Note: If this does not apply to your research, please omit this entry and delete the heading.)
Guidelines:
Describe any appropriate alternative therapeutic, diagnostic, or preventive
procedures that should be considered before people decide whether or not to
participate in the study. If there are no efficacious alternatives, then just state
that choosing not to participate in the study is an alternative to participating
in the study.
2.) Some prospective participants may be suffering from a terminal illness. If
there are no alternative treatments available, you should say so; but add that
treatment of symptoms and pain control are available through supportive care.
In other words, avoid suggesting that participation in the research is the only
way to obtain medical care and attention.
3.) If prospective participants have a chronic, progressive disorder, for which no
treatment had been demonstrated to be safe and effective, say that, as well.
But also describe opportunities for managing symptoms, improving ability to
function, etc. so that it does not appear that the patient will be abandoned if
he/she does not agree to participate.
*PAYMENT FOR PARTICIPATION
Guidelines:
 State whether the subject will be paid or offered other benefits (e.g., free care,
points for participating in the psychology research pool). If not, state so.
2.) If the subject will receive payment, describe remuneration amount. Also
indicate when payment is scheduled. Provide a prorated payment schedule
should the subject decide to withdraw or be withdrawn by the investigator.
3.) If the subject will be reimbursed for expenses such as parking, bus/taxi, etc.,
state so.
*FINANCIAL COSTS TO THE SUBJECT
Guidelines:
1.) If applicable, indicate who is to bear the expense of tests, procedures,
hospitalization, outpatient visits, etc., done solely for research purposes. Be
very clear about the circumstances under which insurance may be billed and
when the study participants may bear costs associated with the study.
2.) If the participant will incur no costs, state that fact.
IRBHP Consent Form Template (Rev. 2/18/2014)
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POSSIBLE COMMERCIAL PRODUCTS
(Note: If this does not apply to your research, please omit this entry and delete the
heading.)
[Suggested text]:
By my consent to participate in this research study, I give up any property rights I
may have in my bodily fluids, substances, or tissues.
Guideline:
1) Inform the participant in the consent form if any human materials, (blood,
hair, etc.) will be stored for other uses.
2) Other uses include use in further research not mentioned in the consent
form.
3) Any intention to commercialize human materials must be disclosed in the
consent form.
4) Although participants may be asked to sign a separate specimen release
form, the participant maintains all legal rights enumerated in Federal and
State statutes.
*MEDICAL CARE FOR RESEARCH RELATED INJURY
If the research could result in injury, describe proposed compensation for research-related
injury and/or emergency medical treatment. Include one of the following statements:
[Suggested text if the sponsoring agency will not provide compensation for
research-related injury use the following text]:
In the event of an injury resulting from the research procedures, no form of
compensation is available from Stetson University. Medical treatment may be
provided at your own expense; or at the expense of your health care insurer,
which may or may not provide coverage. If you have questions, you should
contact your insurer.
[If the sponsoring agency is willing to provide compensation, include the following
statement along with the statement listed above]
[Suggested text]:
In the event of emergency resulting from the research procedures
___________________ will provide reimbursement for the reasonable costs of
medical treatment to the extent that the costs are not covered by your insurance
or by a third party or by a government program providing coverage.
Guidelines:
IRBHP Consent Form Template (Rev. 2/18/2014)
6
1) Federal policy provides that no informed consent, whether oral or written may
include any exculpatory language. Thus, the participant or their representative
may not be asked to waive or appear to waive any of the participant's legal
rights. Participants may not be asked to release or appear to release the
investigator, the sponsor, the institution or its agents from liability for
negligence.
2) The statement provided above—In the event of an injury resulting from the
research procedures, no form of compensation is available from Stetson
University—is considered an acceptable clause.
3) The following statement is unacceptable language: “I understand that I will
not sue the sponsor or investigator for any negligence.”
*CONFIDENTIALITY
Describe how personal identities will be shielded or disguised.
[Suggested text]:
When the results of the research are published or discussed in conferences, your
identity will be protected by [explain your method here].
When the research records may be subject to inspection by FDA, a funding agency, or
industrial sponsor, you must add the following statement:
Authorized representatives of Stetson University (and the sponsoring agency, if
applicable) may need to review records of individual subjects. As a result, they
may see your name; but they are bound by rules of confidentiality not to reveal
your identity to others.
Guidelines:
1) Give a brief description of how personal information, research data, and
related records will be coded, stored, etc. to prevent access by unauthorized
personnel.
2) Explain how specific consent will be solicited, if any other uses are
contemplated
3) If applicable, state if and when individual responses to survey
questionnaires will be destroyed, following analyses of the data.
4) When possible, try to design your research so that a participant’s identity is
anonymous—a more rigorous form of privacy than confidentiality.
IRBHP Consent Form Template (Rev. 2/18/2014)
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AUDIO/VIDEO RECORDING
(Note: If this does not apply to your research, or if you are using a separate release form for
recordings, please omit this entry and delete the heading.)
Guidelines:
1.) Describe the kinds of recordings that will be made. Explain how subjects will know they
are being recorded, and when the equipment is on or off.
2.) Explain how this material will be used within research. Describe how the recordings will
be stored and when they will be destroyed.
3.) Describe the measures taken to ensure subject confidentiality.
Statement from Subject:
I ___________________________ freely consent to the use of photographs, audio, and video
recording of my words and/or actions as described above in this study. I understand that the
recordings may be used as described in presentations, research reports, and other formats,
and I waive the right to inspect or approve use of this material as incorporated in the work. I
acknowledge that investigators shall be under no obligation to use the recordings in the work.
I release investigators, sponsors and successors from any claims that may arise regarding the
use of the recordings, including any claims of defamation, invasion of privacy, or
infringement of moral rights, rights of publicity or copyright. I acknowledge that I have no
ownership rights in the recordings or the research.
Signature of Subject
Date
*PARTICIPATION AND WITHDRAWAL
[Suggested text]:
Your participation in this research is voluntary. If you choose not to participate,
that decision will not affect your relationship with (enter study site) or your right
to health care (or educational services) or other services to which you are
otherwise entitled. If you decide to participate, you are free to withdraw your
consent and discontinue participation at any time without prejudice.
IRBHP Consent Form Template (Rev. 2/18/2014)
8
*CONSEQUENCES OF WITHDRAWAL
(Note: If this does not apply to your research, please omit this entry and delete the
heading.)
Explain the consequences of a subject's decision to withdraw from the research and any
follow up the subject may be asked to complete, for reasons of safety.
WITHDRAWAL OF PARTICIPATION BY THE INVESTIGATOR
[Suggested text]:
The investigator may withdraw you from participating in this research if
circumstances arise which warrant doing so. If you experience any of the
following side effects [list and describe the side effects] or if you become ill
during the research, you may have to drop out, even if you would like to continue.
The investigator will make the decision and let you know if it is not possible for
you to continue. The decision may be made either to protect your health and
safety, or because it is part of the research plan that people who develop certain
conditions may not continue to participate.
*NEW FINDINGS
[Suggested text]:
During the course of the study, you will be informed of any significant new
findings (either good or bad), such as changes in the risks or benefits resulting
from participation in the research or new alternatives to participation that might
cause you to change your mind about continuing in the study. If new information
is provided to you, your consent to continue participating in this study will be reobtained.
IDENTIFICATION OF INVESTIGATORS
[Suggested text]:
In the event of a research related injury or if you experience an adverse reaction,
please immediately contact one of the investigators listed below. If you have any
questions about the research, please feel free to contact [Identify the point of
contact. Include the daytime telephone numbers and addresses. For greater than
minimal risk studies, include night/emergency telephone numbers.]
IRBHP Consent Form Template (Rev. 2/18/2014)
9
RIGHTS OF RESEARCH SUBJECTS
[Suggested text]:
You may withdraw your consent at any time and discontinue participation without
penalty. You are not waiving any legal claims, rights or remedies because of your
participation in this research study. If you have questions regarding your rights
as a research subject, please contact the Chair of the IRBHP or Kathy Leitch,
Executive Assistant to the Provost (386-822-7474 or kleitch@stetson.edu).
Guidelines
1. This section must appear in all consent forms
2. The contact person name and number provided must be an individual not
associated with the study in any way. This individual must also be familiar
with the federal guidelines involved in human research as well as the rights of
research subjects. You may use the name of the chair of the IRB or other
IRB member as long as he or she is not involved with the study in any way.
3. If you have a complaint concerning the IRBHP review process, please contact
the Executive Assistant to the Provost.
4. If VA patients are to be included as subjects, the phone number for the VA
Patient Representative should be included above.
OFFER TO ANSWER QUESTIONS
[Include the statement below]:
If you have any questions about this study, you may call
_________________________(insert contact name here. This person should be
very familiar with the study and should be able to answer study-related
questions.)
If a research related injury occurs, you should call ______________ at
______________. (Insert contact name here. This person should preferably be a
Stetson University faculty or staff member who knows the reporting procedures
for research related injuries and is involved with the study.)
IRBHP Consent Form Template (Rev. 2/18/2014)
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SIGNATURE OF RESEARCH SUBJECT
[Suggested text]:
I have read the information provided above. I have been given an opportunity to
ask questions and all of my questions have been answered to my satisfaction. I
have been given a copy of this form.
________________________________________
Name of Subject
_______________________________________ ______________
Signature of Subject
Date
Address
SIGNATURE OF WITNESS
My signature as witness certifies that the subject signed this consent form in my
presence as his/her voluntary act and deed.
________________________________________
Name of Witness
_______________________________ _____________________________
Signature of Witness
Date
SIGNATURE OF INVESTIGATOR
________________________
Signature of Investigator
IRBHP Consent Form Template (Rev. 2/18/2014)
_
_____________________________
Date