Belmont University Institutional Review Board
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, and 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. If the study involves patients, state
the condition that makes them eligible to participate.
DURATION AND LOCATION
Describe the expected duration of the subject's participation in the study and the location of
the project (i.e., Belmont University, Veterans Affairs Medial Center).
[Suggested text]:
Your participation in this study will last for approximately (insert the estimated
time commitment per subject). This study will be conducted at (name of facility).
PROCEDURES
[Suggested text]:
If you volunteer to participate in this study, we would ask you to do the following
things: List exactly what each subject 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. 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.
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Specify the subject's assignment to study groups, the number of subjects
expected to be enrolled, length of time for participation in each procedure,
the total length of time for participation, frequency of procedures, location of
the procedures to be done, etc.
3.) Specify the number, frequency and duration of visits.
4.) Describe anything subjects should bring or wear to the testing sessions.
5.) Specify the requirements of the research subject, e.g., post-treatment followup, dietary cards, questionnaires, etc.
6.) For research involving randomization of subjects into different groups,
specify the randomization procedures.
7.) For medical research involving the use of placebos, describe “placebo” in lay
terms
8.) If pregnant women will be excluded, include a statement on pregnancy
prevention.
POTENTIAL RISKS AND DISCOMFORTS
Guidelines:
Identify each procedure and then describe any reasonably foreseeable risks,
discomforts, inconveniences, and 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 subjects, 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 subjects 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 subjects resulting from their participation in the
research. If consent will be obtained from a legal representative of the subject, the direct
benefit to the subject 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.”
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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 subjects should be described later in the PAYMENT TO
SUBJECTS section
ALTERNATIVES TO PARTICIPATION
Guidelines:
Describe any appropriate alternative therapeutic, diagnostic, or preventive
procedures that should be considered before the subjects 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.) If the prospective subjects are suffering from a terminal illness, and 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 subjects 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
(Note: If this does not apply to your research, please omit this entry and delete the
heading.)
Guidelines:
 State whether the subject will be paid or offered other benefits (e.g., free
care). If not, state so.
2.) If the subject will receive payment, describe remuneration amount, when
payment is scheduled, and 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
(Note: If this does not apply to your research, please omit this entry and delete the
heading.)
Guidelines:
1.) If applicable, indicate who is to bear the expense of tests, procedures,
hospitalization, outpatient visits, etc., done solely for research purposes. Be
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very clear about the circumstances under which insurance may be billed and
when the study participants may bear costs associated with the study.
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:
If any human materials, (blood, hair, etc.) will be stored for other uses or if samples are
used for establishing a cell line, which may be, shared with other researchers and which
may in the future be of commercial value, the subject must be informed of the fact in the
consent form and asked to sign a separate specimens release form.
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 Belmont 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.
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].
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When the research records may be subject to inspection by FDA, a funding agency, or an
industrial sponsor, you must add the following statement:
Authorized representatives of Belmont 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:
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.
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.
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PARTICIPATION AND WITHDRAWAL
[Suggested text]:
Your participation in this research is voluntary. If you choose not to participate,
that 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.
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.]
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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 Dr. Beverly Schneller, Associate Provost for
Academic Affairs, 615 460-5630.
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 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 contact Dr. Beverly Schneller,
Associate Provost for Academic Affairs, 615 460-5630 and ______________ at
______________. (insert contact name here. This person should preferably be a
Belmont University faculty or staff member who knows the reporting procedures
for research related injuries and is involved with the study.)
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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
_
_____________________________
Date
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